ICER weighs plan to offer trial design advice to pharma companies, for a price

The Institute for Clinical and Economic Review (ICER)—an independent source for information on the cost-effectiveness of new, cutting-edge drugs and big-ticket therapies—is considering offering biotech companies early scientific advice and direct guidance in clinical trial design, for a fee.

In the past, ICER has relied solely on revenues from conferences and unrestricted donations from nonprofit foundations, plus a tiny percentage from government grants and contracts. It has not accepted funding from manufacturers or private insurers earmarked for reviews of specific technologies.

But for some time, it has received requests from drugmakers to help them rethink their trial designs to better measure patient-related outcomes, according to an ICER representative—providing clarity in development that could add value once a drug is approved.

As to whether this will ultimately affect the drug-pricing watchdog’s impartiality, Bernstein analyst Ronny Gal wrote in a note to investors that if ICER does go through with the plan, it would still represent a gain for the pharma industry regardless of its implementation.

“We do not question ICER staff's integrity, but it is very hard to not grow to like your clients,” Gal wrote. “This funding mechanism is (respectfully) inherently problematic for an organization whose mission is to become the fair arbiter of drug value.”

In addition, it will allow developers an early shot at convincing ICER reviewers of the merits of their drug, Gal wrote, even though these pretrial considerations would come before the generation of any data that could be used to determine their cost-effectiveness.

Another lament: “It is incredibly shortsighted of payers (including and especially CMS) not to step up and fund ICER,” Gal wrote. “An independent evaluator of drug value is finally getting off the ground and you let it become funded by Pharma?”

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ICER, meanwhile, pointed to similar scientific advice offerings from organizations, such as the U.K.’s National Institute for Health and Care Excellence and the Canadian Agency for Drugs and Technologies in Health, which have operated for years.

It has not made any definitive plans to provide a similar service in the U.S. yet, however, ICER said it would only attempt to do so in a way that would safeguard its independence and integrity, and only if it reinforced its mission of supporting access to high-value care.