Subject: Erivedge SGM 1785-A P2025

Drug

ERIVEDGE  (vismodegib)

Policy:

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.

FDA-Approved Indication¹

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.

Compendial Uses²

• Basal cell carcinoma
• Adult medulloblastoma

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

Coverage Criteria

Basal Cell Carcinoma (BCC)^1,2

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.

Adult Medulloblastoma²

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.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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™ © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 11, 2024.

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, 2025