A study published by The BMJ has raised concerns about the efficacy and added benefits of many cancer drugs approved by the European Medicines Agency (EMA) between 1995 and 2020.
This comes at a time when global oncology drug spending is expected to surge from $167 billion in 2020 to $269 billion by 2025, according to the study’s findings. [Source]
The researchers specifically highlight the gap in the added benefits of drugs approved through expedited pathways, such as the “fast track” process.
“Many cancer drugs approved…lack proof of added benefit, particularly those approved through expedited pathways,” the study notes, pointing to a troubling trend in the pharmaceutical industry’s push for profitability over patient-centric outcomes.
The concept of “added benefit” is a key measure in healthcare, evaluating a new drug’s therapeutic advantage over existing treatments.
The findings of this analysis suggest a misalignment between drug pricing, research and development (R&D) costs, and the tangible value these medications deliver to patients.
This is a direct challenge to the industry’s justification of high drug prices to offset R&D expenses.
Remarkably, the study reveals that more than half of the drugs evaluated, including those with minimal or no added benefit, recouped their R&D expenses within three years of market entry.
This rapid return on investment stands in stark contrast to the drugs’ clinical value, with a significant portion showing “negative or non-quantifiable added benefit,” particularly among those fast-tracked for approval.
“This underscores the need for better alignment between regulatory and reimbursement processes, particularly for drugs approved through expedited pathways,” the researchers state, advocating for reforms to ensure that only the most beneficial drugs reach patients in need. [Source]
The study draws on ratings from four health technology assessment agencies, two medical oncology societies, and a drug bulletin. [Source]
The disparity in added benefits across different EMA approval pathways is also evident, with drugs approved under conditional marketing authorization (CMA) and authorization under exceptional circumstances (AEC) more likely to receive lower benefit ratings compared to those approved through standard processes.
Further, the analysis challenges the pharmaceutical industry’s narrative that high prices are necessary to recover R&D costs.
“Drug revenues generally increased in line with added benefit…even those lacking proof of added benefits managed to recover the median R&D costs of $684 million within three years,” the study points out, suggesting that the industry’s pricing strategies may not always align with the drugs’ therapeutic advancements.
The study provokes a reexamination of the drug approval process and a rethinking of the value we place on human health versus economic gain.