Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Elahere requires prior authorization.

2)    Elahere is used to treat ovarian cancer.

3)    Elahere is covered under the medical benefit.

Elahere is considered medically necessary when the following criteria are met:

Initial Approval Criteria

Ovarian Cancer

A)   Diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer;

B)   Prescribed by or in consultation with an oncologist;

C)   Age ≥ 18 years;

D)   Member meets all of the following parameters

a.    FRα positive ovarian cancer determined by the Ventana FOLR1 (Folate Receptor 1/Folate Receptor Alpha) Assay;

b.    Platinum resistant ovarian cancer;

c.    Received at least 1 but no more than 3 prior systemic lines of anticancer therapy, including at least 1 line of therapy containing bevacizumab;

E)   Documentation of current actual body weight in kg and height in cm;

F)   Request meets one of the following

a.    Dose does not exceed 6mg/kg dosed based on adjusted ideal body weight

b.    Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Approval Duration: 6 months

Continuation of Therapy

Ovarian Cancer

A)   Member is responding positively to therapy;

B)   Documentation of current actual body weight in kg;

Approval Duration: 12 months

Codes Used In This BI:

1)    C9146 – Ijnection, mirvetuximab soravtansine-gynx, 1mg

1)    Elahere Prescribing Information: Waltham, MA: ImmunoGen, Inc. November 2022. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761310s000lbl.pdf. Accessed January 6, 2023

2)    Mirvetuximab In: National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed. January 6, 2023.

3)    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. Last updated January 23, 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT04296890. Accessed January 23, 2023.