POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
|
Ranibizumab (Lucentis, Susvimo), Lucentis Biosimilars (CP.PHAR.186)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Susvimo, updated Food and Drug Administration (FDA) indication to include diabetic retinopathy
|
Treprostinil (Orenitram, Remodulin, Tyvaso, Yutrepia) (CP.PHAR.199)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added new dosage form, Yutrepia
|
Factor VIII (CP.PHAR.215)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated age from at least 12 years of age to at least 7 years of age for Jivi per age extension
|
Dupilumab (Dupixent) (CP.PHAR.336)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- Added new indication for chronic spontaneous urticaria per updated prescribing information.
- For chronic obstructive pulmonary disease, revised postbronchodilator forced expiratory volume in 1 second (FEV1) requirement from 30-70% to 20-80% to align with Nucala
|
Retifanlimab-dlwr (Zynyz) (CP.PHAR.629)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added new Food and Drug Administration (FDA)-approved indication for squamous cell carcinoma of the anal canal
|
Nipocalimab-aahu (Imaavy) (CP.PHAR.720)
| 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 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: Generalized Myasthenia Gravis (gMG) (must meet all):
- Diagnosis of gMG;
- Prescribed by or in consultation with a neurologist;
- Age at least 12 years;
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) score at least 6 at baseline;
- Myasthenia Gravis Foundation of America (MGFA) clinical classification of Class II to IV;
- Member has positive serologic test for one of the following:
- Anti-AChR antibodies;
- Anti-MuSK antibodies;
- If member has positive serologic test for anti-AChR antibodies: Failure of a cholinesterase inhibitor, unless contraindicated or clinically significant adverse effects are experienced;
- Failure of a corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;
- Failure of at least one immunosuppressive therapy, unless clinically significant adverse effects are experienced or all are contraindicated;
- Imaavy is not prescribed concurrently with Bkemv™/Epysqli®/Soliris®, Rystiggo®, Ultomiris®, Vyvgart®, Vyvgart® Hytrulo, or Zilbrysq®;
- Documentation of member’s current weight (in kg);
- Dose does not exceed both of the following:
- Loading dose: 30 mg/kg once;
- Maintenance dose: 15 mg/kg 2 weeks after the loading dose and every 2 weeks thereafter.
- Approval duration: 6 months
- Continued Therapy: Generalized Myasthenia Gravis (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 a 2-point reduction in MG-ADL total score from baseline;
- Imaavy is not prescribed concurrently with Bkemv/Epysqli/Soliris, Rystiggo, Ultomiris, Vyvgart, Vyvgart Hytrulo, or Zilbrysq;
- Documentation of member’s current weight (in kg);
- If request is for a dose increase, new dose does not exceed 15 mg/kg every 2 weeks.
- Approval duration: 6 months
|
Aripiprazole ODT, oral film (Opipza, Mezofy) (CP.PMN.300)
| Ambetter
| Policy updates include:
- Added newly approved Mezofy to policy
|
Mepolizumab (Nucala) (HIM.PA.175)
| Ambetter
| Policy updates include:
- Added criteria for new Food and Drug Administration (FDA) approved indication of chronic obstructive pulmonary disease
|
Dupilumab (Dupixent) (HIM.PA.SP69)
| Ambetter
| Policy updates include:
- Added new indication for chronic spontaneous urticaria
- For chronic obstructive pulmonary disease, revised postbronchodilator forced expiratory volume in 1 second (FEV1) requirement from 30-70% to 20-80% to align with Nucala
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