POLICY

APPLICABLE PRODUCTS

NEW POLICY OVERVIEW OR UPDATED POLICY REVISIONS

Omalizumab (Xolair, Omlyclo) (CP.PCH.49)

Ambetter

Policy updates include:

• Added newly approved biosimilar Omlyclo.

Tesamorelin (Egrifta SV, Egrfita WR) (CP.PHAR.109)

Ambetter

• Added newly approved Egrifta WR formulation
• Dose limit added for WR

Corticosteroids for ophthalmic inj (Dextenza, Iluvien, Ozurdex, Retisert, Xipere, Yutiq) (CP.PHAR.385)

Ambetter

• 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

Selinexor (Xpovio) (CP.PHAR.431)

Ambetter

• 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.

Tislelizumab-jsgr (Tevimbra) (CP.PHAR.687)

Ambetter

• 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)

Fitusiran (Qfitlia) (CP.PHAR.706)

Ambetter

Policy includes:

• Requests for indications not approved by the FDA are reviewed with the off-label use policy HIM.PHAR.154 for Ambetter.
• 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;

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  • 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

• 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;

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  • 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

House dust mite allergen extract (Odactra) (CP.PMN.111)

Ambetter

Policy updates include:

• Updated indication and criteria with pediatric expansion to age 5 years.

GLP-1 receptor agonists (HIM.PA.53)

Ambetter

• 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.

Brand Name Override and Non-Formulary Medications (HIM.PA.103)

Ambetter

Policy updates include:

• Clarified for brand name drug requests, member must use generic or all preferred biosimilar(s), if available.