vp-0528
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Sarclisa® (isatuximab-irfc) (Intravenous)

Policy Number: VP-0528

Last Review Date: 04/06/2021

Date of Origin: 04/01/2020

Dates Reviewed: 06/2020, 09/2020, 03/2021, 04/2021

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

 

I. Length of Authorization

Coverage will be provided for 6 months and may be renewed. 

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Cycle 1, every week x 4 doses, followed by Cycle 2, and beyond, every 2 weeks
  • Sarclisa 100 mg/5 mL single-dose vial for injection: 4 vials per dose
  • Sarclisa 500 mg/25 mL single dose vial for injection: 2 vials per dose
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • Cycle 1 every week x 4 doses, followed by Cycle 2, and beyond, every 2 weeks
    • 110 billable units per dose

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND
  • Patient is not refractory to previous treatment with anti-CD38 therapy (i.e., daratumumab, etc.) [Note: refractory is defined as progression on or within 60 days after the end of prior anti-CD38 treatment OR failure to achieve at least minimum response to treatment]; AND

Multiple Myeloma † Ф 1-4                                             

  • Patient has 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 in patients who have received 1 to 3 prior lines therapy

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

IV. Renewal Criteria 

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet 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, neutropenia, secondary primary malignancies, etc.

V. Dosage/Administration 

Indication

Dose

Multiple Myeloma

Combination therapy with pomalidomide and dexamethasone OR carfilzomib and dexamethasone:

    • 10 mg/kg of actual body weight given as an intravenous infusion:
  • Weekly                     Cycle 1 (four doses total; Days 1, 8, 15, & 22)
  • Every two weeks     Cycle 2 and beyond (two doses per cycle; Days 1 & 15)

*Each treatment cycle consists of a 28-day period. Treatment is repeated until disease progression or unacceptable toxicity.

VI. 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

VII. References

  1. Sarclisa [package insert]. Bridgewater, NJ; Sanofi-Aventis US, LLC; March 2021. Accessed April 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for isatuximab-irfc. National Comprehensive Cancer Network, 2021. 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 April 2021.
  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.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C90.00

Multiple myeloma not having achieved remission

C90.02

Multiple myeloma, in relapse

C90.10

Plasma cell leukemia not having achieved remission

C90.12

Plasma cell leukemia in relapse

C90.20

Extramedullary plasmacytoma not having achieved remission

C90.22

Extramedullary plasmacytoma in relapse

C90.30

Solitary plasmacytoma not having achieved remission

C90.32

Solitary plasmacytoma in relapse

D47.2

Monoclonal gammopathy

Z85.79

Personal history of other malignant neoplasms of lymphoid, hematopoietic and related tissues

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

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 Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

               

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC