Subject: Gavreto SGM 4206-A P2024_R

Drug

GAVRETO  (pralsetinib)

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

• Gavreto is indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
• Gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Compendial Uses

• NSCLC with RET rearrangement-positive tumors
• Anaplastic thyroid cancer
• Follicular, oncocytic, papillary thyroid cancer
• Gallbladder cancer

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

Documentation

Submission of the following information is necessary to initiate the prior authorization review: Documentation of the presence of a rearranged during transfection (RET) gene fusion in tumor specimens or plasma.

Coverage Criteria

Non-Small Cell Lung Cancer

Authorization of 12 months may be granted as a single agent for treatment of recurrent, advanced, or metastatic non-small cell lung cancer when the tumors have a RET gene fusion and the member has not experienced disease progression on therapy with a RET rearrangement positive-targeted regimen.

Anaplastic Thyroid Cancer

Authorization of 12 months may be granted for treatment of stage IV anaplastic thyroid cancer with a RET gene fusion when used as a single agent.

Thyroid Cancer

Authorization of 12 months may be granted for treatment of members 12 years of age and older with advanced or metastatic follicular, oncocytic, or papillary thyroid cancer not amenable to radioactive iodine therapy (RAI) whose tumors have a RET gene fusion.

Gallbladder Cancer

Authorization of 12 months may be granted for neoadjuvant treatment of resectable locoregionally advanced gallbladder cancer that is RET gene fusion positive when used 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. Gavreto [package insert]. South San Francisco, CA: Rigel Pharmaceuticals, Inc.; June 2024.
2. The NCCN Drugs & Biologics Compendium® 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed July 2, 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