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

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