In December 2021, the Institute for Clinical and Economic Review (ICER) released a new report on Unsupported Price Increases (UPI) of prescription drugs in the United States. In the report, ICER takes issue with seven particular drug price increases in 2020. Those seven “unsupported price increases” cost the United States health system an additional $1.67 billion beyond what would have been spent if their net prices remained flat, even after pharmaceutical rebates and other concessions.
ICER Report Findings
ICER identified a list of ten prescription drugs that met the following criteria:
- In the top 250 drugs by 2020 sales revenue;
- Experienced wholesale acquisition cost (WAC) price increases of more than two percentage points higher than the rate of medical inflation of between the end of 2019 and the end of 2020;
- Even after rebates and other concessions, experienced net price increases; and
- After net price increases were vetted with manufacturers, where found to be the top ten drugs whose price increases – as opposed to volume increases – contributed to the largest increase in United States spending.
This selection process produced a total of ten prescription drugs, for which ICER determined whether, during 2019 and 2020, there was any new moderate- or high-quality evidence that these treatments provide a substantial improvement in net health benefit beyond what was previously known. ICER then reviewed input from manufacturers and conducted a systematic review of evidence available in published studies and determined that seven of the ten drugs lacked adequate evidence to support a claim of additional clinical benefit.
The Seven Drugs
The seven drugs are: Humira® (adalimumab, AbbVie), Promacta® (eltrombopag, Novartis), Tysabri® (natalizumab, Biogen), Xifaxan® (rifaximin, Bausch Health), Trokendi XR® (topiramate, Supernus Pharmaceuticals), Lupron Depot® (leuprorelin, AbbVie), and Krystexxa® (pegloticase, Horizon Pharmaceuticals).
Of those seven drugs, Humira had the greatest increase in United States drug spending, with a net price change of $1,395,000,000. Of the seven drugs, Promacta had the greatest net price increase from 2019-2020, at 14.1%, while Xifaxan had the greatest wholesale acquisition cost increase at 8.4%.
Three Drugs with Positive Clinical Evidence
There were also three drugs assessed by ICER that did have price increases, but with new important positive clinical evidence: Venclexta® (venetoclax, AbbVie), Cimzia® (certolizumab pegol, UCB), and Entresto® (sacubitril/valsartan, Novartis).
The evidence used to justify Entresto’s price increase was the same evidence used to justify its prior year’s price increase. ICER’s determination that new evidence exists for these three treatments should not be interpreted to mean that the new evidence justifies the level of price increase; a full cost-effectiveness assessment was not conducted.
ICER Statement
“While prescription drugs continue to arrive in the US with increasingly high launch prices — often not aligned with those therapies’ ability to improve patients’ lives — year-over-year price increases have slowed considerably since ICER began issuing these UPI reports,” said David Rind, MD, ICER’s Chief Medical Officer. “However, there remain many high-cost brand drugs that continue to experience annual price hikes, even after accounting for their rebates. The most extreme of these is Humira, with an ever-escalating US price that contrasts starkly to its falling price in every country where Humira currently faces biosimilar competition. Even more concerning, several of these treatments have been on the market for many years, with scant evidence that they are any more effective than we understood them to be years ago when they cost far less. If new data emerge that show a treatment may be more beneficial than what was previously understood, perhaps some level of price increase is warranted. For seven of the ten high-cost drugs we profiled in this year’s report, though, we found that the price increases lacked such justification.”