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Fewer than half of new drugs add substantial value over existing treatments

A recent study published in The BMJ examined the effectiveness of new drugs that are approved for multiple uses. The study found that less than half of the initial approved uses for these drugs in the United States and Europe actually provided significant therapeutic benefits compared to existing treatments. Additionally, only about a third of additional approved uses showed substantial therapeutic value when compared to the original uses. The researchers suggest that when these new uses don’t offer added benefits, patients should be informed about it and the price of the drugs should reflect their value.

The researchers looked at data from 2011 to 2020 and analyzed the therapeutic value of 124 initial uses and 335 additional uses approved by the US Food and Drug Administration (FDA), as well as 88 initial uses and 215 additional uses approved by the European Medicines Agency (EMA). They found that almost half of the drugs had one additional use, and some had even more. Most of the approved uses were for treating cancer.

When they examined the ratings given by French and German health technology assessment bodies, they found that 41% of the initial uses and 34% of the additional uses approved by the FDA had high therapeutic value ratings. In Europe, 47% of the initial uses and 36% of the additional uses received high ratings.

The study also showed that when they focused on the first three approved uses, the second and third uses were less likely to have high value ratings compared to the first use.

It’s important to note that these findings are based on observations and not all uses were rated for therapeutic value. The researchers recognize that the assessment methods and scoring system can be influenced by factors specific to each country. However, they conducted additional analyses to confirm the initial results.

In summary, the study found that less than half of the approved initial uses of new drugs in the US and Europe provided significant therapeutic benefits, and the additional uses had even lower rates of value. The researchers stress the need for clear communication with patients when new uses don’t offer added benefits, and they believe the pricing of the drugs should reflect their value.




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