A Look at ICER’s Unsupported Drug Price Increase Report

The Institute for Clinical and Economic Review (ICER), a non-profit organization in the United States with a mandate of  improving patient care and health-care costs through researching medical evidence, recently reported on price increases across the U.S. and assessed whether such increases are justifiably founded in any new medical developments. 

The report, the first of a scheduled series dubbed the Unsupported Price Increase reports,  selected drugs to review whose net price increases over a two-year period led to the highest increases in drug-spending across the U.S. The goal of the research was to analyze whether any new clinical evidence had arisen in the last three years that could be legitimate-cause for the increases. The study was exclusively based on U.S. pricing and sales figures. 

From a list of 100 drugs with the highest sales of 2018, ICER narrowed their study to nine drugs for examination. The selection was based on net price increases, with one drug, lenalidomide (known by the brand name Revlimid), being selected for the study by public nomination. The nine drugs selected for examination were: Humira, Lyrica, Truvada, Rituxan, Neulasta, Cialis, Tecifdera, Genvoya, and Revlimid. 

ICER requested recent “high-quality evidence” i.e., new clinical evidence such as randomized clinical trials and observational studies conducted within the last three years, be presented as justification for the price hikes. Such materials were requested directly from manufacturers.

From a list of 100 drugs with the highest sales of 2018, only two drugs were found to have any new clinical evidence attached to price increases.

Only two of the nine drugs examined were found to have new clinical evidence attached to the price increases: Genvoya and Revlimid.

The other seven drugs had no recent clinical justification for net-price increases that ran anywhere between 10% and 33% in the last 24 months.The agency disqualified any evidence that was previously known, irrelevant to or outside of the scope of the study, or where the indication noted was 10% or less of the drug’s use. The seven manufacturers whose products were found to lack recent clinical evidence tended to submit references like published outcomes-research papers and conference presentations instead of the quality requested by ICER.

Collectively Humira, Lyrica, Truvada, Rituxan, Neulasta, Cialis, and Tecifdera account for price increases of 4.8 billion dollars over the last two years. ICER found no new clinical evidence to support such a drastic increase in spending amongst those seven drugs.

Historically, there has been no national regulatory body in the U.S. that evaluates clinical evidence to determine whether drug price increases are based on legitimate new scientific or medical developments. Nor is there any national agency that regulates drug prices. And, up until now, ICER has focused on health-technology-assessments. In contrast, this report represents ICER’s first foray into drug pricing.  

This latest salvo from a group known for scrutinizing the drug industry's approach to pricing shows that the majority of price increases in the United States are not based on new medical discoveries or research: key information that will inform and guide U.S. politicians, policymakers and the public in the current national debate on drug pricing.

(Diagram via @ICER_Review)