Policy
| Applicable Products
| New Policy Overview or Updated Policy Revisions
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Buprenorphine (Sublocade, Brixadi) (CP.PHAR.289)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Sublocade, updated criteria to include FDA approved rapid initiation protocol (previously required 7 days of transmucosal buprenorphine)
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Denosumab (Prolia, Xgeva), Denosumab-bbdz (Jubbonti, Wyost), Denosumab-dssb (Ospomyv, Xbryk), Denosumab-bmwo (Stoboclo, Osenvelt) (CP.PHAR.58)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added new biosimilars denosumab-dssb, Osenvelt, Ospomyv, Stoboclo, and Xbryk to criteria
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Eladocagene Exuparvovec-tneq (Kebilidi) (CP.PHAR.595)
| Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Revised initial criteria to clarify anti-AAV2 (recombinant serotype 2 adeno-associated virus) neutralizing antibody titer “does not exceed > 1,200 fold.”
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Compounded Medications (CP.PMN.280)
| Ambetter
| Policy updates include:
- Added criterion to check benefit master grid to ensure coverability for Medicaid members
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| Omalizumab (Xolair, Omlyclo) (CP.PCH.49) | Ambetter
| Policy updates include:
- Added newly approved biosimilar Omlyclo.
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| Tesamorelin(Egrifta SV, Egrfita WR) (CP.PHAR.109) | Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Added newly approved Egrifta WR formulation
- Dose limit added for WR
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Corticosteroids
for ophthalmic inj (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq)(CP.PHAR.385) | Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- For Iluvien, added newly approved indication for non-infectious uveitis affecting the posterior segment of the eye
- For Appendix C, updated contraindications section for Iluvien, Ozurdex, and Yutiq to align with prescribing information
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| Selinexor (Xpovio) (CP.PHAR.431) | Ambetter
| Policy updates include:
- Added new 10 mg strength tablet
- Aligned B-cell lymphoma maximum dosing criteria from 60 mg twice a week to 120 mg per week and from 3 tablets twice a week to 6 tablets per week.
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| Tislelizumab-jsgr (Tevimbra) (CP.PHAR.687) | Medicaid (STAR, STAR Health, STAR Kids, STAR+PLUS), CHIP, and Ambetter
| Policy updates include:
- Updated criteria to include new indication for first-line esophageal squamous cell carcinoma treatment in combination with platinum-containing chemotherapy whose tumors express PD-L1 (at least 1)
- For esophageal squamous cell carcinoma, added bypass option for disease criteria of unresectable, locally advanced, recurrent, or metastatic if member is planned for esophagectomy
- For gastric or gastroesophageal junction adenocarcinoma, added option for locally advanced, recurrent disease
- Added criteria for off-label indications: anal carcinoma, chronic lymphocytic leukemia or small lymphocytic lymphoma with histologic (Richter) transformation to diffuse B-cell lymphoma, head and cancers, hepatocellular carcinoma, small bowel adenocarcinoma, and colorectal cancer as supported by National Comprehensive Cancer Network (NCCN)
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| Fitusiran (Qfitlia) (CP.PHAR.706) | 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: Congenital Hemophilia A or B (must meet all):
- Prescribed for routine prophylaxis of bleeding episodes in members with one of the following:
- Congenital hemophilia A (FVIII deficiency);
- Congenital hemophilia B (FIX deficiency);
- Prescribed by or in consultation with a hematologist;
- Age at least 12 years;
- Antithrombin (AT) activity at least 60%;
- For members who are new to Qfitlia therapy and have not previously used bypassing agents, FVIII, or FIX products for routine prophylaxis: Member meets one of the following:
- For hemophilia A: Member has severe hemophilia, defined as a FVIII level at most 1%;
- For hemophilia B: Member has moderately severe to severe hemophilia, defined as a FIX level at most 2%;
- Member has experienced at least one serious spontaneous bleed;
- Member meets one of the following:
- Failure of a bypassing agent, FVIII, or FIX* product used for routine prophylaxis as assessed and documented by prescriber;
- Member had ≥ 6 acute bleeding episodes in the previous 6 months treated with a bypassing agent, FVIII, or FIX product; *Prior authorization may be required for bypassing agents, FVIII, and FIX products
- Provider confirms that member will discontinue any use of Hemlibra®, bypassing agents, FVIII, or FIX products as prophylactic therapy while on Qfitlia (on-demand usage may be continued);
- Dose does not exceed 50 mg per month.
- Approval duration: 6 months (12 months for HIM Texas)
- Continued Therapy: Congenital Hemophilia A or B (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., reduction in the number of all bleeds, joint bleeds, and/or target joint bleeds over time);
- Provider confirms that member will discontinue any use of Hemlibra, bypassing agents, FVIII, or FIX products as prophylactic therapy while on Qfitlia (on-demand usage may be continued);
- If request is for a dose increase, new dose does not exceed 50 mg per month.
- Approval duration: 12 months
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| Housedust mite allergen extract (Odactra) (CP.PMN.111) | Ambetter
| Policy updates include:
- Updated indication and criteria with pediatric expansion to age 5 years.
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| GLP-1receptor agonists (HIM.PA.53) | Ambetter
| Policy updates include:
- Updated policy to reflect Ozempic’s new Food and Drug Administration (FDA) indication for use in diabetic patients with chronic kidney disease
- Added “renal” benefit to criterion I.B.4.c.
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