POLICY
| APPLICABLE PRODUCTS
| NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS
|
Elamipretide (Forzinity) (CP.PHAR.680)
| 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
- Barth Syndrome (must meet all):
- Diagnosis of Barth syndrome confirmed by DNA testing for the presence of a mutation in the tafazzin (TAZ) gene;
- Prescribed by or in consultation with a clinical geneticist, metabolic disease specialist, endocrinologist, cardiologist, hematologist, or neurologist;
- Weight at least 30 kg;
- Documentation of impaired muscle strength (e.g., knee extensor muscle strength measured by handheld dynamometry);
- Dose does not exceed both of the following:
- 40 mg per day;
- 1 vial per 7 days.
- Approval duration: 6 months
- Continued Therapy
- Barth 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;
- Member is responding positively to therapy as evidenced by improvement in muscle strength; (e.g. knee extensor muscle strength measured by handheld dynamometry);.
- If request is for a dose increase, new dose does not exceed both of the following:
- 40 mg per day;
- 1 vial per 7 days.
- Approval duration: 12 months
|
Nerandomilast (Jascayd) (CP.PHAR.759)
| 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
- Idiopathic Pulmonary Fibrosis (IPF) (must meet all):
- Diagnosis of IPF;
- Prescribed by or in consultation with a pulmonologist;
- Age at least 18 years;
- Member meets both of the following:
- Pulmonary fibrosis on high resolution computed tomography (HRCT) with one of the following:
- Usual interstitial pneumonia (UIP) pattern;
- Probable or indeterminate UIP pattern, and surgical lung biopsy, cellular analysis of bronchoalveolar lavage fluid, or transbronchial lung cryobiopsy confirms the diagnosis of IPF;
- Known causes of pulmonary fibrosis have been ruled out;
- Baseline forced vital capacity (FVC) at least 45% of predicted;
- Baseline carbon monoxide diffusing capacity (DLCO) at least 25% of predicted;
- If prescribed in combination with Ofev® or pirfenidone (Esbriet®), documentation supports inadequate response to monotherapy with Ofev or pirfenidone (Esbriet) at up to maximally indicated doses;
- Request does not exceed health plan-approved quantity limit, if applicable;
- Dose does not exceed both of the following:
- 36 mg per day;
- 2 tablets per day.
- Approval duration: 12 months
- Continued Therapy
- Idiopathic Pulmonary Fibrosis (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;
- Request does not exceed health plan-approved quantity limit, if applicable;
- If request is for a dose increase, new dose does not exceed both of the following:
- 36 mg per day;
- 2 tablets per day.
- Approval duration: 12 months
|
Benralizumab (Fasenra) (HIM.PA.SP70)
| Ambetter
| Policy updates include:
- Revised eosinophilic granulomatosis with polyangiitis criteria as follows: added option for eosinophilia to be evidenced by blood eosinophil level at least 150 cells/µl prior to treatment with a monoclonal antibody therapy that can alter blood eosinophil levels
- Modified requirement for “failure of a 4-week trial of a glucocorticoid” to “currently receiving standard therapy for eosinophilic granulomatosis with polyangiitis (i.e., glucocorticoid)”
|
Immune Globulins (CP.PHAR.103)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS) and CHIP
| Policy updates include:
- Added Qivigy to the policy
- Updated Appendix G with revised language and exception for Tennessee
|
Avatrombopag (Doptelet, Doptelet Sprinkle) (CP.PHAR.130)
| Ambetter
| Policy updates include:
- Removed redirection to immune globulin if intolerant or contraindicated to systemic corticosteroid
|
Immune Globulins (HIM.PA.178)
| Ambetter
| Policy updates include:
- Added Qivigy to the policy
|
Pertuzumab (Perjeta, Poherdy) (CP.PHAR.227)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added newly approved biosimilar, Poherdy
|
Obinutuzumab (Gazyva) (CP.PHAR.305)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added new indication of lupus nephritis
|
Daratumumab, Daratumumab-Hyaluronidase-fihj (Darzalex, Darzalex Faspro) (CP.PHAR.310)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Darzalex Faspro added to Food and Drug Administration (FDA) approved indications new use for high-risk smoldering multiple myeloma as monotherapy
- For light chain amyloidosis removed statement regarding accelerated approval to reflect conversion to full approval
- Modified approval durations for Medicaid/Ambetter to 12 months
|
Durvalumab (Imfinzi) (CP.PHAR.339)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added criteria for newly Food and Drug Administration (FDA)-approved indication as neoadjuvant/adjuvant therapy for resectable gastric or gastroesophageal junction adenocarcinoma in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT)
- Added off-label use as induction therapy for esophageal or esophagogastric (gastroesophageal) junction adenocarcinoma per National Comprehensive Cancer Network (NCCN)
- For Medicaid/Ambetter, extended initial approval durations from 6 to 12 months
|
Lurbinectedin (Zepzelca) (CP.PHAR.500)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added option for combination use with Tecentriq or Tecentriq Hybreza following combination use with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide for extensive-stage small cell lung cancer per prescribing information
- Extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition.
|
Tarlatamab-dlle (Imdelltra) (CP.PHAR.685)
| Ambetter
| Policy updates include:
- Updated Food and Drug Administration (FDA) Approved Indication(s) section to reflect conversion from accelerated approval to full approval
- For Medicaid/Ambetter, extended initial approval duration from 6 to 12 months
|
Lumateperone (Caplyta) (CP.PMN.232)
| Ambetter
| Policy updates include:
- Added new indication for use as adjunctive treatment in major depressive disorder
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