ICER Identifies Most Significant 2020 US Drug-Price Hikes Not Supported by New Clinical Evidence

-- Out of 10 identified drugs that had substantial 2020 price increases net of rebates on top of already high current spending, seven were not supported by new clinical evidence; net price increases on these seven drugs cost Americans an additional $1.67 billion in annual drug spend, of which nearly $1.4 billion was due to a single drug alone: Humira --

-- Overall net prices for drugs in the US market have decreased in the past several years, and even list price increases have not exceeded the broader inflation in the economy; this trend helps restrain health insurance premiums and benefits patients --
BOSTON, November 16, 2021 – The Institute for Clinical and Economic Review (ICER) today published its latest report on Unsupported Price Increases (UPI) of prescription drugs in the United States. Among the top drugs with price increases in 2020 that had substantial effects on US spending, ICER determined that seven of 10 lacked adequate new evidence to demonstrate a substantial clinical benefit that was not yet previously known. The 2020 unsupported price increases on these seven treatments, even after pharmaceutical rebates and other concessions, cost the US health system an additional $1.67 billion beyond what would have been spent if their net prices had remained flat.

“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.”

Methodology and Key Findings

Consistent with our protocol announced in April 2021, ICER identified a list of prescription drugs that met each of the following criteria:

  • Were among the top 250 drugs by 2020 US sales revenue;
  • Experienced WAC (list) price increases that were more than 2 percentage points higher than the rate of medical inflation 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, were found to be the top 10 drugs whose price increases -- as opposed to volume increases -- contributed to the largest increase in US spending.

This selection process produced a total of 10 prescription drugs, for which ICER then 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. Following consideration of input from manufacturers and a systematic review of evidence available in published studies, ICER determined that seven of the ten drugs lacked adequate evidence to support a claim of additional clinical benefit. These seven therapies, in order of the impact of their net price increases on US drug spending, are displayed in the following table:
* While potentially surprising to industry observers, it is possible for net-price increases to outpace list-price increases based on a variety of factors, including relative reductions in 1) rebates to payers, 2) fees to wholesalers and others in the supply chain, and/or 3) patient assistance. Each of the manufacturers listed above had an opportunity to volunteer corrections to our estimated net-price changes, and several of them did.

The three drugs assessed that did have new important positive clinical evidence were 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. Importantly, however, 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.

Comparison to Previous Unsupported Price Increases

In October 2019, ICER published our first UPI report, which identified seven specific drugs that experienced unsupported price increases that cost American insurers and patients an additional $4.8 billion across the two-year period of 2017 and 2018. In January 2021, ICER published our second UPI report, this time covering only the single year of 2019, identifying another seven unsupported price increases that cost Americans an additional $1.2 billion in annual drug spend.

Humira is the only treatment to be identified as having significant unsupported price increases across all three UPI reports. Even after subtracting the manufacturer’s rebates, Humira’s net price increased an estimated 29.6% from the beginning of 2017 to the end of 2020. Xifaxan qualified for both this 2020 report and the 2019 report, with an aggregated net price increase of 16.7% from the beginning of 2019 through the end of 2020.

Supplemental Analysis of Drugs Nominated Through Stakeholder Input

ICER’s protocol allowed for stakeholders to recommend up to three additional drugs of concern to be evaluated even if they do not meet all of ICER’s criteria to be defined as one of the costliest net price increases. This supplemental process led Emflaza® (deflazacort, PTC Therapeutics) and Fanapt® (iloperidone, Vanda Pharmaceuticals) to be included within ICER’s evaluation.

After careful review, we concluded that both Emflaza and Fanapt did not have new clinical evidence in either 2019 or 2020 that could support a 2020 price increase. However, while both therapies’ US list prices increased in 2020, there are no reliable data to estimate changes in their net prices. 
About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system. For more information about ICER, please visit ICER’s website.