Last Review Date: 10/03/2024

Date of Origin: 04/01/2020

Dates Reviewed: 06/2020, 09/2020, 03/2021, 04/2021, 03/2022, 3/2023, 03/2024, 10/2024

1. Length of Authorization ⁵

Coverage will be provided for 6 months and may be renewed, unless otherwise specified.

• Primary therapy in Multiple Myeloma for transplant candidates can be authorized up to a maximum of 18 weeks of therapy (11 doses).

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Sarclisa 100 mg/5 mL single-dose vial for injection: 4 vials weekly x 5 doses, then 4 vials every 2 weeks
• Sarclisa 500 mg/25 mL single dose vial for injection: 2 vials weekly x 5 doses, then 2 vials every 2 weeks

2. Max Units (per dose and over time) [HCPCS Unit]:

• 120 billable units weekly x 5 doses, then 720 billable units every 84 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria

• Therapy will not be used in combination with other anti-CD38 therapies (i.e., daratumumab, daratumumab and hyaluronidase-fihj, etc.); AND

Multiple Myeloma † ‡ Ф ^1-6

• Used as primary therapy for symptomatic disease; AND
  • Patient is a transplant or non-transplant candidate (Note: Dosing varies based on transplant eligibility); AND
  • Used in combination with bortezomib, lenalidomide, and dexamethasone; OR
• Used for relapsed, refractory, or progressive disease; AND
  • Used in combination with pomalidomide and dexamethasone after at least two prior therapies including lenalidomide and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib, etc.); OR
  • Used in combination with carfilzomib and dexamethasone

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,5

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion-related reactions, severe infections, neutropenia, secondary primary malignancies, etc.

Multiple Myeloma (primary therapy for transplant candidates)

• May not be renewed

5. Dosage/Administration ^1,5

6. Billing Code/Availability Information

HCPCS Code:

• J9227 – Injection, isatuximab-irfc, 10 mg; 1 billable unit = 10 mg

NDC(s):

• Sarclisa 100 mg/5 mL single-dose vial: 00024-0654-xx
• Sarclisa 500 mg/25 mL single-dose vial: 00024-0656-xx

7. References

1. Sarclisa [package insert]. Bridgewater, NJ; Sanofi-Aventis US, LLC; September 2024. Accessed September 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for isatuximab-irfc. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2024.
3. Attal M, Richardson PG, Rajkumar SV, et al.ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum in: Lancet. 2019 Dec 7;394(10214):2072.
4. Moreau P, Dimopoulos M, Yong K, et al. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design. Future Oncol. 2020 Jan;16(2):4347-4358. doi: 10.2217/fon-2019-0431. Epub 2019 Dec 13.
5. Goldschmidt H, Mai EK, Bertsch U, et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Haematol. 2022 Nov;9(11):e810-e821.
6. Facon T, Dimopoulos MA, Leleu XP, et al; IMROZ Study Group. Isatuximab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2024 Jun 3. doi: 10.1056/NEJMoa2400712. Epub ahead of print. PMID: 38832972.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A