63459-0177-XX Synribo 3.5 MG SOLR (TEVA PHARMACEUTICALS USA)
Omacetaxine mepesuccinate is an antineoplastic agent categorized as a protein synthesis inhibitor. It is prepared in a semi-synthetic process from cephalotaxine, an extract of the leaves of the plum yew, Cephalotaxus sp. The mechanism of action is not fully understood, but its activity inhibits protein synthesis independently of direct BCR-ABL binding, Because of this, omacetaxine mepesuccinate shows activity against disease in the failure of tyrosine kinase inhibitors (TKI).
Omacetaxine mepesuccinate for the treatment of chronic myeloid leukemia (CML) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Omacetaxine mepesuccinate for the treatment of other conditions/diseases is considered investigational.
Omacetaxine mepesuccinate is considered medically appropriate if ALL of the following criteria are:
Diagnosis of chronic myeloid/myelogenous leukemia (CML)
Individual is 18 years of age or older
Disease is confirmed by either a Philadelphia chromosome-positive (Ph+) OR BCR-ABL1 positive laboratory test result
Used as single agent therapy
Individual is ANY ONE of the following:
Advanced phase disease progression to accelerated phase
Post-allogeneic stem cell transplant if ANY ONE of the following:
Follow-up therapy with molecular relapse (BCR-ABL1 transcript positive) following complete cytogenetic response (CCyR)
Follow-up therapy with relapse or those who are not in CCyR
Resistant, intolerant or had an inadequate response to prior tyrosine kinase inhibitor (TKI) therapies consisting of a 3 month trial or longer, with a minimum of TWO of the following: bosutinib, imatinib, dasatinib, ponatinib, or nilotinib
Omacetaxine mepesuccinate is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug including severe neutropenia; and/or thrombocytopenia; hemorrhage (including cerebral and gastrointestinal); hyperglycemia
Individual has been adherent to therapy
Treatment response as indicated by ANY ONE of the following:
BCR-ABL1 (IS) transcript levels:
≤ 10% at 3 months
≤ 10% at 6 months
≤ 1% at 12 months and beyond
NOTE: cytogenetic assessment of response may be used if quantitative RT-PCR (QPCR) using International Scale (IS) for BCR-ABL1 is not available
DOSAGE & ADMINISTRATION
Chronic myelogenous leukemia
Synribo should be prepared in a healthcare facility and must be reconstituted by a healthcare professional
Synribo may be administered by the patient or caregiver with appropriate training and storage of the reconstituted product
1.25 mg/m2 administered by subcutaneous injection twice daily for 14 consecutive days of a 28-day cycle. Repeat until a hematologic response is achieved, then begin maintenance.
1.25 mg/m2 administered by subcutaneous injection twice daily for 7 consecutive days of a 28-day cycle.
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Refer to DOSAGE LIMITS below
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.
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, the express terms of the health plan will govern.
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).
Lexi-Comp Online. (2019). AHFS DI. Omacetaxine mepesuccinate. Retrieved January 28, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, January). Omacetaxine. Retrieved January 28, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2018). NCCN Drugs & Biologics Compendium®. Omacetaxine. Retrieved February 1, 2018 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2017, June). Center for Drug Evaluation and Research. Synribo® (omacetaxine mepesuccinate) for injection. Retrieved January 28, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203585s005lbl.pdf.
ORIGINAL EFFECTIVE DATE: 2/15/2013
MOST RECENT REVIEW DATE: 5/31/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 0.01 mg