Azacitidine
DESCRIPTION
Azacitidine is a pyrimidine nucleoside analog of cytidine. Azacitidine, an antineoplastic agent, causes hypomethylation of DNA and direct cytotoxicity in abnormal hematopoietic cells. It restores normal growth and differentiation of bone marrow cells. Non-proliferating cells are relatively insensitive to azacitidine.
An example of a preparation of azacitidine is Vidaza®.
REFER TO DECISION SUPPORT TREE
POLICY
Azacitidine for the treatment of myelodysplastic syndrome is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Azacitidine for the treatment of other conditions/diseases, including, but not limited to, sickle cell anemia and solid tumors is considered investigational. (See Applicable Tennessee State Mandate Requirements below.)
MEDICAL APPROPRIATENESS
Azacitidine for the treatment of myelodysplastic syndrome is considered medically appropriate for ANY ONE of the following subtypes of myelodysplastic syndrome, as defined by the French-American-British and World Health Organization:
French-American-British (FAB) classification system:
Refractory anemia (RA)
Refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions) (RARS)
Refractory anemia with excess blasts (RAEB)
Refractory anemia with excess blasts in transformation (RAEB-T)
Chronic myelomonocytic leukemia (CMMoL)
World Health Organization (WHO) classification system:
Refractory cytopenia with unilineage dysplasia
Refractory anemia
Refractory neutropenia
Refractory thrombocytopenia
Refractory anemia with ringed sideroblasts
Refractory cytopenia with multilineage dysplasia
Refractory anemia with excess blasts
Myelodysplastic syndrome associated with isolated del(5q)
Myelodysplastic syndrome, unclassified (MDS-U)
Childhood myelodysplastic syndrome
Provisional entity: refractory cytopenia of childhood
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
The AHFS recognizes the use of azacitidine in the treatment of acute myelogenous leukemia for the following:
Multilineage dysplasia, including individuals with poor-risk cytogenetics
Initial treatment in individuals 60 years of age or older who are not candidates for standard induction therapy
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 dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
There is insufficient evidence supporting the use of azacitidine for the treatment of other conditions/diseases, including, but not limited to, sickle cell anemia and solid tumors.
SOURCES
Lexi-Comp Online. (2011). AHFS DI. Azacitidine. Retrieved February 17, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluation. (December, 2010) Azacitidine. Retrieved February 17, 2011 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2011). NCCN Drugs & Biologics Compendium™. Azacitidine. Retrieved January 22, 2010 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2008, August). Center for Drug Evaluation and Research. Vidaza (azacitidine for injection). Retrieved January 22, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050794s011lbl.pdf.
Vardiman, J. W., Thiele, J. T, Arber, D. A., Brunning, R. D., Borowitz, M. J., Porwit, A. e.t. al. (2009, July). The 2008 revision of the WHO classification of myeloid neoplasms and acute leukemia: Rationale and important changes. Blood, 114 (No. 5). 937-951.
ORIGINAL EFFECTIVE DATE: 10/8/2005
MOST RECENT REVIEW DATE: 8/13/2011
ID_BT
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®)
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of myelodysplastic syndrome?
If yes, go to question #3
If no, this does not meet medical necessity and/or medical appropriateness criteria
Does the individual show evidence of ANY ONE of the following subtypes of myelodysplastic syndrome, as defined by the French-American-British and World Health Organization?
French-American-British (FAB) classification system:
Refractory anemia (RA)
Refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions) (RARS)
Refractory anemia with excess blasts (RAEB)
Refractory anemia with excess blasts in transformation (RAEB-T)
Chronic myelomonocytic leukemia (CMMoL)
World Health Organization (WHO) classification system:
Refractory cytopenia with unilineage dysplasia
Refractory anemia
Refractory neutropenia
Refractory thrombocytopenia
Refractory anemia with ringed sideroblasts
Refractory cytopenia with multilineage dysplasia
Refractory anemia with excess blasts
Myelodysplastic syndrome associated with isolated del(5q)
Myelodysplastic syndrome, unclassified (MDS-U)
Childhood myelodysplastic syndrome
Provisional entity: refractory cytopenia of childhood
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.