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Specialty Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Erivedge 1785-A SGM P2022

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 chemotherapy 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™ © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed October 28, 2021.
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 16, 2022
Aetna
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