Mirvetuximab soravtansine-gynx (Elahere) (ARCHIVED)

Policy ID: I-263-005

Section: Injections

Effective Date: February 01, 2023

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-263-005

Section: Injections

Effective Date: February 01, 2023

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial Only

Description

Mirvetuximab soravtansine-gynx (Elahere) is a folate receptor alpha (FR)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult individuals with FR positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one (1) to three (3) prior systemic treatment regimens.

Mirvetuximab soravtansine (Elahere) can cause severe ocular toxicities including visual impairment, dry eye, photophobia, eye pain, and uveitis; prophylactic lubricating eye drops and topical ophthalmic steroids are recommended during treatment.

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.

Mirvetuximab soravtansine-gynx (Elahere) may be considered medically necessary in individuals 18 years and older when ALL of the following criteria are met:

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Individual has a diagnosis of FR positive, platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer confirmed by an FDA-approved test; and
Individual has received one (1) to three (3) prior systemic treatment regimens; and
Individual has received an ophthalmic exam including visual acuity and slit lamp testing prior to treatment; and
Individual will receive subsequent ophthalmic exams prior to every other cycle for the first eight (8) cycles of treatment.

Compendia Sources

Mirvetuximab soravtansine-gynx (Elahere) may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.

The use of mirvetuximab soravtansine-gynx (Elahere) 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

J9063

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

C48.1

C48.2

C48.8

C56.1

C56.2

C56.3

C56.9

C57.00

C57.01

C57.02

C57.10

C57.11

C57.12

C57.20

C57.21

C57.22

C57.3

C57.4

C57.7

C57.8

C57.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-26-2023 Effective February 01, 2023

Adopted policy

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

Added new code, C9146, to the policy

Internal Medical Policy Committee 7-26-2023 - Effective July 01, 2023

Added new code J9347 to the policy
Removed code C9146

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived policy

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.

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