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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Erivedge 1785-A SGM P2024

Drug
ERIVEDGE  (vismodegib)


Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          A.  FDA-Approved Indication
               Erivedge is indicated for the treatment of adults with metastatic basal cell carcinoma, or with
               locally advanced basal cell carcinoma that has recurred following surgery or who are not
               candidates for surgery, and who are not candidates for radiation.

          B.  Compendial Uses
               1.  Basal cell carcinoma
               2.  Adult medulloblastoma

          All other indications are considered experimental/investigational and not medically necessary.


    II.  CRITERIA FOR INITIAL APPROVAL

          A.  Basal Cell Carcinoma (BCC)
               Authorization of 12 months may be granted for treatment of advanced, diffuse (e.g., Gorlin
               syndrome), recurrent, nodal, or metastatic basal cell carcinoma, as a single agent.

          B.  Adult Medulloblastoma
               Authorization of 12 months may be granted for treatment of recurrent adult medulloblastoma
               in patients who have received prior systemic therapy and whose tumor(s) have mutations in
               the sonic hedgehog pathway, as a single agent.


   III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in members requesting
          reauthorization for an indication listed in Section II when there is no evidence of unacceptable
          toxicity or disease progression while on the current regimen.

 


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Erivedge [package insert]. South San Francisco, CA: Genentech USA, Inc.; March 2023.
  2. The NCCN Drugs & Biologics Compendium™ © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed October 19, 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

May 17, 2024
Aetna
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