POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
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Concizumab (NN7415) (CP.PHAR.625)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary 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: Congenital Hemophilia A or B With Inhibitors (must meet all):
- Prescribed for routine prophylaxis of bleeding episodes in patients with congenital hemophilia A (factor VIII deficiency) or congenital hemophilia B (factor IX deficiency);
- Prescribed by or in consultation with a hematologist;
- Age ≥ 12 years;
- Member has inhibitor level ≥ 5 Bethesda units (BU);
- Provider confirms that member will discontinue any use of bypassing agents, factor VIII products, or factor IX products as prophylactic therapy while on NN7415 (ondemand usage may be continued);
- Documentation of member’s current body weight (in kg);
- Dose does not exceed one loading dose of 1 mg/kg followed by 0.25 mg/kg per day.
- Approval duration: 6 months
- Continued Approval Therapy: Congenital Hemophilia A or B With Inhibitors (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 responding positively to therapy;
- Documentation of member’s current body weight (in kg);
- If request is for a dose increase, new dose does not exceed 0.25 mg/kg per day.
- Approval duration: 6 months
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Pozelimab (REGN3918) (CP.PHAR.626)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary 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: CD55-deficient protein-losing enteropathy Disease (must meet all):
- Diagnosis of CD55-deficient protein-losing enteropathy disease confirmed by biallelic CD55 loss-of-function mutation detected by genotype analysis;
- Prescribed by or in consultation with a gastroenterologist or physician specializing in rare genetic disorders;
- Age ≥ 1 year;
- Dose does not exceed the following:
- A single loading dose of 30 mg/kg intravenously on day 1;
- Subcutaneous weekly weight-based doses thereafter.
- Approval duration: 6 months
- Continued Approval Therapy: CHAPLE Disease (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 responding positively to therapy;
- If request is for a dose increase, new dose does not exceed subcutaneous weekly weight-based dose.
- Approval duration: 12 months
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Lovotibeglogene Autotemcel (Lovo-Cel) (CP.PHAR.627)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Criteria will mirror the clinical information from the prescribing information once FDA-approved
- Criteria is only applicable for Medicaid and CHIP when the drug is added to the formulary 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: Sickle Cell Disease (must meet all):
- Diagnosis of Sickle Cell Disease with one of the following genotypes:
- Age ≥ 12 years;
- Prescribed by or in consultation with a hematologist and transplant specialist;
- Member meets one of the following:
- Member has experienced at least 1 vaso-occlusive crisis (VOC) within the past 6 months while on hydroxyurea at up to maximally indicated doses;
- Member has intolerance or contraindication to hydroxyurea and has experienced at least 2 VOC within the past 12 months
- Attestation from transplant specialist for both of the following:
- Member understands the risk and benefits of alternative therapeutic options such as allogenic hematopoietic stem cell transplantation (HSCT);
- Member is clinically stable and eligible to undergo myeloablative conditioning and HSCT;
- Member has not received prior allogenic HSCT or gene therapy;
- Member does not have two α-globin gene deletions (i.e., alpha-thalassemia trait);
- Dose does not exceed the FDA-labeled maximum dose.
- Approval duration: 3 months (one infusion per lifetime)
- Continued Approval Therapy: Sickle Cell Disease:
- Continued therapy will not be authorized as Lovo-Cel is indicated to be dosed one time only.
- Approval duration: Not applicable
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Daprodustat (Jesduvroq) (CP.PHAR.628)
| Ambetter
| Policy includes:
- Initial Approval Criteria: Anemia due to Chronic Kidney Disease (must meet all):
- Diagnosis of anemia of Chronic Kidney Disease;
- Age ≥ 18 years;
- Prescribed by or in consultation with a hematologist or nephrologist;
- Member has received dialysis for ≥ 4 months;
- Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%;
- Pretreatment hemoglobin level of 8 to 11.5 g/dL;
- Member meets one of the following:
- Failure of Retacrit®, unless contraindicated or clinically significant adverse effects are experienced;
- If Retacrit is unavailable due to shortage, failure of Epogen®, unless contraindicated or clinically significant adverse effects are experienced.
- Approval duration: 6 months
- Continued Approval Therapy
- Anemia due to Chronic Kidney Disease (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 responding positively to therapy;
- Adequate iron stores as indicated by current (within the last 3 months) serum ferritin level ≥ 100 mcg/L or serum transferrin saturation ≥ 20%.
- Approval duration: 6 months
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Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Initial Approval Criteria: Merkel Cell Carcinoma (must meet all):
- Diagnosis of Merkel Cell Carcinoma;
- Prescribed by or in consultation with an oncologist;
- Age ≥ 18 years;
- Disease is metastatic or recurrent, locally advanced;
- Disease is not amenable to surgery or radiation therapy;
- Request meets one of the following:
- Dose does not exceed 500 mg (1 vial) every four weeks;
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
- Approval duration: 6 months
- Continued Approval Therapy: Merkel Cell Carcinoma (must meet all):
- Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Zynyz for a covered indication and has received this medication for at least 30 days;
- Member is responding positively to therapy;
- If request is for a dose increase, request meets one of the following:
- New dose does not exceed 500 mg (1 vial) every four weeks;
- New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use.
- Approval duration: 12 months
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Zavegepant (Zavzpret) (CP.PHAR.630)
| Ambetter
| Policy includes:
- Initial Approval Criteria: Acute Migraine Treatment (must meet all):
- Diagnosis of migraine headaches;
- Age ≥ 18 years;
- Failure of at least TWO formulary 5HT1B/1D-agonist migraine medications* (e.g., sumatriptan, rizatriptan, zolmitriptan) at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated;
- Failure of Ubrelvy®* (at up to maximally indicated doses), unless contraindicated or clinically significant adverse effects are experienced;
- For requests of monthly quantities > 1 box of 6 nasal spray devices per month, member meets all of the following:
- Failure of at least TWO oral migraine prophylactic therapies from different therapeutic classes, each for 8 weeks, unless clinically significant adverse effects are experienced or all are contraindicated;
- Failure of at 3-month trial of at least ONE injectable CGRP inhibitor* used for migraine prophylaxis, unless clinically significant adverse effects are experienced or all are contraindicated;
- Member is being treated by or in consultation with a neurologist, headache, or pain specialist;
- Zavzpret is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig®, Ajovy®, Emgality®, Nurtec® ODT, Qulipta™, Ubrelvy, Vyepti™)
- Dose does not exceed 10 mg (1 nasal spray device) per day and 8 days per month.
- Approval duration: 6 months
- Continued Approval Therapy: Migraines (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 responding positively to therapy;
- For requests of monthly quantities > 1 box of 6 nasal spray devices per month, member meets all of the following:
- Failure of at least TWO oral migraine prophylactic therapies from different therapeutic classes, each for 8 weeks, unless clinically significant adverse effects are experienced or all are contraindicated;
- Failure of at 3-month trial of at least ONE injectable CGRP inhibitor* used for migraine prophylaxis, unless clinically significant adverse effects are experienced or all are contraindicated;
- Member is being treated by or in consultation with a neurologist, headache, or pain specialist;
- Zavzpret is not prescribed concurrently with other CGRP inhibitors (e.g., Aimovig, Ajovy, Emgality, Nurtec ODT, Qulipta, Ubrelvy, Vyepti);
- If request is for a dose increase, new dose does not exceed 10 mg (1 nasal spray device) per day and 8 days per month.
- Approval duration: 12 months
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Sparsentan (Filspari) (CP.PHAR.631)
| Ambetter
| Policy includes:
- Initial Approval Criteria: Immunoglobulin A Nephropathy (must meet all):
- Diagnosis of Immunoglobulin A Nephropathy confirmed via kidney biopsy;
- Prescribed by or in consultation with a nephrologist;
- Age ≥ 18 years;
- Documentation of both of the following:
- Proteinuria of ≥ 1 g/day;
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2;
- Member meets both of the following, unless contraindicated or clinically significant adverse effects are experienced:
- Failure of a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., irbesartan, losartan, lisinopril, benazepril) for at least 12 weeks;
- RAAS inhibitor therapy dose was at least 50% of maximum labeled dose;
- Filspari is not prescribed concurrently with RAAS inhibitors, endothelin receptor antagonists (ERAs), or aliskiren;
- Dose does not exceed both of the following:
- 400 mg per day;
- 1 tablet per day.
- Approval duration: 6 months
- Continued Approval Therapy: Immunoglobulin A Nephropathy (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 responding positively to therapy as evidenced by one of the following:
- Decrease in UPCR from baseline;
- Reduction of proteinuria as evidence by a lower total urine protein per day from baseline;
- If request is for a dose increase, new dose does not exceed both of the following:
- 400 mg per day;
- 1 tablet per day.
- Approval duration: 12 months
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Repository Corticotropin Injection (H.P. Acthar Gel, Purified Cortrophin Gel) (HIM.PA.168)
| Ambetter
| Policy includes:
- Initial Approval Criteria: West Syndrome (Infantile Spasms) (must meet all):
- Diagnosis of West syndrome (infantile spasms);
- Request is for H.P. Acthar Gel;
- Diagnosis is confirmed by electroencephalogram (EEG);
- Prescribed by or in consultation with a neurologist;
- Age < 2 years;
- Dose does not exceed 150 U/m2 per day (divided into twice daily injections of 75 U/m2).
- Approval duration: 3 months
- Initial Approval Criteria: Multiple Sclerosis (must meet all):
- Diagnosis of multiple sclerosis;
- Prescribed by or in consultation with a neurologist;
- Age ≥ 18 years;
- Prescribed for acute exacerbations of multiple sclerosis;
- Failure of a recent (within the last 30 days) trial of at least a 7-day course of corticosteroid therapy for acute exacerbations of MS, unless contraindicated or clinically significant adverse effects are experienced;
- Member has not received treatment with H.P. Acthar Gel or Purified Cortrophin Gel for the current MS exacerbation;
- Member has been adherent to disease modifying therapy for MS (e.g., Aubagio®, Avonex®, Betaseron®, Copaxone®, Gilenya®, Plegridy®, Rebif®);
- For Purified Cortrophin Gel requests, member must use H.P. Acthar Gel, unless contraindicated or clinically significant adverse effects are experienced;
- Dose does not exceed 120 units (1.5 mL) per day and 6 vials total.
- Approval duration: 3 weeks
- Initial Approval Criteria: Nephrotic Syndrome (must meet all):
- Diagnosis of nephrotic syndrome associated with one of the following (a - f):
- Idiopathic membranous nephropathy (IMN);
- Focal segmental glomerulosclerosis;
- Minimal change disease (MCD);
- Membranoproliferative glomerulonephritis;
- Lupus nephritis;
- IgA nephropathy;
- Prescribed by or in consultation with a nephrologist;
- Age > 2 years;
- Failure of oral corticosteroid therapy, unless contraindicated or clinically significant adverse effects are experienced;
- For IMN and MCD: Failure of cyclophosphamide, unless contraindicated or clinically significant adverse effects are experienced;
- Failure of two of the following, unless clinically significant adverse effects are experienced or all are contraindicated: tacrolimus, cyclosporine, mycophenolate, rituximab;
- For Purified Cortrophin Gel requests, member must use H.P. Acthar Gel, unless contraindicated or clinically significant adverse effects are experienced;
- Dose does not exceed 80 units (1 mL) per day.
- Approval duration: 3 months
- Continued Therapy: West Syndrome (Infantile Spasms) (must meet all):
- Member meets one of the following:
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
- Age < 2 years;
- Member is responding positively to therapy;
- If request is for a dose increase, new dose does not exceed 150 U/m2 per day (divided into twice daily injections of 75 U/m2).
- Approval duration: 3 months (one renewal limit)
- Continued Therapy: Multiple Sclerosis
- Re-authorization is not permitted. H.P. Acthar is not indicated for continuous use for this indication. Members must meet the initial approval criteria.
- Approval duration: Not applicable
- Continued Therapy: Nephrotic 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 responding positively to therapy;
- For Purified Cortrophin Gel requests, member must use H.P. Acthar Gel, unless contraindicated or clinically significant adverse effects are experienced;
- If request is for a dose increase, new dose does not exceed 80 units (1 mL) per day.
- Approval duration: 3 months
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Aflibercept (Eylea) (CP.PHAR.184)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added criteria for newly FDA-approved indication of retinopathy of prematurity;
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Pegcetacoplan (Empaveli, Syfovre) (CP.PHAR.524)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Intravitreal pegcetacoplan (Syfovre) is now FDA approved for geographic atrophy criteria updated per FDA labeling: revised maximum dosing frequency from every month to every 25 days
- Clarified that choroidal neovascularization exclusion applies only to the eye(s) affected by geographic atrophy per OAKS/DERBY study design;
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Trofinetide (Daybue) (CP.PHAR.600)
| Ambetter
| Policy includes:
- Initial Approval Criteria: Rett Syndrome (must meet all):
- Diagnosis of Rett Syndrome with both of the following:
- Classic/typical Rett Syndrome;
- MECP2 gene mutation confirmed by genetic testing;
- Prescribed by or in consultation with a pediatric neurologist, geneticist, or developmental pediatrician;
- Age ≥ 2 years;
- Weight ≥ 9 kg;
- Member has had no seizures or has a stable pattern of seizures (e.g., no changes in seizure frequency, antiepileptic drugs, or behavioral treatments);
- Documentation of one of the following baseline assessment scores:
- Rett Syndrome Behavior Questionnaire (RSBQ);
- Clinical Global Impression-Severity (CGI-S) of ≥ 4;
- At the time of request, member does not have either of the following:
- Long QT syndrome or baseline QTcF interval > 450 msec;
- Current treatment with insulin;
- Dose does not exceed any of the following:
- Weight 9 kg to < 12 kg: 10,000 mg (50 mL) per day;
- Weight 12 kg to < 20 kg: 12,000 mg (60 mL) per day;
- Weight 20 kg to < 35 kg: 16,000 mg (80 mL) per day;
- Weight 35 kg to < 50 kg: 20,000 mg (100 mL) per day;
- Weight ≥ 50 kg: 24,000 mg (120 mL) per day.
- Approval duration: 6 months
- Continued Therapy: Rett 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 responding positively to therapy as evidenced by, including but not limited to, improvement in any of the following parameters:
- ≥ 3-point reduction in overall RSBQ total score from baseline;
- If the member has received Daybue for 6 months or less, they currently must have a CGI-I score between 1-4;
- If the member has received Daybue for more than 6 months, they currently must have a CGI-I score between 1-3;
- If request is for a dose increase, new does not exceed any of the following:
- Weight 9 kg to < 12 kg: 10,000 mg (50 mL) per day;
- Weight 12 kg to < 20 kg: 12,000 mg (60 mL) per day;
- Weight 20 kg to < 35 kg: 16,000 mg (80 mL) per day;
- Weight 35 kg to < 50 kg: 20,000 mg (100 mL) per day;
- Weight ≥ 50 kg: 24,000 mg (120 mL) per day.
- Approval duration: 6 months
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Velmanase Alfa-tycv (Lamzede) (CP.PHAR.601)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy includes:
- Initial Approval Criteria: Alpha-Mannosidosis (must meet all):
- Diagnosis of AM confirmed by one of the following:
- Reduced AM activity defined as < 10% of normal activity in leukocytes or fibroblasts cells;
- Genetic testing revealing biallelic MAN2B1 gene mutation;
- Prescribed by or in consultation with an endocrinologist, neurologist, ophthalmologist, clinical geneticist, or specialist familiar with the treatment of lysosomal storage disorders;
- Member does not have central nervous system manifestations of AM;
- Member is able to ambulate independently;
- Member has not previously received a bone marrow transplant or hematopoietic stem cell transplantation;
- Documentation of current actual body weight in kg;
- Dose does not exceed 1 mg/kg (actual body weight) per week.
- Approval duration: 6 months
- Continued Approval Therapy:Alpha-Mannosidosis (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 responding positively to therapy as evidenced by stabilization or improvement in, but not limited to, any of the following parameters:
- Serum oligosaccharides levels;
- 3-minute stair climb test;
- 6-minute walk test;
- Bruininks-Oseretsky test of motor proficiency;
- Forced vital capacity;
- Documentation of current actual body weight in kg;
- If request is for a dose increase, new dose does not exceed 1 mg/kg (actual body weight) per week.
- Approval duration: 6 months
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