Inebilizumab-cdon (Uplizna) Form

Inebilizumab-cdon (Uplizna®) is an anti-CD19 monoclonal antibody. FDA Approved Indication(s)
Uplizna is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Uplizna is medically necessary when the following criteria are met:
I. Initial Approval Criteria A. Neuromyelitis Optica Spectrum Disorder (must meet all):

1. Diagnosis of NMOSD;
   2. Prescribed by or in in consultation with a neurologist;
   3. Age ≥ 18 years;
   4. Member has positive serologic test for anti-AQP4 antibodies;
   5. Member has experienced at least one relapse within the previous 12 months;
   6. Member meets one of the following (a or b): a. History of at least one relapse requiring rescue therapy† during the previous 12 months; b. History of two relapses requiring rescue therapy† during the previous 24 months; † Rescue therapies include: IV corticosteroids, IV immunoglobulin, and/or plasma exchange
2. Baseline expanded disability status scale (EDSS) score of ≤ 8;
   8. Failure of rituximab (Ruxience™ and Truxima® are preferred) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization may be required for rituximab
3. At the time of request, member does not have active hepatitis B infection (positive results for hepatitis B surface antigen and anti-hepatitis B virus tests) or active or untreated latent tuberculosis;

4. Uplizna is not prescribed concurrently with rituximab, Soliris®, or Enspryng™;

   11. Dose does not exceed a loading dose of 300 mg on Day 1 and Day 15. Approval duration: 6 months (loading doses only) Page 1 of 6

   CLINICAL POLICY Inebilizumab-cdon B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Neuromyelitis Optica Spectrum Disorder (must meet all):
7. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
8. Member is responding positively to therapy – including but not limited to improvement or stabilization in any of the following parameters: a. Frequency of relapse; b. EDSS;
   c. Visual acuity;
9. Uplizna is not prescribed concurrently with rituximab, Soliris, or Enspryng;
   4. If request is for a dose increase, new dose does not exceed 300 mg every 6 months. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2):

10. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: Page 2 of 6

    CLINICAL POLICY Inebilizumab-cdon CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

11. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AQP-4: aquaporin-4
    EDSS: expanded disability status scale FDA: Food and Drug Administration NMOSD: neuromyelitis optica spectrum disorder Appendix B: Therapeutic Alternatives
    This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.
    Drug Name Dosing Regimen Rituxan®/Riabni™/ Ruxience™/Truxima® (rituximab) Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Off-label IV: 375 mg/m2 per week for 4 weeks as induction, followed by 375 mg/m2 biweekly every 6 to 12 months Dose Limit/ Maximum Dose See regimen Appendix C: Contraindications/Boxed Warnings
    • Contraindication(s): previous life-threatening reaction to infusion of Uplizna, active hepatitis B infection, active or untreated latent tuberculosis • Boxed warning(s): none reported Appendix D: General Information • AQP-4-IgG-seropositive status is confirmed with the use of commercially available cell- binding kit assay (Euroimmun). V. Dosage and Administration
    Indication NMOSD Dosing Regimen Loading dose: 300 mg IV, followed by a second 300 mg IV dose 2 weeks later Maximum Dose See regimen Page 3 of 6

    CLINICAL POLICY Inebilizumab-cdon Indication Dosing Regimen Maintenance dose: 300 mg IV every 6 months, starting 6 months after the first infusion Maximum Dose VI. Product Availability
    Solution for injection in a single-dose vial: 100 mg/10 mL VII.