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For more information about EXCITE and how to apply, please visit:

excite.marsdd.com

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Ontario’s Evidence Revolution Commitment to Evidence in Healthcare

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)

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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

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Dealing with Uncertainty – Field Evaluation Studies

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Barriers to Adoption

Poor pre-market quality clinical trial produces uncertainty

o Accuracy versus clinical utility for diagnostic testso No prospective economic analysiso Research failed to address health system perspectiveso Me-too technologieso Lack of generalisabilityo 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 innovators

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Health Technology Lifecycle in Ontario

Device Development

Pre-clinical- Design- Prototyping- Effectiveness

and safety testing in models

Device Manufacture and Testing

Clinical- Effectiveness

and safety testing in patients or using patient samples

Device Licensing

Government licensing- Application to

Health Canada for Licenses approving sale/use

PRE-MARKET

Patients have access to the device

Marketing, sales, distribution, education, training

POST-MARKET

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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 ff e c ti v e n e s s

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Milestone accomplishments Since December 2011, 20 companies have applied to EXCITE over 3 rounds.

10 technologies from innovative companies have been selected from a

tournament process and are proceeding:• The first round/pilot projects have gone through the full intake process,

consultation & proposal/budget generation, and contract execution. Currently recruiting the first patients into the clinical studies.

• The second round has completed review, consultation, and proposal generation. They are now in contract negotiations.

• The third round are in consultation and proposal generation.• The fourth round applications are due October 7, 2013.

On May 30th, Minister Matthews announced EXCITE’s pilot participants:• ApneaDx – Home Sleep Apnea diagnosis• Medtronic of Canada Ltd. – Symplicity Renal Denervation for hypertension• Rna Diagnostics – Rna Disruption Assay (RDA) for early prediction of complete

response to chemotherapy in breast cancer EXCITE works with home-grown innovators from across Ontario while

also attracting multinationals to conduct critical R&D in Ontario

EXCITE is a world-first process

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The EXCITE process

The application process

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• 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 systemo 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 populationo The stage of readiness of the technology and how effectively it

can be evaluatedo Potential benefit to Ontario, Canada (if relevant)

EXCITE selection criteria

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The EXCITE process

• Acceptance of the invitation is made by way of a $10,000 fee to EXCITE, which is transferred in full to the Methodological Center (MC) to cover costs of developing the evaluation protocols • For SMEs, the amount is $5000 from SMEs, which is then

matched by EXCITE for transfer of $10,000 to the MC.

Consultation/protocol development

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• The company is matched with a suitable MC, who is tasked with developing a proposal/protocol to meet the evaluation needs of the technology.

• Iterative process in consultation with the company• Typically takes 8-10 weeks

• The proposal contains a detailed overview of the proposed evaluation + robust budget for consideration

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Specialized Methodological Centres & 24 Research Hospitals across the province.

METHODS CENTRE

METHODOLOGICAL CENTRES

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• 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

Core Evidentiary Bundle: Optional Additional Analyses:

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EXCITE offers comprehensive analysis packages

The EXCITE process

• Acceptance of the proposal is made by way of signed agreements

The Evaluation

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• The duration and cost of evaluations varies based on the complexity of the technology and the investigational testing protocol, including the sample size required

• Evaluations typically require 12-30 months to complete and cost $1-3 million

• EXCITE and the methodological centre report back regularly regarding progress and any recommendations for technology improvement

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MaRS EXCITE

Methodological Centre Company (Technology Innovator)

A B

C

D-X

Participating Centres

EXCITE contract framework

A: Participation Agreement: MaRS and MC B: Participation Agreement: MaRS and Company C: Statement of Work: MC and Company

D-X: Subcontracts: MC and participating centre/sub-contracting MCs.

The EXCITE process

EXCITE evaluations increase likelihood of adoption and market uptake of disruptive health technology innovations

EXCITE provides access to a vast, coordinated network of world-class medical expertise with experience in real-time evaluation of health technologies

EXCITE’s earlier feedback loop provides insight during formative stage

EXCITE’s single, harmonized pre-market evidence development process helps companies navigate the evidence requirements and accelerate market access

EXCITE’s unique advantages to innovators

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For more information about EXCITE and how to apply, please visit:

excite.marsdd.com