The MaRS EXCITE (Excellence in Clinical Innovation and Technology Evaluation) program helps innovators collaborate with the health system to accelerate the pace of adoption of innovative health technologies in Ontario and global markets.
At the end of the program, innovators will have feedback and data on the effectiveness, competitiveness, and economic value of their medical devices or health technology. With this data, innovators are better equipped to approach payers in multiple markets for reimbursement.
Prioritized by senior executives from the health system, only technologies that have true breakthrough potential are allowed into the program.
For more information visit www.marsdd.com.
2. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
MaRS works with partners to catalyze,
accelerate, scale and diffuse innovation.
We help entrepreneurs start and grow
successful global companies.
Together, we help Canada prosper.
MaRS: Because Our Future Matters
Build the new economy. Improve society.
Health ď Energy ď Work & Learning ď Tech
3. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
MaRS Programs & Services span the innovation
continuum
Talent
Individuals, Inventions,
Ideas
Ventures
High Impact
Companies &
Initiatives
Systems
Health Systems
and Markets
MaRSâ Network: Investors ďIndustry ďHealth orgs ď Policymakers ďAdvisors ď Prof. Services
5. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
Ontarioâs Evidence Revolution Commitment
to Evidence in Healthcare
January
2015
Ontario Excellent Care for All Act (2010)
The people of Ontario and their Government:
⢠Will ensure that healthcare providers are supported to plan for and improve the
quality of care they deliver based on the best available scientific evidence.
(HQO formed to promulgate quality-based evidence)
Drummond Report (2012)
⢠(Healthcare) Policies should be based on evidence that provides guidance on
what services, procedures, devices and drugs are effective, efficient and eligible
for public funding
Ontario Government Budget (2012)
⢠Evidence will drive decisions on funding new and existing procedures. The
government is committed to funding only those services that are supported by
medical evidence.
⢠The government will accelerate the evidence-based approach to care by
building on the mandate of Health Quality Ontario (HQO)
6. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
Dealing with Uncertainty â Field Evaluation
January
2015
⢠Post-market assessment of technology performance in the real world
through primary data gathering
⢠Improves decision making prior to long-term commitment through
appropriate adoption
⢠Designed to inform policy and funded by government
⢠Alternative is passive diffusion and intuitive decision making
⢠Completed 19 and 19 ongoing. Ten CEDs significantly impacted policy
decision making and published in peer reviewed journals
7. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
Whatâs Wrong with the Status Quo?
January
2015
⢠Evidence based analysis (EBA) is used to police the adoption of health
technologies -when it is too late to address relevance or make changes
⢠High rejection rates (OHTAC at 48%) reflects poor quality research in the
pre-market space
⢠Patents for non-drug technologies allow market dominance for only ¹ 18
months â need to evaluate and get to market quickly. Compounds the
problem
⢠Increasing focus on post market comparative effectiveness will continue to
grow
⢠We are stifling innovation by increasing risk to investors and innovators
⢠Why use evidence to criticize rather than to drive innovation?
8. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
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 â leading to low quality evidence
⢠Policy including non-affordability,
competing pressures
⢠Evidence used to police adoption in Isolation from
innovators
Barriers to Adoption
9. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
Can We Better Streamline the Path to
Market?
PRE-MARKET POST-MARKET
Device
Development
Device
Manufacturing
and Testing
Device
Licensing
Pre-clinical
⢠Design
⢠Prototyping
⢠Effectiveness
and safety
testing in
models
Clinical
⢠Effectiveness
and safety
testing in
patients or
using patient
samples
Government
licensing
⢠Application to
Health
Canada for
Licenses
approving
sale/use
Patients have
access to device
Adoption/listing
⢠Health
technology
appraisal for
reimbursement
and adoption
decision-
making
10. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
: Pull model for innovation
EXCITE is a world first partnership between government, the healthcare system,
academia, clinicians and industry, launched in late 2011.
At the end of the program, technology innovators receive a high quality EXCITE core
evidentiary bundle, they can use for both regulatory (Health Canada) licensing and
an application to the payer [Ontario Health Technology Advisory Committee
(OHTAC)] for recommendation to the Ontario Ministry of Health and Long Term
Care and other reimbursement and purchasing reviewers.
As a result, relevant disruptive effective health technologies can get to market
faster for improved health outcomes â in Ontario and globally through a single
harmonized study that was designed collaboratively with the payer and regulator.
For more information, see: http://excite.marsdd.com
Excellence in Clinical Innovation and Technology Evaluation
11. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
The Value of EXCITE
Industry
ďź Efficient HTA & decision-making
ďź Early engagement â prepare
infrastructure for adoption
ďź Alignment with regulator &
broader innovation agenda
ďź Could decrease costs
ďź Relevant issues addressed early
ďź Mitigates re-submissions
ďź Alignment with health system and
broader innovation agenda
ďź Access to new disruptive
technologies â policy impacts,
publications
ďź New methodological challenges
ďź Maintain independence
ďź Single, harmonized process for
regulatory and reimbursement
ďź More efficient, economical and
mitigates investment risk
ďź Earlier feedback on technology
ďź Negotiate conditions of
adoption pre-launch
Academic CROs
Payer/HTA Bodies
EXCITE
Regulator
12. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘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
13. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
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 6 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
* In process
14. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
TORONTO
OTTAWA
METHODS
CENTRE
TORONTO
HAMILTON
TORONTO
⢠MCs are academic units that
have demonstrated
experience and excellence
in clinical trials methodology,
health technology
assessment and in
conducting complex, multi-
centre trials with proven
capacity for data collection,
synthesis and reporting
⢠6 MCs are engaged by
EXCITE
⢠They are responsible for
overseeing the design and
execution of EXCITE
studies, sometimes in
collaboration with one or
more other institutions that
have the appropriate
capabilities/experience to
complete evaluations
successfully.
* In process
15. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
EXCITE analysis packages
ď Assess usability/human factors
ď Develop education system for training
end users
ď Investigate patient preferences
ď Analyze factors influencing of uptake
ď Develop a registry for tracking post-
adoption effectiveness + long-term
safety
ď Knowledge transfer
ď Field evaluation
ď Systematic Review
ď Economic Analysis
Core Evidentiary Bundle Optional Additional Analyses
16. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
Good
Fit?
Robust Study
Design?
Strong
Evidence
?
Evaluation /
Conditions of
Adoption
Application Consultation
EXCITE Involvement
Med Tech
Innovators
- Multinational
- Small and
Medium
enterprises
Regulatory
Licensing
Reimbursement
Patient and
Clinician Use
16
The EXCITE Process
Board
decision
Exploratory
Meeting
Proposal
Approval Contract
Execution
First Patient
Enrollment
Apply
17. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
EXCITE Selection Criteria
⢠Applicants must submit an executive summary and all
relevant reports, articles and materials related to the
technology
⢠Health technologies are prioritized for participation in
EXCITE based on the following criteria:
o Relevance to the needs of the health system
o Disruptive potential (i.e., the promise of substantially better
clinical outcomes, including safety, and/or substantially lower
system costs than existing approaches)
o Opportunities to identify obsolescence for existing alternative
technologies
o Estimated magnitude of effect for the target population
o The stage of readiness of the technology and how effectively it
can be evaluated
o Potential benefit to Ontario, Canada (if relevant)
19. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
The Contract Framework and Money Flow
Process
January
2015
MaRS EXCITE
Methodological
Centre
Technology
Innovator
A B
C
D-X
Participating Sites
A: Participation Agreement: MaRS
EXCITE and MC
B: Participation Agreement: MaRS
and Company
C: Research Agreement: MC and
Company
D-X: Subcontracts: MC and participating
or sub-contracted sites.
Secretariat
20. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
Conditions of Adoption
Projected
Adoption Rates
Infrastructure
Readiness
Reimbursement
Considerations
Economic
Projections
Knowledge
Translation
Procurement
ď Projected volumes ,
incidence rates and target
population?
ď consequences of optimal or
minimal adoption?
ď End-user training
requirements?
ď Human resource
requirements?
ď Facilities requirements?
ď OHIP Fee code
adjustments?
ď MOHLTC + OMA
ď Downstream costs avoided?
ď Impact on health system
costs in optimal and min
adoption?
ď Cost Effective analysis?
ď KT toolkits specific to each
technology?
ď Informing healthcare
professionals?
ď Consider non-price
factors?
ď Collaboration between
industry and hospitals?
EXCITE team helps define and negotiate
21. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
Examples of Participating Companies
January
2015
Pg 10
Apnea Dx, Rna Diagnostics, and MyndTec are currently being evaluated in the field in Ontario.
Results will be available for a reimbursement decision in 2016
Home sleep apnea
diagnosis device
Rna Disruption Assay (RDA) for early
prediction of complete response to
chemotherapy in breast cancer
Electrical stimulation device to enable
voluntary arm and hand movements in
patients recovering from stroke
Symplicity Renal Denervation device
for hypertension
22. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
EXCITE cited as an Innovation Broker
Amongst its recommendations the
Ontario Health Innovation Council
proposed a four-year $20 million Health
Technology Innovation Evaluation Fund to
support pre-market evaluations and early
adoption of home âgrown innovative
health technologies.
The fund will be managed by a the Office
of the Chief Innovation Strategist and will
collaborate with Innovation Brokers like
EXCITE that will be a single point of access
to health system decision makers, test
sites, and funding for development and
commercialization of innovative health
technologies.
To read the full report visit www.ohic..ca
November
2014
23. DEVELOPINGTALENTâ˘GROWINGVENTURESâ˘OPENINGMARKETS
Our Future Matters
January
2015
Zayna Khayat
Program 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:
Hinweis der Redaktion
MaRS EXCITE ( Excellence in Clinical Innovation and Technology Evaluation ) is one of many services and programs that MaRS offers to entrepreneurs and ventures in the health industry.
For more information on the MaRS Health portfolio please visit www.marsdd.com
Since 2010, the Ontario Government has focused on making decisions on health care funding based on strong high quality evidence.
To support evidence based decision making regarding the adoption of new health technologies, the Ontario government and many other jurisdictions worldwide rely on data from field evaluations. These field evaluations are conducted after the technologies have been licensed by Health Canada and are fully funded by the government.
It has been observed that many health technologies lack the sufficient data needed to warrant a government funded field evaluation and therefore do not get recommended or introduced into the healthcare system.
Additionally, innovators often fail to prove the clinical utility or value of the device to the end user ( physicians, hospitals, patients) and do not demonstrate adequate cost savings to the health system to justify the cost of the technology.