NEW YORK (Reuters) – The Institute for Clinical and Economic Review (ICER), a small but influential Boston-based research group, has signed a deal with private technology company Aetion to help it use patient health data in its reports on whether individual drugs are priced properly.
Large national regulators, including the U.S. Food and Drug Administration and United Kingdom’s National Institute for Health and Care Excellence (NICE), are considering increasing the use of data gathered outside of clinical trials on the effectiveness of treatments, often referred to as real-world data.
The FDA is running a pilot project using Aetion’s database of insurance claims to replicate clinical trial results, as part of a requirement to comply with healthcare legislation called the 21st Century Cures Act. It is seeking to determine under what circumstances such data could replace clinical trials, which have long been the foundation of medicine regulation.
Former FDA Commissioner Scott Gottlieb is a board member at Aetion.
The agreement with Aetion will give ICER access to the claims database to help better inform its cost-effectiveness reports beyond clinical trial data and other information provided by patients, pharmaceutical companies and research papers.
ICER will pilot the use of real world analysis in follow-up reports on how patients are being prescribed and how they react to treatments that have reached the market through one of the FDA’s accelerated approval pathways.
ICER President Steve Pearson said it can use Aetion’s claims database to find out more about the standard of care for a disease, or to see if larger numbers of patients in medical practice react similarly to drugs as those in tightly controlled clinical trials.
For instance, he said, patients may be taking different dosages than given in trials, which could impact the cost effectiveness of a drug.
ICER is not a government agency and has no authority to set prices. But many large health insurers take their reports into account when they negotiate prices with drug manufacturers and determine patient access. Drugmakers also take into account ICER estimates when they set prices for new medicines.
New York-based Aetion has funding from venture capitalists including from units of Amgen Inc (AMGN.O) and McKesson Corp (MCN.N), as well as from drugmakers Sanofi SA (SASY.PA) and Ucb SA (UCB.BR) and health insurer Horizon Health Services.
Reporting by Caroline Humer; Editing by Bill Berkrot
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