The Alliance for Health Policy https://allhealthpolicy.org held a Summit with Mark McClellan MD, PhD, Director and Professor of Business, Medicine, and Health Policy at the Margolis Center for Health Policy at Duke University https://healthpolicy.duke.edu. He reports that the many advances occurring with disease and systems biology, genomics, proteomics, metabolomics, and immunology, are affecting the development of drugs.
To further develop the field, bipartisan legislation is supporting regulatory innovation for biomedical progress. As Dr. McClellan explained, the 21st Century Cures Act has provided new tools enabling FDA and private collaborations to develop real-world evidence related to safety surveillance and effectiveness.
Advances have made it possible for expedited FDA drug pathways to lead to faster approvals through the review process. The Fast Track pathway deals with drugs with the potential to address unmet medical needs, and also provide significant advances in medical care. FDA completes the review process within six months instead of the typical goal of 10 months.
There are some concerns on how to obtain value from innovation in the biomedical sector. Concerns relate to the impact of high upfront costs, uncertainty of long-term results, uncertainty of impact on different patients, the positive use of combination therapies, plus the uncertainty in recouping investment with multiple payers.
The thinking is to move toward value-based payments which would produce better results, provide faster and improved access, provide earlier and more accurate diagnoses, provide the ability to target treatments utilizing more modern technology, greatly increase the use of telemedicine, and provide for more coverage flexibility with more accountability for results.
Alternative Payment Models (APM) are in place to support value-based care and would shift paying for specific services or providers by paying at the episode or person level. The payment would depend on performance against benchmarks.
Today, payment and care reforms are combining to support value-based care by sharing data and analytics, working with performance measures derived from care data and patient reports, and forming ideas on how to develop the team workforce.
To achieve value-based care, there is the need for better supporting infrastructure along with addressing regulatory barriers. Today, many regulatory barriers related to medical products are designed to protect program integrity and avoid excess costs in fee-for-service payments. These fee-for-service payments in some cases need to be modified for payments.
Summing up, obtaining Real World Evidence (RWE) includes accomplishing efficient regulatory review, supporting clinical decision-making, and providing for value based payments for drugs and devices. According to many in the field, learning from real world patient experiences would support better informed healthcare decision-making across the health system.