Insurers assess new drugs and biologics as part of their formulary decision making, to provide recommendations for coverage options and associated benefit designs. While formulary decision making draws on information from many sources, there is an incomplete understanding of the pharmaceutical technology assessment (PTA) process that is used and the types of evidence that are applied in formulary assessments of pharmaceuticals.

Researchers at RTI, a not-for-profit research institute, sought to learn about the process used by payers to evaluate new products for potential formulary inclusion, particularly sources and types of evidence that are part of the PTA process.

Michael Halpern, MD, PhD, MPH, co-author and a member of the MANAGED CARE Editorial Advisory Board, says almost all the payers had a strong desire for head-to-head studies and for comparative effectiveness information. However, they acknowledged that comparative effectiveness studies are in a relatively early stage of development. In addition, the survey showed that randomized clinical trials, which often use placebo groups as controls, have limitations when making decisions for formulary inclusion. One key way to improve the PTA process is to more broadly incorporate drug utilization data.

“When internal data are analyzed, it’s to compare how the use of one drug might affect or replace use of another drug, or how costs for a new drug might affect other pharmacy costs ,” says Halpern.-

Rating sources and types of evidence on a 1–5 scale from least to most important

Thirty-two respondents from 26 payers participated in one-hour telephone interviews to address the PTA process. Randomized controlled trials and systematic reviews/meta-analyses were the most valued types of evidence; economic and observational data studies received low ratings.

Sources of evidence

Sources of evidence

Types of evidence

Types of evidence

Source: Leung ML, Halpern MT, West ND. Pharmaceutical technology assessment: Perspectives from Payers. J Manag Care Pharm. 2012;18(3):256–264

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