Subject: Vitrakvi 2799-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.
FDA-Approved Indications
Vitrakvi is indicated for the treatment of adult and pediatric
patients with solid tumors that:
1. have a neurotrophic receptor tyrosine kinase (NTRK) gene
fusion without a known acquired resistance mutation,
2. are metastatic or where surgical resection is likely to result in
severe morbidity, and
3. have no satisfactory alternative treatments or that have
progressed following treatment.
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: Chart documentation indicating a
NTRK gene fusion status.
III. CRITERIA FOR INITIAL APPROVAL
Solid tumors with a NTRK gene fusion
Authorization of 12 months may be granted for treatment of
solid tumors that have a NTRK gene fusion without a known
acquired resistance mutation, as demonstrated by laboratory
testing (e.g., next-generation sequencing [NGS] or fluorescence
in situ hybridization [FISH]).
VI. 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:
- Vitrakvi [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; December 2022.
- The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed August 22, 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.
December 09, 2023
