Subject: Caprelsa 1783-A SGM P2022

Drug

CAPRELSA  (vandetanib)

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
               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.

           B.  Compendial Uses
                Follicular, Hürthle cell, and papillary thyroid carcinoma

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

    II.  CRITERIA FOR INITIAL APPROVAL

          Thyroid carcinoma
          Authorization of 12 months may be granted for treatment of thyroid
          carcinoma when any of the following criteria are met:
          A.  Member has follicular, Hürthle cell, or papillary thyroid carcinoma
               that is not amenable to radioactive iodine (RAI) therapy.
          B.  Member has medullary thyroid carcinoma.

 

  III.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for continued treatment in
          members requesting authorization 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. Caprelsa [package insert]. Cambridge, MA: Genzyme Corporation; June 2020.
2. The NCCN Drugs & Biologics Compendium™ © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 4, 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.

April 16, 2022