Sean D. Sullivan, BSPharm, PhD
Senior Partner and President, Curta
Professor, University of Washington, School of Pharmacy
Eleanor Lucas, MPH
Director, Strategy, Policy and Access, Curta
Here’s a small thought experiment: imagine asking anyone in Medical Affairs, Market Access, or HEOR whether a manufacturer should have an integrated evidence plan (IEP), and you might think you’d get a yes before you can finish the (imaginary) sentence. But then envision yourself asking a colleague for empirical evidence that shows that IEPs lead to more successful launches, better reimbursement decisions, and improved access and uptake. That might give you (imaginary) pause.
Integrated evidence plans are not a new concept. Formally introduced almost 10 years ago1, the premise of an IEP is intuitive: bring together Clinical, Regulatory, Market Access, and HEOR functions to ensure that an asset will have all the relevant supporting evidence required by key stakeholders (regulators, payers, clinicians, patients) at key points in the product life cycle (approval, launch, reimbursement submission, etc.).
In our post-Inflation Reduction Act, Most Favored Nation, Joint Clinical Assessment (JCA), and increasingly resource-constrained world, IEP is meant to ensure that the “Does it work?” and “Is it worth paying for?” questions are answered simultaneously. We share a gut instinct that IEPs are more critical than ever. What makes us hesitate, however, is how rarely anyone, including us, has tested them.
The Evidence Gap in Evidence Planning
If you go looking for empirical evidence that IEPs create value for manufacturers, you won’t find much. One attempt at quantifying their benefits has been made; DiMasi and colleagues searched the literature to identify established benchmarks for development programs that use an integrated evidence model and found “only a few publications which were mainly theoretical and included little quantitative evidence.”2 Using what they found, they then built an expected net present value framework and applied it to two hypothetical lifecycle-management cases. Their conclusion was that an IEP could be worth the investment under their assumptions. But is that proof of benefit? As of the time of this article, we don’t have empirical evidence of IEPs’ worth in the real world.
“If you go looking for empirical evidence that IEPs create value for manufacturers, you won’t find much”
For the HEOR industry that is laser-focused on proving value to stakeholders, this is an awkward place to be. If a manufacturer brings a new product submission to an HTA body that is only supported by expert consensus, two hypothetical case studies, and a strong marketing pitch, we know how that submission would go. That said, when we talk about building evidence to support evidence planning, that’s a tough assignment. There is no control arm, because manufacturers can’t launch the same asset twice, once with an IEP and once without. Perhaps we could round up all the new product launches and compare those with and without IEPs. That might work if companies were willing to share both their IEPs and their sales relative to projections. Good luck with that. Also, IEPs are not one uniform, homogeneous entity, and neither are the competitive landscapes that products enter.
Throw in a general economic slowdown or a new government policy and the whole process of comparison becomes very difficult.
The points above may seem impossible to surmount, but we have high confidence in the ingenuity of HEOR professionals. HEOR has spent decades generating evidence for complex interventions with uneven implementation and confounding factors that challenge evaluation. We would never tell a client that their product’s value can’t be measured. Our own offerings deserve the same treatment. Let’s find a way forward.
“We would never tell a client that their product’s value can’t be measured. Our own offerings deserve the same treatment”
What Can We Measure?
The easiest (and most cost-efficient) place to start is the IEPs that manufacturers have already developed. The well-known AMCP Format might be a good starting place.3 For companies that don’t supply such standardized summaries and aren’t willing to share their IEPs, we can look at HTAs created by NGOs and governments (ICER and UK-NICE come to mind). Manufacturers prepare their evidence packages for HTA bodies. These packages are often the starting point for their evaluations. IEPs are sewn together by predictions that must account for evidence gaps: nontrial populations and comparators, relevant outcomes not measured, real-world care that diverges from trials. We could evaluate these predictions and measure their success by looking at a few of the following:
- Evidence gap identification. What evidence questions raised by regulators, HTA bodies, and payers were absent from the evidence dossier? The EU JCA will be publishing a record of what assessors ask for, which companies can use to grade themselves against.4
- Reactive evidence generation. How many studies were added after the Phase 3 readout or in response to an HTA or payer request?
- Timing. Were key inputs (e.g., epidemiology data for a patient funnel, cost inputs for an economic model) ready when the payer or HTA group needed them?
- Decision outcomes. What did payers and HTA recommend in terms of reimbursement? How did this compare with the offer price? What were the stated reasons for any restrictions? How much time passed from approval to reimbursement?
The reimbursement decision is the real test of an IEP’s value. When IQWiG reviewed Germany’s first 216 AMNOG benefit assessments, more than half of the new drugs had no proven added benefit.5 The most common reason was questionable or limited study designs. Often there was no study comparing against the standard of care, or, in other cases, the comparator was unsuitable. Those are the failures that IEPs are supposed to prevent. However, whether IEPs actually prevent them remains an assumption
Where This Leaves Us
To be clear, we like the logic behind and structure of IEPs. Our concern is that “it works” has slowly morphed into “everyone does it” as the justification for building cookie-cutter IEPs.
We’ve been thinking about this a lot at Curta. For example, how a company could build a lightweight evaluation into its IEP from day one without standing up a whole new program. How to have “hard conversations” about relevant and irrelevant evidence. How IEPs can be done cost-effectively. We would welcome the chance to attempt to do so with our industry colleagues or compare notes with those on the consulting side.
In the meantime, the next time someone tells us that IEP is critical, we will agree, but with a follow-up question: for whom, compared with what, and at what cost?
CONNECT WITH US
The experts at Curta are ready to discuss your evidence and access needs. For more information, contact Scott at Scott.Ramsey@Curta.com.
References
- The concept has been around longer than the formal approach. See Olson MS. Developing an integrated strategy for evidence generation. J Comp Eff Res. 2018;7(1):5-9. doi:10.2217/cer-2017-0073.
- DiMasi JA, Olson MS, Smith Z, Getz KA, Capkun G. Assessing the value of integrated evidence approaches in drug development. Ther Innov Regul Sci. 2025;59(4):808-816. doi:10.1007/s43441-025-00778-y.
- Academy of Managed Care Pharmacy. AMCP Format for Formulary Submissions 6.0. J Manag Care Spec Pharm. 2026;32(10-a Suppl):1-72. doi:10.18553/jmcp.2026.32.10-a.s1.
- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU. Official Journal of the European Union. 2021;L458:1-32.
- IQWiG. Early benefit assessment reveals weaknesses in the development of new drugs [press release]. July 11, 2019. Accessed September 28, 2026. https://www.iqwig.de/en/presse/press-releases/press-releases-detailpage_10070.html.