As medical advancements and an expanding pharmaceutical industry bring new prescription drugs into the market, deciding which ones to cover is becoming an even more difficult choice for health plans to make. How those decisions are made - and what information is used in the process - was the focus of a recent study by researchers at RTI International.
The study, which was sponsored by the National Pharmaceutical Council and published in the April issue of the Journal of Managed Care Pharmacy, found that the process used to examine the short- and long-term health and economic outcomes of adopting new prescription drugs varies considerably among health plans.
"Our goal was to provide an updated and comprehensive understanding of how new drugs are assessed by key decision makers and to identify some of the nuances in this process," said Musetta Leung, Ph.D., a health services researcher at RTI and lead author of the study. "We were able to qualitatively and quantitatively understand how key decision makers value certain sources of information in determining coverage."
For the study, researchers interviewed 32 respondents from 26 organizations between November 2009 and April 2010. Participants included health plans, pharmacy benefit management companies, stand-alone Medicare Part D prescription drug plans, Medicaid agencies and drug compendia.
Specifically, researchers wanted to determine who is involved in decision making, the information and data that are considered, the timing and process of assessment and decision making, and the outcomes of the assessment.
All of the study participants had a structured system in place to review new drugs, but researchers found substantial variation in how the information and evidence was gathered and evaluated. Some organizations used an internal pharmacy team to review drugs and present findings to the decision-making committee while others relied on consultants to review products and to provide recommendations.
The findings also revealed trends in the kinds of information and data used when evaluating new prescription drugs. Researchers found that decision makers valued peer-reviewed studies and technology assessments (from the government or private sector companies) for gathering information about new drugs, but also put substantial weight on their own internal data.
Participants reported that randomized controlled trials were the most important kind of evidence used for making coverage decisions and that "real-world" data from economic and observational studies were less useful. When high-quality randomly controlled trials or other studies were inadequate, decision makers often relied on anecdotal findings or expert opinion.
"The differences in how health plans decide whether or not to cover a new drug doesn't mean that any of the processes are faulty; it just indicates that they aren't uniform," said Michael Halpern, M.D., Ph.D., senior fellow at RTI and paper co-author. "However, these differences could affect reimbursement, patient access and potentially heath care outcomes across health plans."