The Institute for Clinical and Economic Review (ICER) reports that five out of the ten drugs with the largest impact on US medical spending increases in 2023 lacked clinical evidence to justify their price hikes. These unjustified increases contributed to an $815 million rise in healthcare costs.
ICER’s analysis revealed that while half of the assessed drugs demonstrated price adjustments based on new clinical evidence supporting additional benefits or reduced harm, the remaining half lacked such substantiation. This concerning trend underscores a growing disconnect between pricing strategies and demonstrable clinical value in the pharmaceutical industry.
One notable example is Johnson & Johnson’s cancer drug, Darzalex. This marks the second time this year the drug has appeared on ICER’s list for price increases lacking clinical evidence. A 7.6% rise in Darzalex’s list price added approximately $190 million to US healthcare expenditures. A Johnson & Johnson spokesperson countered, stating that ICER’s methodology, which reflects the perspective of insurance companies rather than patients, is flawed and omits crucial information, including a recent FDA approval and several significant study reports.
Other drugs contributing to this trend include Gilead’s HIV treatment Biktarvy, Novartis’ heart medication Entresto, Exelixis’ cancer therapy Cabometyx, and Pfizer’s rheumatoid arthritis drug Xeljanz. According to Foluso Agboola, ICER’s Vice President of Research, Biktarvy’s contribution to the increased spending was the most substantial among the four. A Gilead spokesperson disputed the report’s findings, asserting that it disregarded key evidence on Biktarvy, including data leading to two FDA label updates and two clinical guideline revisions due to its significant clinical implications.
Agboola highlighted the persistent issue of list price increases significantly exceeding inflation rates for many high-cost medications. This observation echoes ICER’s findings from the previous year, where eight out of the ten highest-expenditure drugs saw substantial price increases, resulting in $1.27 billion in added costs.
While Merck’s Keytruda, another top ten most expensive drug, also experienced a 4.1% list price increase, ICER determined that this adjustment was supported by new clinical evidence. However, the report did not assess whether these price increases were fully justified based on a formal cost-effectiveness analysis and a corresponding health-benefit price benchmark. This nuanced perspective highlights the complexity of evaluating pharmaceutical pricing in the context of clinical outcomes and overall healthcare costs. The debate surrounding value-based pricing continues, with stakeholders seeking a sustainable balance between innovation, patient access, and affordability.
