Category Filter
- Advanced Imaging
- Autism Spectrum Mandate
- Behavioral Health
- Blue Advantage Policies
- Chronic Condition Management
- Genetic Testing
- HelpScript Program
- Hemophilia Drugs
- Medical Policies
- Pre-Service Review (Predetermination/Precertification)
- Provider-Administered Drug Policies
- Radiation Therapy
- Self-Administered Drug Policies
- Transgender Services
Asset Publisher
Synribo® (omacetaxine mepesuccinate)
Policy Number: VP-0156
Subcutaneous
Document Number: IC-0156
Last Review Date: 01/05/2023
Date of Origin: 02/07/2013
Dates Reviewed: 11/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 01/2019, 01/2020, 01/2021, 01/2022, 01/2023
Depending on member benefits, additional criteria may apply for coverage of this drug in an outpatient facility setting. Verify any Site of Service requirements with the member’s plan and refer to the Voluntary Site of Service Policy or the Mandatory Site of Service Policy for additional information. |
- Length of Authorization
Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
Synribo 3.5 mg for injection single-dose vial:
- Induction: 28 vials every 28 days (until hematologic response is achieved, then begin maintenance)
- Maintenance: 14 vials every 28 days
- Max Units (per dose and over time) [HCPCS Unit]:
Induction:
- 9,800 billable units every 28 days until hematologic response is achieved, then begin maintenance
Maintenance:
- 4,900 billable units every 28 days
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
- 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 Myeloid Leukemia (CML) † Ф 1-3
- Used as single agent therapy; AND
- Patient is resistant, intolerant, or had an inadequate response after at least 3 months of therapy with at least TWO tyrosine kinase inhibitor (TKI) therapies (e.g., bosutinib, imatinib, dasatinib, ponatinib, or nilotinib); AND
- Patient has chronic phase disease; OR
- Patient has advanced disease that has progressed to accelerated phase; OR
- Used as post-allogeneic hematopoietic stem cell transplant (HSCT) follow-up therapy in patients with molecular relapse (BCR::ABL1 transcript positive) following complete cytogenetic response (CCyR); OR
- Used as post-allogeneic HSCT follow-up therapy in patients with relapse or less than CCyR; OR
- Patient has T315I mutation positive disease
† FDA Approved Indication(s); ‡ Compendia recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1-3
Coverage may be renewed based upon the following criteria:
- Patient continues to meet the indication-specific relevant criteria identified in section III; 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
- Treatment response as indicated by one of the following 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
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 1
Indication |
Dose |
Chronic Myeloid Leukemia |
Induction Dose: 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. Maintenance Dose: 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. |
|
- Billing Code/Availability Information
HCPCS:
- J9262 – Injection, omacetaxine mepesuccinate, 0.01 mg; 1 billing unit = 0.01 mg
NDC:
- Synribo 3.5 mg single-dose vial for injection: 63459-0177-xx
- References
- Synribo [package insert]. North Wales, PA; Teva Pharmaceuticals USA, Inc.; May 2021. Accessed December 2022.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for omacetaxine. National Comprehensive Cancer Network, 2022. 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 2022.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Chronic Myeloid Leukemia 1.2023. National Comprehensive Cancer Network, 2022. 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 2022.
- Cortes J, Digumarti R, Parikh M, et al. Phase 2 study of subcutaneous omacetaxine mepesuccinate for chronic-phase chronic myeloid leukemia patients resistant to or intolerant of tyrosine kinase inhibitors. Am J Hematol. 2013 May;88(5):350-4. doi: 10.1002/ajh.23408. Epub 2013 Mar 7.
- Cortes J, Lipton J, Rea D, et al. Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation. Blood. 2012 Sep 27;120(13):2573-80.doi: 10.1182/blood-2012-03-415307. Epub 2012 Aug 15.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C92.10 |
Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission |
C92.11 |
Chronic myeloid leukemia, BCR/ABL-positive, in remission |
C92.12 |
Chronic myeloid leukemia, BCR/ABL-positive, in relapse |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |