A significant cultural shift may be needed to implement a more personalized approach to medicine in the U.S., according to an International Society for Pharmacoeconomics and Outcomes Research panel.
The American Journal of Managed Care reports that the panel found a lack of economic and clinical value recognition hindered the use of personalized medicine.
“Value assessment frameworks have the potential to encourage the use of personalized medicine, but that can only happen if frameworks incorporate the appropriate elements to demonstrate value,” the report states.
Panelist Dr. Daniel A. Ollendorf, CSO of the Institute for Clinical and Economic Review (ICER), said that organizations such as ICER that analyze clinical and cost-effectiveness of treatments, tests and procedures, must go on information available to them, and personalized potential of a drug candidate is often just emerging at the time of FDA approval. The lack of data on potential secondary benefit leaves most with their hands tied. Data that are important to certain groups of patients are not always part of clinical trials, and subpopulations not analyzed.
According to Panelist Sara Traigle van Geertrudyden, executive director of Partnership to Improve Care, it’s a matter of culture.
“The current culture in the United States, she said, is structured upon a fail-first approach and on limiting access to new, expensive treatments,” the AJMC report states. “A cultural transition should focus on building evidence to know which treatments work for which patients, and when. Such an approach would help to save on costs by preventing adverse events or nonresponse to treatment. One key to achieving this new reality is to invest in real-world evidence earlier, so that payers have more information to work from.”