ICER To Open Cost Effectiveness Models To Drug Firms During Review Process
Executive Summary
Institute for Clinical and Economic Review launching pilot program that allows drug assessment models to be inspected, but not manipulated, by manufacturers.
The Institute for Clinical and Economic Review is piloting an approach to making its cost-effectiveness models available to drug manufacturers during reviews to enhance the transparency of its methods.
"ICER is committed to ensuring the highest level of transparency in all our work, and this pilot program takes our policies one step further," ICER Chief Scientific Officer Dan Ollendorf said in a March 30 announcement.
The initiative responds to manufacturer complaints that the ICER process lacks transparency and does not allow for adequate input from industry before assessments are completed.
"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," the release explains.
The program will be piloted during two current ICER reviews covering:
- Therapies for migraine prevention, and
- The drug elagolix for endometriosis-associated pain.
Feedback received from manufacturers and other stakeholders during the pilot will help determine ICER's future approach to sharing economic models associated with other evidence reviews. 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 the reviews.
Drugs being evaluated for migraine prevention include Amgen Inc. and Novartis AG' Aimovig (erenumab), Teva Pharmaceutical Industries Ltd.'s fremanezumab and Eli Lilly & Co.'s galcanezumab. FDA is expected to make a decision on Aimovig in May, on fremanezumab in the first half of 2018, and on galcanezumab, in the third quarter of this year. ICER released a draft evidence report on the drugs April 11.
Elagolix, being developed byAbbVie Inc. and Neurocrine Biosciences Inc., is also under review by FDA, with a decision expected in mid-2018. ICER is planning to release a draft evidence report on the drug in early May.
ICER collaborates with academic institutions in its cost effectiveness modeling so the cost to its partners of sharing models and intellectual property concerns have been a factor in providing transparency. ICER addresses those concerns in the new initiative by requiring that manufacturers pay the academic collaborators a fee 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 the agreements, manufacturers will be unable to alter the model for their own purposes, access will be for a limited timeframe and will be confined to the team of individuals responsible for the review.
Still, ICER and its collaborators hope that a better understanding of the models will enhance manufacturers' ability to contribute to the assessments.
"Drug manufacturers possess a wealth of important data about their products," said R. Brett McQueen, University of Colorado. "We are excited to use their direct knowledge and understanding of our models to further validate our approach."
Amgen Will Participate In Pilot
Amgen "welcomes ICER’s initiative as a first step towards improved transparency," the company told the Pink Sheet. However, "any endeavor to inform decision-making using cost-effectiveness analysis requires full transparency and would enable experts to 'use' the model to test and vary assumptions to validate the models, which requires time and should be devoid of financial conflicts, payments, or confidentiality agreements."
Nevertheless, Amgen plans to participate in ICER’s pilot as part of their migraine assessment and "we anticipate receiving access to the model structure, base case inputs and assumptions in the coming weeks," the company said. "We are encouraged by this positive evolution of ICER’s approach and are hopeful that ICER will take further steps towards more full transparency and an open source approach in response to expert feedback. We look forward to more collaboration between health economists throughout the healthcare system.”
The issue of whether manufacturers could do their own assessments with the ICER models was also flagged as a potential problem by the Innovation and Value Initiative (IVI) in a statement on the initiative. Formed in 2016, IVI is a research and policy collaboration between academics, pharmaceutical firms, providers and delivery systems.
The organization is working to develop the Open-Source Value Project, a biopharma-industry funded effort to measure the value of prescription drugs that could serve as a counterpoint to efforts by ICER and others. (Also see "Open-Source Rx Value Model Designed To Encourage 'More Productive' Discussions" - Pink Sheet, 22 Jan, 2018.)
"IVI commends ICER for taking an initial step toward a more open scientific review of cost-effectiveness models," the organization said. "At the same time, IVI believes that more is needed to achieve a transparent and relevant approach to value assessment in the US.”
"Stakeholders should be able to use and customize the models, and not simply review, to ensure value assessment that reflects the local situation, setting, and perspectives on value," the group said. In addition, the models "should be available to all stakeholders rather than restricting access to some."
Finally, IVI continued, "confidentiality or licensing agreements impede the free flow of information and models, which should be the goal of an open and transparent scientific process. This approach would also allow stakeholders to update the assessment of value as new clinical evidence becomes available.”