Subject: Gavreto 4206-A SGM P2023
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 fusion-positive thyroid cancer
who require systemic therapy and who are radioactive
iodine-refractory (if radioactive iodine is appropriate).
B. Compendial Uses
1. NSCLC with RET rearrangement-positive tumors
2. Anaplastic thyroid cancer
3. Follicular, oncocytic, papillary thyroid cancer
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 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 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.
B. 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.
C. 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.
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.; July 2023.
- The NCCN Drugs & Biologics Compendium® 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed August 1, 2023.
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 07, 2024
