POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Amikacin (Arikayce) (CP.PHAR.401)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added requirement that member has not received more than 12 months of treatment following conversion to negative sputum status to support existing continued authorization coverage duration requirements
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Atezolizumab (Tecentriq) (CP.PHAR.235)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Removed breast cancer indication and added NSCLC stage II to IIIA treatment indication per updated label
- Added criterion for use as single-agent therapy for urothelial carcinoma per NCCN
- Added criterion for Child-Pugh class A status in HCC per NCCN
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Avapritinib (Ayvakit) (CP.PHAR.454)
| Ambetter
| Policy updates include:
- Added documentation of platelet count ≥ 50 x 109/L (≥ 50,000/mcL) based on NCCN Compendia and prescribing information for systemic mastocystosis
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Avelumab (Bavencio) (CP.PHAR.333)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added criterion that Bavencio be used as single-agent therapy for urothelial carcinoma per NCCN
- Added endometrial carcinoma indication per NCCN
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Brentuximab Vedotin (Adcetris) (CP.PHAR.303)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Initial approval duration shortened from 12 months to 6 months
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C1 Esterase Inhibitors (Berinert Cinryze Haegarda Ruconest) (CP.PHAR.202)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated diagnosis criteria to include a recurrent history of angioedema and either an associated mutation or family history of angioedema with failure of high-dose antihistamines for HAE-nl-C1INH
- Added criterion for age ≥ 18 years for Firazyr redirection
- Clarified the number of doses for treatment of acute attacks and short-term prophylaxis within criteria
- Added auth duration of 4 weeks for short-term prophylaxis
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Ciclopirox (Penlac) (CP.PMN.24)
| Ambetter
| Policy updates include:
- For continued therapy added criteria to ensure member has not received more than 48 weeks of treatment
- Modified approval duration to allow up to 48 weeks of total treatment
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Dupilumab (Dupixent) (CP.PHAR.336)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Expanded age to 6+ years old for asthma and added new 100 mg prefilled syringe formulation
- Added “Acute bronchospasm or status asthmaticus” to section III as indications for which coverage is not authorized per PI
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Ecallantide (Kalbitor) (CP.PHAR.177)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated diagnosis criteria to include a recurrent history of angioedema and either an associated mutation or family history of angioedema with failure of high-dose antihistamines for HAE-nl-C1INH
- Clarified the number of doses for treatment of acute attacks and short-term prophylaxis within criteria
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Efinaconazole (Jublia) (CP.PMN.25)
| Ambetter
| Policy updates include:
- For continued therapy added criteria to ensure member has not received more than 48 weeks of treatment
- Modified approval duration to allow up to 48 weeks of total treatment
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Erwinia Asparaginase (Erwinaze, Rylaze) (CP.PHAR.301)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Specified only Erwinaze recommended for ALL induction therapy per NCCN
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Fostemsavir (Rukobia) (CP.PHAR.516)
| Ambetter
| Policy updates include:
- Clarified that HIV-1 infection should be multi-drug resistant per FDA labeling
- Added requirement for documentation of resistance to at least 1 antiretroviral agent from each of 3 classes (NRTI, NNRTI, PI) as pivotal trial inclusion criteria limited enrollment to those with have ≤ 2 classes of antiretroviral medications remaining at baseline
- Removed requirement for “3 month trial” of Selzentry/Fuzeon and added bypass if member is resistant to both, and revised language for concurrent use with other antiretrovirals
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Givosiran (Givlaari) (CP.PHAR.457)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Clarified that ALA/PBG urine sample must be recent (within the past year)
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Human Growth Hormone (Somapacitan, Somatropin) (CP.PHAR.517)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP
| Policy updates include:
- Modified Zomacton redirection to state member must use
- For adult GHD continuation of therapy added requirement that member is responding positively to therapy
- Sogroya added new 5 mg/1.5 mL formulation
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Human Growth Hormone (Somapacitan, Somatropin)(HIM.PA.161)
| Ambetter
| Policy updates include:
- For adult GHD continuation of therapy added requirement that member is responding positively to therapy
- For ISS clarified that both height criteria are required (SD and predicted height)
- Sogroya added new 5 mg/1.5 mL formulation
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Ibrutinib (Imbruvica) (CP.PHAR.126)
| Ambetter
| Policy updates include:
- Removed indication for CLL/SLL histologic (Richter's) transformation per NCCN as it is now category 2B
- Added indication of lymphoplasmacytic lymphoma to WM criteria per NCCN
- Updated primary CNS lymphoma criterion that ibrutinib may be used as either induction therapy or for relapsed or refractory disease per NCCN
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Icatibant (Firazyr) (CP.PHAR.178)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated diagnosis criteria to include a recurrent history of angioedema and either an associated mutation or family history of angioedema with failure of high-dose antihistamines for HAE-nl-C1INH
- Clarified the number of doses for treatment of acute attacks within criteria
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Interferon Beta-1b (Betaseron, Extavia) (CP.PHAR.256 and CP.PCH.46)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Removed specialist prescribing requirement
- Modified current Extavia redirection requirements to apply to Betaseron instead, removing redirection requirements for Extavi
- For secondary progressive MS added requirement for Betaseron to require failure of an interferon beta agent
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Lanadelumab-fylo (Takhzyro) (CP.PHAR.396)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated diagnosis criteria to include a recurrent history of angioedema and either an associated mutation or family history of angioedema with failure of high-dose antihistamines for HAE-nl-C1INH
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Lifitegrast (Xiidra) (CP.PMN.73)
| Ambetter
| Policy updates include:
- Added requirement for topical anti-inflammatory agents
- Reduced the number of wetting agents required from 2 to 1
- Removed duration of trial
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Mepolizumab (Nucala) (CP.PHAR.200)
| Ambetter
| Policy updates include:
- For EGPA, added diagnostic criteria and requirement for relapsing or refractory disease and modified glucocorticoid trial from 3 months to 4 weeks
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Mometasone Furoate (Sinuva) (CP.PHAR.448)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Specified that one of the tried intranasal steroids must be Xhance
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Nivolumab (Opdivo) (CP.PHAR.121)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updates made per NCCN: for urothelial carcinoma removed requirement for resection to be radical as NCCN also supports partial resection prior to adjuvant therapy and added treatment option of high-risk recurrence as an optional criterion
- Added cervical cancer as off-label indication
- Updated gestational trophoblastic neoplasia treatment settings
- Added criterion for use as single-agent therapy for SCCHN
- Clarified uveal melanoma to be metastatic
- Removed “metastatic” designation for Merkel cell carcinoma
- Clarified small bowel adenocarcinoma be advanced or metastatic
- Small cell lung cancer indication added
- Clarified extranodal NK/T-cell lymphoma to be relapsed or refractory
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Olaparib (Lynparza) (CP.PHAR.360)
| Ambetter
| Policy updates include:
- Added that mutation analysis must be confirmed on a CLIA approved diagnostic test (e.g., Foundation One CDx or BRAC Analysis CDx)
- Added in continued therapy section that total treatment duration as adjuvant therapy in breast cancer does not exceed 1 year
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Ondansetron (Zuplenz) (CP.PMN.45)
| Ambetter
| Policy updates include:
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Pemetrexed (Alimta, Pemfexy) (CP.PHAR.368)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added other sources of malignant mesotheliomas per NCCN
- Added criterion for use as single-agent therapy for thymomas/thymic carcinomas, ovarian/fallopian tube/primary peritoneal cancers, and primary central nervous system lymphomas per NCCN
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Pyrimethamine (Daraprim) (CP.PMN.44)
| Ambetter
| Policy updates include:
- For continuation of therapy, added specific CD4 requirements for members aged < 6 years per HHS guidelines.
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Ramucirumab (Cyramza) (CP.PHAR.119)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Revised criteria for advanced esophageal, EGJ or gastric cancer allowing combination with irinotecan with or without fluorouracil and added requirement for unresectable, locally advanced, recurrent, or metastatic disease per NCCN
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Ranibizumab (Byooviz, Lucentis, Susvimo) (CP.PHAR.186)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Shortened approval durations from 12 months to 3 months for mCNV and 6 months for all other indications
- Added Byoorivz and Susvimo to policy
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Ravulizumab-cwvz (Ultomiris) (CP.PHAR.415)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For PNH, added requirement for no concurrent use with Empaveli
- Added amyotrophic lateral sclerosis to section III as an indication not covered due to lack of efficacy
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Repository Corticotropin Injection (H.P. Acthar Gel) (CP.PHAR.168)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added Purified Cortrophin Gel to policy
- For Acthar added step through Purified Cortrophin Gel
- For infantile spasm added requirement that diagnosis is confirmed by EEG per competitor analysis
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Rimegepant (Nurtec ODT) (CP.PHAR.490)
| Ambetter
| Policy updates include:
- For migraine prophylaxis added redirection to newly approved oral CGRP Qulipta
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Secnidazole (Solosec) (CP.PMN.103)
| Ambetter
| Policy updates include:
- Specified that the requirement for the prior trial of the two generic ophthalmic agents be for agents from different therapeutic classes
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Sodium Oxybate (Xyrem) and Calcium, Magnesium, Potassium, Sodium Oxybate (Xywav) (CP.PMN.42)
| Ambetter
| Policy updates include:
- For narcolepsy with cataplexy added redirection to Xyrem for Xywav requests
- For narcolepsy with EDS added requirement for redirection to Wakix (and for Xywav additional redirection to Xyrem) in a step-wise fashion
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Tavaborole (Kerydin) (CP.PMN.105)
| Ambetter
| Policy updates include:
- For continued therapy added criteria to ensure member has not received more than 48 weeks of treatment
- Modified approval duration to allow up to 48 weeks of total treatment per prescribing information
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Teduglutide (Gattex) (CP.PHAR.114)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added minimum weight requirement based on prescribing information
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Tenapanor (Ibsrela) (CP.PMN.224)
| Ambetter
| Policy updates include:
- Added redirection to generic lubiprostone
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Tisagenlecleucel (Kymriah) (CP.PHAR.361)
| Ambetter
| Policy updates include:
- Added requirement that member has not previously received CAR-T therapy and Kymriah is not prescribed concurrently with other CAR-T therapy
- For ALL clarified that hematopoietic stem cell transplantation should more specifically refer to allogeneic stem cell transplantation
- Added preemptive criteria for the pending FDA approval of FL indication
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Triamcinolone ER Injection (Zilretta) (CP.PHAR.371)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added requirement for diagnosis to be confirmed by imaging and added sports medicine physician as acceptable specialist
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Vandetanib (Caprelsa) (CP.PHAR.80)
| Ambetter
| Policy updates include:
- Clarified DTC be recurrent, advanced or metastatic per NCCN
- Removed lung cancer indication as it now carries a NCCN category 2B rating
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