Commercial

Medical Policy

Title:

Mirvetuximab soravtansine-gynx (Elahere®)

Policy #:

08.02.01c

Policy

The Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition.

MEDICALLY NECESSARY

Mirvetuximab soravtansine-gynx (Elahere) is considered medically necessary and, therefore, covered as a single agent or in combination with bevacizumab for the treatment of adult individuals with folate receptor alpha (FRα)-positive*, platinum-resistant (i.e., disease recurring within 6 months of platinum-based chemotherapy) epithelial ovarian, fallopian tube, or primary peritoneal cancer and who have received one to three prior systemic treatment regimens with one of the following histology types:

Serous, borderline epithelial histology with recurrent disease (National Comprehensive Cancer Network [NCCN]-preferred therapy)
Endometrioid (serous), carcinosarcoma (malignant mixed Müllerian tumors), clear cell, mucinous, or endometrioid (grade 1) with persistent or recurrent disease and one of the following scenarios (NCCN-preferred):

For progression on primary, maintenance, or recurrence therapy (platinum-resistant disease)
For stable or persistent disease (if not on maintenance therapy) (platinum-resistant disease)
For complete remission and relapse <6 months after completing chemotherapy (platinum-resistant disease)

*Select individuals for therapy based on an US Food and Drug Administration (FDA)-approved test.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of mirvetuximab soravtansine-gynx (Elahere) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on Off-label Coverage for Prescription Drugs and Biologics.

MANDATES

PENNSYLVANIA MEMBERS
In accordance with the Commonwealth of Pennsylvania's Act 6 of 2020 or Fair Access to Cancer Treatment Act, for members who are enrolled in Pennsylvania commercial products who have Stage 4, advanced, metastatic cancer, refer to the Medical Policy titled "Coverage of Anticancer Prescription Oral and Injectable Drugs and Biologics and Supportive agents" (08.01.08) for additional information regarding the applicable coverage of drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.

Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

Highlights include the recommendation to conduct an ophthalmic examination, including visual acuity and slit lamp examination, prior to initiation of mirvetuximab soravtansine-gynx (Elahere), every other cycle for the first eight cycles, and as clinically indicated. Administer prophylactic artificial tears and ophthalmic topical steroids.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, mirvetuximab soravtansine-gynx (Elahere) may be covered under the medical benefits of the Company’s products when medical necessity criteria and dosing and frequency requirements listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

The FDA's approval of mirvetuximab soravtansine-gynx (Elahere) was issued on November 14, 2022, for use in the treatment of adult individuals with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Mirvetuximab soravtansine-gynx (Elahere) is administered intravenously at 6 mg/kg adjusted ideal body weight once every 3 weeks until disease progression or unacceptable toxicity.

PEDIATRIC USE

The safety and effectiveness of mirvetuximab soravtansine-gynx (Elahere) in pediatric individuals have not been established.

Description

Ovarian cancer is cancer that originates in the ovaries, or in areas related to them such as the fallopian tubes and the peritoneum (the tissue lining the organs in the abdomen). Ovarian cancer is the second most common gynecologic cancer, and the leading cause of female reproductive system cancer deaths in the world. When ovarian cancer is found in the early stages, it is very treatable with surgery and chemotherapy. Up to 80% of individuals with ovarian cancer will experience a relapse and the cancer will eventually become drug resistant. Outcomes for individuals with platinum-resistant ovarian cancer remain poor with a median overall survival of less than 1 year.

Mirvetuximab soravtansine-gynx (Elahere) is an antibody-drug conjugate. The antibody is folate receptor alpha (FRα)-directed. It is attached to DM4 via a cleavable linker. After binding to FRα, the conjugate is internalized. The linker is broken by proteolytic cleavage. The DM4 disrupts the microtubule network within the cell, causing cell cycle arrest and apoptotic cell death.

PEER-REVIEWED LITERATURE

SUMMARY

The safety and efficacy of mirvetuximab soravtansine-gynx (Elahere) was investigated in a phase III, single arm, open label, multicenter study called A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression (SORAYA; ClinicalTrials.gov Identifier: NCT04296890). Participants had platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that expressed high-level FRα. Participants must have received one to three prior systemic lines of therapy including at least one line of therapy containing bevacizumab. The primary outcome measure was objective response rate (ORR). Secondary outcome measures include duration of response (DOR), adverse events (AEs), progression-free survival (PFS), overall survival (OS), and Cancer Antigen-125 (CA-125) response.

A total of 106 individuals were enrolled, with 104 individuals being included in the efficacy evaluable population. The ORR was 31.7% (4.8% complete responses [CRs], 26.9% partial responses [PRs]). The median DOR was 6.9 months (95% confidence interval [CI], 5.6–9.7).

Conversion to regular approval from accelerated approval was based on data from the confirmatory phase 3 trial called A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression (MIRASOL; NCT04209855), which included 453 adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer patients treated with up to three prior lines of systemic therapy. Study participants were randomly assigned 1:1 to receive either mirvetuximab soravtansine, 6 mg/kg via intravenous (IV) infusion every 3 weeks, or investigator’s choice of chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], or topotecan), until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Key secondary endpoints included ORR and OS.

Findings demonstrated that treatment with mirvetuximab soravtansine achieved a statistically significant improvement in PFS compared with chemotherapy (hazard ratio [HR], 0.65 [95% CI, 0.52–0.81]; P<0.0001); median PFS was 5.6 months (95% CI, 4.3–5.9) in the mirvetuximab soravtansine arm and 4 months (95% CI, 2.9–4.5) in the chemotherapy arm. Additionally, mirvetuximab soravtansine reduced the risk of death by 33% compared with chemotherapy (HR, 0.67 [95% CI, 0.5–-0.88]; P=0.0046); median OS was 16.5 months (95% CI, 14.5–24.6) in the mirvetuximab soravtansine arm and 12.7 months (95% CI, 10.9–14.4) in the chemotherapy arm. The ORR was 42% (95% CI, 36–49) in the mirvetuximab soravtansine arm, of which 5% of patients achieved CR and 37% achieved PR compared with an ORR of 16% (95% CI,12–22) in the chemotherapy arm, of which 0% achieved CR and 16% achieved PR (P<0.0001).

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.

References

American Hospital Formulary Service (AHFS). Elahere^TM (mirvetuximab soravtansine-gynx). AHFS Drug Information 2025. [LexiComp Web site]. 02/24/2024. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed April 1, 2025.

Centers for Disease Control and Prevention (CDC). Basic information about ovarian cancer. 08/31/2022. Available at: https://www.cdc.gov/cancer/ovarian/basic_info/. Accessed April 1, 2025.

ClinicalTrials.gov. A study of mirvetuximab soravtansine in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression (SORAYA). ClinicalTrials.gov Identifier: NCT04296890. First Posted: March 5, 2020. Last Update Posted: September 21, 2022. Available at: https://clinicaltrials.gov/. Accessed April 1, 2025.

ClinicalTrials.gov. A study of mirvetuximab soravtansine vs. investigator's choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression (MIRASOL). ClinicalTrials.gov Identifier: NCT04209855. First Posted: December 24, 2019. Last Update Posted: October 31, 2022. Available at: https://clinicaltrials.gov/. Accessed April 1, 2025.

ClinicalTrials.gov. A study of mirvetuximab soravtansine vs. investigator's choice of chemotherapy in women with folate receptor (FR) alpha positive advanced epithelial ovarian cancer (EOC), primary peritoneal or fallopian tube cancer (FORWARD I). ClinicalTrials.gov Identifier: NCT02631876. First Posted: December 16, 2015. Last Update Posted: October 14, 2020. Available at: https://clinicaltrials.gov/. Accessed April 1, 2025.

Elsevier's Clinical Pharmacology Compendium. Elahere^TM (mirvetuximab soravtansine-gynx). [Clinical Key Web site]. 01/09/2023. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed April 1, 2025.

IBM Micromedex^® DRUGDEX^® (electronic version). Elahere^TM (mirvetuximab soravtansine-gynx). [Micromedex Web site]. IBM Watson Health, Greenwood Village, Colorado, USA. 02/28/2024. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed April 1, 2025.

Lexi-Drugs Compendium. Elahere^TM (mirvetuximab soravtansine-gynx). [LexiComp Web site]. 03/11/2024. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed April 1, 2025.

Moore KN, Oza AM, Colombo N, et al. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021;32(6):757-765.

Moore KN, Vergote I, Oaknin A, et al. FORWARD I: a phase III study of mirvetuximab soravtansine versus chemotherapy in platinum-resistant ovarian cancer. Future Oncol. 2018;14(17):1669-1678.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology^® - Ovarian Cancer Including Fallopian Tube Cancer and Primary Peritoneal Cancer. V1.2025. [NCCN Web site]. 03/05/2025. Available from: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. [via subscription only]. Accessed April 1, 2025.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium^®. [NCCN Web site]. Elahere^TM (mirvetuximab soravtansine-gynx). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed April 1, 2025.

PA House Bill – HB 427; Act 6. Signed February 12, 2020. Available at: https://www.legis.state.pa.us/cfdocs/billinfo/billinfo.cfm?syear=2019&sind=0&body=H&type=B&bn=0427. Accessed April 1, 2025.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Elahere^TM (mirvetuximab soravtansine-gynx). Prescribing information. [FDA Web site]. 03/22/2024. Available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed April 1, 2025.

US Food and Drug Administration (FDA). List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools). 12/21/2022. Available at: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. Accessed April 1, 2025.

Coding

CPT Procedure Code Number(s)

N/A

ICD - 10 Procedure Code Number(s)

N/A

ICD - 10 Diagnosis Code Number(s)

Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

HCPCS Level II Code Number(s)

J9063 Injection, mirvetuximab soravtansine-gynx, 1 mg

Revenue Code Number(s)

N/A

MPMiscCodesNarrativesPub

Coding and Billing Requirements

Cross Reference

Policy History

Revisions From 08.02.01c:

06/16/2025

This version of the policy will become effective 06/16/2025.

This policy has been updated to communicate the Company's coverage position for mirvetuximab soravtansine-gynx (Elahere), in accordance with US Food and Drug Administration (FDA) prescribing information and National Comprehensive Cancer Network (NCCN) compendia.

Mirvetuximab soravtansine-gynx (Elahere) is now identified as a NCCN-preferred regimen for platinum-resistant endometrioid (serous), carcinosarcoma (malignant mixed Müllerian tumors), clear cell, mucinous, or endometrioid (grade 1) disease.

All of the ICD-10 CM codes have been removed from this policy, since they are informational. Report the most appropriate diagnosis code in support of medically necessary criteria as listed in the policy.

Revisions From 08.02.01b:

05/20/2024

This version of the policy will become effective 05/20/2024.

This policy has been updated to communicate the Company's coverage position for ElahereTM (mirvetuximab soravtansine-gynx), in accordance with US Food and Drug Administration (FDA) prescribing information and National Comprehensive Cancer Network (NCCN) compendia.

Elahere now identified as a NCCN-preferrred regimen for borderline epithelial, serous histology. Additionally, it is covered in combination with bevacizumab.

The following ICD-10 CM codes have been removed from this policy, due to specificity:

C56.9 Malignant neoplasm of unspecified ovary

C57.00 Malignant neoplasm of unspecified fallopian tube

C57.10 Malignant neoplasm of unspecified broad ligament

C57.20 Malignant neoplasm of unspecified round ligament

Revisions From 08.02.01a:

07/01/2023

This version of the policy will become effective 07/01/2023
Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

The following HCPCS codes have been removed from this policy:
C9146 Injection, mirvetuximab soravtansine-gynx, 1 mg
J3590 Unclassified biologics

The following HCPCS code has been added to this policy
J9063 Injection, mirvetuximab soravtansine-gynx, 1 mg

Revisions From 08.02.01:

04/24/2023

The policy will become effective 04/24/2023. The following new policy has been developed to communicate the Company’s coverage criteria for mirvetuximab soravtansine-gynx (Elahere^TM).

Version Effective Date:

6/16/2025

Version Issued Date: