CurrentCareSourcePolicy N/A

Elahere (mirvetuximab soravtansine-gynx) — Prior Authorization and Coverage Criteria

Defines prior authorization and medical necessity criteria for Elahere (mirvetuximab soravtansine-gynx) for adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer treated in the medical benefit setting.

Policy Summary

PayerCareSource

PolicyElahere (mirvetuximab soravtansine-gynx) — Prior Authorization and Coverage Criteria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateJun 5, 2024

Key ActionObtain prior authorization and document oncologist involvement and AIBW when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 mg/kg AIBW q3wrecommended dosing

FRα ≥75%biomarker threshold for monotherapy

Platinum-resistantdisease setting addressed

1 yearauthorization period when criteria met

Oncologistprescriber requirement

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Coverage Criteria for Elahere (mirvetuximab soravtansine-gynx)

inv-01: Initial Eligibility for Elahere

Covered when ALL of the following are met:

Main eligibility

FRα positivity options: Patient meets ONE of: (1) using Elahere in combination with bevacizumab; OR (2) tumor has ≥ 75% folate receptor alpha positive tumor cells
From policy: combination with bevacizumab qualifies regardless of percentage, or monotherapy requires ≥ 75% FRα+ tumor cells.

Regimen	Indication / Requirements	Dosing & Frequency	Coverage Status
Elahere (mirvetuximab soravtansine-gynx) in combination with bevacizumab
Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer with folate receptor alpha (FRα) expression; combination with bevacizumab qualifies regardless of percentage of FRα‑positive tumor cells per policy language.
Elahere: 6 mg/kg adjusted ideal body weight (AIBW) IV once every 3 weeks (21‑day cycle); administer per combination regimen as clinically indicated.
Covered when criteria met

Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria.

Requests that fall outside the listed recommended authorization criteria are treated as not covered by policy and are not recommended for approval.

Dosing, Biomarker Thresholds, and Coding Notes

FRα positivity threshold

FRα positivity thresholdTumor cell staining of ≥ 75% defines FRα positivity for eligibility as single‑agent (monotherapy) Elahere.

Combination exceptionUse of Elahere in combination with bevacizumab is allowed regardless of the percentage of FRα expression (combination option qualifies even if <75%).

ContextFRα positivity requirement applies to platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer when Elahere is used as monotherapy.

Dosing frequency

Recommended dose and schedule6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21‑day cycle)

Route and durationIntravenous infusion continued until disease progression or unacceptable toxicity

Folate Receptor Alpha (FRα) Requirements

Folate receptor alpha (FRα)

Monotherapy biomarker thresholdFRα expression of ≥ 75% tumor cells is required to qualify for single‑agent Elahere.

Combination optionElahere combined with bevacizumab may be used regardless of the FRα percentage per policy criteria.

Indication contextApplies to platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer as described in coverage criteria.

Indicated Line(s) of Therapy

inv-13: second-line

Prior lines: Indicated for patients who have received one to three prior systemic treatment regimens (per product overview).

Policy overview states indication for adults who have received one to three systemic regimens; authorization criteria focus on current disease and biomarker requirements.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization is recommended for medical benefit coverage of Elahere. Approval is recommended when the patient meets the Recommended Authorization Criteria and dosing described in the policy. Approvals are generally provided for the duration noted in the decision and may be extended if the patient continues to meet the Criteria and Dosing. Requests for doses outside the dosing documented in this policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Elahere, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (oncologist).

Automation: None

Step Therapy

Step Therapy History Note

Previous policy language requiring that the patient have tried one systemic regimen (and examples of systemic regimens) was removed from the criteria. Do not add an additional step-therapy requirement beyond what is specified in the Recommended Authorization Criteria.

Definitions and Calculation Notes

Adjusted Ideal Body Weight (AIBW)

AIBW formulaAdjusted ideal body weight (AIBW) = Ideal body weight (IBW [kg]) + 0.4*(Actual weight [kg] - IBW [kg]).

PurposeAIBW is used to calculate the dosing weight for Elahere (dose = 6 mg/kg AIBW).

Documentation requirementPolicy requires recorded AIBW and the formula used to calculate IBW/AIBW when dosing is documented.

FRα positive — policy definition

FRα positive definition for monotherapyFRα‑expressing tumor defined as ≥ 75% tumor cells positive to meet eligibility for single‑agent Elahere.

Combination allowanceUse with bevacizumab qualifies regardless of FRα percentage per the policy's FRα positivity options.

Background on Elahere

Elahere is an FRα-directed antibody-drug conjugate indicated for adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.