Mirvetuximab soravtansine-gynx (Elahere)

Policy ID: I-263-001

Section: Injections

Effective Date: February 01, 2023

Last Reviewed: January 26, 2023

Applies To: Commercial and Medicaid Expansion

Description

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

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 Codes

J9999

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 March 01, 2023

Adopted 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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