In the Institute for Clinical and Economic Review’s (ICER’s) annual price-hike report, the U.S. watchdog is taking several pharma majors to task over what it says are "unsupported" price increases.
Still, as is customary following the release of the cost increase data, many of the companies implicated in the review have been quick to hit back against the ICER’s findings.
In its latest yearly report (PDF) on unsupported price increases for prescription drugs, the ICER has put a spotlight on 10 medicines that saw substantial price hikes last year. Of that lot, half of the drugs reviewed “lacked adequate evidence to support any price increase,” the independent nonprofit said in a Thursday press release. These hikes led to $815 million in incremental added costs for U.S. payers last year, the ICER concluded.
The five products flagged by the ICER are Gilead Sciences’ HIV treatment Biktarvy, Johnson & Johnson’s multiple myeloma med Darzalex, Novartis’ Entresto for heart failure, Exelixis’ cancer therapy Cabometyx and Pfizer’s JAK inhibitor Xeljanz, which is approved in rheumatoid arthritis, ulcerative colitis and several other conditions.
The ICER argued that Gilead’s Biktarvy—which saw its wholesale acquisition cost increase 5.9%—was the biggest offender last year, with its hike costing U.S. payers some $359 million in additional drug spending.
Meanwhile, Darzalex saw its price before discounts increase 7.6% last year, compared to 6.2% for Entresto, 7.5% for Cabometyx and 6% for Xeljanz, according to the ICER.
Respectively, those price increases—which the ICER claims were unsupported by new evidence—tacked on an additional $190 million, $108 million, $86 million and $72 million in 2023 U.S. drug spending.
J&J’s Darzalex is the only repeat offender flagged by the ICER on multiple lists, having appeared in the group's 2022 report.
Companies blast 'disregarded' evidence and 'flawed' approach
With the release of the ICER’s report, a now traditional drug-cost sparring match is brewing between the pricing watchdog and the companies named in its findings.
“The report disregarded breakthrough clinical evidence presented on Biktarvy, including data that led to two new FDA label updates and two clinical guideline updates given the importance of the new data for clinical practice,” a Gilead spokesperson told Fierce Pharma over email.
She pointed to two FDA label updates for the drug covering an expanded indication in 2024 to treat HIV patients with suppressed viral loads with known or suspected M184V/I resistance as well as a second expansion vouching for the safety and efficacy profile of Biktarvy in pregnant people with HIV.
Johnson & Johnson echoed that sentiment, with a spokesperson telling Fierce the ICER “applies flawed methodology and represents the perspective of insurance companies, not patients.”
Specifically regarding Darzalex and its subcutaneous Faspro formulation, the spokesperson argued that the ICER’s report omitted “key information” about the drug, including a new FDA approval and several study reports that the company claims support Darzalex as “foundational treatments” in multiple myeloma.
“Over time, the use of ICER’s methodology could limit coverage for groundbreaking medicines and result in fewer new medicines being developed,” the J&J spokesperson warned, adding that policymakers should not base their treatment decisions on the ICER’s “flawed analyses.”
Novartis, Exelixis and Pfizer did not immediately respond to Fierce Pharma’s request for comment on the matter.