Your Industry Insight
The 14th IMPACCT Real World Evidence Summit is your unique forum to more to explore cross-industry collaboration, strengthen integrated evidence planning, and accelerate the translation of real-world insights into impactful decisions that improve patient outcomes and market success.
Learn more about our speakers and what you can expect from the summit by reading our exclusive speaker interviews.
Reg Waldeck
Get exclusive insight from a leading real-world evidence expert as they explore the latest developments shaping the RWE landscape, including innovation in data and analytics, evolving regulatory frameworks, and the opportunities ahead for evidence generation. Discover key takeaways from their upcoming presentation at the 14th IMPACCT Real-World Evidence Summit and gain practical perspectives on the future of RWE.
Real-world evidence has become increasingly influential across the product lifecycle, yet many organizations still struggle to translate strong evidence into favorable access and reimbursement outcomes. What do you see as the biggest reasons for this disconnect?
Answer: A couple of main reasons:
- A clear acknowledgment that RWE does not answer all questions. It provides perspective first and foremost on ‘external validity’. This often gets lost. If comparative, it can also provide a perspective on comparative effectiveness, but with the caveat that (typically) randomization is not fulfilled; and hence, ‘internal validity’ is (by definition) not met.
- Real world evidence is often guided by the question: Which parameters can / should we measure? Increasingly, we should look to attempt to answer questions such as: ‘How can this study inform the actuarial risk of the population under study’ (i.e., a US commercial payer perspective). Can we more closely tie our endpoints/study objectives to directly payer-relevant outcomes, such as existing quality metrics (i.e., US government and commercial perspective). Are prospective matching tools actually useful, or perhaps counter the objective of understanding, real-world clinical effectiveness performance under a ‘counter factual’ (i.e., more technical (ex-US) HTA perspective).
Which topic or discussion at the 14th IMPACCT Real-World Evidence Summit are you most looking forward to, and why do you think it is particularly relevant for evidence and market access leaders today?
Answer: Novel and more automated ways of collecting real world data beyond Claims, EMR, etc.
Many companies are investing heavily in integrated evidence planning. From your perspective, what separates organizations that successfully align evidence generation with payer needs from those that continue to face delays, restrictions, or unfavorable access decisions?
Answer: Successful organizations, in my view, ask themselves the kind of questions mentioned above, catalyzed by an outside-in way of thinking. This doesn't mean there are easy answers, but it can lead to augmented insights for external stakeholders.
As pricing, policy, and reimbursement frameworks continue to evolve globally, what changes do you believe will have the biggest impact on how evidence needs to be generated and communicated over the next few years?
Answer: I would like the ex-US discussion to focus more on the kinds of insights that real world evidence can bring, while clearly acknowledging the methodological caveats, such as mentioned above, rather than an extended deep dive into finding the "perfect" methodologies to apply to RWE.
In your upcoming IMPACCT presentation, you'll discuss why strong evidence alone is often not enough to secure access and reimbursement. What is one key takeaway you're hoping attendees leave with after your session?
Answer: I will look to bring added clarity to what RWE ought to be asked to answer, and what it should not attempt to answer. Second, explore how a more explicit outside-in healthcare ecosystem stakeholder-oriented perspective can further augment the insights and impact of RWE in informing pharmaceutical/health care.
