Months after beginning an update to its value assessment framework, U.S. drug price watchdog ICER has trotted out proposed changes to its methods of looking at costs and benefits.
ICER—the Institute for Clinical and Economic Review—embarked on the update back in October after receiving heated criticism from the drug industry over its some of its reviews. After hearing from drugmakers, academia, payers and others, the group has landed on a few significant changes.
Set for an adjustment is ICER’s quality-adjusted life year threshold, which going forward will be $50,000 to $150,000, compared to the group’s previous range of $100,000 to $150,000. ICER will also review drugs at their price minus rebates, rather than weighing list prices.
To do this, the group will work with consultancy SSR Health, which has a proprietary method to “reverse-engineer” rebates, ICER president Steve Pearson told FiercePharma.
There’s no way to get drug rebate info with data that’s “fully, publicly available,” Pearson said, but ICER has approached payers to ensure that SSR’s method is reliable.
The new framework will also take into account "other benefits or disadvantages" and "contextual considerations" when weighing drugs. Those, Pearson said, include the severity of an untreated condition, a disease’s burden on family and caregivers, total public health impact, and a disease’s impact on a patient’s ability to work and contribute to family lives.
ICER will do away with attempts to estimate uptake, according to the framework overview.
Pearson said that throughout the review process, some comments were "completely in opposition" and in "all different directions." ICER received over 300 pages of comments on its methodology.
The Boston-based group is seeking feedback on the proposals, with the updates set to go final in April. ICER won’t revisit previous reports and is slated to review its methodology again in two years.
Throughout its brief history as a non-profit, ICER has had somewhat of a contentious history with pharma, as it’s frequently said groundbreaking drugs were priced too high to justify their benefits.
Among the meds the group has deemed too pricey are checkpoint inhibitors Opdivo from Bristol-Myers Squibb and Keytruda from Merck in non-small cell lung cancer and new multiple myeloma meds Empliciti from BMS and Kyprolis from Amgen.
During the framework update, several drugmakers called for increased transparency at the group, which ICER said it has worked to address.
Last year, an industry group said the insurance industry was funneling money to ICER to put pressure on U.S. drug prices, a charge ICER denies.