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ICER considers offering drugmakers pre-launch review of clinical trials

U.S. pricing watchdog Institute for Clinical and Economic Review is considering offering a new service to drugmakers to evaluate clinical trials before an official drug launch, though no official decision has been made, an institute spokesperson confirmed in an email.

Speculation on the matter began with an analyst note from Bernstein's Ronny Gal, who suggested that the Institute for Clinical and Economic Review, or ICER, may charge a fee for the new early pricing review program.

"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 spokesperson David Whitrap said in an Oct. 15 email.

Whitrap said that other pricing watchdogs such as the U.K.'s National Institute for Health and Care Excellence and the Canadian Agency for Drugs and Technologies in Health have offered a service to provide early scientific advice and that they have met with success. Both the U.K. and Canadian agencies charge a fee for the early scientific advice.

"We are therefore evaluating the options to provide a similar service but have not made any definitive plans," Whitrap said. "If we do pursue such a program, we would only do so in a manner that would preserve ICER's independence and integrity, and only if offering the early advice to manufacturers would further our core mission of helping all patients achieve access to high-value care."

ICER, a nonprofit organization, uses clinical trial data to determine the value of a drug and decide whether the price tag matches its benefit to patients. Although it has no official jurisdiction over prices, its influence has been growing among drugmakers and investors, and some drug prices have been changed in line with the watchdog's recommendations.

In June, ICER concluded that Vertex Pharmaceuticals Inc. should significantly decrease the price of its cystic fibrosis drugs. And recently, it came to the same conclusion for Alnylam Pharmaceuticals Inc.'s RNA-based rare disease drug Onpattro.

Sanofi and Regeneron Pharmaceuticals Inc. heeded ICER's recommendation when they lowered the cost of their joint cholesterol drug Praluent based on projections issued by the group.