May 20, 2019

Determining the Value of New Therapies: ICER Explores the Role of Real-World Evidence

By Emily Ortman, SWHR Communications Director

New therapies for migraine, endometriosis, and postpartum depression this past year are exciting developments for women’s health, but women won’t benefit from them unless they can access them.  Patient access to new innovations is based, in part, on value assessment.

Organizations like the Institute for Clinical and Economic Review (ICER) seek to determine the value of new drugs, medical tests, and other health care innovations based on clinical and economic evidence. At a recent Society for Women’s Health Research policy committee meeting, ICER Executive Vice President and Chief Operating Officer Sarah K. Emond discussed her organization’s work and the implications for women’s health.

ICER assesses a product’s value by looking at how much better the new intervention is at improving health than the current clinical standard and then determining what it deems to be a fair price for the added clinical benefit. This estimate may then be used by health insurance plans, employers, and other policymakers to make coverage and pricing decisions for that new therapy.

ICER assessed new therapies for migraine and endometriosis last year, and SWHR submitted comments to the organization for both reports, as the diseases disproportionately and exclusively affect women. SWHR recommended that ICER ensure its analyses adequately captured the significant physical, emotional, and social burdens that these diseases have on women, including the effects on their quality of life. In addition, SWHR urged ICER to accurately account for lost productivity from these diseases, including both presenteeism and absenteeism. Read SWHR’s comments on ICER’s migraine and endometriosis assessments.

Most information that ICER uses to assess the value of a medical product comes from clinical trials. While some clinical trials assess the impact of a medical product on the quality of life for patients and caregivers, many do not. In order to address this gap, Emond said ICER is exploring how to incorporate real-world evidence into value assessments.

Real-world evidence (RWE) is derived from data collected during routine health care practice (such as electronic health records, claims and billing activities, and product and disease registries) as opposed to a randomized clinical trial. This information is often collected after a new therapy is already on the market and being used by patients. Emond indicated that ICER is interested in public input on how to improve methods of judging the quality of RWE so that it could potentially play a larger role in future ICER reports.

“We have a commitment to being the leading health technology assessment organization when it comes to real-world evidence,” she said. “We are thinking about the ways that real-world evidence can be used to update our reports.”

For example, data on caregivers — the majority of whom are women — are not typically collected in clinical trials. “We see the impact of a societal structure that does not value women as caregivers and the strain that puts on families and the strain that puts on budgets, and we try to capture that as best we can in our research,” Emond said.

She urged industry to capture information like this in clinical trials whenever possible, even though it is not required for FDA approval of a product. “It will help the national conversation about the full impact of some of these diseases and the full impact that innovative medicines can have on improving those diseases,” she said.

ICER is seeking input through June 10 on how to improve its value assessment framework, a process that takes place every two years and that will apply to all of its assessments initiated in 2020 and thereafter. SWHR plans to submit input recommending that ICER look to the FDA’s real-world evidence program as it makes updates, as FDA provides a positive path forward for developing a set of methods and standards for collecting real-world data.

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