When drug value assessment meets real-world evidence: ICER enlists Aetion in pricing evaluation
In a union of two of the hottest trends in the US biopharma world, ICER is teaming up with a high-profile company to integrate real-world evidence in their assessment of treatment value.
The drug pricing watchdog — formally the Institute for Clinical and Economic Review — said it will utilize Aetion’s evidence platform in “select upcoming assessments” and their new 24-month re-evaluations of drugs granted accelerated approval by the FDA.
Even though ICER doesn’t play an official role in setting drug prices, its verdicts on whether treatments are cost-effective are increasingly shaping payer attitude and consumer perception, as well as, general discourse as the heated debate around US drug prices rages on.
Led by UnitedHealth vet Carolyn Magill, Aetion derives much of its data from insurance claims, but it also works with electronic health records, registries and clinical trials. The FDA and Brigham and Women’s Hospital have a pact in place with the company to try predicting the results of randomized clinical trials in a pilot project involving seven studies.
Scott Gottlieb, who pushed the industry to try new things with RWE during his tenure as FDA commissioner, joined Aetion’s board a few months after leaving the agency.
For its part, ICER has committed to expanding its RWE use, not only using existing sources such as manufacturers and patient organizations but exploring ways to generate data that can complement published sources. The deal with Aetion allows them to do it at greater scale, David Whitrap, ICER’s VP of communications and outreach, told Endpoints News.
Whereas RWE can come in handy for comparisons to existing treatments and the natural trend of certain conditions (such as sickle cell disease, where ICER is conducting a review of therapies with Aetion’s help), their relationship will be most useful in the new process they are piloting: re-evaluating treatments after they’ve been on the market for several years.
“Randomized clinical trials remain the gold standard for developing unbiased evidence, but as the FDA is increasingly approving treatments based on thinner clinical trial data, the entire health industry will need to fill larger knowledge gaps about how well a new drug actually works,” he said. “And RWE is one way to do so.”