From the Regulatory Focus online publication comes this bit of good news for pharma companies worrying about ICER:
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.
“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.
Translation: Nice drug you got there, it would be a shame if something happened to it.
This is a protection racket plain and simple. Moreover, as Regeneron found out, working with ICER only guarantees deeper rebates, not broader uptake of products.
Any company that plays ball with ICER deserves what they will get.
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.
“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.
Translation: Nice drug you got there, it would be a shame if something happened to it.
This is a protection racket plain and simple. Moreover, as Regeneron found out, working with ICER only guarantees deeper rebates, not broader uptake of products.
Any company that plays ball with ICER deserves what they will get.
