Formulary Decision-Making Should Rely on the Best Available Evidence
Abstract
To the Editor—Evidence of effectiveness and cost-effectiveness is inherently dynamic in nature. Cost-effectiveness models based on the best data available at the time are an important contribution to evidence-based decision-making if they reveal the likely outcomes of various scenarios and quantify the degree of uncertainty around the apparently optimal approach. Cost-effectiveness models also illustrate the trade-offs inherent in each potential alternative available to the decision-maker and should be updated as new evidence becomes available.
In 2000, The Academy of Managed Care Pharmacy issued its first Format for Formulary Submissions, which provided US payers with a new tool to proactively request clinical and economic data from health technology manufacturers. The Format, which has been revised substantially in recent years, is now used by health-care organizations covering some 150 million lives in the United States [1]. This guidance recommends that dossiers for new drug products be requested by health plans approximately 6 months before launch, and explicitly calls for the use of economic models “to inform decisions about the value or cost-effectiveness of pharmaceuticals, biologics, and vaccines.” Such models are to be based on International Society for Pharmacoeconomics and Outcomes Research (ISPOR)’s Good Research Practices—Modeling Studies [2], which stipulate that data sources be “clearly defined and from the most recent studies.”
In 2000, The Academy of Managed Care Pharmacy issued its first Format for Formulary Submissions, which provided US payers with a new tool to proactively request clinical and economic data from health technology manufacturers. The Format, which has been revised substantially in recent years, is now used by health-care organizations covering some 150 million lives in the United States [1]. This guidance recommends that dossiers for new drug products be requested by health plans approximately 6 months before launch, and explicitly calls for the use of economic models “to inform decisions about the value or cost-effectiveness of pharmaceuticals, biologics, and vaccines.” Such models are to be based on International Society for Pharmacoeconomics and Outcomes Research (ISPOR)’s Good Research Practices—Modeling Studies [2], which stipulate that data sources be “clearly defined and from the most recent studies.”
Authors