Anchoring HEOR Evidence Generation in the Challenge from the Market

Ross Maclean, MD

The HEOR capability within the pharmaceutical industry is at a tipping point.On one hand are two well-attended recent conferences (ISPOR-US and EU, 2024) with a total of over 10,500 attendees joining multiple workshops and podium presentation, and displaying over 4,500 scientific posters.On the other hand, HEOR has experienced a major reduction in force this year that has impacted many of the biggest HEOR teams in the pharmaceutical industry.

One recurring element of the challenge facing the HEOR discipline is the question “What is the value of HEOR deliverables?” In this brief article we shall describe a framework for HEOR scientists to demonstrate how their work is an integral component of a successful commercial endeavor.

John Graham, PharmD

HEOR represents many diverse disciplines spanning the social, medical and health sciences with the vast majority having a formal research education in an academic setting.The research exposure is grounded in the conventional approach of a gap in human knowledge supporting a research question.In this academic framework, decision making will focus on whether the study objective relates to the knowledge gap and not if it will resolve the gap. Figure 1 illustrates–in the form of stack of books–each research step culminating in the classic academic deliverable, a peer-reviewed paper. The paper in itself relates to the gap, but most often it does not go far enough in resolving the gap.

Figure 1. Academic research approach

However, many HEOR scientists function in a for-profit commercial setting resulting in subtly different pressures and expectations from the academic setting.Foremost among those is that the final deliverable(s) must resolve the gap, therefore supporting the business, with academic rigor a given.Figure 2 illustrates a framework that reflects the pharma setting, refined over 20+ years of practical application.

Figure 2. Applied bookends approach

Referred to as the Bookends Approach, at its core is the same stack of books with several key modifications:

• Challenge:Encourages the HEOR researcher to anchor the research question in the commercial reality of what the challenge in the marketplace is (or is likely to be).In simple terms, it provides discipline to articulate a response to the provocation “Somebody, Somewhere doesn’t know Something” – and how will this proposed research will provide an answer to the customer.Answering the challenge not only serves the HEOR scientist well but also ensures organizational alignment by encouraging discussion on what evidence is to be generated to educate whom about what.
• ResolutionA brief statement of the intended output and its impact. This must be a message that shows resolution of the Challenge. In effect, how will the evidence that is to be generated address the challenge in the marketplace i.e., who will be the “somebody, somewhere” who will be made aware of “something” that will share their decision in favor of the treatment option under study.
• Approach:The research method that is proposed to generate the evidence needed.This may be a single study, but usually involves a comprehensive book of work. This adheres to the standards and best practices that are customary for the type of studies that are to be conducted.Anchoring the studies in the resolution of the challenge in the marketplace will, of course, trigger the question of how quickly the evidence can be generated and pulled through with the customer to help overcome the original challenge?
• Message:A description in lay-terms of the likely “so what” from the study.That is, what will the scientific evidence likely allow the pharma firm to say and in what format should this be packaged to maximize impact.Note that the academic deliverable “publish in a peer reviewed journal” is the default response yet is accompanied with at least a 6-12 month delay, whereas the creation of a Data on File (DoF) report that support a targeted resource for proactive or reactive field use (with a manuscript in due course) is more likely to find a favorable response!

Several points to note on the Bookends model:

• In parallel with articulating the challenge is validating the challenge, either from insights gathered by field-based, customer-facing colleagues in Field Medical, Access Account Executives or Government Affairs i.e., this encourages collaborative behavior and cross-functional alignment.
• Engages colleagues who will ultimately deliver the research results to validate the challenge and to participate in the research conduct and delivery pending formal results
• Assumes selection of robust methods appropriate to address the research question.
• Encourages generation of deliverables pursuant to meeting the originalchallenge yet beyond the conventional academic deliverable.
• Encourages development of an anticipated message at the beginning of the research process to facilitate appropriate Medical-Legal-Compliance review pending formal study results.

The delivery of RWE and economic evidence will continue to be scrutinized from both a value and credibility perspective. It is imperative that individuals and organizations tasked with delivery of HEOR evidence possess the ability to develop comprehensive, integrated strategy plans as well as specific tactical plans which include communication of the relevant, focused message(s) to customers. The Bookends framework is a practical, tried-and-tested, and widely used approach for ensuring the value and impact of your work.