Policy Application
All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.
Coverage is subject to the specific terms of the member's benefit plan.
Mirvetuximab soravtansine-gynx (Elahere) may be considered medically necessary in individuals 18 years and older whenALLof the following criteria are met:
Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Individual has a diagnosis of FR positive, platinum resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer confirmed by an FDA-approved test; and
- Individual has received one (1) to three (3) prior systemic treatment regimens; and
- Individual has received an ophthalmic exam including visual acuity and slit lamp testing prior to treatment; and
- Individual will receive subsequent ophthalmic exams prior to every other cycle for the first eight (8) cycles of treatment.
Compendia Sources
- Mirvetuximab soravtansine-gynx (Elahere) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of mirvetuximab soravtansine-gynx (Elahere) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.
Diagnosis Codes
C48.1
|
C48.2
|
C48.8
|
C56.1
|
C56.2
|
C56.3
|
C56.9
|
C57.00
|
C57.01
|
C57.02
|
C57.10
|
C57.11
|
C57.12
|
C57.20
|
C57.21
|
C57.22
|
C57.3
|
C57.4
|
C57.7
|
C57.8
|
C57.9
|
Professional Statements and Societal Positions Guidelines
Not Applicable
ND Committee Review
Internal Medical Policy Committee 11-19-2024 Effective December 09, 2024
- Adopted Medicaid Expansion specific policy
