CADTH 2015 Symposium

1. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
April
2015
MaRS Excellence in Clinical Innovation and Technology Evaluation program
CADTH Symposium
April 14, 2015
Zayna Khayat I zkhayat@marsdd.com I @ZaynaKhayat

2. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
April
2015
Poor pre-market quality clinical trial produces uncertainty
• Accuracy versus clinical utility for diagnostic tests
• No prospective economic analysis
• Research failed to address health system perspectives
• Me-too technologies
• Lack of generalizability
• Inadequate trial design e.g. randomization,
concealment, ITT – leading to low quality evidence
Policy including non-affordability, competing pressures
Evidence used to police adoption in isolation from
originators of innovation
Is HTA’s placement too late?

3. Pre-Market Partnership formed April 2012 between government, OHTAC, the
health system, regulators, academia, clinicians and industry in selection by the
health system and protocol design by all
Studies funded by industry
Streamlines path to adoption of disruptive technologies through a single
harmonized process that meets regulatory and reimbursement requirements
Process includes evaluation, systematic review, economic analysis and
“conditions of adoption” analysis
Housed at MaRS, a neutral innovation space (MaRS) which provides flow-
through of funds, secretariat, coordinating and quality support
Executed by 4 academic Methodology Centres working with 24 Research
Hospitals
EXCITE Overview
Excellence in Clinical Innovation and Technical Evaluation

4. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
January
2015
Concept
RegulationTIME
U
Pre-Market Post-Market
Cost Effectiveness (CE)
Systematic review
Effectiveness
Obsolescence
Diffusion
Yes
Unconditional 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
Systematic review
• Efficacy Safety
• Value (CE)
Affordability
• Ethical & societal
• Post-market
conditions
Reimbursement

5. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
April
2015
EXCITE: Parallel value propositions
Industry
 Efficient HTA & decision-
making
 Early engagement – prepare
infrastructure for adoption
 Alignment with regulator &
broader innovation agenda
 Could decrease costs
 Relevant issues addressed
early
 Mitigates re-submissions
 Alignment with health system
and broader innovation agenda
 Access to new disruptive
technologies – policy impacts,
publications
 New methodological challenges
 Maintain independence
 Single, harmonized process for
regulatory and reimbursement
 More efficient, economical and
mitigates investment risk
 Earlier feedback on technology
 Negotiate conditions of
adoption pre-launch
Academic Centres
Payer/HTA Bodies
Regulator
Citizens: Faster access to health technologies with a strong value proof

6. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
April
2015
The EXCITE Collaboration Model
• Dr. Les Levin, CSO
• Dr. Zayna Khayat, Director
• Adel Aziziyeh, Project Manager
• Lily Lo, Coordinator
• Advice on science, methodology
• Allocation of projects
• Heads of 5 methodology centres
• Dr. Les Levin, CSO
• Advise prioritization of technologies
• Advice on clinical study design
• Support in conditions of adoption
• Comprised of implementation sub-
committee of OHTAC
Management
Board
• Advice, oversight, direction
• Approve technologies, protocol, budget
• Senior reps: health, economic development,
HTA, AHSCs, industry
• Review protocols for safety
• Chair Tony Easty
• Excellence in complex clinical trial design and execution in collaboration with 24 Research Hospitals
• Contracted in by EXCITE
• Design study with industry;
• Execute and publish the study
• Early advice on design of the evidence
package and study
Methodology Centres

7. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
• Since April 2012, 49 companies applied in 7 Calls for Innovation
• Technologies selected:
- 9 currently active (1 multinational, 2 US, 1 BC, 5 Ont)
- 6 under review (to be approved at April 23 board)
• Publicly discloseable projects are:
- Home sleep apnea test
- Renal denervation for hypertension (discontinued)
- Rna disruption for early prediction of clinical response to chemo
in breast cancer
- Electrical stimulation for voluntary upper limb movements in
stroke
Current state of the EXCITE program
November
2014

8. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
What’s next? 1. Conditions of Adoption
To read the full report visit www.ohic..ca
April
2015
Projected
Adoption Rates
Infrastructure
Readiness
Reimbursement
Considerations
Economic
Projections
Knowledge
Translation
Procurement
EXCITE + Office of Health Innovation
to work collaboratively to prepare
the system

9. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
What’s next? 2. Geographic expansion
April 2015
EXCITE International Planning
Summit (March 27 2015)
• UK – NICE, NHS, regulators,
AHSN
• US – FDA, BCBS, Kaiser, Mayo…
• Canada – Industry Canada,
Health Canada, Federal Innov.
Panel
• Ontario – MoHLTC, CAHO
• Industry – small and
multinational (Canada, US, UK,
NZ)

10. DEVELOPINGTALENT•GROWINGVENTURES•OPENINGMARKETS
Our Future Matters
April
2015
Zayna Khayat
Director
zkhayat@marsdd.com
Lily Lo
Associate
llo@marsdd.com
Adel Aziziyeh
Project Manager
aaziziyeh@marsdd.com
Les Levin
Chief Scientific Officer
llevin@marsdd.com
For more information visit www.excite.marsdd.com
Twitter: #MaRSEXCITE
Or contact us at: