Medical Drug Criteria (MDC)

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

Last Review:       September 22, 2025
Next Review:      September 20, 2026
 

Related MDC: None

ELAHERE^® (mirvetuximab soravtansine-gynx)

Summary

Elahere (mirvetuximab soravtansine-gynx) is a folate receptor alpha (FRα)-directed antibody–drug conjugate (ADC) linked to a microtubule inhibitor. It is 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.

This indication was granted under accelerated approval based on tumor response rate and durability of response. Continued approval may be contingent upon confirmatory clinical benefit in ongoing trials. 

objective

To establish medical necessity criteria for Elahere in FRα-positive, platinum-resistant ovarian and related cancers, ensuring alignment with FDA approval and NCCN guidelines.

Policy Statements

Elahere may be considered medically necessary for adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens, when the conditions in the guidelines are met.

Policy Guidelines

Coverage eligibility will be considered when:

Diagnosis is epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FRα-positivity confirmed by FDA-approved test.

Platinum resistance documented.

One to three prior systemic regimens completed. 

Authorization period: 6 months.

DOSAGE/ADMINISTRATION

Administer as IV infusion only after dilution in 5% Dextrose Injection, USP. ⚠️ Incompatible with normal saline.
 
Recommended dose: 6 mg/kg (adjusted ideal body weight) every 3 weeks until disease progression or unacceptable toxicity.
 
Premedications: corticosteroid, antihistamine, antipyretic, antiemetic, topical ophthalmic steroids, lubricating eye drops.Administer as IV infusion only after dilution in 5% Dextrose Injection, USP. ⚠️ Incompatible with normal saline.
 
Recommended dose: 6 mg/kg (adjusted ideal body weight) every 3 weeks until disease progression or unacceptable toxicity.
 
Premedications: corticosteroid, antihistamine, antipyretic, antiemetic, topical ophthalmic steroids, lubricating eye drops.

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria
 
Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer.
 
1–3 prior systemic regimens.
 
FRα-positive by FDA-approved test.
 
Platinum resistance confirmed.
 
 
Renewal Criteria
 
Patient is currently receiving Elahere.
 
Clinical benefit maintained (tumor response or stable disease).
 
No unacceptable toxicity.

EXCLUSION CRITERIA

None specified.

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.

background

Elahere is the first FDA-approved FRα-targeted ADC. Approval is based on the SORAYA trial showing a 31.7% overall response rate in heavily pretreated patients with FRα-positive, platinum-resistant ovarian cancer. Confirmatory evidence is ongoing through the MIRASOL trial, which demonstrated improved PFS and OS versus chemotherapy, supporting continued FDA approval.

regulatory status

FDA accelerated approval: November 14, 2022.

Label update: March 2024 (prescribing information update for ocular safety). 

NCCN Guidelines (Ovarian Cancer v.2.2023): Category 2A option for FRα-positive platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.

OTHER CRITERIA

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

RATIONAL

Elahere addresses a critical unmet need in platinum-resistant ovarian cancer, where therapeutic options are limited and prognosis is poor. FRα is highly expressed in epithelial ovarian cancers, making it a targeted therapy approach with favorable benefit-risk profile.

PRACTICE GUIDELINES AND POSITION STATEMENTS

NCCN Ovarian Cancer Guidelines (2023–2025): Lists Elahere as an option for platinum-resistant, FRα-positive ovarian cancer (Category 2A).

MEDICARE NATIONAL COVERAGE

No National Coverage Determination (NCD) specific to Elahere. Coverage determined by local MACs.

References

1. Elahere (mirvetuximab soravtansine-gynx) Prescribing Information. ImmunoGen, Inc. Revised March 2024.
 
 
2. Drug Facts and Comparisons, UpToDate Inc. Accessed September 14, 2023.
 
 
3. NCCN Clinical Practice Guidelines in Oncology: Ovarian, Fallopian Tube, and Primary Peritoneal Cancers. Version 2.2023.
 
 
4. Moore KN, et al. Mirvetuximab soravtansine in FRα-positive, platinum-resistant ovarian cancer (SORAYA). Lancet Oncol. 2023.
 
 
5. Banerjee S, et al. Mirvetuximab soravtansine versus chemotherapy in platinum-resistant ovarian cancer (MIRASOL). NEJM. 2023.

Codes

Applicable Modifiers

N/A

Policy History