MaRS Excellence in Clinical Innovation and

Technology Evaluation program CADTH Symposium

Zayna A. Khayat, Ph.D. , Director MaRS EXCITE

April 8, 2014

Pg 1 CONFIDENTIAL

EXCITE Pre-Market Evidentiary Bundle Life-Cycle Diffusion Curve

Pg 2

Investment Regulation TIME

Pre-Market Post-Market

Uncertainty R&D

Cost Effectiveness (CE)

Systematic review

Effectiveness

Yes

No

• Efficacy Safety

• Value (CE) Affordability

• Ethical & societal

• Post-market conditions

E f f e c t i v e n e s s

Cost Effectiveness (CE)

Systematic review

• Efficacy Safety

• Value (CE) Affordability

• Ethical & societal

• Post-market conditions

Management Board

decision

Exploratory Meeting

Interim Protocol Approval

Contract Execution First Patient Enrollment

The EXCITE process

1. Based on conservative end of the range of times expected for each stage 2. Call for Innovation opens every January and July (2X/year), and closes in March and September, respectively

22

EXCITE algorithm (months)1

Apply2

CONFIDENTIAL

HQO Implementation Framework

Pg 4

CONFIDENTIAL

Framework bridges evidence & action

Pg 5 Source: HQO Implementation Subcommittee report recommendations (August 2013)

Outputs, roles, responsibilities

Pg 6 Source: HQO Implementation Subcommittee report recommendations (August 2013)

Implementation considerations

Pg 7 Source: HQO Implementation Subcommittee report recommendations (August 2013)

Alignment with key OHTAC

decision-making determinants

Pg 8 Source: HQO Implementation Subcommittee report recommendations (August 2013)

Excellence in Clinical Innovation and Technology

Evaluation

Pg 9