Real-world evidence (RWE) has been gaining acceptance at a rapid rate in many areas of the life sciences industry including R&D, epidemiology, outcomes research, and commercial groups. The COVID-19 pandemic and resulting research to find treatments and vaccines has accelerated the growth and adoption of RWE as well. The Institute for Clinical and Economic Review (ICER), a U.S. health technology assessment (HTA) organization that evaluates the comparative clinical effectiveness and economic value of a drug, device, or diagnostic, is jumping on the RWE train. ICER recently announced they are expanding the use of observational RWE to complement other sources of information used in their value assessments.
ICER is generating RWE to take certain data points and insert them into their cost-effectiveness models, theorizing that these will be more robust than inputs they might find from available literature or expert opinions.
In a press release announcing this new foray into the use of RWE, ICER stated that they have “long sought data generated outside clinical trials to enhance our understanding of how medical treatments perform in the real world.” The organization aims to use RWE to “set new standards for how RWE can better inform the consequential decisions that biopharma manufacturers, insurers and other stakeholders make every single day around drug pricing and patient access.”
ICER states in its 2020-2023 Value Assessment Framework that they would initiate a pilot program to “generate new RWE to inform updated assessments of therapies approved by the FDA under accelerated approval pathways.” The goal of the pilot is to supplement the limited information used to enable accelerated approval with RWE to provide a better understanding of the early impacts of the therapies.
ICER’s move to include RWE is a positive development overall because it represents the inclusion of data points from the real world. However, life sciences organizations should monitor the evaluations closely to ensure the validity of the new process. Through their use of RWE, ICER will likely evaluate measures that are presumed to have a large impact on their cost-effectiveness model results, their health-benefit price benchmark (i.e., value-based price) findings, and their determination of an intervention’s valuation. Given the likely importance of its RWE findings, manufacturers should consider replicating ICER’s RWE protocol implementation to confirm (1) the methodological robustness of the protocol and (2) that the protocol is being implemented appropriately.
Similarly, there are several questions that life sciences organizations should be asking as ICER begins to include RWE in its evaluations, including:
Who will develop ICER’s RWE protocols and what are their qualifications?
Will ICER allow the public to review and critique the RWE protocols?
Will ICER select the proper real-world data source, including the right data elements, to analyze for their evaluations?
Will ICER follow the same procedures of allowing manufacturers to comment on its RWE findings prior to public dissemination?
Who will be responsible for validating ICER’s RWE?
Since the inclusion of RWE into ICER’s cost-effectiveness models can impact findings, manufacturers may want to consider a separate evaluation tool that can critically appraise the accuracy of ICER’s RWE protocols. Panalgo’s IHD solution can be used to provide an independent verification of ICER’s RWE results.
This additional analysis, using either the same database or a different one, may yield different results from ICER’s; therefore, conducting an analysis separately from ICER will provide a second opinion and provide a “check and balance” of ICER’s findings. If the results from IHD are substantially different, manufacturers should inquire with ICER as to why discrepancies exist.
Panalgo’s Modeling & Strategy service has been mirroring ICER evaluations for life sciences organizations for years to help prepare for and mitigate ICER evaluations. This makes Panalgo perfectly suited to conduct the required analyses now that ICER is including RWE in their evaluations.
If you would like to learn how Panalgo's Modeling & Strategy Services can support you before and during an ICER review, contact us here.
Register for our webinar, "Preparing a Successful ICER Strategy: Lessons from the Frontlines," where a panel of experts will discuss ICER strategies from three different perspectives: a manufacturer, a consultant, and a former ICER executive. The webinar is November 17th, 1-2PM EST.