59572-0102-XX VIDAZA 100mg powder injection (CELGENE)
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.
Azacitidine for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Acute myeloid leukemia
Azacitidine for the treatment of other conditions/diseases is considered investigational.
Azacitidine is considered medically appropriate if ANY ONE of the following criteria are met:
Individual is 18 years of age or older
Diagnosis of ANY ONE of the following:
Acute myeloid leukemia
Azacitidine is considered medically appropriate for renewal for a period of 6 months if ALL of the following criteria are met:
Individual continues to meet the initial approval criteria
Absence of unacceptable toxicity from the agent such as severe neutropenia, severe thrombocytopenia, severe hepatic and renal toxicities, tumor lysis syndrome, etc.
|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/m2 IV if no beneficial effect is seen after 2 treatment cycles. A minimum of 4 to 6 cycles are recommended.|
|Acute myelogenous leukemia (AML) / Myelofibrosis||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.
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).
Leung, M., Highsmith, K., & Rexwinkle, A. (2017). Pharmacologic management of myelofibrosis. Journal of Pharmacologic Practice, 23 (8), 591-601. Abstract retrieved January 3, 2019 from PubMed database.
Lexi-Comp Online. (2018). AHFS DI. Azacitidine. Retrieved January 3, 2019 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluation. (2018, November) Azacitidine. Retrieved January 3, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium™. Azacitidine. Retrieved January 3, 2019 from the National Comprehensive Cancer Network.
Ohba R., Usui, N., Ito, Y., Yanauchi, H., Machishima, T., Ishii, H., et al. (2017). Myelodysplastic syndrome with myelofibrosis in which azacitidine therapy was effective and cord blood transplantation was carried out. Rinsho Ketsueki, 58 (6), 601-606. Abstract retrieved January 3, 2019 from PubMed database.
U. S. Food and Drug Administration. (2018, July). Center for Drug Evaluation and Research. Vidaza (azacitidine for injection). Retrieved January 3, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050794s031lbl.pdf.
ORIGINAL EFFECTIVE DATE: 10/8/2005
MOST RECENT REVIEW DATE: 4/30/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 mg = 1 billable unit