IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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 Indication
Synribo is indicated for the treatment of adult patients with chronic or accelerated phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs).
B. Compendial Uses
1. Treatment of advanced phase CML for patients with disease progression to accelerated phase
2. Follow-up therapy for CML patients after hematopoietic stem cell transplant (HSCT)
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:
Prior to initiation of therapy: results of cytogenetic and/or molecular testing for detection of the Ph chromosome or the BCR-ABL gene
III. CRITERIA FOR INITIAL APPROVAL
Chronic Myeloid Leukemia (CML)
Authorization of 12 months may be granted for treatment of CML confirmed by detection of the Ph chromosome or BCR-ABL gene by cytogenetic and/or molecular testing when all of the following criteria are met:
1. Member meets any of the following:
a. Member has chronic or accelerated phase CML
b. Member has received HSCT for CML
2. Member has experienced resistance or intolerance to two or more tyrosine kinase inhibitors (TKIs) (e.g., bosutinib, dasatinib, imatinib, nilotinib, ponatinib)
3. The requested medication is used as a single agent
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment of CML when there is no evidence of unacceptable toxicity or disease progression while on the current regimen and either of the following criteria is met:
1. Member has CML that has been confirmed by detection of Ph chromosome or BCR-ABL gene by cytogenetic and/ or molecular testing
2. Member has received HSCT for CML
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Synribo [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; May 2021.
2. The NCCN Drugs & Biologics Compendium® © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 14, 2023.
3. NCCN Clinical Practice Guidelines in Oncology® Chronic Myeloid Leukemia (Version 2.2023). © 2023 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 14, 2023.
ORIGINAL EFFECTIVE DATE: 2/15/2013
MOST RECENT REVIEW DATE: 5/14/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.