A new study reveals that less than half of the approved new drugs for initial indications between 2011 and 2020 in the U.S. and Europe offer substantial therapeutic benefits over existing treatments.
Moreover, around a third of approvals for additional indications (supplemental indications) provide substantial therapeutic value compared to the initial ones.
The authors of the study argue that, when new indications do not offer significant therapeutic benefits over existing treatments, this information should be clearly communicated to patients and reflected in the drug prices.
Methodology and Results
To arrive at these conclusions, the researchers examined all new drugs approved for more than one indication in the U.S. and Europe from 2011 to 2020.
They assessed the therapeutic value of additional indications compared to the initial ones.
Data was gathered from public sources, revealing 124 initial and 335 supplemental indications approved by the U.S. Food and Drug Administration (FDA), and 88 initial and 215 supplemental indications approved by the European Medicines Agency (EMA) from January 2011 to December 2020.
Results indicated that 48% of drugs in the U.S. and Europe had one supplemental indication, and a significant majority (58%) of the indications approved by the FDA and EMA were for cancer treatments.
Therapeutic ratings were available for a majority of these approvals.
Among the FDA-approved indications with available ratings, 41% of the initial approvals had high therapeutic value ratings compared to 34% of the supplemental indications. In Europe, these numbers were 47% and 36% respectively.
Key Takeaways
While the findings are observational and have certain limitations, they are crucial as they indicate that “new” does not necessarily mean “better.”
Fewer than half of approved initial indications were rated as having high therapeutic value, and the proportion of approved supplemental indications rated as having high therapeutic value was substantially lower than for approved initial indications.
The researchers conclude that this lack of added therapeutic benefit should be clearly communicated to patients and reflected in drug pricing.
In a related editorial, Beate Wieseler from the German Institute for Quality and Efficiency in Health Care agrees that both patients and clinicians need to understand this.
She writes, “Having experienced the potential of a coordinated drug development effort during the COVID-19 pandemic, we should seek to align current legislation on drug development more closely with defined public health goals.”
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The study was published in The BMJ.
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