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ICER Will Review If Drug Price Hikes Are Supported by New Evidence

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The Institute for Clinical and Economic Review is creating a new analysis of significant drug price increases to determine if the price hikes are supported by new clinical evidence.

In 2018, with attention on drug price hikes, drug makers largely decided to self-monitor themselves and announced they would halt price increases. By the end of the year, nearly 30 drug makers announced that the temporary stay was over and they would be raising the price of their medicines in January 2019.

Following that news, Health Affairs released a study that found cost growth among US drugs is not necessarily driven by new blockbuster therapies but by older products, reported The Center for Biosimilars®, a sister site of The American Journal of Managed Care®. Now, the Institute for Clinical and Economic Review (ICER) has announced it is creating a new analysis of significant drug price increases.

The Unsupported Price Increase (UPI) report will determine whether or not there has been new clinical evidence to support any significant price increases. The draft protocol for the annual analysis is now available for public comment to inform the final version of the protocol.

“Drug prices are often increased substantially over time in the US, and questions are frequently raised regarding whether these price increases are justified,” David Rind, MD, ICER’s chief medical officer, said in a statement. “By identifying drugs with substantial price increases despite no new evidence of added benefit, we hope to make an important first step in providing policy makers with information they can use to advance the public debate on drug price increases.”

The draft protocol was developed using guidance from a multistakeholder advisory group including representatives from patient advocacy groups, pharmaceutical companies, and payers. The draft proposes identifying the top 100 drugs by sales revenue and then identifying those drugs whose list price increased more than twice the medical Consumer Price Index over the past 24 months. ICER will then rank the drugs based on the expected change in budget impact due to the price change and choose the top 10 drugs that would have generated the largest increase in budget impact based on the net price increases. Up to 3 other drugs with substantial price increases may be included based on public input.

Once the list has been created, ICER will identify new information from the previous 36 months and rate the quality of new evidence and the magnitude of added net health benefit. Drugs with no new evidence of a substantial improvement in net benefit will be considered as having unsupported price increases.

“By identifying drugs with substantial price increases for which there is no basis in new evidence we hope to make an important first step in providing the public and policy makers with information they can use to advance the public debate on drug price increases,” the ICER draft protocol explained.

ICER plans for the first report, based on protocol developed from the public comments, to be released October 8, 2019.

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