Isatuximab-irfc (Sarclisa)

Policy ID: I-221-005

Section: Injections

Effective Date: May 15, 2020

Revised Date: March 07, 2024

Revision Effective Date: May 01, 2024

Last Reviewed: March 19, 2024

Applies To: Commercial and Medicaid Expansion

Description

Isatuximab-irfc (Sarclisa®) is an IgG1-derived monoclonal antibody that binds to CD38 expressed on the surface of hematopoietic and tumor cells, including multiple myeloma cells. Isatuximab (Sarclisa) in combination with pomalidomide induces apoptosis of tumor cells and activates immune effector mechanisms.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Isatuximab (Sarclisa) may be considered medically necessary for the following when ALL criteria are met:

Multiple Myeloma

In combination with pomalidomide and dexamethasone, for the treatment of individuals with a diagnosis of multiple myeloma who have received at least two (2) prior therapies including lenalidomide and a proteasome inhibitor; or
In combination with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma in individuals who have received at least one (1) prior line of therapy; or

Compendia Sources

Isatuximab (Sarclisa) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of isatuximab (Sarclisa) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J9227

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered Diagnosis Codes for J9227

C90.00

C90.02

C90.10

C90.12

C90.20

C90.22

C90.30

C90.32

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 5-19-2020 New Policy

Internal Medical Policy Committee 9-21-2020

Added new code, J9227, and
Added additional diagnosis codes to policy

Internal Medical Policy Committee 9-21-2021

Updated FDA indications and NCCN recommendations,
Removed Diagnosis code C90.01 and
Added Diagnosis code D47.2

Internal Medical Policy Committee 9-28-2022 Annual review, no clinical content change

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

Removed NCCN recommendations and added this statement ' Drug may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.'
Removed diagnosis codes D47.2 and Z85.79
Updated experimental/investigational statement

Internal Medical Policy Committee 3-19-2024 Effective May 01, 2024

Annual review no clinical content change

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

Policy ID: I-221-004