ELAHERE (mirvetuximab soravtansine-gynx)

ELAHERE (mirvetuximab soravtansine-gynx)

Medical Administration – intravenous

Diagnosis considered for coverage:

• Indicated for the treatment of 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. Select patients for therapy based on an FDA-approved test
• 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

Coverage Criteria:

For diagnosis of FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer:

• Dose does not exceed 6 mg/kg AIBW every 3 weeks; AND
• Patient is 18 years of age or older; AND
• Patient has a diagnosis of one of the following:
  • Epithelial ovarian cancer 
  • Fallopian tube cancer 
  • Primary peritoneal cancer; AND
• Prescribed by or in consultation with an oncologist; AND
• Tumor is folate receptor-alpha (FRa) positive as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA); AND
• Disease is resistant to platinum-based chemotherapy (e.g., cisplatin, carboplatin); AND
• Patient has received one to three prior systemic treatment regimens (e.g., chemotherapy)

Reauthorization Criteria:

For diagnosis of FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer:

• Dose does not exceed 6 mg/kg AIBW every 3 weeks; AND
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Recommended dose: 6 mg/kg adjusted ideal body weight (AIBW) administered once every 3 weeks (21-day cycle) as an intravenous infusion until disease progression or unacceptable toxicity
• AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] – IBW)
• Female IBW (kg) = 0.9*height(cm) – 92
• Elahere is available as 100 mg/20 mL (5 mg/mL) single-dose vial
• Information on FDA-approved tests for the measurement of FRα tumor expression is available at http://www.fda.gov/CompanionDiagnostics (e.g., VENTANA FOLR1 (FOLR-2.1) RxDx Assay)

Policy Updates:

• 6/1/2023 – New policy approved by P&T

References:

• Elahere Prescribing Information. ImmunoGen, Inc. Waltham, MA. November 2022. 
• The NCCN Drugs and Biologics Compendium (NCCN Compendium). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed on December 13, 2022.