Economic considerations are important in determining the development and use of a new technology in any scientific field. This is particularly true in healthcare, where overall spending in the U.S. is at an unsustainably high rate, thus making cost consciousness imperative in the development of new technologies. Researchers who desire to translate new understandings of disease mechanisms into commercially viable methods of diagnosis, therapy and prevention often neglect or struggle to incorporate health economics into the assessment of the potential value of their innovations. We propose to develop a framework for health economics evaluation, with insights, tools and relevant case studies, specifically targeted to support the research and development goals of early translational researchers. The primary objectives of the framework are:
- to highlight some key economic factors that lead to the adoption or rejection of new technologies into clinical practice, and
- to help researchers better frame the potential economic value of their innovations
Supporting an Unmet Need
In the Catalyst Award Program at UCSF CTSI, early translational researchers receive targeted advice on product development and commercialization strategies, in addition to seed funding. These key insights, provided early in the translation process, have often led researchers to significantly recalibrate their research and development goals and approach to maximize the potential clinical and commercial success of their innovations. Health economics and cost-effectiveness are consistently raised as critical issues in the potential success of new technologies reviewed in the program. A complete economic evaluation of any proposed technology is far beyond the goals and capabilities of the program. However, an accessible framework that provides key insights, tools and case studies to help researchers understand the contributing factors to the economic evaluation and adoption of new technologies, would be invaluable.
An Initial Pilot Project Focused on Medical Devices
Since the proposed framework will be driven by a limited number of case studies, we will maximize its value by initially developing and validating our approach for medical devices. If successful, a similar approach will be used to develop frameworks for therapeutics, diagnostics and digital health technologies, with the expectation of shared and technology-specific elements within each framework.
We will leverage the knowledge of key experts in health economics and policy as well as technology adoption at UCSF. Additional independent experts in health economics, cost-effectiveness, reimbursement, and new technology assessment will also be identified and consulted.
- Pilot Evaluation: A panel consisting of UCSF and external experts will initially be convened to discuss how early translational research projects can be best evaluated using the limited resources available to researchers. The panel will recommend and evaluate up to 5 medical devices whose development and successful (or failed) clinical adoption can be used to highlight important aspects of health economics.
- Draft Development: The output of these reviews will be translated into the first draft of a framework for economic evaluation and is expected to include case studies, methodologies, templates, and resources.
- Rapid Testing: This draft framework will be pilot-tested with 5 UCSF researchers involved in medical device projects that have been reviewed by the Catalyst Program. Their experience with the framework and their resulting economic evaluations will be assessed and discussed by the expert panel.
- Finalize: The results and assessment of the pilot study will be used to develop a final framework for broader distribution.
- Distribution: The final framework will be distributed through the Catalyst Award Program, The Center for Healthcare Value, and other CTSI and UCSF channels, other CTSA network channels, and outreach to relevant publishers, etc.
Short and Long-Term Success Metrics
The short-term success of this approach and of the framework will be determined by the results of the pilot study and the content of future Catalyst Award applications. Long-term success will be measured by the ability of researchers to better understand and incorporate economic factors into their translational projects. Project tracking and feedback mechanisms within the Catalyst Award Program will be used to monitor and evaluate such measures.
This project will be seeking to include a multidisciplinary group of health economics stakeholders, including key researchers at the Institute for Health Policy Studies at UCSF, health economists, reimbursement and technology evaluation experts. Lisa Schoonerman and Ruben Rathnasingham, who will lead the project, have extensive healthcare product development and commercialization experience. This pilot project, focused on medical devices, will require a budget of $15,000 for consultants, meeting expenses, production and promotion.
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