n March 25, the Institute for Clinical and Economic Review (ICER) formally announced the launch of ICER’s Scientific Advice, a new program designed to help sponsors generate clinical trial evidence that supports more comprehensive assessment not only of clinical effectiveness but of value as well.

“Identifying the right kind of evidence needed from clinical trial programs will ensure that value assessments are a foresight, not an afterthought,” said ICER President and CEO Sarah K. Emond, MPP, in this announcement. “Our goal is to improve the evidence that is developed by companies during clinical development to ensure value assessors have the information they need to do a fair assessment at the time of FDA approval.”

This announcement coincides with the 20th anniversary of ICER’s founding as an independent research organization, originally established within Harvard Medical School/Massachusetts General Hospital, and marks an important milestone in ICER’s mission of evaluating the clinical and economic value of prescription drugs and related tests and therapeutics to improve patient access. As Emond explains in the following Q&A with Global Forum Value & Access Editor Wyatt Gotbetter: “There are multiple actors participating in the price and access decision, none of whom are ultimately the one to actually benefit from the product: the patient.”

Read Part 1: Mission, Methodology, and Population Health

Read Part 2: Cost, Clinical, and Competitive Effectiveness