D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
MaRS Excellence in Clinical Innovation and Technology Evaluation program
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CADTH Symposium
April 14, 2015
Zayna Khayat I zkhayat@marsdd.com I @ZaynaKhayat
Our Future Matters
April
2015
Poor pre-market quality clinical trial produces uncertainty
Accuracy versus clinical utility for diagnostic tests
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No prospective economic analysis
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Research failed to address health system perspectives
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Me-too technologies
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Lack of generalizability
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Inadequate trial design e.g. randomization,
concealment, ITT – leading to low quality evidence
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Policy including non-affordability, competing pressures
Evidence used to police adoption in isolation from
originators of innovation
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D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
Is HTA’s placement too late?
April
2015
EXCITE Overview
Excellence in Clinical Innovation and Technical Evaluation
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 flowthrough of funds, secretariat, coordinating and quality support
Executed by 4 academic Methodology Centres working with 24 Research
Hospitals
U
Pre-Market
Diffusion
Post-Market
E f f e c t i v Effectiveness
e n e s s
Systematic review
Cost Effectiveness
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Cost Effectiveness (CE)
Efficacy Safety
Value (CE)
Affordability
Ethical & societal
Post-market
conditions
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•
•
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Efficacy
Safety
Value (CE)
Affordability
Ethical &
societal
Post-market
conditions
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Obsolescence
Systematic review
Yes
Unconditional No
Regulation
TIME
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D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
Concept
Reimbursement
January
2015
Citizens: Faster access to health technologies with a strong value proof
Payer/HTA Bodies
Industry
 Single, harmonized process for
regulatory and reimbursement
 Early engagement – prepare
infrastructure for adoption
 More efficient, economical and
mitigates investment risk
 Alignment with regulator &
broader innovation agenda
 Earlier feedback on technology
 Could decrease costs
 Negotiate conditions of
adoption pre-launch
Regulator
Academic Centres
 Relevant issues addressed
early
 Access to new disruptive
technologies – policy impacts,
publications
 Mitigates re-submissions
 Alignment with health system
and broader innovation agenda
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 New methodological challenges
 Maintain independence
April
2015
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 Efficient HTA & decisionmaking
D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
EXCITE: Parallel value propositions
Management
Board
• Advice, oversight, direction
• Approve technologies, protocol, budget
• Senior reps: health, economic development,
HTA, AHSCs, industry
• Dr. Les Levin, CSO
• Dr. Zayna Khayat, Director
• Adel Aziziyeh, Project Manager
• Lily Lo, Coordinator
• Advise prioritization of technologies
• Advice on clinical study design
• Support in conditions of adoption
• Comprised of implementation subcommittee of OHTAC
• Review protocols for safety
• Chair Tony Easty
• Early advice on design of the evidence
package and study
Methodology Centres
• 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
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April
2015
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• Advice on science, methodology
• Allocation of projects
• Heads of 5 methodology centres
• Dr. Les Levin, CSO
D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
The EXCITE Collaboration Model
• 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)
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November
2014
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• 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
D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
Current state of the EXCITE program
EXCITE + Office of Health Innovation
to work collaboratively to prepare
the system
Reimbursement
Considerations
Projected
Adoption Rates
Procurement
Knowledge
Translation
Economic
Projections
To read the full report visit www.ohic..ca
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April
2015
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Infrastructure
Readiness
D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
What’s next? 1. Conditions of Adoption
EXCITE International Planning
Summit (March 27 2015)
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April 2015
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• 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)
D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
What’s next? 2. Geographic expansion
D E V E L O P I N G TA L E N T • G R O W I N G V E N T U R E S
For more information visit www.excite.marsdd.com
Twitter: #MaRSEXCITE
Les Levin
Chief Scientific Officer
llevin@marsdd.com
Our Future Matters
Zayna Khayat
Director
zkhayat@marsdd.com
Adel Aziziyeh
Project Manager
aaziziyeh@marsdd.com
Lily Lo
Associate
llo@marsdd.com
April
2015
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