The Institute for Clinical and Economic Review (ICER) has become increasingly vocal in the ongoing debate over high drug prices. Now, it’s sounding off about drugs it believes have become too expensive for the U.S. health system to bear given a lack of data justifying recent price increases.
ICER released a report Tuesday pegging AbbVie’s Humira as the No. 1 offender when it comes to costly price increases that are not supported by new clinical evidence. Roche’s Rituxan and Pfizer’s Lyrica rounded out the top three, with well-known drugs from Gilead Sciences, Amgen, Eli Lilly and Biogen completing the list (see table).
ICER collected pricing data for 2017 and 2018, and over those two years, Humira saw an average net price increase of 15.9%, resulting in a net impact on U.S. drug spending of more than $1.8 billion in 2017 and 2018, the report (PDF) said. The total impact on drug spending of all seven products ICER flagged was $5.1 billion over those two years.
Drugmakers have warmed up to ICER in recent years, participating in discussions that sometimes prompt the agency to reverse its critical stance on new products—but some singled out in this new report had plenty of bones to pick.
"AbbVie provided more than 200 recent scientific publications that highlight the clinical and economic value of Humira," a spokeswoman for the company told FiercePharma in an email. AbbVie believe's ICER's data on the net price of Humira is inaccurate, she added.
A spokesman for Pfizer said in a statement emailed to FiercePharma that ICER’s assessment “does not consider external factors that naturally affect the price of drugs, does not assess the true value the medicine brings to patients over time and does not consider what the appropriate value-based price should be.” He added that the price of Lyrica, a pain treatment, reflects its effectiveness in relieving many different conditions.
Roche found ICER's approach "significantly limited" because it excluded evidence supporting both the clinical and economic benefits of Rituxan, a spokeswoman told FiercePharma. Rituxan was associated with 279,704 saved life-years for people diagnosed with the diseases the drug is approved to treat, including non-Hodgkin lymphoma, between 1998 and 2003, translating to "an incremental economic gain of $16.5 billion to the U.S. health care system," according to data the company has collected. She added that over the last several years, Roche's Genentech unit has kept price increases at about 2.5%, which is in line with medical inflation.
A spokesman for Lilly, which took heat from ICER Tuesday on its erectile dysfunction drug Cialis, said the company questioned the agency’s methodology for the report and urged it to “improve the transparency of its analyses so that others can attempt to reproduce their results.” He added that generic versions of Cialis have brought the retail price of the medicine down by 90%.
Gilead also questioned ICER's methodology. A spokesman said the company "had provided real-world evidence and economic evidence which was not considered" for its HIV treatment Truvada. The drug's "continued value is demonstrated through rigorous real-world outcomes data across diverse U.S. populations and settings," he told FiercePharma. Biogen's executives also felt information they had provided to ICER about the benefits of Tecfidera, a multiple sclerosis drug, was not reflected in the analysis.
Amgen did not immediately respond to a request for comment from FiercePharma.
The National Pharmaceutical Council, a D.C.-based health policy firm supported by biopharma companies, deemed ICER’s new report deeply flawed. “Underlying the headlines of this report are flaws with the methodology, particularly with the types of evidence, data and timeframe ICER chose to use in its calculations,” Kimberly Westrich, vice president for health services research at the National Pharmaceutical Council, said in a statement emailed to FiercePharma. “Incomplete or flawed information can lead to flawed health care policy decisions, to the potential detriment of patients and society.”
ICER started its analysis with the 100 top-selling drugs in the U.S., then compared their price increases to growth in the medical consumer price index. It ended up with a list of 11 drugs that saw price hikes—minus rebates and other discounts—that were more than double the rise in the medical consumer price index. ICER cut two of the drugs because of unreliable pricing data, then took input from the manufacturers of the remaining nine products.
The final seven drugs, the agency concluded, were too costly because evidence provided by their manufacturers was “not adequate to support a claim of additional clinical benefit,” ICER said in a statement.
“The goal of ICER’s new UPI report is to provide the public and policymakers an explicit and independent approach to determine whether price increases could potentially be supported by new clinical evidence,” ICER’s chief medical officer, David Rind, M.D., said in the statement. ICER is willing to weigh any data that might emerge in the future, he added.
ICER has taken plenty of heat from the pharmaceutical industry of late. Just last week, it withdrew a 145-page draft report on rheumatoid arthritis drugs that lambasted new JAK inhibitors, including AbbVie’s Rinvoq, Pfizer’s Xeljanz and Eli Lilly and Incyte’s Olumiant. Normally, the agency takes feedback on draft reports it incorporates into a final assessment, but in this case, ICER deemed it necessary to start over because its reviewers needed to analyze prices in a way that would more accurately reflect real-world use of the drugs, ICER told FiercePharma.
So which companies managed to avoid being listed on ICER’s new hall-of-shame of price increases? Celgene caught a break with its multiple myeloma blockbuster Revlimid, and Gilead was able to talk HIV treatment Genvoya off the list.
But ICER qualified the exclusions by pointing out that a full cost-effectiveness assessment was not performed on either Revlimid or Genovya, and therefore their exclusion from the new list “should not be interpreted to mean that the new evidence justifies the level of price increase,” it said.
Editor's note: This story was updated to include comments from AbbVie and Biogen.