Subject: Erivedge 1785-A SGM P2023

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, or
               metastatic basal cell carcinoma.

          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.; July 2020.
2. The NCCN Drugs & Biologics Compendium™ © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 1, 2022.

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.

April 15, 2023