The Healthcare Innovation Challenge: How to increase innovation productivity and reduce the 7+ years on average to launch a new drug? According to figures released by the FDA, CDER, PhRMA and Price Waterhouse Coopers, for 2007, drug industry spending has actually doubled on R & D with the number of drugs actually delivered to patients dropping in half over the past five years. Why is this happening? There are several factors including: scientific issues – better understanding of the body at the molecular level, leadership-policy issues – cost/benefit perspective of the patient, provider and insurer, technology issues – collaboration along the value chain between all parties involved in drug delivery is slow, duplicative, disconnected at times with siloed databases, and regulatory issues – it takes too long to get a new drug approved. Addressing the latter set of issues a team of officials from the federal Health and Human Services agency made a stop in San Francisco, during its tour of the United States.
On December 10th, a team of officials led by Dr. Tevi Troy, Deputy Secretary of Health and Human Services presented, at UCSF, Mission Bay, an update on what federal government agencies were doing to support the innovation process. Dr. Troy introduced the overall theme: Healthcare Innovation in the 21st CenturyCentury. Officials from HHS organizations including NIH (National Institutes for Health), FDA (Food and Drug Administration), CMS (Centers for Medicare and Medicaid Services), and AHRQ (Agency for Healthcare Quality and Research) made presentations on what they were doing to support the innovation process and reduce time to market.
NIH announced future strategies with a capstone framework called the NIH Roadmap for Medical Research on where investments will be made in their portfolio of research programs. They outlined an initiative to translate basic research into better patient therapies by facilitating the development of new professional interactions, programs and research projects called, The Clinical and Translational Science (CTSA) program. NIH has within CTSA an Informatics program to enhance collaboration among researchers and to develop best practices to be shared with global partners. In addition, NIH noted opportunities to leverage federal investments with private investments a number of areas including personalized medicine, as an example the Biomarkers Consortium.
FDA provided an update on their Critical Path Institute (C-PATH), ), a non profit 501 (c) 3 organization co-founded with the University of Arizona and SRI International. A key focus of C-PATH is to accelerate safe medical product development and foster education in applied research and regulatory science. They outlined the objectives of the Sentinel Initiative to develop and implement a nationwide electronic system for monitoring drug safety. On example of surveillance is their use of Medicare data to see trends in patient outcomes. In the informatics area they announced are renewed focus on shifting many FDA paper-based services into electronic data, portal and repository oriented ones.
CMS released an Innovator’s Guide to Navigating CMS, which provides a roadmap to a predictable path to Medicare coverage, coding, and payment. The document outlines processes and standards for approving new technologies. The Guide was developed by the CMS Council for Technology and Innovation, a CMS – wide working group charged with streamlining and creating a more transparent process to get new technologies to patients sooner.
AHRQ announced strategies for the future which include investments in genomics – ie a gene – based dosing calculator for Warfarin. They placed significant emphasis on comparative effectiveness programs dedicated to facilitating decision-making by findings from high-quality research. Of interest, was the Health Care Innovations Exchange which is designed to support health care professionals sharing innovations that improve the delivery of patient care.
This was an impressive demonstration of the commitment by HHS agencies to moving the innovative processes ahead, and to focus how innovation impacts patient outcomes. I asked an official if they were looking at the overall question posed at the beginning of this piece: How to increase innovation productivity and reduce the 7+ years on average to launch a new drug? He replied that they were working hard to integrate the agencies and programs at HHS, though not looking at the overall industry question.
It seems that many different organizations need to be focused on this challenge if the overall innovation process is to be made more productive and to reduce time to market including: federal regulatory agencies, state medical departments, academic researchers, biotech-pharma companies, insurers and providers.
One approach would be to bring these key stakeholders together working on this innovation question while contributing to the success of the Obama administration reform healthcare initiatives. Developing the answers to this question and implementing the necessary infrastructure would have a significant impact on the quality, effectiveness, safety and cost of our healthcare system.