Subject: Caprelsa SGM 1783-A P2024_R

Drug

CAPRELSA  (vandetanib)

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 INDICATIONS

Treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Use Caprelsa in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of Caprelsa.

Compendial Uses

Follicular, oncocytic/Hürthle cell, and papillary thyroid carcinoma
All other indications are considered experimental/investigational and not medically necessary.

Coverage Criteria

Thyroid carcinoma

Authorization of 12 months may be granted for treatment of thyroid carcinoma when any of the following criteria are met:

• Member has follicular, oncocytic/Hürthle cell, or papillary thyroid carcinoma that is not amenable to radioactive iodine (RAI) therapy.
• Member has medullary thyroid carcinoma.

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting authorization 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. Caprelsa [package insert]. Cambridge, MA: Genzyme Corporation; April 2024.
2. The NCCN Drugs & Biologics Compendium © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed July 31, 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.

January 01, 2025