63459-0177-XX SYNRIBO 3.5MG Solution Reconstituted (CEPHALON)
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.
Patient is at least 18 years of age; AND
Patient’s disease is confirmed by either a Philadelphia chromosome-positive (Ph+) or BCR-ABL1 positive laboratory test result; AND
Chronic Myelogenous Leukemia (CML)
Used as single agent therapy for patients resistant, intolerant, or had an inadequate response after at least 3 months of therapy to TWO or more tyrosine kinase inhibitor (TKI) therapies (e.g., bosutinib, imatinib, dasatinib, ponatinib or nilotinib); AND
Patient has chronic phase CML; OR
Patient has advanced disease that has progressed to accelerated phase; OR
For post-allogeneic stem cell transplant follow-up therapy with molecular relapse (BCR-ABL1 transcript positive) following complete cytogenetic response (CCyR); OR
For post-allogeneic stem cell transplant follow-up therapy with relapse or those who are not in CCyR; OR
Patient has T315I mutation positive disease
Patient continues to meet the indication-specific relevant criteria identified in the Initial Approval Criteria; AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: myelosuppression (e.g., severe neutropenia, thrombocytopenia, or anemia), hemorrhage (including cerebral and gastrointestinal), uncontrolled hyperglycemia, etc.; AND
Patient has been adherent to therapy; AND
Treatment response as indicated by one of the following:
Patient has BCR-ABL1 (IS) transcript levels:
≤ 10% at 3 months; OR
≤ 10% at 6 months; OR
≤ 0.1% or a ≥ 3-log reduction in BCR-ABL1 mRNA from the standardized baseline, if qPCR (IS) is not available
DOSAGE & ADMINISTRATION
Chronic myelogenous leukemia
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. Treatment should continue as long as patients are clinically benefiting from therapy.
□ Synribo should be prepared/reconstituted in a healthcare facility by a healthcare professional
□ Synribo may be administered by the patient or caregiver with appropriate training and storage of the reconstituted product Synribo may be administered by the patient or caregiver with appropriate training and storage of the reconstituted product
LENGTH OF AUTHORIZATION
Coverage will be provided for six months and may be renewed
Max Units (per dose and over time) [HCPCS Unit]:
9,800 billable units every 28 days until hematologic response is achieved, then begin maintenance
4,900 billable units every 28 days
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).
1. Synribo [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; November 2019. Accessed December 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for omacetaxine. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2020.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Chronic Myeloid Leukemia 2.2021. National Comprehensive Cancer Network, 2021. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed December 2020.
4. Lexi-Comp Online. (2020). AHFS DI. Omacetaxine mepesuccinate. Retrieved January 13, 2020 from Lexi-Comp Online with AHFS.
5. MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, December). Omacetaxine. Retrieved January 13, 2020 from MICROMEDEX Healthcare Series.
ORIGINAL EFFECTIVE DATE: 2/15/2013
MOST RECENT REVIEW DATE: 3/9/2021
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.
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