Published Jan 2010
Mullins CD, Seal B, Seoane-Vazquez E, et al. Good research practices for measuring drug costs in cost-effectiveness analyses: Medicare, Medicaid and other US government payers perspectives: the ISPOR Drug Cost Task Force Report-part IV. Value Health. 2010;13(1):18-24.
Objectives: Public programs finance a large share of the US pharmaceutical
expenditures. To date, there are not guidelines for estimating the cost
of drugs financed by US public programs. The objective of this study was
to provide standards for estimating the cost of drugs financed by US public
programs for utilization in pharmacoeconomic evaluations.
Methods: This report was prepared by the ISPOR Task Force on Good
Research Practices—Use of Drug Costs for Cost-Effectiveness Analysis
Medicare, Medicaid, and other US Government Payers Subgroup. The
Subgroup was convened to assess the methodological and practical issues
confronted by researchers when estimating the cost of drugs financed by
US public programs, and to propose standards for more transparent,
accurate and consistent costing methods.
Results: The Subgroup proposed these recommendations: 1) researchers
must consider regulation requirements that affect the drug cost paid by
public programs; 2) drug cost must represent the actual acquisition cost,
incorporating any rebates or discounts; 3) transparency with respect to
cost inputs must be ensured; 4) inclusion of the public program’s perspective
is recommended; 5) high cost drugs require special attention, particularly
when drugs represent a significant proportion of health-care
expenditures for a specific disease; and 6) because of variations across
public programs, sensitivity analyses for actual acquisition cost, real-world
adherence, and generics availability are warranted. Specific recommendations
also were proposed for the Medicare and Medicaid programs.
Conclusions: As pharmacoeconomic evaluations for coverage decisions
made by US public programs grows, the need for precise and consistent
estimation of drug costs is warranted. Application of the proposed recommendations
will allow researchers to include accurate and unbiased
cost estimates in pharmacoeconomic evaluations.
Keywords: cost study, drug cost, Medicaid, Medicare, pharmacoeconomic.
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