PMC members shape and advance the future of personalized medicine.
March 02 | Business of Biotech Conference 2018
In a video recently published by Politico, FDA Commissioner Scott Gottlieb, M.D., contends that gene therapy has crossed a "scientific bridge." From a regulatory standpoint, he said, that means FDA needs to consider how to "regulate the process" by which gene therapies are created for individual patients.
In a white paper titled Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps, PMC contends that most value assessment frameworks still make sweeping conclusions about the economic worth of a particular treatment based almost exclusively on population averages. As a result, the paper contends, most value assessment frameworks could unintentionally discourage payers and providers from considering important information about a patient's biology, values and preferences that can improve health outcomes — especially when value assessment frameworks influence the coverage and payment decisions that determine whether patients have access to treatment options that will work for them.
» Personalized Medicine and Value Assessment Frameworks: Context, Considerations, and Next Steps (PDF)