For Price Hikes Without New Data, 3 Drugs With Approved Biosimilars Are Key Offenders, Says ICER

The Institute for Clinical and Economic Review (ICER) has issued its first annual report on unsupported price increases for US drugs. The report found that 3 brand-name biologics that have FDA-approved biosimilars—adalimumab, rituximab, and pegfilgrastim—have had significant price increases that were not supported by new clinical evidence.

“The norm in the United States has been for most pharmaceutical manufacturers to increase prices year after year—even accounting for the discounts they give insurers, and even for drugs that already sit at the top of the chart of spending for drugs in the US,” said David Rind, MD, ICER’s chief medical officer, in a statement, adding that the new report can help provide policy makers with an independent approach to determining whether price increases can be supported by new data.

In its analysis, ICER ranked the top 100 drugs by US sales revenue, and evaluated whether their prices, after accounting for rebates and concessions, were more than twice the level of growth in the medical consumer price index from 2017 to 2018. The ICER team then evaluated whether any relevant new evidence had emerged for these drugs over the past 3 years that could support a price increase.

They found that there were 7 drugs that had price hikes without adequate data to support the new costs, and the product that had the price increase with the greatest impact on US spending was the brand-name adalimumab, Humira.

With its 19.1% increase in its wholesale acquisition cost (WAC) from the end of 2016 to the end of 2018, and an estimated 15.9% net price increase over the same period, ICER estimates that increases to Humira’s price cost the United States $1857 million between 2017 and 2018.

The drug whose price hikes had the second greatest impact on spending was brand-name rituximab, Rituxan. With a 17.0% increase in WAC and a 23.6% estimated increase in net price, Rituxan was responsible for a US spending impact of $806 million.

A third biologic with approved biosimilars that saw its prices rise without support was brand-name pegfilgrastim, Neulasta. Pegfilgrastim came in fifth in terms of its impact on US spending, with a 14.6% WAC increase, an estimated 13.4% net price increase, and a $489 million increase in spending.

The other drugs identified by ICER as having unsupported price increases were pregabalin (Lyrica), tenofovir disoproxil fumarate (Truvada), tadalafil (Cialis), and dimethyl fumarate (Tecfidera).

While Humira has 4 FDA-approved biosimilars, no products are set to launch in the US market until 2023 as a result of patent settlements between Humira-maker AbbVie and biosimilar developers. In the case of Rituxan, 2 products have been approved by the FDA, but no launch date has been disclosed for either one. Neulasta currently faces US market competition from Coherus BioScience’s Udenyca and Mylan and Biocon’s Fulphila.