Subject: Gavreto 4206-A SGM P2022
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 Indications
1. 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.
2. Gavreto is indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or
metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy.
3. 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).
B. Compendial Uses
NSCLC with RET rearrangement-positive tumors
All other indications are considered experimental/investigational and not medically necessary.
II. 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 (NSCLC or thyroid cancer) or a specific RET gene mutation (MTC) in tumor specimens or plasma.
III. CRITERIA FOR INITIAL APPROVAL
A. Non-Small Cell Lung Cancer
Authorization of 12 months may be granted as a single agent for treatment of advanced or metastatic non-small cell lung cancer
when the tumors have a RET gene fusion.
B. Medullary Thyroid Cancer
Authorization of 12 months may be granted for treatment of members 12 years of age and older with advanced or metastatic
medullary thyroid cancer with a RET gene mutation.
C. 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 single agent.
D. Thyroid Cancer
Authorization of 12 months may be granted for treatment of members 12 years of age and older with advanced or
metastatic thyroid cancer not amenable to radioactive iodine therapy (RAI) whose tumors have a RET gene fusion.
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section III 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:
- Gavreto [package insert]. South San Francisco, CA: Genentech, Inc.; February 2022.
- The NCCN Drugs & Biologics Compendium® 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed July 6, 2022.
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 28, 2023
