The Institute for Clinical and Economic Review (ICER) today announced plans for the first phase of a new program in which ICER will work with its academic collaborators to share executable versions of draft cost-effectiveness models with relevant drug manufacturers during ICER evidence reviews. By directly viewing a model's structure, estimates, key assumptions, and calculations, manufacturers may be better equipped to provide valuable feedback during the public comment period that follows the release of an ICER draft evidence report.
"ICER is committed to ensuring the highest level of transparency in all our work, and this pilot program takes our policies one step further," noted Dan Ollendorf, PhD, ICER's Chief Scientific Officer. "We have always made every effort to share information about economic model structure and inputs with manufacturers during our review so that they could understand and critique the models during their development. But now we will pilot a way that we think can balance the intellectual property rights of our collaborators with the goal of even greater model transparency. We hope this new program will provide the opportunity for manufacturers, and ultimately patient groups and other qualified stakeholders, to gain even greater insights into draft models so that their feedback can enhance the accuracy and relevance of final versions."
Under the pilot, manufacturers of the interventions and comparators of interest for a given review will pay a fee to ICER's academic collaborators to cover the time needed to produce sharable executable files and all supporting documentation. To protect the intellectual property of the researchers and their institutions, models will be shared under confidentiality or licensing agreements. Under these agreements, manufacturers will be unable to alter the model for their own purposes. In addition, their access will be for a limited timeframe and will be confined to the team of individuals responsible for the review. The expectation is that such a review will inform the written public comments on the draft report.
The program will be piloted during ICER's two current reviews of therapies for migraine prevention and of the drug elagolix for endometriosis-associated pain. Academic collaborators from the University of Illinois at Chicago College of Pharmacy and the University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, respectively, are developing the economic models for these reviews.
"Drug manufacturers possess a wealth of important data about their products," said R. Brett McQueen, PhD, Assistant Professor at University of Colorado. "We are excited to use their direct knowledge and understanding of our models to further validate our approach."
Daniel Touchette, PharmD, MA, Associate Professor at the University of Illinois at Chicago, stated, "Along with ICER's existing processes that allow all stakeholders to provide valuable feedback during an evidence review, this new pilot further underscores our collective commitment to fairness, transparency, and scientific rigor."
Feedback received from manufacturers and other stakeholders during this pilot will help determine ICER's future approach to sharing economic models associated with other evidence reviews.
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