BlueCross BlueShield of Tennessee Medical Policy Manual

Omacetaxine Mepesuccinate

NDC CODE(S)

63459-0177-XX Synribo 3.5 MG SOLR (CEPHALON)

DESCRIPTION

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).  

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

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

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.

LENGTH OF AUTHORIZATION

Coverage will be provided for six months and may be renewed

Click here to view DOSAGE LIMITS

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.

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, the express terms of the health plan will govern.

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).

No controlled studies were found in the published literature that validate the use of omacetaxine mepesuccinate for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2018). AHFS DI. Omacetaxine mepesuccinate. Retrieved February 1, 2018 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, October). Omacetaxine. Retrieved February 1, 2018 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 February 1, 2018 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203585s005lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/15/2013

MOST RECENT REVIEW DATE:  4/10/2018

ID_MRx

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.

 

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 0.01 mg

DIAGNOSIS

MAXIMUM UNITS

Chronic myelogenous leukemia (CML)

Induction – 9800 billable units every 28 days until hematologic response is achieved, then begin maintenance

Maintenance – 4900 billable units every 28 days