Currentblue cross blue shield - tennesseePolicy ID_CHS_2025

Mirvetuximab Soravtansine-gynx (Elahere™)

Defines coverage and prior-authorization criteria for Elahere (mirvetuximab soravtansine-gynx) for adult patients with folate receptor-alpha positive epithelial ovarian, fallopian tube, or primary peritoneal cancer, including FDA-approved and certain compendial uses, plus continuation/reauthorization rules and documentation requirements.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyMirvetuximab Soravtansine-gynx (Elahere™)

Policy CodePolicy ID_CHS_2025

Change Typeclarified

Effective DateJun 2, 2026

Next Review Date

Key ActionSubmission of documentation is necessary to initiate prior authorization review, including testing or laboratory results confirming folate receptor-alpha status where applicable.

SourceLink

POLICY UPDATE CHANGES

Policy lists FDA-approved indication and compendial use criteria for Elahere and documents required for prior authorization.

1FDA-Approved Indications

1Compendial Use Indications (specified)

12Authorization Duration (months)

Coverage Summary & Indications

Coverage: covered_with_criteria for adult patients with folate receptor-alpha positive epithelial ovarian, fallopian tube, or primary peritoneal cancer per FDA-approved indication and certain compendial uses. FDA-approved coverage applies for platinum-resistant disease in adults who have received 1-3 prior systemic treatment regimens. Compendial use coverage is specified for recurrent platinum-sensitive disease when criteria are met (including tumor expression and prior platinum therapy thresholds). Continuation/reauthorization rules and documentation requirements apply.

Covered Indications - FDA-Approved

Covered when ALL of the following are met:

FDA-Approved indication

Diagnosis of folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Age: Adult patient
Prior regimens: Member has received 1-3 prior systemic treatment regimens1-3 prior systemic treatment regimens

Group intro: All criteria above must be met for coverage under the FDA-approved indication.

Covered Indications - Compendial Uses (Platinum-sensitive recurrent disease)

Covered when ALL of the following are met:

Compendial use (platinum-sensitive recurrent disease)

Diagnosis of recurrent folate receptor-alpha positive, platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer
Prior platinum therapies: Member has received two prior lines of platinum-based therapy>= 2 prior lines of platinum-based therapy
Single agent use: Requested medication will be used as a single agent
FR-alpha expression: Tumor is at least 75% positive for folate receptor-alpha expression>= 75% positive

Group intro: All criteria above must be met for coverage under the compendial platinum-sensitive recurrent indication.

Alternative covered regimen for platinum-resistant disease

Authorization may be granted when ALL of the following are met:

Alternative regimen for platinum-resistant disease

Platinum-resistant status: Member has platinum-resistant disease
Prior therapy: Member has received at least one prior systemic therapy
Agent use: Requested medication will be used as a single agent or in combination with bevacizumab

Group note: Authorization for this alternative regimen may be granted when all criteria are met.

Initial Authorization Criteria

Initial Authorization (FDA-Approved criteria)

For initial authorization specifics:

Initial authorization - FDA-approved

Diagnosis of folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer
Age: Adult patient
Prior regimens: Member has received 1-3 prior systemic treatment regimens1-3 prior systemic treatment regimens

Workflow note: Provide documentation of prior systemic therapies (number and type) as part of prior authorization submission.

Refer to provider documentation requirements

Continuation of Therapy / Reauthorization Criteria

Continuation of Therapy / Reauthorization

Covered when ALL of the following are met:

Continuation of therapy / reauthorization

Previously authorized indication: Member previously authorized for an indication listed in the coverage criteria section
Toxicity: No evidence of unacceptable toxicity while on the current regimen
Disease progression: No evidence of disease progression while on the current regimen

Operational note: Authorization of 12 months may be granted for continued treatment when coverage criteria are met and there is no unacceptable toxicity or disease progression.12 months

Per provider_actions

Authorization and Thresholds

Authorization duration12 months

Prior systemic regimens1-3 prior systemic treatment regimens

Prior platinum-based therapies>= 2 prior lines

Folate receptor-alpha expression>= 75%

Prior Authorization & Documentation Requirements

Prior Authorization

Prior authorization required

Submission of documentation is necessary to initiate prior authorization review, including testing or laboratory results confirming folate receptor-alpha status where applicable.

Submit testing or laboratory results confirming folate receptor-alpha status

Documentation Required

Clinical documentation requirements

Provide documentation of prior systemic therapies (number and type), platinum-sensitivity or platinum-resistance status, and folate receptor-alpha testing results. Include percent positivity for folate receptor‑alpha when applicable (e.g., ≥75% positivity required for the compendial platinum-sensitive indication).

List prior systemic therapies (number and agents)
Document platinum-sensitivity or platinum-resistance status
Include folate receptor‑alpha test results and percent positivity (report %; ≥75% required for compendial use)

Prior Authorization

Authorization duration

Authorization of 12 months may be granted for initial treatment when coverage criteria are met, and authorization of 12 months may be granted for continued treatment (reauthorization) when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Initial authorization: up to 12 months when criteria for platinum‑resistant or platinum‑sensitive indications are met
Reauthorization: up to 12 months if no unacceptable toxicity or disease progression

Evidence & References

Evidence sources listed in the policy brief: Elahere [package insert] (AbbVie, July 2025) and the NCCN Drugs & Biologics Compendium® 2025 (compendia reference).

Note: The brief does not provide clinical trial-specific metrics (e.g., response rates, hazard ratios) within the policy text; clinical trial details should be sought in the cited package insert or compendia.

Background & Definitions

Background: Elahere (mirvetuximab soravtansine-gynx) is an antibody-drug conjugate indicated for adult patients with folate receptor-alpha positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. The policy also documents certain compendial uses, including recurrent folate receptor-alpha positive, platinum-sensitive disease, and specifies documentation and authorization procedures for treatment and reauthorization.

Definitions:

• Platinum-resistant: As used in the policy, denotes platinum-resistant disease (the document does not supply an exact timeframe; clinical determination is required).

• Platinum-sensitive: Recurrent platinum-sensitive disease as defined in policy requires receipt of two prior lines of platinum-based therapy for the compendial indication.

• Folate receptor-alpha positive: Tumor testing confirming folate receptor-alpha expression; policy requires tumor expression of ≥ 75% positive for the compendial platinum-sensitive indication.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyMirvetuximab Soravtansine-gynx (Elahere™)

Policy CodePolicy ID_CHS_2025

Change Typeclarified

Effective DateJun 2, 2026

Next Review Date

Key ActionSubmission of documentation is necessary to initiate prior authorization review, including testing or laboratory results confirming folate receptor-alpha status where applicable.

SourceLink

On This Page

OpenPayer

Mirvetuximab Soravtansine-gynx (Elahere™)

Coverage Summary & Indications

Initial Authorization Criteria

Continuation of Therapy / Reauthorization Criteria

Prior Authorization & Documentation Requirements

Applicable Codes

Evidence & References

Background & Definitions

Policy Revision History