Evidence-Generation in Digital Healthcare: Demonstrating Value

Prakash Navaratnam, PhDSygeny Oy

Helsinki, May 31st, 2016

Value in the context of healthcare

Realized Value: Based on evidence of use of the product in a ‘real world’ setting

Perceived value: Based on product’s characteristics, degree of innovation or uniqueness.

Reference Value:Value of a product or service that is the current standard within the market

Evidence-based Evidence-basedNot Evidence-Based

Value Premium:Difference between Realized and Reference Value

Demonstrating the value premium in healthcare is further complicated by two important factors

Stakeholder Audience

Budget Constraints

Patients, provider, payer, CIO/CTO, regulatory audience, etc. who have different priorities and value perception

Decision-making in healthcare is constrained by costs. If costs outweigh any realized benefit, the product may not be adopted

Measuring value to ensure adoptability and reimbursement

Clinical:

End-points that show reduction or prevention of morbidity and/or mortality.

Economic:

End-points that can show an economic gain in reduced resource use and/or reduced spending.

Humanistic:

End-points that can show an improvement in patient quality of life or patient reported outcomes.

Process:

End-points that are related to the product technical capabilities and the user interaction with

Critical factors to consider prior to value based generation activities

Salience:

-Is there an unmet need the product addresses?

-Is there a rationale that supports the use of this product to address the unmet need?

Perspective:

-Whose perspective do we adopt? -Is it the patient, the payer or society in general?

Metrics:

-Is the data to develop evidence readily available?

-Is it measurable? What is the effort required to develop the evidence needed?

Timing:

-How quickly will the product provide evidence of value?

-What are the both short-term and long-term anticipated gains?

Multiple audiences demand differing evidence that demonstrates value

Evidence of Quality Evidence of Safety

Evidence to Support (Adoption/

Reimbursement)

Evidence of Efficacy (Effectiveness)

Evidence of Value for Money

(Cost-Effectiveness)

Value Assessment Case Studies: Cautionary Tales

Case 1

Case 2

Case 3-Telemedicine Derm Sites

Case 4-Cardiovascular Apps

The importance of Outcomes Validation

• Why do Outcomes Validation?– Demonstrate Value for Market Access– Regulatory Approval– Competitive Advantage– Investor Acceptance: Demonstrate ROI

• Why Sygeny?– Significant experience in health outcomes research and

evidence generation activities.– Complimentary deep experience in product/service

commercialization, market access and regulatory affairs.– Global Presence: Understand the global healthcare

marketplace.

Unlocking the promise in digital healthPrakash Navaratnam | prakash@sygeny.com