FDA should consider for this patient population
February 2014 Vol 7, No 1, Special Issue ASH 2013 Payers' Perspectives in Oncology - Health Economics
Wayne Kuznar

New Orleans, LA—Decitabine (Dacogen) is more cost-effective than conventional induction therapy for patients aged >60 years with acute myeloid leukemia (AML), according to an economic analysis presented at ASH 2013.

The accepted treatments for patients with AML include cytarabine (Cytosar-U) plus daunorubicin, as well as hypomethylating agents such as decitabine. Complete remission rates with either approach are approximately 50%, noted the investigators. Furthermore, the 1-year overall survival (OS) rates are approximately 50% with either approach; 30-day mortality is slightly lower in patients receiving decitabine, but decitabine is not approved in the United States by the US Food and Drug Administration (FDA) for the treatment of AML.

Given the economic pressures in the US health system, the FDA should consider approving decitabine for patients aged >60 years with newly diagnosed AML, suggested Nicolas Batty, MD, a hematology/oncology fellow at Roswell Park Cancer Institute, Buffalo, NY, and lead investigator of this analysis.

Comparing Cost and Efficacy
His team compared the direct costs of decitabine and conventional induction therapy in patients with AML (aged >60 years) using a semi-Markov model compiling survival and cost data. Derived from the 2012 US market, the costs of the drugs were assumed to be $1637.94 for 50 mg of decitabine, $12.08 for 2 g of cytarabine, and $58.62 for 20 mg/4 mL of daunorubicin.

The hospital costs were evaluated in a diagnosis-related group system. The estimated cost of a direct hospital stay of 1 day was $2104.75, and the cost of an infusion clinic visit was $524.07. The cost-effectiveness was assessed using an incremental cost-­effectiveness ratio (ICER).

The cytarabine plus daunorubicin regimen consisted of cytarabine 100 mg/m2 continuous infusion for 7 days, and daunorubicin 60 mg/m2 for 3 days. Consolidation therapy with high-dose cytarabine followed the cytarabine plus daunorubicin regimen. The decitabine dosage used in the model was 20 mg/m2 daily as a 1-hour infusion for 10 days until remission, and then 5 days every 4 weeks until progression.

The survival probabilities were taken from published literature. Data accounted for reinduction therapy with IDA-FLAG (idarubicin, fludar­abine, cytarabine, and granulocyte colony-stimulating factor) and consolidation therapy with high-dose cytarabine (HiDAC). The model assumed a maximum of 4 cycles of HiDAC and continuing decitabine until loss of benefit.

At 3 months, the OS rates were 98% with decitabine and 63.6% with cytarabine plus daunorubicin, and at 6 months, the OS rates were 59% and 50.4%, respectively. The survival rate at the end of 12 months was 47% in the cytarabine plus daunorubicin group and 52.6% in the decitabine group.

Life expectancy was 0.16 years long­­er with decitabine versus with cytarabine plus daunorubicin (0.77 vs 0.61 years), and the quality-adjusted life-year (QALY) was 0.46 in the cytarabine plus daunorubicin group and 0.54 in the decitabine group.

The expected cost was nearly the same in both groups, with $88,325 for patients receiving cytarabine plus daunorubicin versus $91,312 with decitabine. The ICER per QALY with decitabine was $38,839.

Decitabine was the most cost-ef­fective therapy. Decitabine was dom­inant in the model when the cost of cytarabine plus daunorubicin in­creased by 10%, when the cost of decitabine decreased by 10%, and when the time horizon (the period for which the costs and treatment benefits were accounted) was 3 months or 6 months.

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