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AdminSep 16, 20205 min read

ICPE research spotlight: Part I: Expanding real-world applications of RWE

This year at ICPE All Access, Aetion’s scientific research is represented across 15 posters and presentations spanning novel applications of real-world evidence (RWE), innovative methods for epidemiologic research, and the standards needed to facilitate decision-grade RWE generation. In our “ICPE research spotlight” series, we share what you need to know about each, including important takeaways, a breakdown of the study design, and how the work shines new light on the ways RWE can inform decision-making.

As RWE adoption ramps up across the health care industry, we see the range of potential applications for RWE expanding rapidly. Currently, regulators are assessing how RWE can inform decisions on treatment safety and efficacy, and health technology assessment (HTA) bodies are exploring how RWE can support value assessments. Now, we ask: How can we further expand RWE use to continue to inform better decisions, and support better patient care? 

In the following five posters and presentations, all prepared by Aetion scientists and their collaborators using the Aetion Evidence Platform® for ICPE All Access, we share the range of real-world applications for RWE, and their implications on decision-making. 

Read on to learn more, including first-of-its kind research which illuminates how real-world data (RWD) can help identify patient subgroups who may be treated contrary to guidelines, first attempts at using RWE to understand the burden of certain rare diseases, and ways in which RWE can complement data from randomized controlled trials (RCTs) to inform decisions across stakeholders. 

Frequency of opioid dispensing following surgical abortion in the United States
Liza Gibbs; Julia Pisc; Kari Braaten, M.D., M.P.H.; Brian Bateman, M.D., M.Sc.; and Liz Garry, Ph.D.

This is the first research to use RWD to describe oral opioid dispensing following surgical abortion in the U.S. Over 500,000 surgical abortions occur annually in the United States, and the research team—comprised of scientists from Aetion, Brigham and Women’s Hospital, and the Planned Parenthood League of Massachusetts—found that, contrary to guidelines, over eight percent of commercially insured patients with an outpatient surgical abortion filled a prescription for an oral opioid following the procedure. Additionally, those with an opioid fill were more than three times as likely than those without to demonstrate chronic opioid use over the following year. This signals that opioid prescribing after surgical abortion may represent a source of overprescribing, which may increase the potential for chronic opioid use or abuse. 

In this presentation, learn the ways in which RWD can be used to identify and characterize patient subgroups which may be treated contrary to guidelines, representing potential opportunities to improve prescribing patterns and deliver more appropriate treatments to patients. This will be especially relevant for groups interested in value, like HTA bodies or payers, who want to ensure they are paying for evidence-based treatment that will deliver the best outcomes for patients. 

View the presentation here

Assessing fit-for-purpose: Surrogate endpoints and clinically important outcomes in Japanese RWD source in type-2 diabetes
Jocelyn Wang, M.S.; Mandy Patrick, M.S.; Pattra Mattox, M.S, C.M.P.P.; and Ashley Jaksa, M.P.H.

This research assesses the extent to which RWE can complement data from RCTs to offer additional insights on direct clinical endpoints in patients with chronic conditions. 

While RCTs often include surrogate endpoints—which are intermediate outcomes that can be more easily measured in short-term clinical trials—direct clinical endpoints as gleaned from RWE are more relevant to patients, and demonstrate the long-term impact of the treatment. Here, researchers examined the fitness for use of the Japanese Medical Data Center (JMDC)’s data source by looking at the availability of both surrogate endpoints and direct clinical endpoints in type-2 diabetes patients in Japan. 

This study demonstrates that JMDC’s RWD includes high-quality data on patient-relevant, direct clinical endpoints for type-2 diabetes, and further supports the relevance of RWE to supplement RCT data. This is highly relevant to regulators, HTAs, and payers who are focused on understanding the long-term safety and effectiveness of treatments.

View the poster here

Real-world treatment patterns and adherence of first-line anti-diabetic treatments among type-2 diabetes patients using Japanese claims data
Jocelyn Wang, M.S.; Mandy Patrick, M.S.; Pattra Mattox, M.S, C.M.P.P.; and Ashley Jaksa, M.P.H.

Similarly to the above research, this study also provided insights on type-2 diabetes treatment in Japanese patient populations to shed light on ways that RWE can contextualize RCT data used in decision-making. 

Here, researchers used RWE to assess the complex treatment patterns, adherence, and persistence of common type-2 diabetes treatments in real clinical practice. This information on real-world utilization patterns is especially relevant to regulators and HTA bodies, as suboptimal adherence and persistence can reduce the effectiveness of treatments. It’s also helpful for biopharma, as the data can help manufacturers in a crowded market better understand the patient experience, as well as the value their product can bring to the current landscape. 

View the poster here.

Clinical course and health care resource utilization (HCRU) in patients with generalized pustular psoriasis: A claims database study and Clinical course and HCRU in patients with palmoplantar pustulosis: A claims database study
Nirali Kotowsky, M.P.H.; Ran Gao, Ph.D.; David Singer, Pharm.D.; Liz Garry, Ph.D.; and Amanda Golembesky, Ph.D.

These two studies, co-authored by Aetion and Boehringer-Ingelheim scientists, describe the clinical burden and HCRU in the U.S. in patients with rare forms of psoriasis—generalized pustular psoriasis and palmoplantar pustulosis, respectively—compared to those with psoriasis vulgaris, to understand and evaluate unmet needs in the poorly understood patient populations.

These exemplify some of the first attempts to use RWE to understand the burden of these rare diseases, demonstrating a key step forward for biopharma as they research potential treatment options for a rare, severe, potentially life-threatening systemic disease. .

View the poster evaluating generalized pustular psoriasis here, and the poster on palmoplantar pustulosis here.