BlueCross BlueShield of Tennessee Medical Policy Manual

Azacitidine

NDC CODE(S)

Vidaza 100mg powder injection: 59572-0102-xx (Celgene)

DESCRIPTION

Azacitidine is a nucleoside metabolic inhibitor which is a pyrimidine nucleoside analog of cytidine.  Its antineoplastic effects are thought to be from the hypomethylation of DNA.  Azacitidine exerts direct cytotoxicity on hematopoietic cells in the bone marrow where it causes the death of rapidly dividing cells, including cancer cells which are no longer responsive to normal growth control mechanisms.  Cells which are non-proliferative are relatively unaffected by azacitidine.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Myelodysplastic syndromes 75 mg/m2daily for 7 days to be administered by subcutaneous (SC) injection or intravenous (IV) infusion. Repeat cycle every 4 weeks. The dose may be increased to 100 mg/m2IV if no beneficial effect is seen after 2 treatment cycles. A minimum of 4 to 6 cycles are recommended.
Acute myelogenous leukemia (AML) 75 mg/m2daily for 5 to 7 days to be administered by subcutaneous (SC) injection. Repeat cycle every 4 weeks

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 azacitidine for the treatment or prevention of other conditions or diseases.

SOURCES

Lexi-Comp Online. (2016). AHFS DI. Azacitidine. Retrieved September 16, 2016 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluation. (2016, August) Azacitidine. Retrieved September 16, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Azacitidine. Retrieved September 16, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2016, August). Center for Drug Evaluation and Research. Vidaza (azacitidine for injection). Retrieved September 16, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050794s029lbl.pdf.

ORIGINAL EFFECTIVE DATE:  10/8/2005

MOST RECENT REVIEW DATE:  2/27/2018

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.

Pharmaceutical Decision Support Tree

Azacitidine (Vidaza®)

  1. Is this the initial request for this agent?

If yes, go to question #2

If no, go to question #12

  1. Does the individual have a diagnosis of myelodysplastic syndrome?

If yes, go to question #3

If no, go to question #8

  1. Does the individual have concomitant refractory anemia?

If yes, go to question #7

If no, go to question #4

  1. Is the request for initial treatment for lower risk disease for an individual with symptomatic anemia with ALL of the following?

If yes, go to question #5

If no, go to question #6

  1. Does the individual have ANY ONE of the following?

If yes, go to question #7

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

  1. Is the request for treatment for lower risk disease for individual with symptomatic anemia with ALL of the following?

If yes, go to question #7

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

  1. Is the request for 2100 billable units or less every 28 days with dosage of 75 mg/m2 daily by subcutaneous (SC) injection or intravenous (IV) infusion for 7 days repeated every 4 weeks (may be increased to 100 mg/m2 IV if no beneficial effect is seen after 2 treatment cycles with a minimum of 4 to 6 cycles recommended) for an authorization period of 6 months?

If yes, this meets medical necessity and/or medical appropriateness criteria

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

  1. Does the individual have a diagnosis of acute myeloid leukemia?

If yes, go to question #9

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

  1. Will the agent be used as a single agent in an individual 60 years of age or older as ANY ONE of the following?

If yes, go to question #11

If no, go to question #10

  1. Will the agent be used as therapy for relapsed or refractory disease in an individual who cannot tolerate more aggressive regimens as ANY ONE of the following?

If yes, go to question #11

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

  1. Is the request for 2100 billable units or less every 28 days with dosage of 75 mg/m2daily for 5 to 7 days to be administered by subcutaneous (SC) injection with the cycle repeated every 4 weeks?

If yes, this meets medical necessity and/or medical appropriateness criteria

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

  1. Does the individual meet ALL of the following?

If yes, this meets medical necessity and/or medical appropriateness criteria for renewal of 6 months

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

This document has been classified as public information.