www.HQOntario.ca
Leslie Levin MD, FRCP (Lon), FRCPCVice 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 StudiesRecognizing 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
UncertaintyR&D
Unconditional No
Obsolescence
HORIZON
DEVELOP
TEST
UPre-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: Urban Innovation HubLinking 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 GeneralHospital 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 RehabRyerson University
Pg 10
Memory at Work
SME and MNE
Technologies
Prioritization
and Selection
by EXCITE
Board
Apply
Review by
OHTAC
subcommittee
- Relevance
- Disruptive potential
- Identify obsolescence
- Magnitude of effect on
patient outcomes and
system efficiencies
- Stage of readiness
- OHTAC recommendations
- Potential economic benefit
- Feasibility
- Capacity
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 Evidentiary Bundle: Optional Additional Analyses:
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 BoardRichard 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
of Ontario (CAHO)Karen Michell, Catherine Zahn
www.hqontario.ca