End-to-End EXCITE

End-to-End EXCITE is a comprehensive evidence generation service. Our team works with health technology companies and system stakeholders to determine how a disruptive technology aligns with the needs of Ontario’s health system. Regulatory and reimbursement study outcomes are defined and then we support companies to generate robust clinical and economic evidence that demonstrates the value of their product. We facilitate an implementation navigation process with key system stakeholders, including the Ministry of Health, that explores uptake opportunities for the technology and identifies any systemic barriers hindering adoption. Finally, we identify potential market access pathways and implementation opportunities for your technology and its class as a whole.


What You Receive:

  • Early indication of whether or not your technology aligns with the needs of the Ontario health system
  • A robust evidence dossier, incorporating regulatory and reimbursement endpoints, detailing clinical efficacy and value to the health system
  • A comprehensive market access report

Is Your Company Eligible?

End-to-End EXCITE is ideal for small- to medium-sized companies that need clinical research evidence for regulatory and reimbursement purposes and are looking to better understand market access considerations.

If your company meets the following criteria, you may be eligible:

  • Your product is a disruptive health technology (digital and health IT included) *
  • You have generated proof-of-concept or preliminary safety/efficacy data
  • Your company requires further evidence to demonstrate clinical and cost effectiveness
  • Your class of technology faces significant systemic barriers to being implemented

*At present, EXCITE does not evaluate pharmaceutical products. However, applications for the evaluation of pharmaceuticals linked to non-pharmaceutical products, such as pharmacogenomics targeted therapy, may be considered.


How It Works

End-to-End EXCITE consists of three high-level phases: Technology appraisal, Evaluation design & evidence generation, and Implementation navigation.
 

STEP 1: Technology Appraisal

After receipt of an application, we review the submission for completion and alignment to the program. The technology is then reviewed, using the criteria below, by committees consisting of key stakeholders to determine alignment with Ontario’s health system needs as well as a company’s business viability:

  • Relevance to the health system
  • Disruptive potential
  • Opportunities for obsolescence of older technologies or displacement of current solutions
  • Magnitude of impact
  • Stage of readiness of technology
  • Potential benefit to Ontario and Canada

Technologies that meet the prioritization criteria are selected to the program.
 

STEP 2: Evaluation Design & Evidence Generation

Technology companies are paired with a methodology centre and, together, they develop and conduct a research protocol reflecting outcomes relevant to the regulator and payer. Protocols are vetted directly with the Ontario Ministry of Health to ensure system alignment.
 

STEP 3: Implementation Navigation

Near the completion of evidence generation, EXCITE begins implementation planning through a series of working groups comprised of the Ontario Ministry of Health, clinical experts, industry, and other key stakeholders relevant to market access decision making. This group analyzes opportunities and potential implementation pathways – including potential systemic barriers that would hinder adoption of the technology. This ultimately results in a market access report that has been co-created by industry, the Ministry of Health, and other key system stakeholders. This report highlights the key system infrastructure that needs to be changed or created to support market access at scale in Ontario (should the result of the study be positive).

The resulting research evidence and implementation planning work is presented to the EXCITE Management Board, which makes a decision to recommend the technology be considered for adoption by the Ministry of Health.

View the End-to-End EXCITE Process

The length of the EXCITE process depends on your technology, patient population and evidence requirements. Every innovation and trial is different.
 


Fees

Participation in End-to-End EXCITE costs $150,000 (CAD), structured as phased payments made at fixed intervals. This does not include associated costs of protocol development or clinical trial execution.

Fee schedule is subject to change without notice.


How to Apply

Applications for End-to-End EXCITE are accepted throughout the year and are reviewed quarterly for selection into the program.

To express your interest in applying, or for further information, please contact excite@marsdd.com.