Mirvetuximab Soravtansine-gynx (Elahere)

Number: 1021

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses mirvetuximab soravtansine-gynx (Elahere) for commercial medical plans. For Medicare criteria, see Medicare Part B Criteria.

Note: Requires Precertification:

Precertification of mirvetuximab soravtansine-gynx (Elahere) is required of all Aetna participating providers and members in applicable plan designs. For precertification of mirvetuximab soravtansine-gynx (Elahere), call (866) 752-7021 or fax (888) 267-3277. For Statement of Medical Necessity (SMN) precertification forms, see Specialty Pharmacy Precertification.   

1. Criteria for Initial Approval

   Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

   Aetna considers mirvetuximab soravtansine-gynx (Elahere) medically necessary for treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer as a single agent or in combination with bevacizumab when all of the following criteria are met:

   1. Member has folate receptor-alpha positive disease; and
   2. Member has platinum-resistant disease; and
   3. Member has received at least one prior systemic therapy.

   Aetna considers all other indications as experimental, investigational, or unproven.

2. Continuation of Therapy

   Aetna considers continuation of mirvetuximab soravtansine-gynx (Elahere) therapy medically necessary in members requesting reauthorization for an indication listed in Section I when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Dosage and Administration

Mirvetuximab soravtansine-gynx is supplied as Elahere 100 mg/20 mL (5 mg/mL) in single-dose vial for injection for intravenous use.

Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

The recommended dose of Elahere is 6 mg/kg adjusted ideal body weight (AIBW) given once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity.

Refer to full prescribing information for Elahere for preparation and administration instructions and dosage modifications.

Source: ImmunoGen, 2022

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
Other CPT codes related to the CPB:
96365 - 96368	Intravenous infusion
96413 - 96417	Chemotherapy administration, intravenous infusion technique
HCPCS codes covered if selection criteria are met:
J9063	Injection, mirvetuximab soravtansine-gynx, 1 mg
Other HCPCS codes related to the CPB:
C9257	Injection, bevacizumab, 0.25 mg
J9035	Injection, bevacizumab, 10 mg
J9045	Injection, carboplatin, 50 mg
J9060	Injection, cisplatin, powder or solution, 10 mg
J9263	Injection, oxaliplatin, 0.5 mg
ICD-10 codes covered if selection criteria are met:
C48.0 – C48.8	Malignant neoplasm of retroperitoneum and peritoneum
C56.1 – C56.9	Malignant neoplasm of ovary
C57.00 – C57.02	Malignant neoplasm of fallopian tube

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Background

U.S. Food and Drug Administration (FDA)-Approved Indications 

• Elahere is indicated for the treatment of 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.

Mirvetuximab soravtansine-gynx is available as Elahere (ImmunoGen, Inc.) and is a folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate. The antibody is a chimeric IgG1 directed against FRα. The small molecule anti-tubulin agent, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRα, mirvetuximab soravtansine-gynx is internalized with ensuing intracellular release of DM4 via protelytic cleavage. DM4 interferes with the microtuble network within the cell with resultant cell cycle arrest and apoptic cell death (ImmunoGen, 2022). 

According to the prescribing information, Elahere carries the following black box warning of ocular toxicity:

• Elahere can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
• Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
• Administer prophylactic artificial tears and ophthalmic topical steroids.
• Withhold Elahere for ocular toxicities until improvement and resume at the same or reduced dose.
• Discontinue Elahere for Grade 4 ocular toxicities.

Additional warnings and precautions per the prescribing information include:

• Pneumonitis
• Peripheral neuropathy
• Embryo-fetal toxicity

Per the prescribing information, the most common (≥20 %) adverse reactions, including laboratory abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eye, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin.

Refer to full prescribing information for Elahere for drug interactions and use in specific populations.

On November 14, 2022, the Food and Drug Administration granted accelerated approval to Elahere mirvetuximab soravtansine-gynx (Elahere) for adult patients 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. Patients are selected for therapy based on an FDA-approved test. The FDA also approved the VENTANA FOLR1 (FOLR-2.1) RxDx Assay (Ventana Medical Systems, Inc.) as a companion diagnostic device to select patients for the indication (FDA, 2022).

The FDA approval was based on supporting data from Study 0417 which evaluated efficacy of Elahere. The study was a a single-arm trial of 106 patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients were permitted to receive up to three prior lines of systemic therapy. All patients were required to have received bevacizumab. The trial enrolled patients whose tumors were positive for FRα expression as determined by the above assay. Patients were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease. Patients received mirvetuximab soravtansine-gynx 6 mg/kg (based on adjusted ideal body weight) as an intravenous infusion every three weeks until disease progression or unacceptable toxicity. Tumor response assessments occurred every six weeks for the first 36 weeks and every 12 weeks thereafter. The main efficacy outcome measures were investigator-assessed overall response rate (ORR) and duration of response (DOR). In the efficacy evaluable population of patients who had platinum resistant, measurable disease, and received at least one dose (104 patients), the confirmed ORR was 31.7% (95% Confidence Interval [CI]: 22.9, 41.6) and median DOR was 6.9 months (95% CI: 5.6, 9.7).

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References