Innovation in HTA: What is the additional value? Stirling Bryan Centre for Clinical Epidemiology & Evaluation, Vancouver Coastal Health Research Institute School of Population & Public Health, UBC
My co-authors and funders: Craig Mitton Senior Scientist, Centre for Clinical Epidemiology & Evaluation, VCHRI Associate Professor, School of Population & Public Health, UBC Helen Lee Research Assistant, Centre for Clinical Epidemiology & Evaluation, VCHRI PhD candidate, University of Calgary Funding support Unrestricted grants from: -Vancouver Coastal Health Research Institute -Pfizer Canada
Everyone s talking innovation CHSPR 2009 Health Policy Conference Health Innovation for Patients and Populations McGill University Innovation Centre Utrecht University MSc in Drug Innovation Steve Jobs: Innovation distinguishes leaders from followers Woody Allen: If you re not failing every now and again, it s a sign you re not doing anything very innovative
Overview The issue: A lack of innovation in health care Definition: What is innovation? Demand side question: Is there an independent social value associated with innovation? Next steps and conclusions
Background Much discussion recently about 'innovation', or more precisely the lack of it, in the health care sector The concern: National guideline bodies (CDR, NICE) apply strict costeffectiveness criteria and so fail adequately to recognise the full benefits that come from innovation Sir David Cooksey: NICE appraisals do not operate in a way that is supportive of innovation... and therefore dissuade companies from investing in the UK (Cooksey, 2009) Sir Ian Kennedy: NICE should consider... agreeing a higher *cost-effectiveness] threshold in the case of innovation... and maintaining it for a fixed period (e.g. from 3-5 years) (Kennedy, 2009)
The drug itself has no side effects but the number of health economists needed to prove its value may cause dizziness and nausea
Background Much discussion recently about 'innovation', or more precisely the lack of it, in the health care sector The concern: National guideline bodies (CDR, NICE) apply strict costeffectiveness criteria and so fail adequately to recognise the full benefits that come from innovation Sir David Cooksey: NICE appraisals do not operate in a way that is supportive of innovation... and therefore dissuade companies from investing in the UK (Cooksey, 2009) Sir Ian Kennedy: NICE should consider... agreeing a higher *cost-effectiveness] threshold in the case of innovation... and maintaining it for a fixed period (e.g. from 3-5 years) (Kennedy, 2009)
Coverage decision-making criteria Clinical effectiveness Cost-effectiveness Acceptability Terminality Orphan drug Ministry priorities Innovativeness Wider societal considerations Etc. Dowie (2008)
(Dowie, 2008)
(Dowie, 2008)
To explore this issue, we need: A clear and agreed definition of innovation Clarity of the arguments: Demand side: Is there an independent (separable) social value associated with innovation? Supply side: What are the appropriate incentives to offer (e.g. patents, premium prices, other support for research) to ensure that socially valuable investment takes place?
What is innovation? Morgan, Lopert & Greyson (2008): Innovatory products must both meet unmet need and improve health outcomes. Kennedy (2009): Innovations must be new, must provide an improvement on existing products and must offer a step-change in terms of patient outcomes. Ferner, Hughes & Aronson (2010): An innovation offers treatment of a condition with no existing effective, or at least no completely satisfactory, intervention. Health Canada (2009): An innovation represents effective treatment, prevention or diagnosis of a disease or condition for which no drug (or medical device) is currently licensed in Canada.
Demand side considerations Is there an independent (separable) social value associated with innovation? Hypothetical example: Two groups of patients, A and B Equivalent in all important respects bar: Group A has no effective therapy currently Effective therapy is currently available for group B Extensive R&D delivers: An innovation for group A, NT a A new more effective therapy for group B, NT b
Patient Group A Patient Group B Full health Full health Health gain with NT a Health with NT a Health gain with NT b Health with NT b Original health Health gain With T b Current health Original health Additional QALYs for NT a : 1 Additional cost for NT a : $60,000 Additional QALYs for NT b : 1 Additional cost for NT b : $40,000
Example: Riluzole for ALS Prior to the launch of riluzole, patients with ALS had no effective therapy The development of riluzole was, therefore, an innovation It addressed an unmet need NICE CE estimate: approx. 40,000 per QALY NICE CE threshold: 20,000 per QALY But reimbursement guidance was positive The innovation premium is 20,000
Innovation, social value and incentives Demand side: Is there an independent (separable) social value associated with innovation (i.e. providing effective therapy for the first time)? Patients experiencing a serious condition for which no effective therapy is currently available Do they represent a disadvantaged group? Only if the answer is yes should we consider supply side incentives to promote innovations For example: a higher *cost-effectiveness] threshold in the case of innovation... (Kennedy, 2009) Others: patent enhancements, premium prices, innovation weights, other support for research
Thoughts? Questions? Email: stirling.bryan@ubc.ca