CADTH Symposium, May 6-7 th 2013 Leslie Levin MD, FRCP (Lon), FRCPC - - PowerPoint PPT Presentation

www.HQOntario.ca 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

Disruptive Health Technologies Implications for HTA CADTH Symposium, May 6-7th 2013

1

Disruptive Technology (Christensen, 1997)

• Radically transforms markets, creates wholly new markets or

destroys existing markets

2

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

3

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

Health Technology Life-Cycle Diffusion Curve

U

TIME R&D Diffusion Steady State Inflection Point

a b c

Unconditional Yes Uncertainty Unconditional No Field Study

Evidence & Uncertainty

4

5

>110 Single Technology Analyses by MAS, PATH &THETA 92% Conversion to Policy

GRADE (Quality of Evidence Following Systematic Review) Will Further Research Change Confidence in the Estimate? Level of Uncertainty

Uncertainty Drove Field Evaluation Studies

Recognizing Uncertainty – Effect of GRADE

6

Uncertainty High Moderate Low Very Low Very unlikely Likely Very Likely Any estimate of effect is very uncertain Certainty

7

“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?

Pg 8

Device Development

Pre-clinical

• Design
• Prototyping
• Efficacy and

safety testing

Device Manufacture and Testing

Clinical

• Efficacy and

safety testing in patients

Device Licensing

Application to approve sale/use

Patients have access to the device

Marketing, sales, distribution, education, training Is there an alternative to Evidence Policing Uptake of Technologies?

9

Investment Regulation

Life-Cycle Diffusion Curve

(Pre-Market Evidence Based Analysis)

1 TIME

Diffusion Unconditional Yes Uncertainty R&D Unconditional No Obsolescence HORIZON DEVELOP TEST

U

Pre-Market Post-Market

Systematic review Cost-Effectiveness (CE) Effectiveness

• Efficacy

Safety

• Value (CE)

Affordability

• Ethical &

societal

• Post market

conditions

Systematic review Cost-Effectiveness (CE) E f f e c t i v e n e s s

MaRS MaRS: Urban Innovation Hub

Linking Creative and Business Assets of Toronto

Discovery District Financial District Creative & Arts District Gardiner Museum of Ceramic Art Royal Ontario Museum Women’s College

The MaRS Centre

UHN Toronto General Hospital for Sick children Entertainment District Four Seasons Centre University of Toronto UHN Princess Margaret Mount Sinai Art Gallery of Ontario Royal Conservatory of Music TIFF & OCAD Financial District Toronto Rehab Ryerson University

Pg 10

Memory at Work

SME and MNE Technologies Prioritization and Selection by EXCITE Board Apply Review by OHTAC subcommittee

• Rele

leva vance nce

• Disrupt

uptive ive potent ntia ial

• Ident

ntif ify y obsole lesc scence nce

• Magnit

nitude ude of effect on patient nt outcome

• mes

s and system em efficienci encies es

• Stage

ge of readine ness ss

• OHTAC

AC recommend ndatio ions ns

• Potent

ntia ial l econom

• mic

ic benefi fit

• Feasi

sibil bilit ity

• Capacit

ity

Memory at Work

SME and MNE Industry Prioritization and Selection by EXCITE Board Apply *Evaluation by EXCITE Methodological Centres Review by OHTAC subcommittee Communication re - accrual, safety, and recommendations for improvement MOHLTC and Broader Health System

Pg 14

• Assess usability/human factors
• Develop education system for

training end users

• Investigate patient preferences
• Analyze factors influencing of

uptake

• Develop a registry for tracking post-

adoption effectiveness + long-terms safety

• Knowledge transfer
• Safety + Effectiveness
• Systematic Review
• Economic Analysis

Completed by: Methodological Centres Completed by: Specialized Methodological Centres

Core Evidentia dentiary ry Bundl dle: e: Optional ional Additio ditional nal Analys lyses: es:

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

Pg 17

Pg 17

Represented Group Members MaRS Board Richard Ivey (Chair) Ilse Treurnicht, EXCITE Chief Scientific Officer Dr Leslie Levin Industry: MEDEC (MNEs) HTX (SMEs) Brian Lewis, Peter Robertson John Soloninka, Peter Goodhand Government: MOHLTC, MEDI ADM Vasanthi Srinivasan ADM Bill Mantell Health System: OHTAC Dr Charles Wright Academia: Council of Academic Hospitals

• f Ontario (CAHO)

Karen Michell, Catherine Zahn

www.hqontario.ca