Personalized medicine is greatly changing health care practices, as well as how innovative treatments are being developed.
According to the Personalized Medicine Coalition, “more than one of every four drugs approved by the Food and Drug Administration over the past four years is a personalized medicine, with a record number of 16 new personalized medicines approved in 2017. Those numbers are a sharp increase from 10 years ago, when personalized medicines accounted for less than 10 percent of new molecular entity approvals annually.”
As a result, today patients are benefiting from targeted therapies with fewer side effects, and doctors have more tools available to practice medicine more effectively.
But there are policy, economic and regulatory disincentives that are having an impact on the development of precision medicines and their use to better diagnose and treat patients. These include:
- Challenges of reimbursement;
- Evidentiary standards and data requirement for payer coverage;
- Clinical guidelines;
- Investment in molecular diagnostics;
- Issues impacting market access; and
- Incentives for personalized medicine development.
Policy experts will gather on Monday, May 8 for a Health Affairs Issue Briefing on Precision Medicine to discuss these challenges and how precision medicine works, as well as consider policy prescriptions advancing its implementation and impact in the United States and the world. We’re looking forward to hearing the conversation.