Satisfying stakeholder demands is paramount to an intervention’s success and to rapid adoption and market access
Join us as we discuss an approach to evidence-generation strategies in drug and medical device development that enables integrated teams to develop and implement targeted and effective value propositions.
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While there are many definitions of value, Michael Porter’s “health outcomes achieved per dollar spent” resonates well. To apply this requires recognition of what stakeholder spends the dollar, what they get for their investment, over what time period that investment results in a return, or health-related value, and how and who defines that value. Considered broadly, this relates to how various healthcare resources are utilized as well as how they are allocated across the health care system. Once launched, an ideal new intervention should lead to more efficient resource utilization for all stakeholders.
Conceptually, an economic investment in a new drug or device designed to deliver a high quality health outcome results in a meaningful and reproducible improvement in clinical or humanistic outcomes for patients. An improved health outcome for the patient defines the fundamental value for the new intervention.
It is reasonable to expect that an economic investment in a high quality health outcome should offer an offsetting value, or reason why patients and care providers should have access to that new entity. The reality, however, is that stakeholders’ values often are not universally aligned and one or more of them may perceive that their opportunity to obtain value from the new product is somehow compromised. In the United States health care system, this often relates to an imbalance in the perception of the timeline between purchasing the investment and realizing the offsetting value.
We will discuss value return periods, how various stakeholders perceive them, and how this relationship must be mapped out prior to determining what value proposition may be best aligned throughout the health care system and how that understanding will inform the strategic process for design and implementation of a robust evidence development plan.
Key insights include:
- Development of stakeholder value maps as a guide for evidence development
- Encouraging interdisciplinary collaborations to define differentiating value
- Prioritization of stakeholders as customers for robust evidence
- Conceptualizing a stakeholder targeted evidence planning process
Paul Just, PharmD
Senior Principal, Medical Device Health Economics, Commercialisation and Outcomes
Dr. Just is a health economist and market access champion with over 30 years of US and international experience in identifying and communicating products’ and procedures’ differentiating value through the strategic design, assessment and application of health economic and value evidence. His experience spans the medical device, pharmaceutical, payer, hospital, group purchasing, and academic sectors, including senior positions in health economics and real world evidence at Smith & Nephew, Inc. and Baxter Healthcare. He pioneered development of clinical pharmacy services at Premier, Inc., and held positions at Mercy Hospital in Chicago, the University of Illinois, and University of Nebraska Medical Centers.
Sarah Clifford, PhD
Senior Principal, Clinical Outcomes Assessments, Commercialisation and Outcomes
Dr. Clifford is a clinical outcomes assessments (COA) specialist, with 20 years of US and EU experience in patient-reported outcomes and health-services research, in both consultancy and academia. She has considerable experience developing and evaluating new COAs and supports drug and medical device companies in designing and implementing relevant COA strategies in their product development programs, from early in the product development lifecycle, through pivotal trials and post-approval, to real-world evidence studies. Her work spans a wide range of therapeutic areas, including inflammation, respiratory, infectious diseases, and gastroenterology.
Those working in:
- Health Economics and Outcomes Research (HEOR)
- Reimbursement and Pricing
- Marketing and Market Access
- Policy and Government Affairs
- Clinical / Medical Affairs
- Regulatory Affairs