Anifrolumab-fnia (Saphnelo) Form

Anifrolumab-fnia (Saphnelo™) is a type I interferon (IFN) receptor antagonist. FDA Approved Indication(s) Saphnelo is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitation(s) of use: The efficacy of Saphnelo has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of Saphnelo is not recommended in these situations. 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 Saphnelo is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Systemic Lupus Erythematosus (must meet all):

1. Diagnosis of SLE;
   2. Prescribed by or in consultation with a rheumatologist;
   3. Age ≥ 18 years;
   4. Documentation confirms that member is positive for an SLE autoantibody (e.g., anti- nuclear antibody (ANA), anti-double-stranded DNA (anti-dsDNA), anti-Smith (anti- Sm), anti-ribonucleoprotein (anti-RNP), anti-Ro/SSA, anti-La/SSB, antiphospholipid antibody);
2. Prescribed in combination with standard therapy for SLE that includes one or more of the following agents, unless all agents are contraindicated: glucocorticoids (e.g., prednisone), antimalarial (e.g., hydroxychloroquine or chloroquine), non-biologic immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate);
   6. Member is not receiving Saphnelo in combination with a biologic agent (e.g., Benlysta);

3. Dose does not exceed 300 mg every 4 weeks. Approval duration:
   Medicaid/HIM – 6 months Commercial – 6 months or to member’s renewal date, whichever is longer Page 1 of 6

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   Anifrolumab-fnia B. Other diagnoses/indications (must meet 1 or 2):

4. 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
5. 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. Systemic Lupus Erythematosus (must meet all):
   
   1. 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);
   2. Member is responding positively to therapy;
   3. Prescribed in combination with standard therapy for SLE that includes one or more of the following agents, unless all agents are contraindicated: glucocorticoids (e.g., prednisone), antimalarial (e.g., hydroxychloroquine or chloroquine), non-biologic immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate);
   4. Member is not receiving Saphnelo in combination with a biologic agent (e.g., Benlysta);
6. If request is for a dose increase, new dose does not exceed 300 mg every 4 weeks. Approval duration:
   Medicaid/HIM – 12 months Commercial – 6 months or to member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):

7. 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 Page 2 of 6

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   Anifrolumab-fnia 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

8. 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; B. Autoantibody negative SLE.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key ANA: anti-nuclear antibody
   Anti-dsDNA: anti-double-stranded DNA Anti-Sm: anti-Smith DNA: deoxyribonucleic acid FDA: Food and Drug Administration LN: lupus nephritis SLE: systemic lupus erythematosus 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 glucocorticoids (e.g., prednisone) antimalarial agents (e.g., hydroxychloroquine, chloroquine) non-biologic immunosuppressants (e.g., azathioprine, methotrexate, mycophenolate)* 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.

   • For LN, cyclophosphamide is also an acceptable immunosuppressant. Dosing Regimen Varies Varies Varies Dose Limit/ Maximum Dose Varies Varies Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): previous anaphylaxis with anifrolumab-fnia • Boxed warning(s): none reported Appendix D: Autoantibody Positive Versus Negative SLE The pivotal clinical trials for Saphnelo enrolled patients with at least one of the following:
     • Positive antinuclear antibody test at screening by immunofluorescent assay (IFA) at the central laboratory with titer ≥ 1:80; Page 3 of 6

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   Anifrolumab-fnia • Anti-dsDNA antibodies at screening elevated to above normal (including indeterminate), as per the central laboratory; • Anti-Smith antibody at screening elevated to above normal as per the central laboratory V. Dosage and Administration
   Indication Dosing Regimen SLE 300 mg IV every 4 weeks VI. Product Availability
   Single-dose vial: 300 mg/2 mL
   Maximum Dose See dosing regimen VII.