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ICER plots early scientific advice program for biopharma

The Institute for Clinical and Economic Review (ICER) is looking to help the biopharma industry with earlier reviews of clinical work, adding to their current independent evaluations of the clinical and economic value of prescription drugs, medical tests and other health innovations.

David Whitrap

“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,” David Whitrap, ICER VP of communications and outreach, told Focus.

The idea floated is that biopharma companies pay a fee for such a pre-market or pre-clinical review, though it’s unclear at this stage what that fee would be or how such a review would be conducted.

“Some international health technology organizations, such as NICE and CADTH, have offered this ‘early scientific advice’ to industry for many years with general success. We are therefore evaluating the options to provide a similar service but have not made any definitive plans,” Whitrap said.

Bernstein biotech analyst Ronny Gal noted that the potential move for ICER would be a funding shift from their past reliance on donations and conference organizing.

“We do not question ICER staff’s integrity, but it is very hard to not grow to like your clients,” Gal said. “This funding mechanism is (respectfully) inherently problematic for an organization whose mission is to become the fair arbiter of drug value … It is incredibly shortsighted of payers (including and especially CMS) not to step up and fund ICER. An independent evaluator of drug value is finally getting off the ground and you let it become funded by Pharma?”

But Whitrap reassured that if ICER does 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.”

Gal also called the idea “a positive for the drug industry” as it will allow drug developers “to be the ones to educate ICER early about the merit of their drug — they will get to comprehensively present their case and gain clarity as to what data they need to put together to obtain better prices.”

Whitrap added: “We’re still evaluating all of our options at this point regarding early scientific advice, including how to support the staffing requirements it would entail … any potential offering in this area would be structured in a way that would safeguard the independence of the drug assessments we conduct at or around FDA approval.”


First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.


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