Commercial
Advanced Search

Mirvetuximab soravtansine-gynx (Elahere TM)
08.02.01a

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​TM), as an intravenous (IV) infusion, is considered medically necessary and, therefore, covered 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:
  • Low-grade serous, borderline epithelial histology with recurrent disease
  • Endometrioid (serous), carcinosarcoma (malignant mixed Mullerian tumors), ​clear cell, mucinous, or endometrioid (grade 1) with persistent or recurrent disease and one of the following scenarios:
    • For progression on primary, maintenance, or recurrence therapy
    • For stable or persistent disease (if not on maintenance therapy)
    • For complete remission and relapse <6 months after completing chemotherapy
*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.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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 percent 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.

The safety and efficacy of mirvetuximab soravtansine-gynx (Elahere) was investigated in a phase III, single arm, open label, multicenter study (SORAYA; 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 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 percent (4.8 percent complete responses, 26.9 percent partial responses). The median DOR was 6.9 months (95 percent confidence interval [CI] 5.6 to 9.7). The study data continues to mature.

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). ​ElahereTM (mirvetuximab soravtansine-gynx). AHFS Drug Information 2022. [LexiComp Web site]. 12/14/2022. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed December 27, 2022.


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 December 27, 2022.


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 December 27, 2022.


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 December 27, 2022.


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 December 27, 2022.


ElahereTM (mirvetuximab soravtansine-gynx) [prescribing information]. Waltham, MA: ImmunoGen, Inc.; 11/2022. Available at: https://www.immunogen.com/wp-content/uploads/2022/11/ELAHERE_PI.pdf. Accessed December 27, 2022.


Elsevier's Clinical Pharmacology Compendium. ElahereTM (mirvetuximab soravtansine-gynx). [Clinical Key Web site]. 11/28/2022. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed December 27, 2022.


IBM Micromedex® DRUGDEX® (electronic version). ElahereTM (mirvetuximab soravtansine-gynx). [Micromedex Web site]. IBM Watson Health, Greenwood Village, Colorado, USA. 12/16/2022. Available at: https://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed December 27, 2022.


Lexi-Drugs Compendium. ElahereTM (mirvetuximab soravtansine-gynx). [LexiComp Web site]. 11/16/2022. Available at: https://online.lexi.com/lco/action/home [via subscription only]. Accessed December 27, 2022.


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 V1.2023. [NCCN Web site]. 12/22/2022. Available from: https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. [via subscription only]. Accessed December 27, 2022.


National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium®. [NCCN Web site]. ElahereTM (mirvetuximab soravtansine-gynx). Available at: https://www.nccn.org/professionals/drug_compendium/content/ [via subscription only]. Accessed December 27, 2022.


US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. ElahereTM (mirvetuximab soravtansine-gynx). Prescribing information. [FDA Web site]. 11/14/2022. Available at https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed December 27, 2022.


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 December 27, 2022.

Coding

CPT Procedure Code Number(s)
N/A
ICD - 10 Procedure Code Number(s)
N/A
ICD - 10 Diagnosis Code Number(s)
C48.1Malignant neoplasm of specified parts of peritoneum
C48.2Malignant neoplasm of peritoneum, unspecified
C48.8Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C56.1Malignant neoplasm of right ovary
C56.2Malignant neoplasm of left ovary
C56.3Malignant neoplasm of bilateral ovaries
C56.9Malignant neoplasm of unspecified ovary
C57.00Malignant neoplasm of unspecified fallopian tube
C57.01Malignant neoplasm of right fallopian tube
C57.02Malignant neoplasm of left fallopian tube
C57.10Malignant neoplasm of unspecified broad ligament
C57.11Malignant neoplasm of right broad ligament
C57.12Malignant neoplasm of left broad ligament
C57.20Malignant neoplasm of unspecified round ligament
C57.21Malignant neoplasm of right round ligament
C57.22Malignant neoplasm of left round ligament
C57.3Malignant neoplasm of parametrium
C57.4Malignant neoplasm of uterine adnexa, unspecified
C57.7Malignant neoplasm of other specified female genital organs
C57.8Malignant neoplasm of overlapping sites of female genital organs
C57.9Malignant neoplasm of female genital organ, unspecified


HCPCS Level II Code Number(s)
J9063
Injection, mirvetuximab soravtansine-gynx, 1 mg



Revenue Code Number(s)
N/A

Coding and Billing Requirements

Policy History


Revisions from 08.02.01a
07/01/2023This 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 biol​ogics​

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

08.02.01:
04/24/2023The 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 (ElahereTM). ​

7/1/2023
6/30/2023
08.02.01
Medical Policy Bulletin
Commercial
No
Connect with Us

2024 Independence Blue Cross

Independence Blue Cross is a subsidiary of Independence Health Group, Inc. — independent licensees of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.