Research institute taps into RWE to assess angioedema therapies

By Jenni Spinner

- Last updated on GMT

(marchmeena29/iStock via Getty Images Plus)
(marchmeena29/iStock via Getty Images Plus)
The Institute for Clinical and Economic Review will use Aetion observational real-world evidence to evaluate potential drugs from Takeda and CSL Behring.

The Institute for Clinical and Economic Review (ICER), a non-profit research institute that evaluates potential therapies and medical devices, announced it will turn to observational real-world evidence (RWE) analyzed by Aetion to update its 2018 assessments of three potential angioedema treatments. The treatments are intended for long-term prophylaxis against hereditary angioedema (HAE) attacks: Takeda’s lanadelumab (Takhzyro), and two C1 esterase inhibitors: CSL Behring’s Haegarda, and Takeda’s Cinryze).

The updated assessment is part of an ongoing research partnership between the two organizations, in line with ICER’s stated commitment to expand the use of RWE in its value assessments. According to the companies, Aetion researchers will use Optum’s de-identified Clinformatics Data Mart, Commercial, and Medicare Advantage claims database, to generate the RWE.

ICER senior vice president of health economics Jon Campbell commented that during its earlier assessment of the HAE therapies, the economics were sensitive to small changes in assumptions in a number of areas, such as the frequency of attacks, the amount of on-demand treatment required, and the exact dosing regimens of prophylactic therapy.

Three years later, we hope to use observational RWE from the Aetion Evidence Platform to help close some of these information gaps​,” Campbell remarked. “By defining the baseline demographics and utilization characteristics of patients who start HAE prophylaxis, evaluating HAE attack rates before initiation of prophylaxis, and updating our health cost assumptions accordingly, ICER aims to further clarify the overall value of these HAE therapies in real-world settings​.”

Carolyn Magill, CEO of Aetion, said the collaboration will help further ICER’s commendable mission to continually look for ways that life sciences professionals can make better use of RWE.

Pilots like this will help inform efforts of HTA organizations around the world in their quest to evaluate how and when to base their decisions on RWE while advancing how we as a health care industry—and a society—determine value​,” Magill said.

As part of this pilot, ICER has engaged clinical experts and the manufacturers of the HAE therapies. Each of the pharma firms was given a number of weeks to respond to the ICER data request, and to comment on the approach being proposed. ICER, Aetion, and academic collaborators from the University of Washington incorporated manufacturer and clinical expert feedback into the revised Research Protocol and Modeling Analysis Plan.

ICER included broad stakeholder input in the initial assessment of the three potential therapies; the organization plans to go ahead with a condensed timeline for integrating RWE in the re-assessment, with the goal of publishing the RWE update on July 27.

Related news

Show more

Related products

show more

Saama accelerates data review processes

Saama accelerates data review processes

Content provided by Saama | 25-Mar-2024 | Infographic

In this new infographic, learn how Saama accelerates data review processes. Only Saama has AI/ML models trained for life sciences on over 300 million data...

More Data, More Insights, More Progress

More Data, More Insights, More Progress

Content provided by Saama | 04-Mar-2024 | Case Study

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data in a single location

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Related suppliers

Follow us

Products

View more

Webinars