CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Elahere (mirvetuximab soravtansine-gynx) — coverage criteria

Defines coverage criteria and requirements for use of Elahere in members with high folate receptor alpha (FRα) platinum‑resistant high‑grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer; applies to providers submitting medication requests to Evolent on behalf of Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyElahere (mirvetuximab soravtansine-gynx) — coverage criteria

Policy CodePolicy N/A

Change TypeTemplate conversionindication wording revisedcoding added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit claims using HCPCS code J9063 with documentation of FRα ≥75% (2+ intensity) and platinum‑resistant status.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaces UM ONC_1471 Elahere (mirvetuximab soravtansine-gynx).

Removed verbiage under indication section regarding disease progression on Avastin (bevacizumab/bevacizumab biosimilar) containing regimen as a requirement.

Added Coding Information section with HCPCS code J9063 for mirvetuximab soravtansine-gynx.

>=75% (2+)FRα high expression definition

<=3Max prior systemic regimens

6 mg/kgSingle dose max (Elahere)

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Coverage Criteria

Initial therapy

Covered when ALL of the following are met

Indication and biomarker: Confirmed diagnosis of high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is platinum-resistant and high FRα positiveFRα >=75% with 2+ intensity

FRα testing via Ventana FOLR1 Assay or any FDA-approved test required

Prior therapy limits: Disease progression on no more than three prior systemic treatment regimens (maintenance therapies excluded)<=3 prior systemic regimens

Prior therapies may not include maintenance therapies; monotherapy only; concurrent anti-cancer therapies are excluded

Safety screening: Baseline ophthalmic exam prior to initiation and ophthalmic exams every other cycle for the first 8 cycles for ocular adverse reactions; withhold or discontinue per ocular toxicity guidanceN/A

Active uncontrolled ocular disorder is exclusionary

Dosing limits: Single dose must not exceed 6 mg/kg using adjusted or ideal body weight<=6 mg/kg

Dosing above single dose limit is exclusionary

The following additional exclusions, limitations, and exceptions apply to coverage of Elahere (mirvetuximab soravtansine‑gynx). Treatment is not covered for members with documented disease progression on or after prior Elahere therapy. Concurrent administration with other anti‑cancer therapies is excluded. Members without platinum‑resistant disease — defined as progression within 6 months of the last platinum‑containing chemotherapy dose — are not eligible. Disallowed histologies include endometrioid, clear cell, mucinous, sarcomatous histology, mixed tumors containing any of these histologies, and low‑grade ovarian cancer.

Coverage requires documented FRα positivity by an FDA‑approved companion diagnostic; lack of such documentation is exclusionary. Dosing that exceeds a single dose of 6 mg/kg (using adjusted or ideal body weight) is not permitted. Active, uncontrolled ocular disorders are exclusionary — baseline ophthalmic exam is required prior to initiation with ophthalmic assessments every other cycle for the first eight cycles and withholding or discontinuation per ocular toxicity guidance.

Use of Elahere for investigational or off‑label indications lacking sufficient evidence or not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature is excluded. The policy considers the adequacy of clinical evidence (trial design, representativeness of the population and regimen, and whether outcomes are clinically meaningful) when determining whether an off‑label use is supportable.

Requests for Elahere for indications not specified in this policy or without adequate supporting evidence will be considered investigational and not approvable. The policy excludes uses supported only by low‑quality evidence such as isolated case reports or meeting abstracts without full peer‑reviewed publications. Non‑randomized trials may be supportive if they include a significant number of subjects and otherwise provide adequate evidence, but case reports and abstracts alone are insufficient.

When evaluating off‑label or investigational requests, reviewers will assess whether the clinical characteristics of the patient and tumor match those represented in published evidence, whether the regimens in the literature are comparable to the proposed regimen, and whether reported outcomes meet standards for clinical meaningfulness (for example, hazard ratios and survival benefits consistent with accepted oncology guidance).

Regimen	Key Requirements / Monitoring	Dose Limit
Elahere (mirvetuximab soravtansine-gynx) monotherapy for FRα-high, platinum‑resistant high‑grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer	Confirmed HIGH FRα positivity (Ventana FOLR1 Assay or any FDA‑approved test: ≥75% tumor cells with 2+ intensity); disease progression on no more than three prior systemic regimens (maintenance excluded); baseline ophthalmic exam prior to initiation; ophthalmic exams every other cycle for first 8 cycles; prophylactic artificial tears and topical ophthalmic steroids; withhold or discontinue per ocular toxicity guidance (discontinue for grade 4 ocular toxicities). Concurrent use with other anti-cancer therapies is excluded.	Single dose must not exceed 6 mg/kg (using adjusted or ideal body weight)

Coding and Biomarker Thresholds

Covered HCPCS CodesHCPCSCovered

J9063

Injection, mirvetuximab soravtansine-gynx, 1 mg

FRα positivity threshold

FRα positivity threshold>= 75% tumor cells staining with 2+ intensity

Assay examplesVentana FOLR1 Assay or any FDA‑approved test

Required for coverageDocumented high FRα positivity is a coverage requirement for Elahere monotherapy

Maximum single dose

Maximum single dose6 mg/kg (using adjusted or ideal body weight)

Dose limit enforcementDosing that exceeds the single dose limit is exclusionary

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Use HCPCS code J9063 for billing.

Prior authorization required
Billing: HCPCS J9063

Documentation Required

Required Documentation

Provide documentation that supports medical necessity. Acceptable sources include FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS standards. Include documentation of: disease histology, prior systemic therapies and dates, platinum-resistance status, dosing calculations (weight/adjusted or ideal body weight) and proposed dose (not to exceed 6 mg/kg single dose), baseline and follow-up ophthalmic evaluation plan, and results of an FDA‑approved companion diagnostic demonstrating FRα positivity.

Required: FDA-approved product labeling, CMS compendia, NCCN or ASCO guidelines, or peer-reviewed literature

Line of Therapy / Salvage

salvage

Line of therapy: Used in platinum-resistant disease after progression on no more than three prior systemic regimens (maintenance therapies excluded)<=3 prior regimens

Monotherapy only; not combined with other anti-cancer therapies

Biomarker Requirements

FRα (folate receptor alpha)

FRα definition>=75% tumor cells staining with 2+ intensity by Ventana FOLR1 Assay or any FDA‑approved test

Use for indicationRequired biomarker for coverage in platinum‑resistant high‑grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer

Documentation sourceConfirmation via FDA‑approved companion diagnostic (e.g., Ventana FOLR1) required

Definitions

FRα high expression

FRα high expression definitionDefined by Ventana FOLR1 Assay or any FDA‑approved test as ≥75% tumor cells staining with 2+ intensity

Role in coverageClassifies patients as eligible for Elahere when other criteria met

Testing requirementLaboratory report confirming percentage and intensity required in documentation

Platinum‑resistant disease

Platinum‑resistant diseaseDisease progression within 6 months of the last dose of platinum‑containing chemotherapy

Coverage implicationNon‑platinum‑resistant disease (progression >6 months after last platinum) is excluded

Background

Mirvetuximab soravtansine is an antibody‑drug conjugate that targets folate receptor alpha (FRα) and is indicated as monotherapy for members with confirmed FRα‑high platinum‑resistant high‑grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Coverage requires confirmation of FRα positivity by the Ventana FOLR1 Assay or another FDA‑approved test, defined as tumor cell staining in ≥75% of tumor cells at 2+ intensity.

Ocular toxicity is a prominent safety concern with mirvetuximab soravtansine; the product labeling includes boxed warnings and recommends baseline and periodic ophthalmic monitoring plus prophylactic ocular care. The policy limits prior systemic therapy to no more than three prior systemic regimens (maintenance therapies excluded) and restricts single doses to a maximum of 6 mg/kg (adjusted or ideal body weight).