Disruptive Health Technologies Implications for HTA CADTH Symposium, May 6-7 th 2013 Leslie Levin MD, FRCP (Lon), FRCPC Vice President, Evidence Development and Standards, Health Quality Ontario Professor of Medicine, University of Toronto Staff Medical Oncologist, Princess Margaret Hospital www.HQOntario.ca
Disruptive Technology (Christensen, 1997) • Radically transforms markets, creates wholly new markets or destroys existing markets 1
Behavioural Dynamics of Adoption Barriers • Resistance to change/ Inherent conservativism • Infrastructure malaise Facilitators • Institutional and professional profiling • Public expectation • Patent laws and limited market exclusivity for non-drug technologies 2
Barriers to Adoption Poor pre-market quality clinical trial produce uncertainty • Accuracy versus clinical utility for diagnostic tests • No prospective economic analysis • Research failed to address health system perspectives • Me-too technologies • Lack of generalisability • Inadequate trial design e.g. randomization, concealment, ITT – leading to low quality evidence Policy including non-affordability, competing pressures 3
Health Technology Life-Cycle Diffusion Curve a Steady State b c U Evidence & Uncertainty Diffusion Unconditional Yes R&D Field Uncertainty Study Inflection Point Unconditional No TIME 4
>110 Single Technology Analyses by MAS, PATH &THETA 92% Conversion to Policy 5
Uncertainty Drove Field Evaluation Studies Recognizing Uncertainty – Effect of GRADE GRADE Will Further Research Level of Uncertainty (Quality of Evidence Change Confidence in Following Systematic the Estimate? Review) High Very unlikely Certainty Moderate Likely Low Very Likely Any estimate of effect Very Low is very uncertain Uncertainty 6
“Something is Rotten in the State of Denmark” – Hamlet Act 1, Scene 4 • Does HTA cover the full spectrum of evidence required to inform decision making? • RCTs assess efficacy within a “perfect world.” How do we deal with generalizability/external validity? • How to deal with low quality evidence from pre-market evaluation? 7
Device Device Device Patients have Development Manufacture Licensing access to the and Testing device Pre-clinical Clinical Application Marketing, sales, - Design - Efficacy and to approve distribution, - Prototyping safety testing sale/use education, - Efficacy and in patients training safety testing Is there an alternative to Evidence Policing Uptake of Technologies? Pg 8
Life-Cycle Diffusion Curve (Pre-Market Evidence Based Analysis) Pre-Market Post-Market U E f f e c t i v e n e s s Effectiveness Obsolescence Systematic review Systematic review Cost-Effectiveness (CE) Cost-Effectiveness (CE) • Efficacy 1 HORIZON Safety • Value (CE) Diffusion DEVELOP Affordability TEST • Ethical & societal Unconditional Yes • Post market conditions Unconditional No Uncertainty R&D Investment Regulation TIME 9
MaRS : Urban Innovation Hub MaRS Linking Creative and Business Assets of Toronto Discovery District Financial District Creative & Arts District Gardiner Museum of Ceramic Art Royal Conservatory of Music Royal Ontario Museum Women’s College University of Toronto The MaRS Centre UHN Toronto General Hospital for Sick children UHN Princess Margaret Mount Sinai Ryerson Toronto Rehab University Art Gallery of Ontario TIFF & OCAD Four Seasons Centre Financial District Entertainment District Pg 10
Memory at Work Prioritization Review by and Selection SME and MNE OHTAC Apply by EXCITE Technologies subcommittee Board - Rele leva vance nce - OHTAC AC recommend ndatio ions ns - Disrupt uptive ive potent ntia ial - Potent ntia ial l econom omic ic benefi fit - Ident ntif ify y obsole lesc scence nce - Feasi sibil bilit ity - Magnit nitude ude of effect on - Capacit ity patient nt outcome omes s and system em efficienci encies es - Stage ge of readine ness ss
Memory at Work *Evaluation Prioritization Review by by EXCITE and Selection SME and MNE OHTAC Apply Methodological by EXCITE Industry subcommittee Centres Board MOHLTC and Broader Health System Communication re - accrual, safety, and recommendations for improvement
Core Evidentia dentiary ry Bundl dle: e: Optional ional Additio ditional nal Analys lyses: es: • Safety + Effectiveness • Assess usability/human factors • Systematic Review • Develop education system for • Economic Analysis training end users • Investigate patient preferences • Analyze factors influencing of uptake • Develop a registry for tracking post- adoption effectiveness + long-terms safety • Knowledge transfer Completed by: Completed by: Methodological Specialized Methodological Centres Centres 14 Pg 14
Increased likelihood of adoption Access to a coordinated network of world-class expertise in evaluation of health technologies Early feedback provides insight during formative stage Single, harmonized pre-market process • Duration and cost depends on complexity and protocol design • Evaluations typically require 12-30 months to complete • Company pays the cost which range from C$1-3 million • Consideration for defining conditions of adoption pre-market Pg 15
EXCITE - Progress in Year One Endovascular renal nerve ablation Home based apnoea diagnostic RNA disruption to predict chemotherapy response IV delivery not gravity/ electricity/ battery dependent Rapid recovery from stroke in hand/upper limb MRI-guided RTMS for treatment refractory depression Hand held device to detect pneumothorax and fluid IT system to track hospital acquired infections Remote ischemic conditioning Point of care diagnosis of infection in wounds
Memory at Work Represented Group Members Richard Ivey (Chair) MaRS Board Ilse Treurnicht, EXCITE Chief Scientific Officer Dr Leslie Levin Industry: MEDEC (MNEs) Brian Lewis, Peter Robertson HTX (SMEs) John Soloninka, Peter Goodhand Government: MOHLTC, ADM Vasanthi Srinivasan MEDI ADM Bill Mantell Health System: OHTAC Dr Charles Wright Academia: Council of Academic Hospitals Karen Michell, Catherine Zahn of Ontario (CAHO) Pg 17 Pg 17
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