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Elahere™ (mirvetuximab soravtansine-gynx) (Intravenous)

Policy Number: VP-0686

Last Review Date: 03/02/2023

Date of Origin: 12/01/2022

Dates Reviewed: 12/2022, 03/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

I. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Elahere 100 mg/20 mL single-dose vial: 6 vials every 21 days 
  1. Max Units (per dose and over time) [HCPCS Unit]:
  • 600 billable units (600 mg) every 21 days

III. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient at least 18 years of age; AND

Universal Criteria 1

  • Therapy will be used in combination with artificial tears and ophthalmic topical steroids; AND
  • Patient has a baseline ophthalmological test (i.e., visual acuity and slit lamp exam) obtained prior to initiation of therapy and will continue to have follow-up ophthalmological examinations periodically thereafter (i.e., every other cycle for the first 8 cycles, and as clinically indicated); AND
  • Patient does not have moderate to severe hepatic impairment (Child-Pugh Class B or C); AND
  • Patient does not have any of the following:
        •  
    • Non-infectious interstitial lung disease or pneumonitis (Grade 3 or 4); AND
    • Peripheral neuropathy greater than Grade 1; AND
    • Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring (e.g., uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision); AND

Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer † Ф 1-3

  • Used as a single agent; AND
  • Patient has folate receptor alpha (FRα) expression positive disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Patient has platinum-resistant disease; AND
    • Patient has persistent or recurrent epithelial ovarian/fallopian tube/primary peritoneal cancer, carcinosarcoma (Malignant Mixed Müllerian Tumors), clear cell carcinoma of the ovary, mucinous carcinoma of the ovary, or grade 1 endometrioid carcinoma; OR
    • Patient has recurrent low-grade serous carcinoma

v If confirmed using an immunotherapy assay-http://www.fda.gov/companiondiagnostics

FDA Approved Indication(s);Compendia Recommended Indication(s); Ф Orphan Drug

IV. Renewal Criteria 1

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: persistent or recurrent pneumonitis, severe peripheral neuropathy, severe ocular toxicities (i.e., visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis), etc.

V. Dosage/Administration 1

Indication

Dose

Ovarian Cancer

Administer 6 mg/kg adjusted ideal body weight (AIBW) administered as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity.

The total dose is calculated based on AIBW using the following formula:

AIBW = Ideal Body Weight (IBW [kg]) + 0.4*(Actual weight [kg] – IBW)

  • Female IBW (kg) = 0.9*height(cm) – 92

VI. Billing Code/Availability Information

HCPCS Code:

  • J9999 ­­­– Not otherwise classified, antineoplastic drugs
  • C9146 – Injection, mirvetuximab soravtansine-gynx, 1 mg; 1 billable unit = 1 mg (Discontinue on 07/01/2023)
  • J9063 – Injection, mirvetuximab soravtansine-gynx, 1 mg; 1 billable unit = 1 mg (Effective 07/01/2023)

NDC:

  • Elahere 100 mg/20 mL (5 mg/mL) single-dose vial: 72903-0853-xx 

VII. References

  1. Elahere [package insert].  Waltham, MA; ImmunoGen, Inc; November 2022. Accessed February 2023.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) mirvetuximab soravtansine. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2023.
  3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Ovarian Cancer - Fallopian Tube Cancer and Primary Peritoneal Cancer 1.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2023.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.3

Malignant neoplasm of bilateral ovaries

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

Z85.43

Personal history of malignant neoplasm of ovary

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs)  may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC