ModifiedCentenePolicy CP PHAR.617

Mirvetuximab soravtasnine-gynx (Elahere) coverage and coding implications

Governs medical necessity, authorization, dosing, and documentation requirements for Elahere (mirvetuximab soravtasnine-gynx) for treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer for Centene line(s) of business.

Policy Summary

PayerCentene

PolicyMirvetuximab soravtasnine-gynx (Elahere) coverage and coding implications

Policy CodePolicy CP PHAR.617

Change TypeHCPCS code addedindication and prior‑therapy criteria revised

Effective DateMar 1, 2023

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, Ventana FOLR1/FRα assay results, oncology consultation, age ≥18, weight/height for AIBW, and prior systemic therapy count (1–3).

SourceLink

POLICY UPDATE CHANGES

Added updated HCPCS code J9063 for mirvetuximab soravtansine.

Removed limitation of use language due to accelerated approval per updated labeling.

Added platinum-sensitive ovarian cancer to platinum-resistant cancer criterion and removed requirement that a prior line include bevacizumab per NCCN and phase 3 trial.

6 mg/kgstandard dose per 3-week cycle

1-3systemic prior therapy lines required

Ocular toxicityserious adverse effect

100 mg

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Coverage Criteria for Elahere (mirvetuximab soravtansine)

Initial Therapy — Covered when ALL criteria are met

Covered when ALL of the following are met:

Initial Approval: 1. Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. FRα (Folate Receptor Alpha) positive tumor as determined by the Ventana FOLR1/FOLRα Assay; 5. Member has received ≥1 and ≤3 systemic lines of anticancer therapy; 6. Documentation of current actual body weight (kg) and height (cm) to calculate adjusted ideal body weight (AIBW); 7. Requested dose does not exceed 6 mg/kg dosed based on AIBW every 3-week cycle OR the requested dose is supported by practice guidelines or peer-reviewed literature for the off‑label use (prescriber must submit supporting evidence).

Approval duration: Commercial/Medicaid 6 months (initial).

Continuation Therapy — Covered when ALL criteria are met

Covered for continuation when ALL of the following are met:

Continuation Therapy: 1. Member is currently receiving Elahere via the Centene benefit or documentation confirms at least 30 days of therapy; 2. Member is responding positively to therapy (clinical benefit documented in chart notes); 3. Documentation of current actual body weight in kilograms for dosing; 4. If a dose increase is requested, the new dose does not exceed 6 mg/kg based on AIBW per 3-week cycle OR the new dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Approval duration: Commercial/Medicaid 12 months for continuation.

Updated Indication and Prior Therapy Criteria

Policy criteria were updated to include additional disease states and to remove prior bevacizumab requirement:

Indication scope change: Platinum‑sensitive ovarian cancer was added to the prior platinum‑resistant criterion per NCCN; Appendix D updated with definitions of platinum‑resistant and platinum‑sensitive disease.

Per 1Q 2025 annual review and NCCN compendium/phase 3 trial

Prior therapy requirement removed: Removed the prior requirement that at least one prior line of therapy included bevacizumab.

Per NCCN Compendium and phase 3 confirmatory trial

Diagnoses or uses that are not FDA‑approved and are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient evidence of efficacy and safety consistent with the referenced off‑label use policies. See the off‑label use policies (e.g., CP.CPA.09 for Commercial and CP.PMN.53 for Medicaid) for the standards of acceptable supporting documentation and evidence.

The presence or absence of procedure, supply, or diagnosis codes in this clinical policy is for informational purposes only and does not, by itself, guarantee that a service will be reimbursed. Providers must consult and follow the most current professional coding guidance and payer billing instructions when submitting claims for covered services.

Requests to use the drug for indications outside those listed in this policy must be supported by adequate clinical evidence consistent with the payer's off‑label use policies. Uses without sufficient supporting evidence per the referenced off‑label policies may be considered not medically necessary and may be denied.

Coding and Billing Information

No explicit CPT/HCPCS/ICD-10 codes listed in this sectionmixed

No codes listed

HCPCS codesHCPCS

J9063

Injection, mirvetuximab soravtansine-gynx, 1 mg

Maximum dose per cycle / weight basis

Maximum dose per cycle6 mg/kg based on adjusted ideal body weight (AIBW) every 3-week cycle

Dose calculation requiredTotal dose calculated using each patient’s AIBW (see AIBW/IBW formula in Definitions)

Administration route/frequencyIV infusion once every 3 weeks

Vial concentration

Vial concentration5 mg/mL (100 mg per 20 mL single-dose vial)

PresentationSingle-dose vial for injection: 100 mg/20 mL

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests for mirvetuximab soravtansine (Elahere). Approval is contingent on meeting the clinical criteria in this policy and any applicable line-of-business prior authorization procedures.

Affected code: HCPCS J9063 (Injection, mirvetuximab soravtansine-gynx, 1 mg) — prior authorization applies.
Prior authorization requests must indicate the member meets the policy’s diagnosis and treatment criteria (see Initial Approval Criteria).

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office/consultation notes, pathology and cytology reports, lab results (including FRα testing reports), radiology reports, and prior systemic therapy records.

Document FRα positivity via the Ventana FOLR1/FOLRα assay when required by the criteria.

Initial Authorization Criteria

Initial Therapy — Operational Authorization and Dosing

Initial authorization requirements and dosing (all criteria must be met):

Initial Therapy (operational): 1. Confirm diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer; 2. Treatment prescribed by or in consultation with an oncologist; 3. Patient age ≥ 18 years; 4. Document FRα positivity by Ventana FOLR1/FOLRα Assay; 5. Member has received between 1 and 3 prior systemic anticancer regimens (count maintenance per Appendix D rules); 6. Submit current actual body weight (kg) and height (cm) to calculate AIBW (Female IBW = 0.9*height(cm) - 92; AIBW = IBW + 0.4*(Actual wt - IBW)); 7. Dosing: 6 mg/kg IV based on AIBW every 3 weeks (dose must not exceed this unless supported by guidelines/peer‑reviewed literature; prescriber must submit evidence); 8. Provide documentation sufficient for prior authorization (office notes, labs, oncology consult).

Dose calculation and vial strength: 6 mg/kg AIBW q3w; product available as 100 mg/20 mL single‑dose vial (5 mg/mL). Approval duration: Commercial/Medicaid 6 months (initial).

Continuation Authorization Criteria

Continuation — Criteria for Continued Approval

Criteria for continued approval — all conditions must be satisfied:

Continuation (operational): 1. Member has received Elahere for at least 30 days or is currently receiving Elahere via the Centene benefit; 2. Documented positive response to therapy (clinical assessment/chart notes); 3. Provide current actual body weight in kg for ongoing dosing calculations; 4. Any requested dose increase must not exceed 6 mg/kg AIBW per 3‑week cycle unless justified by practice guidelines or peer‑reviewed literature (prescriber must provide supporting evidence); 5. Ongoing monitoring and documentation of toxicity (including ocular toxicity) per labeling and clinical practice should be available in the medical record for renewal review.

Approval duration for continuation: Commercial/Medicaid 12 months.

Step Therapy and Therapeutic Alternatives

Therapeutic alternative	Notes
See Appendix B (Therapeutic alternatives listing)	Alternatives listed in Appendix B may not be formulary agents and may require prior authorization; follow formulary/PDL pathways per line of business.

Quantity Limits and Dosing

Elahere dosing key

Dose per administration6 mg/kg IV based on adjusted ideal body weight (AIBW) per administration

Dosing intervalOne administration every 3 weeks

Dose ceiling guidanceDose should not exceed 6 mg/kg AIBW unless supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)

mirvetuximab soravtansine

Single-dose vial strength100 mg per single-dose vial (20 mL, 5 mg/mL)

Packaging100 mg/20 mL vial for injection

Quantity calculation

Site of Care

Note

Infusion center administration per dosing regimen

Elahere is administered intravenously at 6 mg/kg based on adjusted ideal body weight every 3 weeks; administration typically occurs in an infusion center or hospital outpatient setting.

Dosing regimen: 6 mg/kg IV based on AIBW every 3‑week cycle
Typical site of care: infusion center or hospital outpatient infusion setting

Background

Elahere (mirvetuximab soravtansine‑gynx) is an antibody–drug conjugate directed to folate receptor alpha (FRα), designed to deliver a cytotoxic payload selectively to FRα‑expressing tumor cells. It is indicated for adult patients with FRα‑positive epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic regimens. The recommended dosing regimen is 6 mg/kg IV based on adjusted ideal body weight (AIBW) every 3 weeks, and the product is supplied as a single‑dose vial: 100 mg/20 mL (5 mg/mL).

Definitions and Calculations

Platinum-resistant

Policy definitionPlatinum-resistant disease is defined in Appendix D and includes progression on primary, maintenance, or recurrence therapy and stable or persistent disease if not on maintenance therapy.

Clinical examplesProgression on primary, maintenance, or recurrence therapy qualifies as platinum-resistant per Appendix D

Therapy-line contextMembers must have received at least 1 but no more than 3 systemic lines of anticancer therapy (applies to platinum-resistant criteria)

Platinum-sensitive

Use in coverage decisionsPlatinum-sensitive status was added to the policy indication scope per NCCN updates (see Coding Implications)

Revision History and Policy Changes

2025-01-29criteria_revisionLatest

Platinum-sensitive ovarian cancer was added to the platinum-resistant criterion and Appendix D was updated with definitions per NCCN; requirement that a prior line include bevacizumab was removed based on NCCN compendium and phase 3 trial.

2024-03-28labeling_update

Limitation-of-use language was removed from the policy following accelerated approval and updated product labeling.

2023-05-24coding_addition