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).

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Chronic myelogenous 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.

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 any other conditions or diseases.

SOURCES

Lexi-Comp Online. (2017, March). AHFS DI. Omacetaxine mepesuccinate. Retrieved April 19, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, December). Omacetaxine. Retrieved April 19, 2017 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Omacetaxine. Retrieved April 19, 2017 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2014, May). Center for Drug Evaluation and Research. Synribo® (omacetaxine mepesuccinate) for injection. Retrieved November 22, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203585s003lbl.pdf.

ORIGINAL EFFECTIVE DATE:  2/15/2013

MOST RECENT REVIEW DATE:  7/11/2017

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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.

Pharmaceutical Decision Support Tree

Omacetaxine Mepesuccinate (Synribo ®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #6

  1. Is the individual 18 years of age or older with a diagnosis of chronic myeloid leukemia (CML) in ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the Individual had 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 with the outcome of ANY ONE of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. At the request of the BCBST’s Pharmacy & Therapeutics Committee, is there documentation that treatment is ALL of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 9800 billable units every 28 days until hematologic response is achieved, then maintenance of 4900 billable units every 28 days, for dosage of 1.25 mg/m2 administered by subcutaneous injection twice daily for 14 consecutive days of a 28-day cycle then maintenance dosage of 1.25 mg/m2 administered by subcutaneous injection twice daily for 7 consecutive days of a 28-day cycle for an authorization period of 6 months with possible renewal?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet initial approval criteria in questions 2 through 5?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the drug including Grade 4 neutropenia (ANC<0.5 x 109/L); Grade 3 thrombocytopenia (platelets< 50 x 109/L); hemorrhage (including cerebral and gastrointestinal); Grade 3 or 4 hyperglycemia?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has the individual been adherent to therapy?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Treatment response as indicated by ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

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