Subject: Qinlock 3901-A SGM P2021
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 Indication
Qinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
All other indications are considered experimental/investigational and not medically necessary.
- CRITERIA FOR INITIAL APPROVAL
Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted as a single agent for treatment of advanced gastrointestinal stromal tumor (GIST) in members who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
- CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization 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:
- Qinlock [package insert]. Waltham, MA: Deciphera Pharmaceuticals, LLC; May 2020.
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.
August 01, 2021