The Institute for Clinical and Economic Review (ICER) is considering a new program to help biopharmaceutical companies with early clinical reviews, which could open the door to a new funding paradigm for the organization, the Regulatory Affairs Professional Society reports.
According to the report, biopharma companies would pay a fee for pre-market or pre-clinical reviews, though details remain scarce.
“For some time, ICER has been receiving requests from life sciences companies to help them rethink clinical trial design, so that the trials more adequately measure the types of outcomes that matter most to patients and their families,” ICER Vice President of Communications and Outreach told Focus.
Ronny Gal, Bernstein biotech analyst, says allowing pharma to fund ICER is a missed opportunity for payers.
“This funding mechanism is (respectfully) inherently problematic for an organization whose mission is to become the fair arbiter of drug value,” Gal said. “It is incredibly shortsighted of payers (including and especially CMS) not to step up and fund ICER. An independent evaluater of drug value is finally getting off the ground and you let it become funded by pharma?”