Sunflower Health Plan Isatuximab-irfc (Sarclisa) Form

Isatuximab-irfc (Sarclisa®) is a CD38-directed cytolytic antibody FDA Approved Indication(s) Sarclisa is indicated • In combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor (PI) In combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory MM who have received 1 to 3 prior lines of therapy • 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 Sarclisa is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Multiple Myeloma (must meet all): 1. Diagnosis of MM; 2. Prescribed by or in consultation with an oncologist or hematologist; 3. Age ≥ 18 years; 4. Sarclisa is prescribed in one of the following ways (a or b): a. In combination with pomalidomide and dexamethasone, after 2 prior therapies, including lenalidomide and a PI (e.g., bortezomib, Kyprolis®, Ninlaro®);* b. In combination with Kyprolis and dexamethasone, for relapsed or refractory disease after 1 to 3 prior lines of therapy;* *Prior authorization may be required for prior therapies, including lenalidomide, bortezomib, Kyprolis and Ninlaro. 5. Request meets one of the following (a or b):* a. Dose does not exceed 10 mg/kg per week for the first 4 weeks, then every 2 weeks thereafter; b. Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 6 months Page 1 of 6 CLINICAL POLICY Isatuximab-irfc B. Other diagnoses/indications (must meet 1 or 2): 1. 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 2. 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. Multiple Myeloma (must meet all): 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Sarclisa for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, request meets one of the following (a or b):* a. New dose does not exceed 10 mg/kg every 2 weeks; b. New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence). *Prescribed regimen must be FDA-approved or recommended by NCCN Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2): 1. 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 2. 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 Page 2 of 6 CLINICAL POLICY Isatuximab-irfc 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 FDA: Food and Drug Administration MM: multiple myeloma PI: proteasome inhibitor 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 Dose Limit/ Maximum Dose See FDA approved dosing regimen See FDA approved dosing regimen See FDA approved dosing regimen See FDA approved dosing regimen 4 mg/day Varies Varies Varies Varies Varies Revlimid® (lenalidomide) Ninlaro® (ixazomib) bortezomib (Velcade®) Kyprolis® (carfilzomib) Pomalyst® (pomalidomide) bortezomib/lenalidomide/ dexamethasone carfilzomib/lenalidomide/ dexamethasone daratumumab/lenalidomide/ bortezomib/dexamethasone ixazomib/lenalidomide/ dexamethasone daratumumab/lenalidomide/ dexamethasone 10 mg or 25 mg PO QD; dose and frequency of administration vary based on specific use 4 mg PO on days 1, 8, and 15 of every 28-day treatment cycle 1.3 mg/m2 SC or IV; frequency of administration varies based on specific use 20 mg/m2, 27 mg/m2, and/or 56 mg/m2 IV; frequency of administration varies based on specific use 4 mg PO QD on days 1-21 of repeated 28-day cycles. Varies Varies Varies Varies Varies Page 3 of 6 CLINICAL POLICY Isatuximab-irfc Drug Name Dosing Regimen Varies daratumumab/bortezomib/ melphalan/prednisone daratumumab/cyclophosphamide/ bortezomib/dexamethasone 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. Varies Varies Dose Limit/ Maximum Dose Varies Appendix C: Contraindications/Boxed Warnings • Contraindication(s): severe hypersensitivity to isatuximab-irfc or to any of its excipients • Boxed warning(s): none reported V. Dosage and Administration Indication MM Dosing Regimen 10 mg/kg IV in combination with pomalidomide and dexamethasone or with carfilzomib and dexamethasone according to the dosing schedule below: • Cycle 1: Days 1, 8, 15, and 22 (weekly) • Cycle 2 and beyond: Days 1, 15 (every 2 weeks) Maximum Dose 10 mg/kg/week for the first 4 weeks, then every 2 weeks thereafter Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity VI. Product Availability Single-dose vial with solution for injection: 100 mg/5 mL (20 mg/mL), 500 mg/25 mL (20 mg/mL) VII.