Effective March 1, 2026: Pharmacy and Biopharmacy Policies

POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Omalizumab (Xolair) (CP.PCH.49)

Ambetter

Policy updates include:

• Added coverage for moderate (G2) immune checkpoint inhibitor-related pruritus per National Comprehensive Cancer Network (NCCN)
• For all indications, revised initial approval duration for Ambetter from 6 to 12 months and for Commercial to include “or to the member’s renewal date, whichever is longer” and for National Comprehensive Cancer Network (NCCN) compendial uses, revised continued approval duration for Ambetter from 6 to 12 months and for Commercial to include “or to the member’s renewal date, whichever is longer”
• Added eosinophilic esophagitis as an indication not covered in section III given lack of demonstrated efficacy and recommendation against use by the 2025 American College of Gastroenterology guideline
• Added newly approved 300 mg/2 ml strength for Omlyclo

Axitinib (Inlyta) (CP.PHAR.100)

Ambetter

Policy updates include:

• For differentiated thyroid carcinoma, removed requirement for radioactive iodine therapy for oncocytic carcinoma and revised status from “not amenable” to “refractory” per National Comprehensive Cancer Network (NCCN)
• Added off-label indication of endometrial carcinoma per National Comprehensive Cancer Network (NCCN)
• Revised initial approval durations for Medicaid and Ambetter to 12 months
• Added request does not exceed health plan-approved quantity limit, if applicable

Enzalutamide (Xtandi) (CP.PHAR.106)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium added off-label use in non-metastatic castration-resistant prostate cancer as secondary hormone therapy with prostate-specific antigen doubling time at most 10 months
• Added template language “Request does not exceed health plan-approved quantity limit
• Revised initial approval duration from 6 to 12 months, if applicable

Cabozantinib (Cabometyx, Cometriq) (CP.PHAR.111)

Ambetter

Policy updates include:

• For renal cell carcinoma, added combination with Opdivo Qvantig as option to Opdivo
• For hepatocellular carcinoma, removed disease qualifiers per National Comprehensive Cancer Network (NCCN)
• For differentiated thyroid carcinoma, revised drug request requirement to allow only Cabometyx, removed requirement for radioactive iodine therapy for oncocytic carcinoma, and revised radioactive iodine therapy status from “not amenable” to “refractory” per National Comprehensive Cancer Network (NCCN)
• For non-small cell lung cancer, added requirement for use as subsequent therapy per National Comprehensive Cancer Network (NCCN)
• Removed brain metastases from off-label indications as these are metastases f renal cell carcinoma
• For off-label indications, added supported bone cancer types, supported soft tissue sarcoma types, requirement for monotherapy use in soft tissue sarcoma, and disease qualifiers for gastrointestinal stromal tumor per National Comprehensive Cancer Network (NCCN)
• Revised initial approval durations for Medicaid and Ambetter to 12 months
• Added request does not exceed health plan-approved quantity limit, if applicable

Ramucirumab (Cyramza) (CP.PHAR.119)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For hepatocellular carcinoma, revised progression on sorafenib to subsequent therapy use per National Comprehensive Cancer Network (NCCN)
• Removed appendiceal adenocarcinoma indication and added thymic carcinoma as off-label indication per National Comprehensive Cancer Network (NCCN)
• Revised approval durations for Medicaid/ Ambetter to 12 months and for Commercial line of business to “6 months or duration of request, whichever is less”

Nivolumab (Opdivo), Nivolumab/Hyaluronidase-nvhy (Opdivo Qvantig) (CP.PHAR.121)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For melanoma, added option for resectable stage III or limited local satellite/in-transit recurrence or nodal recurrence
• For malignant pleural mesothelioma, removed requirement for unresectable
• For renal cell carcinoma, added option to be prescribed for hereditary leiomyomatosis and renal cell carcinoma-associated renal cell carcinoma
• For classic Hodgkin lymphoma: added request is for Opdivo as National Comprehensive Cancer Network (NCCN) does not included recommended use in this setting, for primary treatment, removed staging requirement (III-IV) and added option if member is not candidate for anthracycline
• Added option for use post allogenic hematopoietic cell transplant
• For relapsed/refractory/or progressive disease, added option for combo use with Adcentris or ICE (ifosfomaide, carboplatin, etoposide)
• Added off-label indications for appendiceal neoplasms and cancers, squamous cell skin cancer, and uterine sarcoma per National Comprehensive Cancer Network (NCCN)
• For bone cancer, added option for combination use with Sutent for dedifferentiated chrondrosarcoma
• For chronic lymphocytic leukemia/small lymphocytic lymphoma, removed combo use with Yervoy and added single agent or combination with Imbruvica
• For vaginal cancer, added prescribed as a single agent or in combination with Yervoy
• For pediatric Hodgkin lymphoma, removed requirement for re-induction therapy or subsequent therapy
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
• For Opdivo Qvantig: for colorectal cancer added new indication for use that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan and converted from accelerated approval to full approval for use following combination treatment
• For hepatocellular carcinoma, added new indication for use as first-line treatment following combination treatment and converted from accelerated approval to full approval for those who have been previously treated with sorafenib and removed requirement that member is deemed ineligible for resection, transplant, or locoregional therapy
• For Opdivo Qvantig, for melanoma and colorectal cancer added pediatric extension to age at least 12 years (previously approved in adults) and new dosage strength (300 mg/5,000 units).

Ibrutinib (Imbruvica) (CP.PHAR.126)

Ambetter

Policy updates include:

• Updated criteria to align with the latest National Comprehensive Cancer Network (NCCN) guidelines: specified that coverage for post-transplant lymphoproliferative disorders is for monomorphic post-transplant lymphoproliferative disorders, removed the requirement for del(17p)/TP53 mutation in the setting of histologic transformation to diffuse large B-cell lymphoma, removed relapsed brain metastases in lymphoma
• For Waldenström’s macroglobulinemia and marginal zone lymphoma added exclusion against concomitant use with Calquence or Brukinsa to align with existing Brukinsa and Calquence criteria
• Updated initial auth durations from 6 months to 12 months for Medicaid and Ambetter

Romiplostim (Nplate) (CP.PHAR.179)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off label use for immune checkpoint inhibitor-related toxicities when member has had no response to corticosteroids after 1-2 weeks

Eltrombopag (Alvaiz, Promacta) (CP.PHAR.180)

Ambetter

Policy updates include:

• For post-hematopoietic cell transplant with prolonged thrombocytopenia, added requirement that member has poor graft function per National Comprehensive Cancer Network (NCCN)
• Added National Comprehensive Cancer Network (NCCN)-supported indications of immune effector cell-associated hematologic toxicity and immunotherapy-related thrombocytopenia
• For eltrombpag and Promacta, added request does not exceed health plan-approved quantity limit, if applicable

Aflibercept (Eylea, Eylea HD), Aflibercept-yszy (Opuviz), Aflibercept-jbvf (Yesafili), Aflibercept-mrbb (Ahzantive), Aflibercept-abzv (Enzeevu), Aflibercept-ayyh (Pavblu) (CP.PHAR.184)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Combined retinal vein occlusion section with neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy section
• For adult ophthalmic diseases, extended continued therapy duration from 6 months to 12 months for this maintenance medication for a chronic condition
• For retinopathy of prematurity, clarified 3 lifetime doses per eye
•  For Eylea HD, added criteria for newly Food and Drug Administration (FDA)-approved indication of retinal vein occlusion
• In continued therapy, added option for every 4 week dosing if documentation supports evidence of continued disease activity.

Ranibizumab (Byooviz, Cimerli, Lucentis, Susvimo) (CP.PHAR.186)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For diabetic macular edema, diabetic retinopathy, retinal vein occlusion, and neovascular (wet) age-related macular degeneration, extended continued therapy duration from 6 months to 12 months for this maintenance medication for a chronic condition

Verteporfin (Visudyne) (CP.PHAR.187)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Clarified one dose every 3 months

Ambrisentan (Letairis) (CP.PHAR.190)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Bosentan (Tracleer) (CP.PHAR.191)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Epoprostenol (Flolan, Veletri) (CP.PHAR.192)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Iloprost (Ventavis) (CP.PHAR.193)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Macitentan (Opsumit) (CP.PHAR.194)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Riociguat (Adempas) (CP.PHAR.195)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Selexipag (Uptravi) (CP.PHAR.196)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Clarified maximum dose for concomitant administration with CYP2C8 inducers
• Clarified requirement for titration plan is for oral Uptravi
• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Sildenafil (Revatio, Liqrev) (CP.PHAR.197)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Tadalafil (Adcirca, Alyq, Tadliq) (CP.PHAR.198)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Treprostinil (Orenitram, Remodulin, Tyvaso, Tyvaso DPI) (CP.PHAR.199)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For Orenitram, added requirement that request does not exceed health-plan approved quantity limit
• For Tyvaso and Tyvaso DPI, revised maximum dose criterion to member must submit a titration plan if member requires titration
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Trabectedin (Yondelis) (CP.PHAR.204)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added the following sub-types of soft tissue sarcoma without requiring disease to be unresectable or metastatic: solitary fibrous tumor, epithelioid hemangioendothelioma, or dedifferentiated liposarcoma with or without concurrent well-differentiated liposarcoma per National Comprehensive Cancer Network (NCCN)
• For Medicaid and Ambetter extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition

Factor VIIa, Recombinant (NovoSeven RT, SevenFact) (CP.PHAR.220)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For “Hemophilia, Congenital Factor VII Deficiency” indication, clarified terminology from “prevention” to Food and Drug Administration (FDA)-labeled indication of “control” of bleeding episodes to prevent misinterpretation of criteria

OnabotulinumtoxinA (Botox) (CP.PHAR.232)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For chronic migraine removed requirement for evidence from two high quality published studies to support concurrent use of Botox and calcitonin gene-related peptide (CGRP) therapy.

Atezolizumab (Tecentriq), Atezolizumab-Hyaluronidase (Tecentriq Hybreza) (CP.PHAR.235)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For non-small cell lung cancer, revised stage from IIA to IB and modified criterion to meet all requirements, including previous resection per National Comprehensive Cancer Network (NCCN)
• For hepatocellular carcinoma, removed requirement for use as first-line therapy or as adjuvant therapy
• For cervical cancer, expanded diagnosis to cervical cancer and added option to be prescribed in combination with bevacizumab, paclitaxel, and cisplatin/carboplatin
• Added criteria for the following off-label indications: thymomas and thymic carcinomas, chronic lymphocytic leukemia/small lymphocytic lymphoma and colon cancer per National Comprehensive Cancer Network (NCCN)
• For Medicaid and Ambetter lines of business, extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
• For small cell lung cancer, added option for combination use with Zepzelca following combination use with carboplatin plus etoposide
• Added pediatric extension for age at least 12 years (previously only approved in adults) for alveolar soft part sarcomper prescribing information.

Siltuximab (Sylvant) (CP.PHAR.329)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
• In cytokine release syndrome initial criteria, added Avtozma may be used to replace the second dose of Tyenne per National Comprehensive Cancer Network (NCCN)
• For off-label unicentric Castleman’s disease, revised usage from “relapsed or refractory” to “surgically unresectable/or if incomplete resection” per National Comprehensive Cancer Network (NCCN)
• For off-label cytokine release syndrome, removed option as replacement for second dose for immunotherapy related neurotoxicity and added option for usage in addition to toclizumab for grade 2-4 cytokine release syndrome per National Comprehensive Cancer Network (NCCN)
• Added off-label indication for Kaposi-sarcoma associated herpesvirus (KSHV)-associated inflammatory cytokine syndromeper National Comprehensive Cancer Network (NCCN)

Deflazacort (Emflaza) (CP.PHAR.331)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health plan-approved quantity limit, if applicable
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition

Avelumab (Bavencio) (CP.PHAR.333)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For Merkel cell carcinoma, added disease qualifier of locally advanced per National Comprehensive Cancer Network (NCCN)
• For off label indications per National Comprehensive Cancer Network (NCCN), revised disease qualifiers for thymic carcinoma, added option for combination with Inlyta for endometrial carcinoma, and added requirement for combination with Inlyta for salivary gland tumors
• For Medicaid and Ambetter lines of business, revised initial approval durations from 6 months to 12 months

Rucaparib (Rubraca) (CP.PHAR.350)

Ambetter

Policy updates include:

• For all indications, added requirement that request does not exceed health-plan approved quantity limit, revised quantity limit to 1,200mg per day and 4 tablets per day, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• For pancreatic adenocarcinoma, added off-label use in PALB2 mutations per National Comprehensive Cancer Network (NCCN)

Olaparib (Lynparza) (CP.PHAR.360)

Ambetter

Policy updates include:

• For all indications, added requirement that request does not exceed health-plan approved quantity limit, revised quantity limit to 600mg per day and 4 tablets per day, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• For breast cancer, added off-label use in deleterious germline PALB2 mutations per National Comprehensive Cancer Network (NCCN)
• For pancreatic adenocarcinoma, revised greater than (>) to greater than or equal to (≥) for platinum-based chemotherapy requirement and added prescribed as single agent therapy requirement
• For uterine neoplasms, added off-label use in mismatch repair proficient (pMMR) endometrial carcinoma per National Comprehensive Cancer Network (NCCN)

Tisagenlecleucel (Kymriah) (CP.PHAR.361)

Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use in large B-cell lymphoma for Richter transformation and HIV-related plasmablastic lymphoma

Axicabtagene Ciloleucel (Yescarta) (CP.PHAR.362)

Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) Compendium supported off-label use for large B-cell lymphoma in Richter transformation, primary mediastinal large B-cell lymphomafor Age less than 18 years, and human immunodeficiency virus (HIV)-related plasmablastic lymphoma
• Clarified for marginal zone lymphoma disease is refractory or member has relapsed after at least 2 lines of systemic therapy per National Comprehensive Cancer Network (NCCN) Compendium

Acalabrutinib (Calquence) (CP.PHAR.366)

Ambetter

Policy updates include:

• Added the following National Comprehensive Cancer Network (NCCN)-supported uses: first-line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma with Venclexta, single-agent therapy following Richter transformation
• Updated initial auth durations from 6 months to 12 months for Medicaid and Ambetter

Voretigene Neparvovec-rzyl (Luxturna) (CP.PHAR.372)

Ambetter

Policy updates include:

• Removed full-field stimulus testing testing requirement

Niraparib (Zejula) (CP.PHAR.408)

Ambetter

Policy updates include:

• For ovarian cancer, clarified requirements that member meets one of the following: member is in complete response or partial response or member has platinum-sensitive persistent or recurrent disease per National Comprehensive Cancer Network (NCCN)
• Removed capsules from criteria as formulation is obsolete and no longer available
• For all indications, added requirement that request does not exceed health-plan approved quantity limit, revised quantity limit to 300 mg per day and 1 tablet per day, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• Added off-label criteria for prostate cancer per National Comprehensive Cancer Network (NCCN) compendium

Talazoparib (Talzenna) (CP.PHAR.409)

Ambetter

Policy updates include:

• For all indications, added requirement that request does not exceed health-plan approved quantity limit, revised quantity limit to maximum dose per day and 1 capsule per day, extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Bortezomib (Velcade) (CP.PHAR.410)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For off-label indications per National Comprehensive Cancer Network (NCCN): added KICS indication, added disease qualifiers for Castleman disease and Kaposi sarcoma, added monotherapy requirement for adult T-cell leukemia/lymphoma, and removed requirement for use as subsequent therapy for pediatric acute lymphoblastic leukemia
• For Medicaid and Ambetter lines of business, revised initial approval durations from 6 months to 12 months

Glasdegib (Daurismo) (CP.PHAR.413)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) guidelines removed use of Daurismo for relapsed/refractory disease
• Updated initial auth duration from 6 months to 12 months for Medicaid and Ambetter

Larotrectinib (Vitrakvi) (CP.PHAR.414)

Ambetter

Policy updates include:

• Added required use as a single agent
• Added approval pathway for members who failed or are not candidates for primary therapy (e.g., surgery, chemotherapy, or radiation)
• Added requirement that request does not exceed health-plan approved quantity limit
• Added dose maximum and prescriber attestation for concomitant use with CYP3A4 inducers
• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Brolucizumab-dbll (Beovu) (CP.PHAR.445)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For all indications, extended continued therapy approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Avapritinib (Ayvakit) (CP.PHAR.454)

Ambetter

Policy updates include:

• For gastrointestinal stromal tumor, added Qinlock, Sutent, and Stivarga as examples of prior lines of therapy
• For myeloid/lymphoid neoplasm with eosinophilia and FIP1L1- platelet-derived growth factor receptor (PDGFRA), revised criteria from “failure of imatinib” to “documentation of PDGFRA D842 mutation that is resistant to imatinib”
• Medicaid and Ambetter line of business, extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
• Added request does not exceed health plan-approved quantity limit, if applicable

Enfortumab Vedotin-ejfv (Padcev) (CP.PHAR.455)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
• Added option to be prescribed in combination with Keytruda Qlex
• New indication for muscle invasive bladder cancer added per updated prescribing information.

Fam-Trastuzumab Deruxtecan-nxki (Enhertu) (CP.PHAR.456)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN)-supported uses for recurrent non-small cell lung cancer (in addition to unresectable or metastatic), ampullary adenocarcinoma, pancreatic adenocarcinoma, and vaginal cancer
• Per National Comprehensive Cancer Network (NCCN) recs added a requirement for BRCA 1/2 negativity if using Enhertu for hormone-receptor-negative breast cancer as second-line or later therapy
• Updated initial auth durations from 6 months to 12 months for Medicaid and Ambetter
• Added approved indication for HR-positive, HER2-low or HER2-ultralow breast cancer.

Selumetinib (Koselugo) (CP.PHAR.464)

Ambetter

Policy updates include:

• For LCH, added option to be prescribed for LCH-associated abnormal central nervous system (CNS) imaging/neurodegeneration (LACI/ND) and clarified trial and failure of cobimetinib or trametinib only applies to adults
• Revised dose limit from 25 mg/m2 per day to 50 mg/m2 per day based on twice a day dosing
• Added request does not exceed health plan-approved quantity limit, if applicable
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition revised criteria for neurofibromatosis type 1 to reflect adult extension with removal of upper age limit

Valoctocogene Roxaparvovec-rvox (Roctavian) (CP.PHAR.466)

Ambetter

Policy updates include:

• Added qualifier that the 150 eds criterion applies to members who have had previous FVIII use
• Removed requirement for documentation of body weight

Zanubrutinib (Brukinsa) (CP.PHAR.467)

Ambetter

Policy updates include:

• For chronic lymphocytic leukemia/small lymphocytic lymphoma, added option to be prescribed in combination with Venetoclax per National Comprehensive Cancer Network (NCCN)
• Added off-label indication for primary central nervous system lymphoma per National Comprehensive Cancer Network (NCCN): add request does not exceed health plan-approved quantity limit, if applicable
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition

Belantamab Mafodotin-blmf (Blenrep) (CP.PHAR.469)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Policy reinstated due to Food and Drug Administration (FDA)’s accelerated approval in relapsed, refractory multiple myeloma in combination with dexamethasone and bortezomib.

Naxitamab-gqgk (Danyelza) (CP.PHAR.523)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added treatment combination option with granulocyte-macrophage colony-stimulating factor, Temodar, and irinotecan per National Comprehensive Cancer Network (NCCN)
• Revised Medicaid and Ambetter initial approval duration to 12 months

Efgartigimod Alfa-fcab, Efgartigimod/Hyaluronidase-qvfc (Vyvgart, Vyvgart Hytrulo) (CP.PHAR.555)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For generalized myasthenia gravis, clarified that immunosuppressive therapy should be non-steroidal
• For chronic inflammatory demyelinating polyneuropathy, revised “failure” to “insufficient response” for immune globulin therapy
• For continued criteria, clarified that generalized myasthenia gravis response criterion for 2-point reduction can also be greater than 2 points
• For concurrent therapy exclusions agents, added Imaavy
• For Medicaid and Ambetter lines of business, revised approval durations to 12 months

Antithrombin III (ATryn, Thrombate III) (CP.PHAR.564)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Atryn was discontinued and removed from criteria
• Updated Thrombate III indication for pediatric extension and removed requirement for age at least 18 years
• Revised approval durations for prevention from 6 months to 12 months

Asciminib (Scemblix) (CP.PHAR.565)

Ambetter

Policy updates include:

• Updated or added criteria in alignment with National Comprehensive Cancer Network (NCCN) recommendations: changed use for tyrosine kinase inhibitor (TKI)-experienced patients from those in accelerated phase to those in chronic phase, added a requirement for documentation of presence of ABL1 exon 2, added off-label use for Ph+ B-cell acute lymphoblastic leukemia
• Updated initial auth durations from 6 months to 12 months

Inclisiran (Leqvio) (CP.PHAR.568)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Reduced statin adherence duration from 4 months to 8 weeks
• Simplified statin trial and failure criteria for moderate- and low-intensity statin regimens to require insufficient therapeutic response to one high intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin
• Extended Medicaid and Ambetter initial approval duration from 9 months to 12 months for this maintenance medication for a chronic condition

Ropeginterferon Alfa-2b-njft (BESREMi) (CP.PHAR.570)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added bypass language for states with regulations against step therapy in certain oncology settings
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition
• For PV, added option for usage as for use as substitute for peginterferon alfa-2a due to product unavailability per National Comprehensive Cancer Network (NCCN)
• Added off-label criterion for systemic mastocytosis, myelofibrosis, essential thrombocythemia, and chronic myeloid leukemia per National Comprehensive Cancer Network (NCCN)

Budesonide (Tarpeyo) (CP.PHAR.572)

Ambetter

Policy updates include:

• Removed requirement of one alternative systemic corticosteroid and revised criterion for proteinuria at least 0.5 g/day per updated Kidney Disease: Improving Global Outcomes (KDIGO) 2025 guidance 

Cabotegravir (Apretude), Cabotegravir/Rilpivirine (Cabenuva) (CP.PHAR.573)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Etranacogene Dezaparvovec-drlb (Hemgenix) (CP.PHAR.580)

Ambetter

Policy updates include:

• Added qualifier that the 150 EDS criterion applies to members who have had previous factor IX use
• Removed requirement for documentation of body weight

Faricimab-svoa (Vabysmo) (CP.PHAR.581)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• For neovascular (wet) age-related macular degeneration and diabetic macular edema, extended continued therapy duration from 6 months to 12 months for this maintenance medication for a chronic condition
• Clarified initial approval for retinal vein occlusion is for a total of 6 months of therapy (6 doses)

Zoledronic Acid (Reclast) (CP.PHAR.59)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per competitor analysis for multiple myeloma, removed requirement that member is receiving or initiating therapy (e.g., chemotherapy, transplant) for symptomatic disease
• For initial approval revised approval duration for Medicaid and Ambetter from 6 to 12 months for multiple myeloma, solid tumor, systemic mastocytosis, and histiocytic neoplasms

Exagamglogene Autotemcel (Casgevy) (CP.PHAR.603)

Ambetter

Policy updates include:

• Added option of sickle cell disease genotype βs/β+ (hbs β+) for sickle cell disease
• Added genotype descriptors of hbss and hbs β0
• Removed requirement for documentation of body weight

Adagrasib (Krazati) (CP.PHAR.605)

Ambetter

Policy updates include:

• Added small bowel adenocarcinoma and appendiceal neoplasms as off-label indications per National Comprehensive Cancer Network (NCCN)
• Revised initial approval durations for Medicaid and Ambetter to 12 months

Furosemide (Furoscix) (CP.PHAR.608)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added new dosage form Lasix ONYU

Teclistamab-cqyv (Tecvayli) (CP.PHAR.611)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Revised initial Medicaid and Ambetter approval duration to 12 months
• Added combination therapy option with Talvey for at least 3 prior lines of therapy per National Comprehensive Cancer Network (NCCN)
• For continued therapy, added dosing option for not exceeding 1.5 mg/kg every two weeks and if dose requested is 1.5 mg/kg per week, added requirement for documentation supporting member has not achieved and maintained a complete response or better for a minimum of 6 months

Tremelimumab-actl (Imjudo) (CP.PHAR.612)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) compendium– for non-small cell lung cancer, removed uses for RET rearrangement positive, EGFR exon 19 deletion, exon 21 L858R, ALK rearrangement positive, and ROSI rearrangement positive tumors
• Added recommended uses for NRG1 gene fusion positive tumors
• For gastric, esophageal, and esophagogastric junction cancer, clarified approval is for one dose
• For all indications, revised continued therapy section to not permit reauthorizations

Olutasidenib (Rezlidhia) (CP.PHAR.615)

Ambetter

Policy updates include:

• Added requirement for use as a single agent and added option for use for lower intensity therapy per National Comprehensive Cancer Network (NCCN)
• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Mosunetuzumab-axgb (Lunsumio) (CP.PHAR.618)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium added off-label use in additional B-cell lymphomas subtypes

Lovotibeglogene Autotemcel (Lyfgenia) (CP.PHAR.627)

Ambetter

Policy updates include:

• Added coverage for additional sickle cell disease genotypes βs/β0 (hbs β0) and βs/β+ (hbs β+)
• Removed requirement for documentation of body weight

Everolimus (Afinitor, Afinitor Disperz, Zortress) (CP.PHAR.63)

Ambetter

Policy updates include:

• Extended initial approval durations from 6 to 12 months for this maintenance medication for a chronic condition
• Added request does not exceed health plan-approved quantity limit, if applicable

ADAMTS13, Recombinant-krhn (Adzynma) (CP.PHAR.635)

Ambetter

Policy updates include:

• Removed requirement for plasma therapy failure per updated guideline
• Revised Medicaid and Ambetter initial approval duration for prophylaxis to 12 months and revised Commercial approval durations for prophylaxis to “6 months or to member’s renewal date, whichever is longer”

Sotatercept (Winrevair) (CP.PHAR.657)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Extended Medicaid and Ambetter initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• Revised Commercial approval duration to “6 months or to the member’s renewal date, whichever is longer”
• Added HCPCS codes J3590 and C9399

Capivasertib (Truqap) (CP.PHAR.663)

Ambetter

Policy updates include:

• Added use of Truqap for recurrence within 12 months of adjuvant therapy to align with its original Food and Drug Administration (FDA) approval
• Updated initial auth duration from 6 months to 12 months

Fruquintinib (Fruzaqla) (CP.PHAR.666)

Ambetter

Policy updates include:

• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Repotrectinib (Augtyro) (CP.PHAR.667)

Ambetter

Policy updates include:

• Clarified age restriction does not apply to pediatric diffuse high-grade glioma
• For all indications, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition, added required use as a single agent
• Per National Comprehensive Cancer Network (NCCN) compendium– for NTRK fusion-positive cancer, added bypass for ampullary adenocarcinoma, brain metastases, esophageal and esophagogastric junction cancers, gastric cancer, pediatric diffuse high-grade glioma, and uterine sarcoma

Toripalimab-tpzi (Loqtorzi) (CP.PHAR.668)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added National Comprehensive Cancer Network (NCCN) recommended off-label indications for anal carcinoma, small bowel adenocarcinoma, appendiceal neoplasms and cancers, colon cancer and rectal cancer per National Comprehensive Cancer Network (NCCN)
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition

Nirogacestat (Ogsiveo) (CP.PHAR.671)

Ambetter

Policy updates include:

• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Marstacimab-hncq (Hympavzi) (CP.PHAR.674)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added clarification that requirement for hemophilia severity associated with factor level is taken at baseline prior to use of factor products for routine prophylaxis
• Revised provider confirmation of discontinuation of factor products as prophylaxis to exclusion for concurrent use of hemophilia prophylaxis agent with more examples
• Revised initial approval duration from 6 months to 12 months

Cosibelimab-Ipdl (Unloxcyt) (CP.PHAR.711)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added option for satellitosis/in-transit metastasis per National Comprehensive Cancer Network (NCCN)
• Added criterion, prescribed as a single agent per National Comprehensive Cancer Network (NCCN)
• Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition

Plozasiran (Redemplo) (CP.PHAR.721)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria:  Familial Chylomicronemia Syndrome (FCS) (must meet all):
  • Diagnosis of FCS as evidenced by both of the following:
    • Fasting triglycerides at least 880 mg/dL or at least 10 mmol/L (lab must be dated within 90 days);
    • One of the following:
      • Genetic testing confirms the presence a loss-of-function mutation in an FCS-causing gene (e.g., LPL, APOC2, APOA5, GPIHBP1, LMF1);
      • History of elevated triglycerides in excess of 1,000 mg/dL at least three times, and one of the following:
        • History of pancreatitis;
        • Family history of hypertriglyceridemia;
        • History of recurrent abdominal pain without other explainable cause;
  • Prescribed by or in consultation with an endocrinologist, lipid specialist, or cardiologist;
  • Age at least 18 years;
  • Redemplo is not prescribed concurrently with Tryngolza;
  • Dose does not exceed 25 mg every 3 months.
  • Approval duration: 6 months
• Continued Therapy: Familial Chylomicronemia Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by reduction in fasting triglycerides from baseline;
  • If request is for a dose increase, new dose does not exceed 25 mg every 3 months.
  • Approval duration: 12 months

Doxecitine and doxribtimine (Kygevvi) (CP.PHAR.738)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Thymidine Kinase 2 Deficiency (must meet all):
  • Diagnosis of TK2d as evidenced by a mutation in the thymidine kinase 2 (TK2) gene;
  • Prescribed by or in consultation with a neurologist or metabolic disease specialist;
  • Age of symptom onset at most 12 years (e.g., proximal muscle weakness, respiratory weakness, facial diplegia);
  • Documentation of member’s current weight in kg;
  • Dose does not exceed doxecitine 400 mg/kg and doxribtimine 400 mg/kg per day
  • Approval duration: 12 months
  • Continued Therapy
  • Thymidine Kinase 2 Deficiency (must meet all):
    • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;
  • Documentation of member’s current weight in kg;
  • If request is for a dose increase, new dose does not exceed doxecitine 400 mg/kg and doxribtimine 400 mg/kg per day.
  • Approval duration: 12 months

Sevabertinib (Hyrnuo) (CP.PHAR.764)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Non-Small Cell Lung Cancer (NSCLC) (must meet all):
  • Diagnosis of recurrent, advanced (including locally advanced), or metastatic NSCLC;
  • Prescribed by or in consultation with an oncologist;
  • Age at least 18 years;
  • Prescribed as single agent;
  • Disease has activating HER2 (ERBB2) mutations;
  • Failure of a prior systemic;
  • Member has not previously experienced disease progression while on Hernexeos® (zongertinib);
  • For Hyrnuo requests, member must use sevabertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Dose of Hyrnuo is at least 10 mg per day;
  • Request meets one of the following:*
    • Dose does not exceed 40 mg (4 tablets) per day;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 12 months
• Continued Therapy: Non-Small Cell Lung Cancer (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Hyrnuo for a covered indication and has received this medication for at least 30 days;
  • Member is responding positively to therapy;
  • For Hyrnuo requests, member must use sevabertinib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Dose of Hyrnuo is at least 10 mg per day;
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 40 mg (4 tablets) per day;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence. *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 12 months

Ziftomenib (Komzifti) (CP.PHAR.765)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Acute Myeloid Leukemia (AML) (must meet all):
  • Diagnosis of relapsed or refractory AML;
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age at least 18 years;
  • Disease is positive for a NPM1 mutation;
  • Dose of Komzifti is at least 200 mg per day;
  • Prescribed as a single agent;
  • For Komzifti requests, member must use ziftomenib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • Request meets one of the following:*
    • Dose does not exceed 600 mg (3 capsules) per day;
    • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 12 months
• Continued Therapy: Acute Myeloid Leukemia (must meet all):
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Komzifti for a covered indication and has received this  medication for at least 30 days;
  • Member is responding positively to therapy;
  • Dose of Komzifti is at least 200 mg per day;
  • Prescribed as a single agent;
  • For Komzifti requests, member must use ziftomenib, if available, unless contraindicated or clinically significant adverse effects are experienced;
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 600 mg (3 capsules) per day;
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 12 months

Vandetanib (Caprelsa) (CP.PHAR.80)

Ambetter

Policy updates include:

• For differentiated thyroid carcinoma, added disease qualifiers of progressive and/or symptomatic, removed requirement for radioactive iodine therapy for oncocytic carcinoma, and revised status from “not amenable” to “refractory” per National Comprehensive Cancer Network (NCCN)
• Added request does not exceed health plan-approved quantity limit, if applicable
• Extended initial approval duration for Medicaid and Ambetter lines of business from 6 months to 12 months

Abiraterone (Zytiga, Yonsa) (CP.PHAR.84)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) Compendium added off-label use in salivary gland tumor
• Revised initial approval duration for Medicaid and Ambetter in prostate cancer form 6 to 12 months
• Added template language “Request does not exceed health plan-approved quantity limit, if applicable”

Vemurafenib (Zelboraf) (CP.PHAR.91)

Ambetter

Policy updates include:

• Revised criteria to align with National Comprehensive Cancer Network (NCCN) guidelines: added BRAF V600E mutation requirement for off-label use for hairy cell leukemia, added grade 3 pleomorphic xanthoastrocytoma and high-grade astrocytoma with piloid features as covered uses
• Updated initial auth durations from 6 months to 12 months for Medicaid and Ambetter

Alpha1-Proteinase Inhibitors (Aralast NP, Glassia, Prolastin-C, Zemaira) (CP.PHAR.94)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added off-label indication of steroid-refractory acute GVHD per National Comprehensive Cancer Network (NCCN)
• For Medicaid and Ambetter, extended initial approval duration from 6 to 12 months for these maintenance medications for a chronic condition

Ruxolitinib (Jakafi, Opzelura) (CP.PHAR.98)

Ambetter

Policy updates include:

• Added request does not exceed health plan-approved quantity limit, if applicable for indications for Jakafi
• For Medicaid and Ambetter, extended initial and continued approval duration from 6 to 12 months for this maintenance medication for the chronic conditions of oncology (myelofibrosis, polycythemia vera, graft-versus-host diseas, myelodysplastic/myeloproliferative neoplasms, acute lymphoblastic leukemia, myeloid/lymphoid neoplasm, T-cell lymphomas) and essential thrombocythemia
• For polycythemia vera, added option to be prescribed as initial treatment for high-risk polycythemia vera
• For immunotherapy-related toxicities, added option to be prescribed for management of immune effector cell-parkinsonism and hemophagocytic lymphohistiocytosis-like syndrome

Safinamide (Xadago) (CP.PMN.113)

Ambetter

Policy updates include:

• Removed “idiopathic” as a Parkinson’s disease qualifier from diagnostic criterion
• Corrected reference from Appendix B to Appendix D for “off” time definition
• Revised initial approval duration from 6 months to 12 months
• For continued therapy, aligned initial therapy requirement for concurrent treatment with carbidopa/levodopa
• Revised Commercial approval duration to 12 months

Colchicine (Colcrys, Lodoco) (CP.PMN.123)

Ambetter

Policy updates include:

• Removed brand Colcrys from policy due to product discontinuation and its corresponding indications [familial mediterranean fever, treatment of acute gout attack, gout anti-inflammatory prophylaxis, pericarditis (off-label)]

Icosapent Ethyl (Vascepa) (CP.PMN.187)

Ambetter

Policy updates include:

• For all indications, added request does not exceed health-plan approved quantity limit, extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition
• For reduction of cardiovascular disease risk, reduced statin adherence duration from 4 months to 8 weeks, simplified statin trial and failure criteria for moderate- and low-intensity statin regimens to require insufficient therapeutic response to one high intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin
• References reviewed and updated

Istradefylline (Nourianz) (CP.PMN.217)

Ambetter

Policy updates include:

• Revised initial approval duration and continued approval duration for all lines of business to 12 months
• For continued therapy, aligned initial therapy requirement for concurrent treatment with carbidopa/levodopa

Bempedoic Acid (Nexletol), Bempedoic Acid/Ezetimibe (Nexlizet) (CP.PMN.237)

Ambetter

Policy updates include:

• Updated indication to reflect the following revised uses: as an adjunct to exercise (rather than low density lipoprotein cholesterol (LDL)-lowering therapy) for hefh for Nexlizet and to reduce major adverse cardiovascular events in adults at increased risk for these events (rather than adults with established cardiovascular disease) for both Nexlizet and Nexletol
• Revised “hyperlipidemia” to “hypercholesterolemia” throughout the criteria.

Varenicline (Tyrvaya) (CP.PMN.273)

Ambetter

Policy updates include:

• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Elinzanetant (Lynkuet) (CP.PMN.304)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Vasomotor Symptoms (must meet all):
  • Diagnosis of vasomotor symptoms associated with menopause;
  • Age at least 18 years;
  • Failure of two formulary estrogen products, unless contraindicated or clinically significant adverse effects are experienced;
  • Dose does not exceed 120 mg (2 capsules) per day.
  • Approval duration: 12 months
• Continued Therapy: Vasomotor Symptoms (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy (e.g., vasomotor symptom reduction);
  • If request is for a dose increase, new dose does not exceed 120 mg (2 capsules) per day.
  • Approval duration: 12 months

Febuxostat (Uloric) (CP.PMN.57)

Ambetter

Policy updates include:

• Added request does not exceed health plan-approved quantity limit, if applicable
• For Medicaid, changed approval duration from length of benefit to 12 months

Buprenorphine/Naloxone (Suboxone, Zubsolv) (CP.PMN.81)

Ambetter

Policy updates include:

• Revised maximum dose limitation to 32 mg/8 mg for suboxone and 22.8 mg/5.8 mg for Zubsolv with option for usage exceeding 32 mg per day or 22.8 mg per day (buprenorphine component) for Suboxone or Zubsolv, respectively, with medical justification

Amantadine ER (Gocovri, Osmolex ER) (CP.PMN.89)

Ambetter

Policy updates include:

• Removed Osmolex ER from policy due to discontinuation
• For Parkinson’s disease with “off” episodes, moved the failure of immediate-release amantadine within the overall failure of two Parkinson’s disease adjunct drugs
• For continued therapy, aligned initial therapy requirement for concurrent treatment with carbidopa/levodopa
• Revised Commercial approval durations to 12 months

Secnidazole (Solosec) (CP.PMN.103)

Ambetter

Policy updates include:

• Added allowable time elapsed for bacterial vaginosis and trichomoniasis retreatment from continued therapy within initial criteria
• Added request does not exceed health plan-approved quantity limit, if applicable

Vorapaxar (Zontivity) (HIM.PA.146)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health-plan approved quantity limit

Evolocumab (Repatha) (HIM.PA.156)

Ambetter

Policy updates include:

• For all indications, extended initial approval duration from 3 months to 12 months for this maintenance medication for a chronic condition

Evinacumab-dgnb (Evkeeza) (HIM.PA.166)

Ambetter

Policy updates include:

• Reduced statin adherence duration from 4 months to 8 weeks
• Simplified statin trial and failure criteria for moderate- and low-intensity statin regimens to require insufficient therapeutic response to one high intensity statin for 8 weeks or reversible muscle-related symptoms associated with both rosuvastatin and atorvastatin
• Extended initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (HIM.PA.58)

Ambetter

Policy updates include:

• Added requirement that request does not exceed health plan-approved quantity limit, if applicable

Dupilumab (Dupixent) (HIM.PA.SP69)

Ambetter

Policy updates include:

• Per National Comprehensive Cancer Network (NCCN) for immunotherapy-related toxicity, added option for G2 pruritus, added requirement for diagnostic confirmation of BP for bullous dermatitis, and removed corticosteroid requirement for bullous dermatitis
• For immunotherapy-related toxicity, revised approval durations from 6 to 12 months

Onasemnogene Abeparvovec-xioi (Zolgensma) (CP.PHAR.421)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Pre-emptive policy created for intrathecal Zolgensma
• Initial Approval Criteria*:  Spinal Muscular Atrophy (SMA) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of SMA confirmed by the presence of one of the following:*
    • Homozygous deletions of SMN1 gene (e.g., absence of the SMN1 gene);
    • Homozygous mutation in the SMN1 gene (e.g., biallelic mutations of exon 7);
    • Compound heterozygous mutation in the SMN1 gene (e.g., deletion of SMN1 exon 7 (allele 1) and mutation of SMN1 (allele 2));
  • Genetic testing quantifying number of copies of SMN2 gene and one of the following:*
    • One, two, or three copies of SMN2 gene;
    • Four copies of SMN2 gene, determined by a quantitative assay that is able to distinguish between four SMN2 gene copies and five or more SMN2 gene copies;
  • Request is for intrathecal formulation;*
  • Prescribed by or in consultation with a neurologist;*
  • Age 2 years to less than 18 years;*
  • Documentation that member is able to sit independently;
  • Documentation of one of the following baseline scores:*
    • Hammersmith functional motor scale expanded (HFMSE) score;
    • Revised Hammersmith Scale (RHS);
    • Upper Limb Module (ULM);
    • Revised Upper Limb Module (RULM);
    • 6-Minute Walk Test (6MWT);
  • Documentation of both of the following:*
    • Baseline laboratory tests demonstrating Anti-AAV9 antibody titers at most 1:50 as determined by ELISA binding immunoassay;
    • Baseline liver function test;
  • Member does not require tracheostomy, invasive, noninvasive ventilation for greater than 12 hours/day, or awake noninvasive ventilation for greater than 6 hours/day;*
  • Member has not been previously treated with Zolgensma;*
  • Zolgensma is not prescribed concurrently with Spinraza®or Evrysdi™;*
  • If the member is currently on Spinraza or Evrysdi, one of the following:*
    • Spinraza or Evrysdi is being used as a bridge therapy to Zolgensma;
    • Both of the following:
      • Provider must submit evidence of clinical deterioration (e.g., sustained decrease in HFMSE score over a period of 3 to 6 months) upon completion of all loading doses of Spinraza;
      • Documentation of provider attestation of clinical deterioration and Spinraza/Evrysdi discontinuation;
  • Member does not have an active viral infection;*
  • Dose does not exceed 1.2 x 1014vector genomes (vg).*
  • Approval duration: 4 weeks (one time intrathecal dose per lifetime)

• Continued Therapy*:  Spinal Muscular Atrophy
  • Continued therapy will not be authorized as Zolgensma is indicated to be dosed one time only.
  • Approval duration: Not applicable

Setmelanotide (Imcivree) (CP.PHAR.491)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Acquired Hypothalamic Obesity (HO) (must meet all):* *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of acquired HO as evidenced by all of the following:*
    • Evidence of hypothalamic injury (i.e., hypothalamic lesions) assessed by magnetic resonance imagining (MRI);
    • Diagnosis of craniopharyngioma or other brain tumors affecting the hypothalamic region;
    • Member has undergone surgery, chemotherapy, or radiation for at least 6 months;
  • Prescribed by or in consultation with an  endocrinologist;*
  • Member meets one of the following:*
    • Age at least 4 and less than 18 years with body mass index (BMI) at least 95th percentile for age and sex;
    • Age at least 18 years with BMI at least 30 kg/m2;
  • Weight at least 15 kg;
  • Documentation of baseline weight (in the past 60 days) in kilograms;
  • Documentation of creatinine clearance at least 30 mL/min/1.73 m2;
  • If member has had prior gastric bypass surgery, member meets one of the following:
    • Member has not had greater than 10% weight loss from baseline pre-operative weight;
    • Member has regained weight after an initial response to surgery;
  • For age at least 6 years: Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet and increased physical activity adjunct to therapy;*
  • Dose does not exceed 3 mg per day.*
  • Approval duration: 12 months

• Continued Therapy: Acquired Hypothalamic Obesity (must meet all):* *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by one of the following:*
    • Initial re-authorization: After 1 year of treatment, reduction of at least 5% of baseline body weight or 5% of baseline BMI;
    • Subsequent re-authorizations: Maintenance of at least 5% reduction in weight or BMI compared with baseline;
  • If request is for a dose increase, new dose does not exceed 3 mg per day.*
  • Approval duration: 12 months

Teplizumab-mzwv (Tzield) (CP.PHAR.492)

Ambetter

Policy includes:

• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
•  
• Initial Approval Criteria*: Delayed Progression of Recently Diagnosed Stage 3 Type 1 Diabetes (T1D) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of Stage 3 T1D;*
  • Diagnosis was made within the last 6 weeks;*
  • Diagnosis is confirmed by one of the following:*
    • A1c at least 6.5% (at least 48 mmol/mol);
    • Fasting plasma glucose at least 126 mg/dL (at least 7.0 mmol/L);
    • 2-hour plasma glucose at least 200 mg/dL (at least 11.1 mmol/L) during oral glucose tolerance test;
    • Random plasma glucose at least 200 mg/dL (at least 11.1 mmol/L) during classic symptoms of hyperglycemia (e.g., polyuria, polydipsia, unexplained weight loss) or hyperglycemic crisis;
  • Prescribed by or in consultation with an endocrinologist;
  • Age at least 8 years;*
  • Presence of at least one T1D-related autoantibody: glutamic acid decarboxylase 65 (GAD65) autoantibodies, islet antigen 2 (IA-2) autoantibodies, zinc transporter 8 (ZnT8) autoantibody, islet cell autoantibodies (ICA), insulin autoantibodies (if testing obtained within first 14 days of insulin treatment);*
  • Peak stimulated C-peptide at least 0.2 pmol/mL from a 2-hour mixed meal tolerance test performed at least 6 days after diagnosis;*
  • Member does not have a diagnosis of Stage 4 T1D or type 2 diabetes; *
  • Member has not previously received Tzield for Stage 2 T1D to delay the onset to Stage 3 T1D;
  • Member has not previously received two 12-day treatment courses of Tzield for Stage 3 T1D;
  • Documentation of member’s current body surface area (BSA) (m2);*
  • Dose does not exceed a total of 9 mg/m2per 12-day treatment course;*
  • Request does not exceed a total of two 12-day treatment courses, administered approximately 6 months apart.*
  • Approval duration: 12 months (total of two 12-day treatment courses only)
• Continued Therapy*: Delayed Progression of Recently Diagnosed Stage 3 Type 1 Diabetes. *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as Tzield is indicated to be administered for a total of 2 treatment courses only.*
  • Approval duration: Not applicable

Narsoplimab (OMS721) (CP.PHAR.527)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
•  
• Initial Approval Criteria*: Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of HSCT-TMA;*
  • Prescribed by or in consultation with a hematologist or transplant specialist;
  • Age at least 18 years;*
  • Member has signs of persistent TMA as evidenced by presence of all of the following for at least 2 weeks after modification or discontinuation of calcineurin inhibitor therapy (e.g., cyclosporine, tacrolimus):*
    • Platelet count at most 150 x 109/L;
    • Hemolysis such as an elevation in serum lactate dehydrogenase (LDH);
    • Serum creatinine above the upper limits of normal or member requires dialysis;
  • Documentation that member does not have any of the following:*
    • A disintegrin and metalloproteinase with thrombospondin type 1 motif, member 13 (ADAMTS13) deficiency;
    • Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS);
    • Atypical hemolytic uremic syndrome (aHUS);
  • OMS721 is not prescribed concurrently with Soliris®or Ultomiris®;*
  • Dose does not exceed 4 mg/kg once weekly.*
  • Approval duration: 8 weeks

• Continued Therapy*: Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:*
    • Improved measures of intravascular hemolysis (e.g., normalization of LDH);
    • Increased or stabilized platelet counts;
    • Improved or stabilized serum creatinine or estimated glomerular filtration rate (eGFR);
    • Reduced need for dialysis;
  • Member has not received OMS721 for greater than 12 weeks;
  • OMS721 is not prescribed concurrently with Soliris or Ultomiris;*
  • If request is for a dose increase, new dose does not exceed 4 mg/kg once weekly.*
  • Approval duration: Up to 12 weeks total

Carbetocin (CP.PHAR.546)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Prader-Willi Syndrome (PWS) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of PWS confirmed by genetic testing;*
  • Prescribed by or in consultation an endocrinologist or expert in rare genetic disorders of obesity;
  • Age at least 5 years and at most 30 years;*
  • Objective signs of PWS nutritional phase 3 as evidenced by persistent hyperphagia;
  • Documentation of current (within the last month) body mass index (BMI);
  • Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet and increased physical activity adjunct to therapy;
  • Dose does not exceed 9.6 mg of carbetocin per dose, three times daily.*
  • Approval duration: 8 weeks

• Continued Therapy*: Prader-Willi Syndrome (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy evidenced by both of the following:
    • Decrease in hyperphagia;
    • Decrease in BMI from baseline;
  • If request is for a dose increase, new dose does not exceed 9.6 mg of carbetocin per dose, three times daily.*
  • Approval duration: 6 months

Udenafil (CP.PHAR.557)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Single Ventricle Heart Disease (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of SVHD;*
  • Prescribed by or in consultation with a cardiologist;
  • Age at least 12 years and at most 18 years at therapy initiation;*
  • Member has undergone Fontan palliation;*
  • Documentation of baseline peak oxygen consumption;*
  • Peak oxygen consumption greater than 50% of predicted for age and sex;*
  • Respiratory exchange ratio at least 1.10 at peak exercise during cardiopulmonary exercise test;*
  • At the time of request, member meets all of the following:*
    • No hospitalization for acute decompensated heart failure within the last 12 months;
    • Member does not have a diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or history of liver cirrhosis;
    • Member does not have Fontan baffle obstruction, branch pulmonary artery or vein stenosis, severe ventricular dysfunction, or atrioventricular valve regurgitation assessed by echocardiography within the last six months;
  • Dose does not exceed 175 mg per day.*
  • Approval duration: 6 months

• Continued Therapy*: Single Ventricle Heart Disease (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively as evidenced by, including but not limited to, improvement or maintenance of positive peak oxygen consumption compared to baseline;*
  • If request is for a dose increase, new dose does not exceed 175 mg per day.*
  • Approval duration: 12 months

Pegzilarginase (AEB1102) (CP.PHAR.587)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Arginase 1 Deficiency (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of ARG1-D confirmed by one of the following:*
    • Genetic confirmation of an ARG1 pathogenic variant;
    • Documentation of reduced arginase enzyme activity in red blood cells;
  • Prescribed by or in consultation with a physician experienced in treating metabolic disorders;
  • Age at least 2 years;*
  • Provider attestation that member is currently on a protein-restricted diet and will continue this diet during treatment with pegzilarginase;
  • Documentation of plasma arginine level from within the last 3 months;*
  • Dose does not exceed the FDA-approved maximum recommended dose.*
  • Approval duration: 6 months

• Continued Therapy*: Arginase 1 Deficiency (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by a reduction in plasma arginine levels since initiation of therapy;*
  • Provider attestation that member is currently on a protein-restricted diet and will continue this diet during treatment with pegzilarginase;
  • If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose.*
  • Approval duration: 12 months

Bulevirtide (Hepcludex) (CP.PHAR.589)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Chronic Hepatitis D Infection (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of chronic hepatitis D virus (HDV) infection as evidenced by detectable serum HDV RNA levels by quantitative assay in the last 6 months;*
  • Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease specialist;
  • Age at least 18 years;*
  • Two elevated alanine transaminase (ALT) lab values within the past 12 months (at least 70 IU/L for men, at least 50 IU/L for women);*
  • Child-Pugh hepatic insufficiency score less than 7 (Child-Pugh Class A);*
  • No previous (within the last 2 years) or current decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage;*
  • Dose does not exceed 2 mg (1 vial) per day. *
  • Approval duration: 6 months

• Continued Therapy*: Chronic Hepatitis D Infection (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by both of the following:
    • A reduction in HDV RNA levels or undetectable HDV RNA levels by quantitative assay;
    • A reduction or normalization (at most 35 IU/L for men, at most 25 IU/L for women) of ALT lab values;
  • If request is for a dose increase, new dose does not exceed 2 mg (1 vial) per day.*
  • Approval duration: 12 months

Marnetegragene Autotemcel (Kresladi) (CP.PHAR.599)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Leukocyte Adhesion Deficiency Type 1 (LAD-I) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Confirmed diagnosis of LAD-I as demonstrated by flow cytometry indicating one of the following:*
    • CD18 expression on less than 2% neutrophils (polymorphonuclear neutrophils [PMNs]);
    • CD18 expression on at least 2% PMNs concurrently with all of the following (i, ii, and iii):
      • CD11a or CD11b expression on less than 2% PMNs;
      • Genetic testing showing ITGB2 gene mutation;
      • Clinical history consistent with LAD-I or a known family history;
  • Prescribed by or in consultation with both of the following:*
    • Transplant specialist;
    • One of the following:
• Hematologist;
• Oncologist;
• Immunologist;
• Infectious disease specialist;
  • Age at least 3 months;*
  • For members without documented family history of LAD-I: at least 1 prior significant bacterial or fungal infection;*
  • One of the following:*
    • Member has no available human leukocyte antigen (HLA)-matched sibling donors;
    • Member has an available HLA-matched sibling donor, and both of the following:
      • Provider submits medical rationale that stem cell collection is not feasible (e.g., donor is in utero, is a newborn from whom cord blood was not collected, or is unable to undergo donation procedure because of medical impairments);
      • Member/caregiver understands the risks and benefits of alternative therapeutic options such as allogeneic hematopoietic stem cell transplantation (HSCT);
  • Transplant specialist attestation that member is clinically stable and eligible to undergo myeloablative conditioning and HSCT;*
  • Dose is at least 2 x 10^6 total CD34+ cells/kg.*
  • Approval duration: 3 months (one time infusion per lifetime)*

• Continued Therapy*: Leukocyte Adhesion Deficiency Type 1 *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as Kresladi is indicated to be dosed one time only.
  • Approval duration: Not applicable

Debamestrocel (NurOwn) (CP.PHAR.637)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Amyotrophic Lateral Sclerosis (ALS) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of ALS;*
  • Prescribed by or in consultation with a neurologist;
  • Age at least 18 years;*
  • Disease duration of at most 2 years;*
  • Percent predicted slow vital capacity (SVC) at least 65%;*
  • Baseline revised ALS Functional Rating Scale (ALSFRS-R) score at least 35 points;*
  • NurOwn is prescribed concurrently with riluzole (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced;
  • Member does not have presence of tracheostomy or assisted ventilation (including invasive and non-invasive);*
  • Dose does not exceed maximum FDA-labeled dose.*
  • Approval duration: 6 months (total of 3 intrathecal injections)*

• Continued Therapy*: Amyotrophic Lateral Sclerosis *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Re-authorization is not permitted. Treatment should not exceed a total of three intrathecal injections at weeks 0, 8, and 16.*
  • Approval duration: Not applicable

Troriluzole (BHV-4157) (CP.PHAR.639)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Spinocerebellar Ataxia (SCA) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Confirmed genotypic diagnosis of one of the following SCA genotypes: 1, 2, 3, 6, 7, 8, or 10;*
  • Prescribed by or in consultation with a neurologist;
  • Age at least 18 years;*
  • Baseline modified functional Scale for the Assessment and Rating of Ataxia (f-SARA) score meets all of the following:*
    • Total score at least 3;
    • Gait subsection score at least 1;
    • For each individual item of the scale, score less than 4;
  • Mini-Mental State Examination (MMSE) score at least 24;*
  • Member is able to ambulate at least 8 meters without human assistance (canes and other devices are allowed);*
  • BHV-4157 is not prescribed concurrently with riluzole;*
  • Dose does not exceed 200 mg per day.*
  • Approval duration: 12 months

• Continued Therapy*: Spinocerebellar Ataxia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;*
  • If request is for a dose increase, new dose does not exceed 200 mg per day.*
  • Approval duration: 12 months

Dasiglucagon (ZP4207) (CP.PHAR.642)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Congenital Hyperinsulinism (CHI) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of CHI as evidence by any one of the following:*
    • Plasma insulin detection during an event of hypoglycemia;
    • Plasma free fatty acid less than 1.7 mmol/L;
    • Beta-hydroxybutyrate less than 1.8 mmol/L;
    • Plasma glucose greater than 30 mg/dL after one administration of glucagon administration;
  • Prescribed by or in consultation with an endocrinologist or geneticist;*
  • Age at least 7 days;*
  • Body weight at least 2 kg;*
  • Documentation of number of hypoglycemic events per week;*
  • Failure of diazoxide, unless member has a mutation in the ABCC8 or KCNJ11 genes or contraindicated or clinically significant adverse effects are experienced;* †
  • †For Illinois HIM requests, the step therapy requirement above does not apply as of 1/1/2026 per IL HB 5395
  • Member has previously undergone near-total pancreatectomy or is not eligible for pancreatic surgery;*
  • Prescriber attestation that member is concurrently receiving standard of care for CHI intensive medical therapy (e.g., continuous dextrose administration, somatotstatin analog);*
  • Dose does not exceed FDA maximum dose.*
  • Approval duration: 12 months

• Continued Therapy*: Congenital Hyperinsulinism (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
    • Decrease in number of hypoglycemic events per week;
    • Reduction of time in hypoglycemic events;
  • If request is for a dose increase, new dose does not exceed FDA maximum dose.*
  • Approval duration: 12 months

Govorestat (AT-007) (CP.PHAR.681)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
•  
• Initial Approval Criteria*: Classic Galactosemia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of classic galactosemia confirmed by reduced (at most 3% of normal) GALT activity;*
  • Prescribed by or in consultation with a geneticist or metabolic specialist;
  • Age at least 2 years;*
  • Dose does not exceed the FDA approved maximum.*
  • Approval duration: 6 months

• Continued Therapy*: Classic Galactosemia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;
  • If request is for a dose increase, new dose does not exceed the FDA approved maximum.*
  • Approval duration: 12 months

Olezarsen (Tryngolza) (CP.PHAR.689)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Hypertriglyceridemia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of hypertriglyceridemia as evidenced by fasting triglycerides at least 500 mg/dL (lab must be dated within 90 days);*
  • Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist;
  • Age at least 18 years;*
  • Failure of at least 3 consecutive month trial of both of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;* *For Illinois HIM requests, the step therapy requirements above do not apply per IL HB 5395
    • Fibrate therapy;
    • Omega-3 fatty acids therapy^; ^Prior authorization may be required for omega-3 fatty acids
  • Member is concurrently receiving standard of care lipid-lowering treatment (e.g., statins, ezetimibe, fibrates, omega-3 fatty acids, niacin), if clinically appropriate;
  • Dose does not exceed 80 mg per month.*
  • Approval duration: 12 months

• Continued Therapy*: Hypertriglyceridemia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by reduction in fasting triglycerides from baseline;
  • Member is concurrently receiving standard of care lipid-lowering treatment (e.g., statins, ezetimibe, fibrates, omega-3 fatty acids, niacin), if clinically appropriate;
  • If request is for a dose increase, new dose does not exceed 80 mg per month.*
  • Approval duration: 12 months

Glepaglutide (ZP1848) (CP.PHAR.694)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Short Bowel Syndrome (SBS) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of SBS;*
  • Prescribed by or in consultation with a gastroenterologist;
  • Age at least 18 years;*
  • Member is currently receiving parenteral support (i.e., parenteral nutrition and/or intravenous fluids) at least 3 days per week;*
  • Glepaglutide is not prescribed concurrently with Gattex®;
  • Dose does not exceed 20 mg per week.*
  • Approval duration: 12 months

• Continued Therapy*: Short Bowel Syndrome (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Requirement for parenteral nutrition or other intravenous support has decreased since initiation of glepaglutide;*
  • Glepaglutide is not prescribed concurrently with Gattex;
  • If request is for a dose increase, new dose does not exceed 20 mg per week.*
  • Approval duration: 12 months

Ataluren (Translarna) (CP.PHAR.710)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Duchenne Muscular Dystrophy (DMD) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of nonsense mutation DMD
  • (nmDMD) confirmed by genetic testing;*
  • Prescribed by or in consultation with a neurologist;
  • Age at least 5 years;*
  • Member has all of the following assessed within the last 30 days:
    • Ambulatory function (e.g., ability to walk with or without assistive devices, not wheelchair dependent) with a 6-minute walk test (6MWT) distance at least 150 m;
    • Stable cardiac function with left ventricular ejection fraction (LVEF) greater than 40%;
    • Stable pulmonary function with predicted forced vital capacity (FVC) at least 50%;
  • Inadequate response (as evidenced by a significant decline in 6MWT, LVEF, or FVC) despite adherent use of an oral corticosteroid (e.g., prednisone, Emflaza®, Agamree®) for at least 12 months, unless contraindicated or clinically significant adverse effects are experienced;
  • *Prior authorization is required for Emflaza and Agamree
  • Translarna is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Translarna is not prescribed concurrently with exon-skipping therapies (e.g., Amondys 45®, Exondys 51®, Vyondys 53®, Viltepso®);
  • Member has not previously received gene replacement therapy for DMD (e.g., Elevidys®);
  • Documentation of member’s current body weight in kg;
  • Dose does not exceed 40 mg/kg per day.*
  • Approval duration: 6 months

• Continued Therapy*: Duchenne Muscular Dystrophy (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Currently receiving medication for nmDMD or member has previously met initial approval criteria;
  • Member is responding positively to therapy as evidenced by one of the following:
    • All of the following assessed within the last 6 months (i, ii, and iii):
      • Ambulatory function (e.g., ability to walk with or without assistive devices, not wheelchair dependent) with a 6MWT distance at least 150 m;
      • Stable cardiac function with LVEF greater than 40%;
      • Stable pulmonary function with predicted FVC at least 50%;
    • Member has received this medication via a healthcare insurer without meeting the requirements above (see criterion 2a), and medical record shows improved or stable LVEF and FVC, assessed within the last 6 months;
  • Member has been assessed by a neurologist within the last 6 months;
  • Translarna is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Translarna is not prescribed concurrently with exon-skipping therapies (e.g., Amondys 45, Exondys 51, Vyondys 53, Viltepso);
  • Member has not previously received gene replacement therapy for DMD (e.g., Elevidys);
  • Documentation of member’s current body weight in kg;
  • If request is for a dose increase, new dose does not exceed 40 mg/kg per day.*
  • Approval duration: 6 months

Copper Histidinate (CUTX-101) (CP.PHAR.714)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Menkes Disease (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of Menkes disease;*
  • Diagnosis is confirmed by one of the following methods:*
    • Genetic testing demonstrating mutation in the ATP7A gene;
    • Both of the following:
      • Biochemically with one of the following:
        • Low serum copper levels (less than 75 mcg/dL);
        • Low ceruloplasmin;
        • Abnormal plasma catecholamine levels;
      • Clinically based on signs of abnormal hair color/texture, seizures, hypotonia, or developmental delay;
  • Prescribed by or in consultation with a neonatologist, neurologist, or specialist with expertise in the management of metabolic disorders (e.g., pediatric geneticist);
  • Dose does not exceed one of the following:*
    • Age at most 12 months: 2,900 mcg per day;
    • Age greater than 12 months: 1,450 mcg per day.
  • Approval duration: 6 months*
  • Continued Therapy*: Menkes Disease (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
    • Member meets one of the following:
      • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
      • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
    • Member is responding positively to therapy;*
    • If request is for a dose increase, new dose does not exceed one of the following:*
      • Age at most 12 months: 2,900 mcg per day;
      • Age greater than 12 months: 1,450 mcg per day.
    • Approval duration: 12 months

Deramiocel (CAP-1002) (CP.PHAR.716)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Duchenne Muscular Dystrophy (DMD) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of DMD confirmed by genetic testing;*
  • One of the following:
    • Prescribed by or in consultation with a neurologist;
    • Member is being treated at a certified Duchenne care center or a Muscular Dystrophy Association care center;*
  • Age at least 10 years;*
  • Member has a performance upper limb (PUL 2.0) entry item score of 2 – 5;*
  • One of the following:*
    • Member is non-ambulatory;
    • If member is late ambulatory (i.e., ability to walk with or without assistive devices, not wheelchair dependent) defined as a 10-meter walk time of greater than 10 seconds, age is less than 18 years;
  • Member meets both of the following assessed within the last 30 days:*
    • Stable cardiac function with left ventricular ejection fraction (LVEF) at least 35%;
    • Stable pulmonary function with predicted forced vital capacity (FVC) at least 35%;
  • Member has been on a stable dose of an oral corticosteroid (e.g., prednisone, Emflaza®*, Agamree®*) for at least 6 months, unless contraindicated or clinically significant adverse effects are experienced;* *Prior authorization is required for Emflaza and Agamree
  • CAP-1002 is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;*
  • Member has not received prior stem cell therapy;*
  • Member has not previously received gene replacement therapy for DMD (e.g., Elevidys®);*
  • If member is currently on an exon-skipping therapy (e.g., Amondys 45™, Exondys 51®, Viltepso™, Vyondys 53™), member must discontinue therapy prior to CAP-1002;
  • Dose does not exceed 150 million cells every 3 months.*
  • Approval duration: 6 months

• Continued Therapy*: Duchenne Muscular Dystrophy (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement or stabilization in member’s PUL score, LVEF, and FVC ;*
  • Member has been assessed by a neurologist within the last 6 months;
  • CAP-1002 is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
  • Member has not received prior stem cell therapy;*
  • Member has not previously received gene replacement therapy for DMD (e.g., Elevidys);*
  • CAP-1002 is not prescribed concurrently with exon-skipping therapies (e.g., Amondys 45, Exondys 51, Viltepso, Vyondys 53);*
  • If request is for a dose increase, new dose does not exceed 150 million cells every 3 months.*
  • Approval duration: 6 months

Mozafancogene Autotemcel (RP-L102) (CP.PHAR.719)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Fanconi Anemia (FA) (must meet all): Criteria will mirror the clinical information from the prescribing information once FDA-approved
• *Only for initial treatment dose; subsequent doses will not be covered.
  • Diagnosis of FA complementation group A as evidenced by both of the following;*
    • FANCA gene mutation confirmed by genetic testing;
    • One of the following:
      • Positive chromosome breakage test in peripheral blood;
      • Documentation of potential somatic mosaicism (e.g., negative, or equivocal chromosome breakage test) and medically significant decrease in at least one blood cell lineage over time;
  • Prescribed by or in consultation with a transplant specialist, hematologist, or geneticist;
  • Age at least 1 year and at most 12 years;*
  • Weight at least 8 kg;*
  • One of the following:
    • Member has no available human leukocyte antigen (HLA)-matched (i.e., full HLA-matching of all evaluated alleles) donor;
    • Member has an available HLA-matched donor, and both of the following:
      • Provider submits medical rationale that allogeneic hematopoietic stem cell transplantation (HSCT) is not feasible (e.g., donor unable to undergo donation procedure because of medical impairments);
      • ii. Member understands the risks and benefits of alternative therapeutic options such as allogeneic HSCT;
  • Transplant specialist attestation that member is clinically stable and eligible to undergo myeloablative conditioning and HSCT;
  • Member has not received prior allogeneic HSCT;
  • Member has not received prior gene therapy;
  • Both of the following:
    • Dose does not exceed a single administration;
    • Dose contains a minimum of 3 x 105CD34+ cells/kg.*
  • Approval duration: 6 months (one time infusion per lifetime)

• Continued Therapy*: Fanconi Anemia *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as RP-L102 is indicated to be dosed one time only.
  • Approval duration: Not applicable

Plozasiran (ARO-APOC3) (CP.PHAR.721)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Familial Chylomicronemia Syndrome (FCS) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of FCS as evidenced by all of the following:*
    • Fasting triglycerides at least 880 mg/dL or at least 10 mmol/L (lab must be dated within 90 days);
    • One of the following:
      • Genetic testing confirms the presence a loss-of-function mutation in a FCS-causing gene (e.g., LPL, APOC2, APOA5, GPIHBP1, LMF1);
      • History of pancreatitis;
      • Family history of hypertriglyceridemia;
      • History of recurrent abdominal pain without other explainable cause;
    • Documentation of nonresponse to both of the following, at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated:
      • Fibrates (e.g., fenofibric acid, fenofibrate, fenofibrate micronized, gemfibrozil);
      • Omega-3 fatty acids (e.g., omega-3-acid-ethyl esters, icosapent ethyl);
  • Prescribed by or in consultation with an endocrinologist, lipid specialist, or cardiologist;
  • Age at least 18 years;*
  • ARO-APOC3 is not prescribed concurrently with Tryngolza™;
  • Dose does not exceed 50 mg every 3 months.*
  • Approval duration: 6 months

• Continued Therapy*: Familial Chylomicronemia Syndrome (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Familial Chylomicronemia Syndrome (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by reduction in fasting triglycerides from baseline;
  • If request is for a dose increase, new dose does not exceed 50 mg every 3 months.*
  • Approval duration: 12 months

Rebisufligene Etisparvovec (UX111) (CP.PHAR.722)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Mucopolysaccharidosis IIIA: Sanfilippo Syndrome Type A (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of MPS IIIA confirmed by both of the following:*
    • Genetic confirmation of homozygous or compound heterozygous mutations in the SGSH gene;
    • Leukocyte assay demonstrating undetectable or significantly reduced SGSH enzyme activity;
  • Prescribed by or in consultation with a specialist with expertise in lysosomal storage diseases (e.g., medical geneticist, pediatric endocrinologist) or neurologist;
  • Age at most 4 years;*
  • Member does not have anti-AAV9 antibody titers at least 1:100;*
  • Member does not have either of the following via genetic testing:*
    • Two nonsense or null variants of the SGSH gene;
    • One or more S298P mutation(s) in the SGSH gene;
  • Member has not previously received hematopoietic stem cell transplantation;*
  • Member has not previously received cell or gene therapy;*
  • Documentation of member’s current weight in kg;
  • Dose does not exceed 3 × 1013vector genomes/kg.*
  • Approval duration: 3 months (one infusion per lifetime)

• Continued Therapy*: Mucopolysaccharidosis IIIA: Sanfilippo Syndrome Type A *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Re-authorization is not permitted as UX111 is indicated to be dosed one time only.
  • Approval duration: Not applicable

Sodium Dichloroacetate (SL-1009) (CP.PHAR.724)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Pyruvate Dehydrogenase Complex Deficiency (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of PDCD confirmed by the presence of clinical or metabolic features of PDCD and one of the following (a or b; see Appendix D):*
    • Known pathogenic mutation of a gene that is specifically associated with PDCD;
    • Both of the following:
      • A variant of uncertain significance for a mutation in a gene that is specifically associated with PDCD;
      • Enzyme assay demonstrating a deficiency of pyruvate dehydrogenase complex activity;
  • Prescribed by or in consultation with an endocrinologist, geneticist, neurologist, pediatrician, or metabolic disease specialist;*
  • Age at most 17 years;*
  • Member is currently on a ketogenic diet (i.e., a high fat, low carbohydrate diet) and will continue this diet during treatment with SL-1009;*
  • Dose does not exceed the FDA-approved maximum dose.*
  • Approval duration: 6 months

• Continued Therapy*: Pyruvate Dehydrogenase Complex Deficiency (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;*
  • Member is currently on a ketogenic diet and will continue this diet during treatment with SL-1009;*
  • If request is for a dose increase, new dose does not exceed the FDA-approved maximum dose.*
  • Approval duration: 12 months

Rexlemestrocel-L (Revascor) (CP.PHAR.728)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria* *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Advanced Heart Failure (must meet all):^^If member has an LVAD, please refer to criteria set I.B below.
    • Diagnosis of advanced HFrEF with all of the following characteristics (a-e):*
      • High-risk defined as one of the following (i, ii, or iii):
        • At least 1 heart failure hospitalization in the last 9 months;
        • At least 1 outpatient urgent care heart failure visit requiring intravenous diuretic, vasodilator, and/or positive inotropic therapy in the last 9 months;
        • Plasma levels of N-terminal pro–B-type natriuretic peptide (NT-proBNP) greater than 1,000 pg/mL (greater than 1,200 pg/mL for members with atrial fibrillation);
      • Left ventricular ejection fraction (LVEF) at most 40% by 2-dimensional echocardiogram or at most 35% by multigated acquisition scan;
      • New York Heart Association (NYHA) functional class II or III;
      • Presence of ischemic cardiomyopathy;
      • Presence of inflammation as evidenced by baseline plasma high-sensitivity C-reactive protein (CRP) at least 2 mg/L;
    • Prescribed by or in consultation with a cardiologist;
    • Age at least 18 years;*
    • Member is receiving stable (i.e., no changes in dose for at least the last month), optimally tolerated dosages of guideline-directed medical therapies for HFrEF that includes all of the following, unless clinically significant adverse effects are experienced or all are contraindicated (a, b, c, and d; see Appendix B):*
      • Beta-blocker;
      • Angiotensin receptor/neprilysin inhibitor (ARNI), angiotensin-converting enzyme (ACE) inhibitor, or angiotensin-receptor blocker (ARB);
      • Mineralocorticoid antagonist;
      • Sodium-glucose cotransporter 2 (SGLT2) inhibitor;
    • Member has not previously received any stem cell therapy;*
    • Dose does not exceed a single transendocardial injection.*
    • Approval duration: 3 months (one transendocardial injection per lifetime)
  • End-Stage Heart Failure (must meet all):
    • Diagnosis of end-stage chronic HFrEF with all of the following characteristics:*
      • LVEF at most 40% by 2-dimensional echocardiogram or at most 35% by multigated acquisition scan;
      • NYHA functional class III or IV;
      • Presence of ischemic cardiomyopathy;
    • Prescribed by or in consultation with a cardiologist;
    • Age at least 18 years;*
    • Member has an implanted LVAD, or is scheduled to receive an LVAD and will receive Revascor at the time of LVAD implantation;*
    • Member is receiving stable (i.e., no changes in dose for at least the last month), optimally tolerated dosages of guideline-directed medical therapies for HFrEF that includes all of the following, unless clinically significant adverse effects are experienced or all are contraindicated (a, b, c, and d; see Appendix B):*
      • Beta-blocker;
      • ARNI, ACE inhibitor, or ARB;
      • Mineralocorticoid antagonist;
      • SGLT2 inhibitor;
    • Member has not previously received any stem cell therapy;*
    • Dose does not exceed a single transendocardial injection.*
    • Approval duration: 3 months (one transendocardial injection per lifetime)

• Continued Therapy* *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Heart Failure
    • Continued therapy will not be authorized as Revascor is indicated to be dosed one time only.*
    • Approval duration: Not applicable

Vatiquinone (PTC743) (CP.PHAR.729)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Friedreich’s Ataxia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of FA;*
  • Documentation of genetic testing that shows a GAA triplet-repeat expansion in the frataxin (FXN) gene; *
  • Prescribed by or in consultation with a neurologist;
  • Age at least 7 years;*
  • Recent (within the last 30 days) baseline modified Functional Assessment Rating Scale (mFARS) score; *
  • Recent (within the last 30 days) baseline ventricular ejection fraction at least 50%;*
  • PTC743 is not prescribed concurrently with Skyclarys®;*
  • Dose does not exceed 1,200 mg per day.*
  • Approval duration: 6 months

• Continued Therapy*: Friedreich’s Ataxia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: FA symptoms or mFARS score; *
  • If request is for a dose increase, new dose does not exceed 1,200 mg per day.*
  • Approval duration: 12 months

Clemidsogene Lanparvovec (RGX-121) (CP.PHAR.734)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Mucopolysaccharidosis II: Hunter Syndrome (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of MPS II (Hunter syndrome) confirmed by both of the following:*
    • Genetic confirmation of pathogenic or likely pathogenic mutation(s) in the iduronate-2-sulfatase (IDS) gene;
    • Enzyme assay demonstrating a deficiency of IDS activity;
  • Prescribed by or in consultation with a specialist with expertise in lysosomal storage diseases (e.g., medical geneticist, pediatric endocrinologist) or a neurologist;*
  • Age at least 4 months to at most 5 years;*
  • Member has or is expected to have a neuronopathic form of MPS II as evidenced by one of the following:*
    • Neurocognitive testing demonstrating neuronopathic involvement;
    • Documented mutation(s) in IDS gene known to result in a neuronopathic phenotype;
    • Both of the following:
      • Member has a relative clinically diagnosed with neuronopathic MPS II who has the same IDS gene mutation as the member;
      • Geneticist determines member has inherited a neuronopathic form of MPS II;
  • Member has not previously received hematopoietic stem cell transplantation;*
  • Member has not previously received an AAV-based gene therapy product;*
  • Dose does not exceed 2.9 x 1011 genome copies/g brain mass.*
  • Approval duration: 3 months (one intracisternal injection per lifetime)

• Continued Therapy*: Mucopolysaccharidosis II: Hunter Syndrome *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Re-authorization is not permitted as RGX-121 is indicated to be dosed one time only.
  • Approval duration: Not applicable

Relacorilant (CP.PHAR.736)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria: Cushing’s Syndrome (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of Cushing’s syndrome;*
  • Member has one of the following:*
    • Type 2 diabetes mellitus;
    • Impaired glucose tolerance as evidenced by plasma glucose at least 140 and less than 200 mg/dL on 2-hour oral glucose tolerance test in the last 30 days;
    • Uncontrolled hypertension as evidenced by one of the following in the last 30 days:
      • Mean systolic blood pressure at least 135 to at most 170 mmHg;
      • Mean diastolic blood pressure at least 85 to at most 110 mmHg;
  • Prescribed by or in consultation with an endocrinologist;
  • Age at least 18 years;*
  • Member meets one of the:*
    • Surgery was not curative;
    • Member is not eligible for surgery;
  • Dose does not exceed 400 mg per day.*
  • Approval duration: 6 months
• Continued Therapy*: Cushing’s Syndrome (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;
  • If request is for a dose increase, new dose does not exceed 400 mg per day.*
  • Approval duration: 12 months

Apitegromab (SRK-015) (CP.PHAR.737)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Spinal Muscular Atrophy *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of SMA confirmed by the presence of one of the following:*
    • Homozygous deletions of SMN1 gene (e.g., absence of the SMN1 gene);
    • Homozygous mutation in the SMN1 gene (e.g., biallelic mutations of exon 7);
    • Compound heterozygous mutation in the SMN1 gene (e.g., deletion of SMN1 exon 7 (allele 1) and mutation of SMN1 (allele 2));
  • Documentation of genetic testing confirming no more than 4 copies of SMN2 gene;*
  • Prescribed by or in consultation with a neurologist;
  • Age at least 2 years;*
  • Member meets one of the following:*
    • Has been receiving Spinraza® for at least 10 months;
    • Has been receiving Evrysdi® for at least 6 months;
  • Member is concurrently receiving treatment with Spinraza or Evrysdi;*
  • Member has not been previously treated with Zolgensma®;*
  • Documentation of baseline Hammersmith functional motor scale expanded (HFMSE) score;
  • Member does not require tracheostomy or invasive or noninvasive ventilation for greater than 16 hours/day continuously for at least 14 days;*
  • Documentation of member’s current weight in kg;*
  • Dose does not exceed 20 mg/kg every 4 weeks.*
  • Approval duration: 6 months

• Continued Therapy*: Spinal Muscular Atrophy *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Currently receiving medication for SMA with 1 to 4 copies of the SMN2 gene, or member has previously met initial approval criteria;*
  • Member does not require tracheostomy or invasive or noninvasive ventilation for greater than 16 hours/day continuously for at least 14 days;*
  • Member is responding positively to therapy as evidenced by one of the following:*
    • Must demonstrate HFMSE score improvement or maintenance of previous score improvement from baseline;
    • Member has not had a decline in motor function test score(s) from baseline AND medical justification demonstrates and supports that member is responding positively to therapy;
  • Member is concurrently receiving treatment with Spinraza or Evrysdi;*
  • Member has not been previously treated with Zolgensma;*
  • Documentation of member’s current weight in kg;*
  • If request is for a dose increase, new dose does not exceed 20 mg/kg every 4 weeks.*
  • Approval duration:  12 months

Doxecitine and Doxribtimine (MT1621) (CP.PHAR.738)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Thymidine Kinase 2 Deficiency *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of TK2d as evidenced by a mutation in the thymidine kinase 2 (TK2) gene;*
  • Prescribed by or in consultation with a neurologist or metabolic disease specialist;*
  • Age of symptom onset at most 12 years (e.g., proximal muscle weakness, respiratory weakness, facial diplegia);*
  • Documentation of member’s current weight in kg;*
  • Dose does not exceed doxecitine 400 mg/kg and doxribtimine 400 mg/kg per day.*
  • Approval duration: 6 months

• Continued Therapy*: Thymidine Kinase 2 Deficiency *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters: improvement in motor function, walking ability, sitting ability, respiratory symptoms, nutritional status (e.g., body mass index), quality of life;*
  • Documentation of member’s current weight in kg;*
  • If request is for a dose increase, new dose does not exceed doxecitine 400 mg/kg and doxiribtimine 400 mg/kg per day.*
  • Approval duration: 12 months

Navepegritide (TransCon CNP) (CP.PHAR.746)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Achondroplasia (must meet all):' *Criteria will mirror the clinical information fANVe prescribing information once FDA-approved
  • Diagnosis of achondroplasia with genetic testing confirming a mutation in the fibroblast growth receptor 3 (FGFR3) gene;
  • Prescribed by or in consultation with a pediatric endocrinologist;
  • Age between 2 and 11 years;
  • At the time of request, radiographic evidence indicates open epiphyses (growth plates);
  • Documentation of baseline annualized growth velocity, calculated based on standing height measured over the course of 6 months prior to request;
  • Documentation of member's current weight (in kg);
  • TransCon CNP is not prescribed concurrently with any human growth hormone products (e.g., Genotropin®, Humatrope®, Norditropin®, Nutropin AQ®, Omnitrope®, Saizen®, Zomacton®);
  • TransCon CNP is not prescribed concurrently with Voxzogo;
  • Dose does not exceed 100 mcg/kg per week.
  • Approval duration: 6 months

• Continued Therapy*: Achondroplasia (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by improvement in annualized growth velocity from baseline;
  • Radiographic evidence within the last four months indicates that the member continues to have open epiphyses (growth plates);
  • Documentation of member's current weight (in kg);
  • If request is for a dose increase, new dose does not exceed 100 mcg/kg per week.
  • Approval duration: 6 months

Tabelecleucel (Tab-cel) (CP.PHAR.747)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Post-Transplant Lymphoproliferative Disease *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of PTLD;*
  • Prescribed by or in consultation with an oncologist, hematologist, or transplant specialist;
  • Age at least 2 years;*
  • Member has previously received a hematopoietic cell transplantation or a solid organ transplant;
  • Disease is EBV seropositive;
  • One of the following:
    • Disease is refractory;
    • Member has relapsed after at least one line of therapy that includes rituximab or a rituximab biosimilar (see Appendix B for examples);* *Prior authorization may be required for rituximab or rituximab biosimilar
    • Tab-cel is not prescribed concurrently with chimeric antigen receptor (CAR) T-cell immunotherapy (e.g., Abecma®, Carvykti®, Breyanzi®, Kymriah™, Tecartus®, Yescarta®);
    • Documentation of member’s current body weight in kg;
    • Request meets one of the following:*
      • Dose does not exceed 2 x 106 viable T cells/kg (per dose) on days 1, 8, and 15 of a 35 day cycle;*
      • Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months
• Continued Therapy*: Post-Transplant Lymphoproliferative Disease *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tab-cel for a covered indication and has received this medication for at least 30 days;
  • Member has not switched at least 4 times to a Tab-cel lot with a different human leukocyte antigen (HLA) restriction;
  • Member has not achieved 2 consecutive complete responses to the same Tab-cel lot;
  • Member has not achieved 3 consecutive partial responses to the same Tab-cel lot;
  • Member has not received at least 15 cycles (45 doses) of Tab-cel;
  • Tab-cel is not prescribed concurrently with CAR T-cell immunotherapy (e.g., Abecma, Carvykti, Breyanzi, Kymriah, Tecartus, Yescarta);
  • If request is for a dose increase, documentation of member’s current body weight in kg;
  • If request is for a dose increase, request meets one of the following:*
    • New dose does not exceed 2 x 106 viable T cells/kg (per dose) on days 1, 8, and 15 of a 35 day cycle;*
    • New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN
  • Approval duration: 6 months

Tividenofusp Alfa (DNL310) (CP.PHAR.748)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Mucopolysaccharidosis II (MPS II): Hunter Syndrome *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of MPS II (Hunter syndrome) confirmed by one of the following:
    • Enzyme assay demonstrating a deficiency of iduronate 2-sulfatase (IDS) activity;
    • Genetic confirmation of pathogenic or likely pathogenic mutation(s) in the IDS gene;
  • Age at least 3 months;*
  • DNL310 is not prescribed concurrently with Elaprase®;*
  •  Documentation of member’s current weight (in kg);
  • Dose does not exceed FDA-labeled maximum dose.*
  • Approval duration:  12 months
• Continued Therapy*: Mucopolysaccharidosis II: Hunter Syndrome *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by improvement or stabilization in the individual member’s MPS II manifestation profile;*
  • DNL310 is not prescribed concurrently with Elaprase;*
  • Documentation of member’s current weight (in kg);
  • If request is for a dose increase, new dose does not exceed FDA-labeled maximum dose.*
  • Approval duration:  12 months 

Sonpiretigene Isteparvovec (MCO-010) (CP.PHAR.749)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Retinitis Pigmentosa (RP) *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of RP as confirmed by genetic testing;*
  • Prescribed by an ophthalmologist or retina specialist;*
  • Age at least 18 years;*
  • Member has significant vision loss as evidenced by both of the following:
    • Best-corrected visual acuity (BCVA) worse than 1.9 logMAR in the eye receiving MCO-010;
    • BCVA less than 1.6 logMAR in the eye not receiving treatment;
  • Provider attestation that treatment with MCO-010 will only be given in the eye with the lowest visual acuity;*
  • Member has not previously been treated with MCO-010;*
  • Dose does not exceed FDA maximum dose.*
  • Approval duration: 4 weeks (1 lifetime dose)

• Continued Therapy*: Retinitis Pigmentosa  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as MCO-010 is indicated to be a one-time application per lifetime.*
  • Approval duration: Not applicable

Idebenone (Brand Name) (CP.PHAR.752)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Leber’s Hereditary Optic Neuropathy (LHON) *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of LHON;*
  • Genetic testing confirms the presence of one of the following):*
    • m.11778G>A mutation in the MT-ND4 gene;
    • m.3460G>A mutation in the MT-ND1 gene;
    • m.14484T>C mutation in the MT-ND6 gene;
  • Prescribed by or in consultation with an ophthalmologist;
  • Age at least 12 years;*
  •  Documentation of member’s baseline visual acuity (VA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart;*
  • Member has impaired VA in at least one eye due to LHON;*
  • Onset of vision loss due to LHON occurred within the last 5 years;*
  • Dose does not exceed 900 mg (6 tablets) per day.*
  • Approval duration: 12 months  

• Continued Therapy*: Leber’s Hereditary Optic Neuropathy *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;  
  • Member is responding positively to therapy as evidenced by one of the following:*
    • For the first re-authorization request, one of the following:
      • If member had an off-chart VA (i.e., unable to read any letter on the ETDRS chart) at baseline, improvement of VA to reading at least 5 letters on the ETDRS chart (i.e., VA is at most 1.6 logMAR);
      • If member had an on-chart VA (i.e., able to read letters on the ETDRS chart) at baseline, improvement of VA by at least 10 additional letters (i.e., change of -0.2 logMAR) on the ETDRS chart;
      • iMaintenance of VA from baseline without deterioration to legal blindness (i.e., VA remains less than 1.0 logMAR) at the most recent visit on the ETDRS chart;
    • For second or subsequent re-authorization requests: Improvement or maintenance of VA from the last request at the most recent visit on the ETDRS chart;
  • If request is for a dose increase, new dose does not exceed 900 mg (6 tablets) per day.*
  • Approval duration: 12 months

DB-OTO (CP.PHAR.757)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Congenital Hearing Loss *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of profound congenital hearing loss as evidenced by both of the following:*
    • Genetic testing confirms biallelic pathogenic or likely pathogenic OTOF mutation;
    • Member meets all of the following in the requested treatment ear(s):
      • Profound hearing loss defined by an average audiometric threshold of greater than 90 dB  hearing level;
      • Absent auditory brainstem response (ABR);
      • Intact outer hair cell function as evidenced by one of the following:
        • Presence of otoacoustic emissions (OAE);
        • Presence of a cochlear microphonic;
  • Prescribed by or in consultation with an otolaryngologist;
  • Age less than 18 years;*
  • Member does not have a history of a cochlear implant in the requested treatment ear(s);
  • Member has not previously been treated with DB-OTO in the requested treatment ear(s);
  • Member has not received prior gene therapy;
  • Dose does not exceed 7.2 x 1012 vector genomes (vg) per ear.*
  • Approval duration: 3 months (one lifetime injection per ear

• Continued Therapy*: Congenital Hearing Loss  *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Re-authorization is not permitted. Members must meet the initial approval criteria.
  • Approval duration: Not applicable

Bitopertin (Brand Name) (CP.PHAR.758)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Erythropoietic Protoporphyria  (EPP) and X-Linked Protoporphyria (XLP) *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of EPP or XLP confirmed by both of the following tests:*
  • Elevated total erythrocyte protoporphyrin (e.g., 300 to 5,000 mcg/dL vs. normal at 80 mcg/dL);
  • Erythrocyte fractionation shows at least 50% metal-free vs. zinc protoporphyrin (certified laboratories include University of Texas Medical Branch at Galveston - Porphyria Center, and Mayo Medical Laboratories);
  • Prescribed by or in consultation with a dermatologist;
  • Age at least 12 years;*
  • Evidence of EPP/XLP-associated acute non-blistering cutaneous reactions (e.g., pain, stinging, redness, swelling, blanching) following exposure to sun;*
  • Sun avoidance and use of sunscreen, protective clothing, and pain medication have proven inadequate in controlling EPP/XLP-associated painful skin reactions;*
  • Member does not have any of the following:
    • Aspartate aminotransferase and alanine transaminase at least 2 times upper limit of normal (ULN);
    • Total bilirubin at least ULN;
    • History of liver transplantation;
    • An inherited or acquired red cell disease associated with anemia (e.g., sickle cell anemia, iron-deficiency anemia, aplastic anemia, autoimmune hemolytic anemia, thalassemias);
  • Bitopertin is not prescribed concurrently with Scenesse®;*
  • Dose does not exceed 60 mg per day.*
  • Approval duration: 12 months

• Continued Therapy*: Erythropoietic Protoporphyria and X-Linked Protoporphyria *Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Member meets one of the following:
  • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
  • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by any of the following:
  • Reduction in acute non-blistering cutaneous reactions (e.g., pain, stinging, redness, swelling, blanching) following exposure to sun;
    Increase in pain-free period during direct sunlight exposure;
  • Bitopertin is not prescribed concurrently with Scenesse;
  • If request is for a dose increase, new dose does not exceed 60 mg per day.*
  • Approval duration: 12 months

Nanoencapsulated Sirolimus plus Pegadricase (NASP) (CP.PHAR.760)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Chronic Gout Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of chronic gout;*
  • Age at least 21 years;*
  • Positive for symptomatic gout with one or more of the following:
    • At least 3 gout flares in the previous 18 months;
    • At least 1 gout tophus;
    • Chronic gouty arthritis;
  • Failure to normalize uric acid to less than 6 mg/dL with allopurinol and febuxostat at maximally indicated doses, each used for at least 3 months unless clinically significant adverse effects are experienced or both are contraindicated;
  • Failure of probenecid, at maximally indicated doses, in combination with allopurinol or febuxostat unless clinically significant adverse effects are experienced or all are contraindicated;
  • NASP is not prescribed concurrently with oral urate-lowering agents (e.g., allopurinol, febuxostat, probenecid) or injectable urate-lowering agents (e.g., pegloticase);*
  • Dose does not exceed 0.2 mg/kg of pegadricase and 0.15 mg/kg of sirolimus every 28 days.*
  • Approval duration: 12 months

• Continued Therapy*: Chronic Gout Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by a decrease in plasma uric acid levels;
  • NASP is not prescribed concurrently with oral urate-lowering agents (e.g., allopurinol, febuxostat, probenecid) or injectable urate lowering agents (e.g., pegloticase); *
  • If request is for a dose increase, new dose does not exceed 0.2 mg/kg of pegadricase and 0.15 mg/kg of sirolimus every 28 days.*
  • Approval duration: 12 months

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (CP.PMN.183)

Medicaid

Policy includes:

• Added pre-emptive criteria for Rybelsus (diabetic patients with established cardiovascular disease) and Ozempic (diabetic patients with symptomatic PAD)

• Initial Approval Criteria*: Type 2 Diabetes Mellitus *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of type 2 diabetes mellitus;
  • Age is one of the following:
    • Bydureon BCise, Trulicity, Victoza: at least 10 years;
    • All other GLP-1 receptor agonists: at least 18 years;
  • Member meets one of the following:
    • Request is for Soliqua;
    • Member has metabolic dysfunction-associated steatotic liver disease (MASLD), and:
      • Member is overweight (body mass index [BMI] 25-29.9 kg/m2) or obese (BMI at least 30 kg/m2);
    • Member has metabolic dysfunction-associated steatohepatitis (MASH), and:
      • Failure of at least 3 consecutive month trial of pioglitazone, unless contraindicated or clinically significant adverse effects are experienced;
      • Member has peripheral artery disease (PAD), and all of the following:*
        • Diagnosis is confirmed by ankle-brachial index at most 0.90 or toe-brachial index at most 0.70;
        • Member has intermittent claudication corresponding to Fontaine stage IIa (i.e., member is able to walk greater than 200 m without pain or stopping);
        • Member has demonstrated limitations due to PAD as evidenced by a maximum walking distance of less than 600 m;
        • Request is for Ozempic;
    • Member has established atherosclerotic cardiovascular disease (ASCVD), indicators of high ASCVD risk, heart failure with preserved ejection fraction, or chronic kidney disease, and both of the following:
      • Request is for an agent with proven cardiovascular or renal benefit (Ozempic, Rybelsus*, Trulicity, Victoza);
      • Failure of at least 3 consecutive months of a sodium-glucose co-transporter 2 (SGLT2) inhibitor or SGLT2 inhibitor-containing product (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated;
    • For members without PAD, established ASCVD, indicators of high ASCVD risk, heart failure with preserved ejection fraction, chronic kidney disease, MASLD, or MASH: Failure of at least 3 consecutive month trial of two agents from any of the following classes, unless clinically significant adverse effects are experienced or all are contraindicated: biguanides, sulfonylureas (SU), thiazolidinediones (TZD), dipeptidyl peptidase-4 inhibitors (DPP-4), or SGLT2 inhibitor or SGLT2 inhibitor-containing product;
  • Member meets one of the following:
    • If request is for Trulicity: Failure of liraglutide (Victoza), unless contraindicated or clinically significant adverse effects are experienced;
    • If request is for Soliqua: Member was prescribed one of the following within the past 180 days:
      • Basal insulin (see Appendix B);
      • GLP-1 receptor agonist;
    • If request is for brand Victoza: Member must use liraglutide (Victoza), unless contraindicated or clinically significant adverse effects are experienced;
    • If request is for a non-preferred GLP-1 receptor agonist, one of the following:
      • Failure of both of the following preferred GLP-1 receptor agonists, each used for at least 3 consecutive months, unless clinically significant adverse effects are experienced or both are contraindicated:
        • Liraglutide (Victoza);
        • If member has failed liraglutide (Victoza), then failure of Trulicity;
      • Member has chronic kidney disease or symptomatic PAD (as defined in criterion 3.d above), and request is for Ozempic;
  • Requested product is not prescribed concurrently with another GLP-1 receptor agonist;
  • Dose does not exceed the FDA-approved maximum recommended dose.
  • Approval duration: 12 months

• Continued Therapy: Type 2 Diabetes Mellitus
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;
  • Requested product is not prescribed concurrently with another GLP-1 receptor agonist;
  • If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose

Semaglutide (Wegovy, NN9932) (CP.PMN.295)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Initial Approval Criteria*: Heart Failure (HF)*Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Request is for Wegovy;
  • Diagnosis of chronic HF of New York Heart Association (NYHA) Class II, III, or IV;
  • Prescribed by or in consultation with a cardiologist;
  • Age at least 18 years;
  • Body mass index (BMI) at least 30 kg/m2;*
  • Member has a left ventricular ejection fraction (LVEF) at least 50%;*
  • Member is receiving stable (i.e., no changes in dose for at least the last month) optimally tolerated dosages of guideline-directed medical therapies for heart failure with preserved ejection fraction (HFpEF) that includes all of the following classes, unless clinically significant adverse effects are experienced or all are contraindicated: ** For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB 5395
    • Sodium-glucose cotransporter 2 (SGLT2) inhibitor;
    • Secondary therapies, if applicable: loop diuretic, mineralocorticoid antagonist (MRA), and/or angiotensin receptor-neprilysin inhibitor (ARNI) or angiotensin receptor blocker (ARB) (see Appendix B for examples);
  • For members with concurrent type 2 diabetes mellitus (T2DM), both of the following:** **For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB 5395
    • Failure of at least 3 consecutive months of Ozempic ®, Trulicity ®, and Victoza ®, unless clinically significant adverse effects are experienced or all are contraindicated;* *Prior authorization may be required
    • If member is currently receiving a glucagon-like peptide-1 (GLP-1) receptor agonist and is requesting to switch to Wegovy therapy, medical justification* supports necessity for Wegovy; *Intolerance due to common adverse effects of the GLP-1 receptor agonist class such as gastrointestinal symptoms is not considered acceptable medical justification
  • Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s);
  • Documentation support’s member’s participation in a physician-directed weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification that meets both of the following:*
    • Been actively enrolled in a physician-directed weight loss program for at least 6 months;
    • Will continue to be enrolled in a physician-directed weight loss program while concomitantly prescribed Wegovy;
  • Documentation of member’s baseline body weight in kg;
  • Dose does not exceed the following:*
    • Week 1 through 4: 0.25 mg once weekly;
    • Week 5 through 8: 0.5 mg once weekly;
    • Week 9 through 12: 1 mg once weekly;
    • Week 13 through 16: 1.7 mg once weekly;
    • Week 17 and onward: 2.4 mg once weekly.
  • Approval duration: 6 months

• Initial Approval Criteria*: Weight Management
  • Use of Wegovy or NN9932 for the treatment of weight management is a benefit exclusion and will not be authorized.
  • Approval duration: Not applicable

• Continued Therapy* Heart Failure *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by one of the following:
    • If this is the first renewal request, both of the following:
      • Member has lost at least 5% of baseline body weight;
      • Improvement in any of the following parameters: heart failure symptom frequency (e.g., fatigue, dyspnea, edema), physical limitations, and exercise function;
    • If this is a second or subsequent renewal request, both of the following:
      • Member has lost weight and/or maintained weight loss on therapy;
      • Stabilization or improvement in any of the following parameters: heart failure symptom frequency (e.g., fatigue, dyspnea, edema), physical limitations, and exercise function;
  • Documentation of member’s current body weight in kg;
  • Provider attestation that member is currently receiving guideline-directed medical therapies for HFpEF;
  • Wegovy is not prescribed concurrently with other semaglutide-containing products or any other GLP-1 receptor agonist(s);
  • Documentation that member is actively enrolled in a weight loss program that involves a reduced calorie diet, increased physical activity, and behavioral modification adjunct to therapy;
  • Request meets both of the following:
  • Dose does not exceed 2.4 mg once weekly;
  • After the initial dose escalation period, maintenance dose is at least 1.7 mg once weekly.
  • Approval duration: 12 months

• Continued Therapy*: Weight Management
  • Use of Wegovy or NN9932 for the treatment of weight management is a benefit exclusion and will not be authorized.
  • Approval duration: Not applicable

Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (HIM.PA.53)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Added pre-emptive criteria for Rybelsus (diabetic patients with established cardiovascular disease) and Ozempic (diabetic patients with symptomatic PAD)
• Initial Approval Criteria*: Preferred glucagon-like peptide-1 (GLP-1) receptor agonist (RA) Therapy* *Criteria will mirror the clinical information from the prescribing information once FDA-approved*If request is for a GLP-1 RA other than liraglutide (Victoza), Trulicity, Ozempic, Rybelsus, Soliqua, or Xultophy, please refer to criteria set I.B below.
  • Diagnosis of type 2 diabetes mellitus;
  • Request is for liraglutide (Victoza), Trulicity, Ozempic, Rybelsus, Soliqua, or Xultophy;
  • Age is one of the following:
    • Trulicity, liraglutide (Victoza): at least 10 years;
    • Ozempic, Rybelsus, Soliqua, Xultophy: at least 18 years;
  • If request is for Victoza, member must use generic liraglutide, unless contraindicated or clinically significant adverse effects are experienced;
  • Requested product is not prescribed concurrently with another GLP-1 receptor agonist;
  • Dose does not exceed the FDA-approved maximum recommended dose.
  • Approval duration: 12 months

• Initial Approval Criteria*: Type 2 Diabetes Mellitus* If request is for liraglutide (Victoza), Trulicity, Ozempic, Rybelsus, Soliqua, or Xultophy, please refer to criteria set I.A above for preferred GLP-1 RA Therapy.
  • Diagnosis of type 2 diabetes mellitus;
  • Request is for Adlyxin, Bydureon, Bydureon BCise, Byetta, or Mounjaro;
  • Age is one of the following:
    • Bydureon BCise: at least 10 years;
    • Adlyxin, Byetta, Mounjaro: at least 18 years;
  • Member meets one of the following:
    • Failure of at least 3 consecutive months of metformin as evidenced by HbA1c at least 7%, unless contraindicated or clinically significant adverse effects are experienced;
    • For antidiabetic medication-naïve members, requested agent is approvable if intended for concurrent use with metformin due to HbA1c at least 8.5% (drawn within the past 3 months);
    • Request is for an agent with proven cardiovascular or renal benefit (Ozempic, Rybelsus*, Trulicity, liraglutide [Victoza]), and member has established atherosclerotic cardiovascular disease (ASCVD), indicators of high ASCVD risk, heart failure with preserved ejection fraction, chronic kidney disease, or symptomatic PAD*;
    • Member has metabolic dysfunction-associated steatotic liver disease (MASLD), and:
      • Member is overweight (body mass index [BMI] 25-29.9 kg/m2) or obese (BMI at least 30 kg/m2);
    • Member has metabolic dysfunction-associated steatohepatitis (MASH), and:
      • Failure of at least 3 consecutive month trial of pioglitazone, unless contraindicated or clinically significant adverse effects are experienced;
  • Failure of all of the following, unless clinically significant adverse effects are experienced or all are contraindicated:
    • At least 3 consecutive months of each of the following:
      • Liraglutide (Victoza);
      • Trulicity;
      • Ozempic or Rybelsus;
    • Sodium-glucose co-transporter 2 (SGLT2) inhibitor, unless the member has MASLD or MASH;
  • Requested product is not prescribed concurrently with another GLP-1 receptor agonist;
  • Dose does not exceed the FDA-approved maximum recommended dose.
  • Approval duration: 12 months

• Continued Therapy
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;
  • If request is for Victoza, member must use generic liraglutide, unless contraindicated or clinically significant adverse effects are experienced;
  • Requested product is not prescribed concurrently with another GLP-1 receptor agonist;
  • If request is for a dose increase, new dose does not exceed the FDA-approved maximum recommended dose.
  • Approval duration: 12 months

Immune Globulins (CP.PHAR.103)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy updates include:

• Added off-label measles post-exposure prophylaxis criteria for intravenous immunoglobulin

 Rituximab (Rituxan, Riabni, Ruxience, Truxima, Rituxan Hycela) (CP.PHAR.260)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy updates include:

• Added off-label criteria for Wiskott-Aldrich syndrome infection prophylaxis associated with Waskyra gene therapy

Lisocabtagene maraleucel (Breyanzi) (CP.PHAR.483)

Ambetter

Policy updates include:

• Added new indication for marginal zone lymphoma

Etuvetidigene Autotemcel (Waskyra) (CP.PHAR.735)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Wiskott-Aldrich Syndrome (WAS) (must meet all):
  • Diagnosis of WAS confirmed by the presence of a WAS genetic mutation and one of the following:
    • Severe WAS gene mutation;
    • Absent or markedly reduced WAS protein expression;
    • Severe WAS clinical phenotype defined as a Zhu, Ochs, or Zhu-Ochs clinical score of 3 or higher;
    • Clinically significant disease as evidenced by documented classic clinical manifestations of WAS (e.g., microthrombocytopenia with bleeding, recurrent or severe infections, eczema, immune dysfunction or autoimmunity);
  • Prescribed by or in consultation with a medical geneticist, transplant specialist, or specialist with expertise in treating WAS (e.g., hematologist, immunologist);
  • Age at least 6 months;
  • Member has no available human leukocyte antige (HLA)-matched related stem cell donor;
  • Transplant specialist attestation that member is clinically stable and eligible to undergo myeloablative conditioning and hematopoietic stem cell transplantation (HSCT);
  • If member has previously received allogeneic HSCT, both of the following:
    • It has been greater than 6 months since the transplant;
    • There is no evidence of residual cells of donor origin;
  • Member has not received prior hematopoietic stem cell gene therapy;
  • Dose is a single infusion containing a minimum of 7 x 106 CD34+ cells per kg.
  • Approval duration: 3 months (one time infusion per lifetime

• Continued Therapy: Wiskott-Aldrich Syndrome
  • Re-authorization is not permitted as Waskyra is indicated to be dosed one time only.
  • Approval duration: Not applicable

Aficamten (Myqorzo) (CP.PHAR.766)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
  • Initial Approval Criteria: Obstructive Hypertrophic Cardiomyopathy (oHCM) (must meet all):
  • Diagnosis of oHCM;
  • Member exhibits New York Heart Association (NYHA) Class II to III symptoms, including but not limited to: effort-related dyspnea or chest pain, or syncope or near syncope attributed to left ventricular outflow tract obstruction;
  • Prescribed by or in consultation with a cardiologist;
  • Age at least 18 years;
  • Member has left ventricular hypertrophy with maximal left ventricular wall thickness of one of the following:
    • at least 15 mm;
    • at least 13 mm if member has familial HCM or in conjunction with a positive genetic test;
  • Member has a left ventricular ejection fraction (LVEF) at least 55%;
  • Member has peak left ventricular outflow tract (LVOT) gradients of both of the following:
    • at least 30 mmHg at rest;
    • at least 50 mmHg with provocation;
  • Failure of TWO of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated:* *For Illinois HIM requests, the step therapy requirements below do not apply as of 1/1/2026 per IL HB 5395
    • Non-vasodilating beta-blocker (e.g., atenolol, metoprolol, bisoprolol, propranolol);
    • Non-dihydropyridine calcium channel blocker (e.g., verapamil, diltiazem);
    • Add-on disopyramide therapy after failure of beta-blocker or calcium channel blocker monotherapy;
  • Myqorzo is not prescribed concurrently with Camzyos®; 10. Dose does not exceed 20 mg per day.
  • Approval duration: 12 months

• Continued Therapy: Obstructive Hypertrophic Cardiomyopathy (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy as evidenced by improvement in obstructive HCM symptoms;
  • Myqorzo is not prescribed concurrently with Camzyos;
  • If request is for a dose increase, new dose does not exceed 20 mg per day.
  • Approval duration: 12 months

Depemokimab-ulaa (Exdensur) (CP.PHAR.767)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria: Severe Asthma* (must meet all):
  • Diagnosis of asthma;
  • Member has an absolute blood eosinophil count at least 150 cells/mcL within the past 3 months;
  • Prescribed by or in consultation with an allergist, immunologist, or pulmonologist;
  • Age at least 12 years;
  • Member has experienced at least 2 exacerbations within the last 12 months, requiring one of the following despite adherent use of controller therapy (i.e., medium- to high-dose inhaled corticosteroid [ICS] plus either a long acting beta-2 agonist [LABA] or leukotriene modifier [LTRA] if LABA contraindication/intolerance):
    • Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid);
    • Urgent care/emergency room (ER) visit or hospital admission;
  • Exdensur is prescribed concurrently with an ICS plus either a LABA or LTRA;
  • Exdensur is not prescribed concurrently with Cinqair®, Fasenra®, Nucala®, Dupixent®, Xolair®, or Tezspire®;
  • Dose does not exceed 100 mg every 6 months.
  • Approval duration: 12 months

• Continued Therapy: Severe Asthma* (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Demonstrated adherence to asthma controller therapy (an ICS plus either an LABA or LTRA) as evidenced by proportion of days covered (PDC) of 0.8 in the last 6 months (i.e., member has received asthma controller therapy for at least 5 of the last 6 months);
  • Member is responding positively to therapy (examples may include but are not limited to: reduction in exacerbations or corticosteroid dose, improvement in forced expiratory volume over one second since baseline, reduction in the use of rescue therapy);
  • Exdensur is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, Xolair, or Tezspire;
  • If request is for a dose increase, new dose does not exceed 100 mg every 6 months.
  • Approval duration: 12 months

Lerodalcibep-liga (Lerochol) (CP.PHAR.768)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
•  
• Initial Approval Criteria: Primary Hypercholesterolemia (including heterozygous familial hypercholesterolemia (HeFH)) and Cardiovascular (CV) Event Risk Reduction (must meet all):
  • Diagnosis of one of the following:
    • HeFH, and both of the following:
      • Baseline low density lipoprotein cholesterol (LDL-C) (prior to any lipid-lowering pharmacologic therapy) was one of the following:
        • If age less than 20 years: at least 160 mg/dL;
        • If age at least 20 years: at least 190 mg/dL;
      • HeFH diagnosis is confirmed by one of the following:
        • World Health Organization (WHO)/Dutch Lipid Network familial hypercholesterolemia diagnostic criteria score of greater than 8 as determined by requesting provider;
        • Definite diagnosis per Simon Broome criteria;
        • Primary hypercholesterolemia that is not HeFH, and both of the following:
          • Documentation of one of the following:
          • Presence of a genetically mediated form of primary hypercholesterolemia as evidenced by confirmatory genetic testing results;
          • A diagnosis of secondary hypercholesterolemia has been ruled out with absence of all of the following potential causes of elevated cholesterol:
            • Poor diet;
            • Hypothyroidism;
            • Obstructive liver disease;
            • Renal liver disease;
            • Nephrosis;
            • Medications that have had a clinically relevant contributory effect on the current degree of the member’s elevated lipid levels including, but not limited to: glucocorticoids, sex hormones, antipsychotics, antiretrovirals, immunosuppressive agents, retinoic acid derivatives;
    • Baseline LDL-C (prior to any lipid-lowering pharmacologic therapy) was at least 190 mg/dL;
  • Increased risk for CV events as evidenced by a history of atherosclerotic cardiovascular disease (ASCVD) including any one of the following conditions (i-vii):
    • Acute coronary syndromes;
    • Clinically significant coronary heart disease (CHD) diagnosed by invasive or noninvasive testing (such as coronary angiography, stress test using treadmill, stress echocardiography, or nuclear imaging);
    • Coronary or other arterial revascularization;
    • Myocardial infarction;
    • Peripheral arterial disease presumed to be of atherosclerotic origin;
    • Stable or unstable angina;
    • Stroke or transient ischemic attack (TIA);
  • Prescribed by or in consultation with a cardiologist, endocrinologist, or lipid specialist;
  • Age at least 18 years;
  • Failure of an 8-week trial of a preferred PCSK9 inhibitor*, if applicable, at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced;^ Prior authorization may be required for PCSK9 inhibitors
  • For members on statin therapy, both of the following:*
    • Lerochol is prescribed in conjunction with a statin at the maximally tolerated dose;
    • Member has been adherent for at least the last 8 weeks to maximally tolerated doses of one of the following statin regimens:
      • A high intensity statin;
      • A moderate or low intensity statin, and member has one of the following:
        • Previous use of one high-intensity statin (i.e., atorvastatin at least 40 mg daily; rosuvastatin at least 20 mg daily [as a single-entity or as a combination product]) for a minimum of 8 weeks continuously and LDL-C remained at least 70 mg/dL;
        • Member has tried both rosuvastatin and atorvastatin and has experienced skeletal-muscle related symptoms on both agents which also resolved upon discontinuation;
  • For members not on statin therapy, member meets one of the following:*
    • Statin therapy is contraindicated:
    • For members who are statin intolerant, both of the following:
      • Member has tried at least two statins, one of which must be hydrophilic (pravastatin, fluvastatin, or rosuvastatin);
      • Member meets one of the following:
      • Member has documented statin risk factors;
      • Member is statin intolerant due to statin-associated muscle symptoms (SAMS) and meets both of the following:
        • Documentation of intolerable SAMS persisting at least two weeks, which disappeared with discontinuing the statin therapy and recurred with a statin re-challenge;
        • Documentation of re-challenge with titration from lowest possible dose and/or intermittent dosing frequency (e.g., 1 to 3 times weekly);
  • Member has been adherent to ezetimibe therapy used concomitantly with a statin at the maximally tolerated dose for at least the last 4 months, unless contraindicated per Appendix F or member has a history of ezetimibe intolerance (e.g., associated diarrhea or upper respiratory tract infection);*
    • Documentation of recent (within the last 60 days) LDL-C of one of the following:
      • If member has ASCVD:
        • at least 70 mg/dL;
        • at least 55 mg/dL, and member is at very high risk;
    • If member has severe primary hypercholesterolemia (including HeFH): at least 100 mg/dL;
  • Treatment plan does not include coadministration with Leqvio^®, Juxtapid^®, Repatha^®, or Praluent^®;
  • Dose does not exceed 300 mg per month.
  • Approval duration: 12 months
• Continued Therapy: Primary Hypercholesterolemia (including HeFH) and Cardiovascular Event Risk Reduction (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • If statin tolerant, documentation of adherence to a statin at the maximally tolerated dose;*
  • Member is responding positively to therapy as evidenced by lab results within the last 3 months showing an LDL-C reduction since initiation of Lerochol therapy;
  • Treatment plan does not include coadministration with Leqvio, Juxtapid, Repatha, or Praluent;
  • If request is for a dose increase, new dose does not exceed 300 mg per month.
  • Approval duration: 12 months

Anitocabtagene autoleucel (KITE-772)_PEPP (CP.PHAR.769_PEPP)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Multiple Myeloma (MM)* (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved *Only for initial treatment dose; subsequent doses will not be covered.
  • Diagnosis of relapsed or refractory MM;*
  • Prescribed by or in consultation with an oncologist or hematologist;
  • Age at least 18 years;
  • One of the following:*
    • Member has measurable disease as evidenced by one of the following assessed within the last 30 days:
      • Serum M-protein at least 1.0 g/dL;
      • Urine M-protein at least 200 mg/24 h;
      • Serum free light chain (FLC) assay: involved FLC level at least 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal;
    • Member has progressive disease, as defined by the  International Myeloma Working Group (IMWG) response criteria, assessed within 60 days following the last dose of the last anti-myeloma drug regimen received;
  • Member has received at least 3 prior lines of therapy, that included all of the following:*
    • One immunomodulatory dru (IMiD) (e.g., Revlimid^®, Pomalyst^®, Thalomid^®);
    • One proteasome inhibitor (PI) (e.g., bortezomib, Kyprolis^®, Ninlaro^®);
    • One anti-CD38 antibody (e.g., Darzalex^®/Darzalex Faspro^™, Sarclisa^®); *Prior authorization may be required. Induction with or without hematopoietic stem cell transplant, consolidation and maintenance therapy is considered a single line of therapy.
  • Member does not have active central nervous system (CNS) involvement by malignancy, or history or presence of clinically relevant CNS pathology (e.g., epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis);*
  • Member has not previously received treatment with anti-BCMA targeted therapy (e.g., Blenrep^™, Tecvayli^™);*
  • Member has not previously received treatment with chimeric antigen receptor (CAR) T-cell immunotherapy (e.g., Abecma^®, Breyanzi^®, Carvykti^™, Kymriah^™, Tecartus^™, Yescarta^™);*
  • KITE-772 is not prescribed concurrently with other CAR T-cell immunotherapy (e.g., Abecma, Breyanzi, Carvykti, Kymriah, Tecartus, Yescarta); *
  • Dose does not exceed 115 x 10⁶ CAR-positive viable T cells.*
  • Approval duration: 3 months (1 dose only, with 4 doses of tocilizumab (Actemra) if requested at up to 800 mg per dose)
• Continued Therapy: Multiple Myeloma: *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as KITE-772 is indicated to be dosed one time only.
  • Approval duration: Not applicable

HSPCs, Tregs, and Tcons (Orca-T)_PEPP (CP.PHAR.770_PEPP)

Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter

Policy includes:

• Criteria is only applicable for Medicaid and CHIP when the drug is added to the medical benefit for coverage
• Criteria will mirror the clinical information from the prescribing information once FDA-approved
• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter, and CP.PMN.53 for Medicaid and CHIP
• Initial Approval Criteria*: Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), and Myelodysplastic Syndromes (MDS) (must meet all): *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Diagnosis of one of the following:*
    • AML or ALL, and one of the following:
      • Disease is in complete remission (CR);
      • Disease is in complete remission with incomplete hematologic recovery (CRi);
    • MDS, and both of the following:
      • Member has at most 10% blast burden in the bone marrow;
      • One of the following:
        • Member is indicated for allogeneic hematopoietic stem cell transplantation (HSCT) per 2017 International Expert Panel recommendations;
        • Member has therapy-related/secondary MDS per the World Health Organization classification of myeloid malignancies;
  • Prescribed by or in consultation with a hematologist, oncologist, or transplant specialist;
  • Age at least 18 years;*
  • Member has a matched donor (related or unrelated) who is an 8/8 match for human leukocyte antigen (HLA)-A, -B, -C, and -DRB1;*
  • Transplant specialist attestation that member is clinically stable and eligible to undergo myeloablative conditioning and allogeneic HSCT;*
  • Member has not received prior allogeneic HSCT or Orca-T transplant;*
  • Member will receive standard of care therapy for prophylaxis of graft-versus-host disease (e.g., tacrolimus, methotrexate, post-transplant cyclophosphamide, anti-thymocyte globulin, sirolimus, alemtuzumab, mycophenolate mofetil, ursodiol) following Orca-T transplant;*
  • Dose does not exceed the FDA-approved maximum.*
  • Approval duration: 3 months (one-time transplant per lifetime)

• Continued Therapy*: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, and Myelodysplastic Syndromes *Criteria will mirror the clinical information from the prescribing information once FDA-approved
  • Continued therapy will not be authorized as there is no evidence to support repeat Orca-T transplants.*
  • Approval duration: Not applicable

Semaglutide (Wegovy) (CP.PMN.295)

Ambetter

Policy updates include:

• Added new formulation Wegovy tablets to policy
• For cardiovascular event prevention, revised language for members with concurrent type 2 diabetes mellitus language from "failure" to "member has received optimal diabetic standard of care therapy as evidenced by a trial" to align with verbiage in metabolic dysfunction-associated steatohepatitis criterion

Etripamil (Cardamyst)  (CP.PMN.306)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Paroxysmal Supraventricular Tachycardia (PSVT) (must meet all):
  • Diagnosis of PSVT confirmed by electrocardiogram (ECG);
  • Prescribed by or in consultation with a cardiologist or electrophysiologist;
  • Age at least 18 years;
  • Member has a history of sustained, symptomatic episodes of PSVT (i.e., typically lasting approximately 20 minutes or longer);
  • One of the following:
    • Member has experienced at least one episode of PSVT that required hospitalization or visit to an emergency department/urgent care within the last 12 months;
    • Member is currently receiving oral pharmacologic therapy for prevention of PSVT episodes (e.g., diltiazem, verapamil, metoprolol, atenolol, propranolol, nadolol, flecainide, propafenone);
  • If member is currently receiving oral pharmacologic therapy for prevention of PSVT episodes, Cardamyst is prescribed concurrently with ongoing oral pharmacologic therapy for prevention;
  • Provider attestation that catheter ablation has been considered but is not appropriate for the member at this time;
    • At the time of request, member has none of the following contraindications:
    • Wolff-Parkinson-White syndrome;
    • Lown-Ganong-Levine syndrome;
    • Manifest pre-excitation (delta wave) on a 12-lead ECG;
    • Second degree atrioventricular (AV) Mobitz 2 block or higher degree of AV block;
    • New York Heart Association (NYHA) Class II to IV heart failure;
    • Sick sinus syndrome without a permanent pacemaker;
  • Request does not exceed 4 nasal spray devices per month;
  • Dose does not exceed both of the following in a 24-hour period:
    • 140 mg;
    • 2 nasal spray devices.
  • Approval duration: 12 months (up to 4 nasal spray devices per month)

• Continued Therapy: Paroxysmal Supraventricular Tachycardia (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Member is responding positively to therapy;
  • If member was previously receiving oral pharmacologic therapy for prevention of PSVT episodes, Cardamyst is prescribed concurrently with ongoing oral pharmacologic therapy for prevention;
  • Request does not exceed 4 nasal spray devices per month;
  • If request is for a dose increase, new dose does not exceed both of the following in a 24-hour period:
    • 140 mg;
    • 2 nasal spray devices.
  • Approval duration: 12 months (up to 4 nasal spray devices per month)

Immune Globulins (HIM.PA.178)

Ambetter

Policy updates include:

• Added off-label measles post-exposure prophylaxis criteria for intravenous immunoglobulin

Depemokimab-ulaa (Exdensur) (HIM.PA.179)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy for the relevant line of business: HIM.PHAR.154 for Ambetter
• Initial Approval Criteria: Severe Asthma (must meet all):
  • Diagnosis of asthma;
  • Member has an absolute blood eosinophil count at least 150 cells/mcL within the past 3 months;
  • Prescribed by or in consultation with an allergist, immunologist, or pulmonologist;
  • Age at least 12 years;
  • Member has experienced at least 2 exacerbations within the last 12 months, requiring one of the following despite adherent use of controller therapy (i.e., medium- to high-dose inhaled corticosteroid [ICS] plus either a long acting beta-2 agonist [LABA] or leukotriene modifier [LTRA] if LABA contraindication/intolerance):
    • Oral/systemic corticosteroid treatment (or increase in dose if already on oral corticosteroid);
    • Urgent care/emergency room (ER) visit or hospital admission;
  • Failure of Dupixent^® and Fasenra^®, each used for at least 4 consecutive months at up to maximally indicated doses, unless clinically significant adverse effects are experienced or both are contraindicated;^ *Prior authorization may be required for Dupixent and Fasenra
  • Exdensur is prescribed concurrently with an ICS plus either a LABA or LTRA;
  • Exdensur is not prescribed concurrently with Cinqair^®, Fasenra, Nucala^®, Dupixent, Xolair^®, or Tezspire^®;
  • Dose does not exceed 100 mg every 6 months.
  • Approval duration: 12 months

• Continued Therapy: Severe Asthma (must meet all):
  • Member meets one of the following:
    • Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
    • Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;
  • Demonstrated adherence to asthma controller therapy (an ICS plus either an LABA or LTRA) as evidenced by proportion of days covered (PDC) of 0.8 in the last 6 months (i.e., member has received asthma controller therapy for at least 5 of the last 6 months);
  • Member is responding positively to therapy (examples may include but are not limited to: reduction in exacerbations or corticosteroid dose, improvement in forced expiratory volume over one second since baseline, reduction in the use of rescue therapy);
  • Exdensur is not prescribed concurrently with Cinqair, Fasenra, Nucala, Dupixent, Xolair, or Tezspire;
  • If request is for a dose increase, new dose does not exceed 100 mg every 6 months.
  • Approval duration: 12 months