This week, Energy and Commerce Committee Chairman Fred Upton (R-MI) and Rep. Diana Degette (D-CO) outlined broad goals for the 21st Century Cures bill they are drafting. The bill is designed to eliminate roadblocks to medical innovation by introducing legislative proposals to accelerate the development of medical treatments and cures.
A new paper from Avalere provides insight into “what’s in” and “what’s out” as a result of the public discussion on the 21st Century Cures Bill held in 2014. Public submissions and testimony have largely focused on orphan and rare diseases and barriers to development. About one-third of comments addressed approval pathways and/or the regulatory burden on innovators. Thirty-seven percent of comments mentioned improving clinical trials, 30 percent had a Health IT focus, and 24 percent were interested in advancing development and research through greater patient engagement.
In contrast to significant attention to innovation for rare diseases and unmet needs, there has been relatively little discussion about treatments for the most common and costly diseases in the U.S., such as obesity-related and cardiovascular diseases that contribute to morbidity, mortality, and growing national health care expenditures.
Avalere continues to follow the public debate on 21st Century Cures and has highlighted ten major issues to watch, including regulatory incentives, a shift towards post-market evidence, innovations in data collection including clinical trial recruitment and interoperability, patient focus, and data access, as this initiative moves forward.
“21st Century Cures: Who’s In, Who’s Out, and What’s Next” can be found here. If you would like to talk to an Avalere expert about the report or the trends to follow, please contact Amy Martin Vogt at [email protected] or 202-745-5052.
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Avalere Health is a strategic advisory company whose core purpose is to create innovative solutions to complex healthcare problems. Based in Washington, D.C., the firm delivers actionable insights, business intelligence tools and custom analytics for leaders in healthcare business and policy. Avalere's experts span 230 staff drawn from Fortune 500 healthcare companies, the federal government (e.g., CMS, OMB, CBO and the Congress), top consultancies and nonprofits. The firm offers deep substance on the full range of healthcare business issues affecting the Fortune 500 healthcare companies. Avalere’s focus on strategy is supported by a rigorous, in-house analytic research group that uses public and private data to generate quantitative insight. Through events, publications and interactive programs, Avalere insights are accessible to a broad range of customers. For more information, visit avalere.com, or follow us on Twitter @avalerehealth.
