L29063

 

AZACITIDINE (VIDAZA®)

 

12/03/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

 

Indications

Medicare will cover VIDAZA for the following FDA-approved labeled indications:

• VIDAZA is indicated for treatment of patients with the following myelodysplastic syndrome subtypes:

o Refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusion).

o Refractory anemia with excess blasts.

o Refractory anemia with excess blasts in transformation.

o Chronic myelomonocytic leukemia (CMML).

Medicare will cover VIDAZA for the following off-label indication:

• Acute Myeloid Leukemia (AML).

Limitations

• VIDAZA is contraindicated in patients with a known hypersensitivity to azacitidine or mannitol.

• VIDAZA is also contraindicated in patients with advanced malignant hepatic tumors.

 

CPT/HCPCS Codes

 

 

 

J9025 INJECTION, AZACITIDINE, 1 MG

 

 

ICD-9 Codes that Support Medical Necessity

 

 

 

205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.01 MYELOID LEUKEMIA ACUTE IN REMISSION

205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE

238.71 ESSENTIAL THROMBOCYTHEMIA

238.72 LOW GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.73 HIGH GRADE MYELODYSPLASTIC SYNDROME LESIONS

238.74 MYELODYSPLASTIC SYNDROME WITH 5Q DELETION

238.75 MYELODYSPLASTIC SYNDROME, UNSPECIFIED

238.76 MYELOFIBROSIS WITH MYELOID METAPLASIA

 

 

Documentation Requirements

• The medical record should contain a history and physical that substantiates the medical necessity of using this drug.

• The medical record should also contain laboratory studies indicated under the utilization guidelines and the medical record must support the ongoing treatment and that there is a continued benefit to the patient receiving additional treatment beyond 6 treatment cycles.

• The medical record must support that dosages are reduced for subsequent treatment cycles based on the FDA drug label.

• All laboratory tests performed to determine the dose reductions must be reported in the medical record. The medical record must be made available to Medicare upon request.

 

Utilization Guidelines

 

Dosage and Administration

• First Treatment Cycle

o The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75mg/m2 subcutaneously or intravenously, daily for 7 days.

o Patients should be pre-medicated for nausea and vomiting.

• Subsequent Treatment Cycles

o Cycles should be repeated every 4 weeks.

o The dose may be increased to 100mg/m2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred.

o It is recommended that patients be treated for a minimum of 4 cycles.

o However, complete or partial response may require more than 4 treatment cycles.

• Treatment may continue as long as the patient continues to benefit.

• Patients should be monitored for hematologic response and renal toxicities, and dosage delay or reduction may be necessary.

• Complete blood counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each dosing cycle.

o Liver chemistries and serum creatinine should be obtained prior to initiation of therapy.

• After administration of the recommended dosage for the first cycle, dosage for subsequent cycles should be reduced or delayed based on nadir counts and hematologic response as described in the FDA approved drug label for VIDAZA®.

o Liver chemistries and serum creatinine should be obtained prior to initiation of therapy.

Treatment Logic:

• Azacitidine is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow.

• The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis.

• Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation.

• The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanism.

• Non-proliferating cells are relatively insensitive to VIDAZA.

 

Sources of Information and Basis for Decision

 

American Hospital Formulary Service’s Drug Information (2008) (Compendia).

 

Clinical Pharmacology (2009) (Compendia).

 

DrugDex Evaluations (2009) (Compendia).

 

FCSO LCD 29063, Azacitidine (Vidaza®), 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

National Cancer Institute. Myelodysplastic Syndromes (PDQ®): Treatment. Accessed via www.cancer.gov

 

Sudan, N., Rossetti, J.M., Shadduck, R.K., Latsko, J., Lech, J.A., Kaplan, R.B., et al. (2006). Treatment of acute myelogenous leukemia with outpatient azacitidine. American Cancer Society.

 

Vidaza product information (2007). Pharmion Corp.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2011 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

© Automated Clinical Guidelines, LLC 2009-2013

 

CMS LCD AZACITIDINE (VIDAZA®)

 

 

L29063