Medical Drug Criteria (MDC)

Policy Num:       P1.001.009
Policy Name:     ELAHERE^® (mirvetuximab soravtansine-gynx)
Policy ID:          [P1.001.009] [Ac/ L /MDC/ P+ ][0.00.00]

Last Review:       September 17, 2024
Next Review:      September 20, 2025
 

Related MDC: None

ELAHERE^® (mirvetuximab soravtansine-gynx)

Summary

Elahere is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adults with FRα positive, platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.  Select patients for therapy based on an FDA-approved test. 

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Elahere has a black box warning for ocular toxicity. Elahere can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
 

Policy Statements

Initiation of Elahere meets the definition of medical necessity when used to treat the following indication and the specific criteria below are met.

Policy Guidelines

Coverage eligibility for Elahere will be considered when the following criteria is met:
Authorization of 6 months may be granted for treatment of FRα positive, platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens in adult patients.

DOSAGE/ADMINISTRATION

• Administer ELAHERE as an intravenous infusion only after dilution in 5% Dextrose Injection, USP. ELAHERE is incompatible with normal saline.

• The recommended dose of ELAHERE is 6 mg/kg adjusted ideal body weight administered as an intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. 

• Premedicate with a corticosteroid, antihistamine, and antipyretic. 

• Premedicate with an antiemetic, ophthalmic topical steroids, and lubricating eye drops.

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

Individual has a diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; AND
•    Individual has received one to three prior systemic treatment regimens; AND
•    Individual is folate receptor-alpha (FRα) positive as determined by an FDA-approved test; AND
•    Individual is platinum resistant.

Renewal Approval Criteria 

a)    The patient is currently receiving Elahere and continues to meet initial criteria with clinical benefit and absence of unacceptable toxicity.

EXCLUSION CRITERIA

NONE

BENEFIT APPLICATION

BlueCard/National Account Issues

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

OTHER CRITERIA

Validate that the treatment regimen is following the most up to date NCCN guidelines recommendations.

Population Reference No. 1 Policy Statement

References

1.    Elahere (mirvetuximab soravtansine) [prescribing information]. Waltham, MA: ImmunoGen, Inc; Revised: 03/2024
2.    Drug Facts and Comparisons online, Facts and Comparisons eAnswers online. Waltham, MA: UpToDate Inc. https://fco.factsandcomparisons.com. Accessed: September 14, 2023.
3.    NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer - Fallopian Tube Cancer and Primary Peritoneal Cancer 2.2023.  National Comprehensive Cancer Network. Retrieved September 14, 2023, from                 https://www.nccn.org/

Codes9063

Applicable Modifiers

N/A

Policy History