ICER Releases Revised Protocol for Reviewing Drug Price Increases

After receiving feedback from pharmaceutical companies and other stakeholders, The Institute for Clinical and Economic Review (ICER) this week released a revised protocol for conducting a new annual analysis to determine whether significant prescription drug price increases are backed by new clinical evidence, but ICER left most of the protocol substantially unchanged.

ICER released the draft protocol in January. The first report is scheduled to be released on October 8, 2019.

As might be expected, drug makers took issue with many aspects of the upcoming report, starting with its name, “Unsupported Price Increase Report,” as well as aspects of the report’s methodology, the source of the data, various aspects related to different time frames in the report, and the fact that the analysis will not consider all aspects of the healthcare system, such as hospital and physician prices.

ICER responded to the comments in detail, sometimes repetitively. “Thank you, but we feel that large price increases for existing drugs in the absence of new evidence raise important public policy considerations,” was one common response.

Some stakeholders raised questions about how orphan drugs or biosimilars would be analyzed in the report. ICER’s response to both were similar: it did not understand why drugs for orphan diseases or the market entry of biosimilars would lead to rapid price increases.

In addition, ICER said it is not inherently looking to exclude biosimilars or generic drugs, but said it is not “looking across all producers of a molecule to calculate budget impact.”

To another stakeholder opposed to the report—a patient advocacy group that receives much of its funding from some of the same biotechnology companies that also submitted comments—ICER responded, “We do not understand why an organization purportedly worried about patient access and patient care would not support a report looking at large unsupported increases in drug prices.”

ICER said manufacturers will be able to submit additional information on other reasons for price increases, and give input on net price increases. It also said it may include other information on a case-by-case basis, and pointed out that since this is the first year of the report, it may consider altering the protocol in the future.

Regarding concerns about the possible public release of confidential commercial or trade secret information, ICER was more blunt, saying, “We feel that for these price increases that have had the largest budget impacts on the US economy, manufacturers should either be able to provide public justification or accept ICER's review of public information.”

ICER said its report will focus on at least 10 prescription drugs that experienced the most significant US price increases over the past 24 months, based primarily on which net price increases resulted in the largest overall budget impact for the US health system.

In addition, ICER will accept public recommendations for up to 3 additional drugs that may not qualify for the initial top 10 list but still meet some of the following criteria:

• Drugs with extremely high price increases that do not have substantial budget impact at the national level
• Drugs used by millions of Americans with price increases that fell just below 2 times the medical care consumer price index
• Drugs whose price increases have important affordability implications for individual patients even if not for the health system
• Drugs whose price increases raise concerns about the fairness of the price increases

Those criteria would allow review of a drug like Daraprim, which became infamous because of a price hike from $13.50 to $750 a pill in a single day.

ICER is an independent, nonprofit organization that seeks to improve healthcare value by providing comprehensive clinical and cost-effectiveness analyses of treatments, tests, and procedures.