A nonprofit group is calling out drugmakers that it says have raised prices on their products without providing evidence to support the increases, resulting in a more than $5 billion increase in drug spending between 2017-2018.

The Institute for Clinical and Economic Review published its first annual report of what it called unsupported price increases on Tuesday, which it compiled from data supplied by SSR Health, part of the investment research firm SSR.

To compile the 125-page report, ICER obtained a list of the top 100 drugs by U.S. sales, excluded 23 whose increase in wholesale acquisition cost between fourth quarter 2016 and fourth quarter 2018 was no larger than twice that of the medical consumer price increase. It then took the remaining 77 and, when possible, determined the increase in spending that was due to increases in net price. From that, ICER created a list of nine drugs for assessment, finding that seven had price increases not supported by new clinical evidence.

ICER reviewed randomized clinical trials, high-quality comparative observational studies and – for low-frequency harms – large uncontrolled studies, focusing on indications responsible for at least 10 percent of a drug’s utilization in cases when drugs were approved for multiple uses. The quality of evidence was reviewed based on GRADE, a method of rating quality of evidence. ICER then reviewed high- or moderate-quality evidence to assess the magnitude of additional net clinical benefit compared with what was previously known, deeming those drugs without evidence meeting those criteria as having experienced unsupported price increases.

The drugs named in the report were AbbVie’s Humira (adalimumab), Roche’s Rituxan (rituximab), Pfizer’s Lyrica (pregabalin), Gilead Sciences’ Truvada (tenofovir disoproxil fumarate/emtricitabine), Amgen’s Neulasta (pegfilgrastim), Eli Lilly & Co.’s Cialis (tadalifil) and Biogen’s Tecfidera (dimethyl fumarate).

Together, ICER said, the price increases resulted in a $5.1 billion increase in U.S. drug spending, with Humira having the largest effect, with a 15.9 percent increase in price that resulted in $1.86 billion more in spending on the drug than would have occurred without the price increase. Humira had sales of $19.9 billion in 2018, according to AbbVie, an 8.2 percent increase over 2017.

Unsurprisingly, the drugmakers disagreed.

In an emailed statement, AbbVie said ICER’s data on net pricing were “inaccurate” and called its methodology into question, pointing to more than 200 recent scientific publications on the drug’s clinical and economic value. Statements from Biogen, Pfizer and Lilly also criticized ICER’s methodology. Gilead said that it provided real-world and economic evidence that ICER did not consider and called its decision to limit the types of evidence the analysis used “a missed opportunity to evaluate evidence that provides insight into medicines’ impact on patients, societies and economies.” Roche stated that when taking discounts to private payers, the government and others, Rituxan’s net price increase was 2.5 percent, which it called in line with medical inflation. Amgen said that when it conducted its own analysis for Neulasta using ICER’s methods, it found the increase in price consistent with healthcare inflation.

Nevertheless, the report comes at a time when drug pricing has become a hot-button political topic ahead of the 2020 election. The Trump administration unveiled its “blueprint” to lower drug prices last year, though it has since faced setbacks. In a speech last week, Trump baselessly suggested that drugmakers are behind Congressional efforts to impeach him. Several Democratic candidates have issued drug-pricing plans as well.

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