December 13, 2023 Source: drugdu 95
After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most.
In an annual report (PDF) on "unsupported price increases" (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren't supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending.
This year's edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry's pricing moves in 2022.
For Humira, 2022 was the last year of market exclusivity before the med's dive off of the patent cliff. Humira captured ICER's top spot on its UPI list with a 7.11% wholesale acquisition (WAC) price hike and a 1.95% net price adjustment that led to a $386 million increase in U.S. drug spending.
It’s certainly not uncommon to see prices jump ahead of looming biosimilar competition, but that doesn’t justify the strategy, ICER’s chief medical officer David Rind, M.D., said in a recent interview.
Johnson & Johnson’s multiple myeloma med Darzalex, Pfizer’s breast cancer therapy Ibrance, Amgen’s bone health products Prolia and Xgeva, Bausch’s irritable bowel syndrome blockbuster Xifaxan, Genentech’s HER2 inhibitor Perjeta and Seagen’s antibody-drug conjugate Adcetris also made this year's list.
Darzalex's 6.80% increase in WAC led to additional spending of $248 million, ICER said; Ibrance’s 6.92% WAC jump caused a $151 million increase in spending. Adcentris' 8.69% increase in WAC was the largest overall list-price increase among these medicines, according to ICER.
Over the years, ICER has caught plenty of heat for its report and the way it comes to its conclusions. This year is no different.
In an emailed statement, Johnson & Johnson called the report’s methodology “deeply flawed," noting that it didn't include four new FDA approvals and five study readouts during ICER’s evaluation period. J&J says these developments support Darzalex and its newer combination formulation Darzalex Faspro as “foundational treatments” in multiple myeloma and amyloidosis.
“We take a responsible approach to pricing that recognizes our commitment to patients, and work closely with healthcare systems, policymakers, healthcare professionals, and advocacy associations to help patients access and afford our medicines,” J&J's spokesperson said.
Genentech, too, is “disappointed” with the methodology ICER used in its UPI assessment and its final conclusion on Perjeta, a company representative said over email.
“An assessment of Perjeta should comprehensively account for all available evidence, including that beyond randomized clinical trial data” to present a “balanced picture of drug value and investment in clinical research,” Genentech said. “We take pricing decisions seriously and remain committed to fair, reasonable pricing over the lifecycle of Perjeta as part of a patient-first approach.”
Meanwhile, Pfizer said it “respectfully disagrees” with its Ibrance’s inclusion in the assessment. According to a spokesperson, the net price adjustment of 4.45% fell in line with the rate of medical inflation and reflects “increased costs and continued investment” including a real-world research program.
“ICER’s decision to exclude key publications that provide additional information on the effectiveness of Ibrance likely detracted from the final assessment,” Pfizer's spokesperson said in an emailed statement. “We remain dedicated to improving access and affordability for patients who rely on our medications and work with an array of healthcare stakeholders to develop sustainable solutions addressing these issues, including a potential reform to the current US healthcare system.”
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