ICER to Review Price Hikes to Prescription Drugs

The Institute for Clinical and Economic Review (ICER), an independent, nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures, has announced that it is undertaking a new annual analysis—an Unsupported Price Increase report (UPI)—that will review significant prescription drug prices increases and determine whether those increases are supported by new clinical evidence.

"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."

ICER has developed a draft protocol for how it will conduct the UPI assessments, and it plans to assess up to 13 products in its first UPI.

These drugs will be identified through research into the 100 drugs with the largest dollar sales in the United States and analysis of wholesale acquisition costs (WAC) to these drugs over the past 24 months. ICER will determine which drugs have had a WAC increase that is twice the rate of the medical consumer price index (CPI) or higher. Among that group of products, ICER will obtain net price information and determine changes over the prior 24 months and then rank the 10 drugs whose net price increases have had the largest impact on US healthcare spending over the past 2 years.

ICER may also review an additional 3 drugs that have had extreme increase in price that may not impact national spending, are widely used but carried price increases that fell just below the set CPI threshold, have price increases that have affordability implications for individual patients, or have price increases that raise questions about the fairness of the increase.

Manufacturers are invited to submit data on net price changes, new clinical evidence relating to comparator therapies that the drug maker believes indicate fresh evidence of their drug’s advantages, and potential justifications for price hikes over the past 36 months.

ICER has opened a public comment period on the draft protocol, and will consider comments received by February 13, 2019. The organization expects to publish its first UPI report in October 2019.

Announcement of the UPI assessments comes as policy and law makers are demonstrating renewed interest in the problem of price hikes to drugs. In recent weeks, the House has signaled that it will begin an investigation into the high costs of drugs, such as Humira and Enbrel, and legislation has been introduced in the Senate that would restrict pay-for-delay deals over biosimilars and generics, link US prices to those paid for pharmaceuticals in other countries, and allow for importation of cheaper drugs from Canada.