A study by The BMJ in Europe reveals that less than half of the approved first indications for new drugs between 2011 and 2020 provide substantial therapeutic value over existing treatments. Additionally, only about a third of supplemental approvals offer substantial therapeutic value compared to first indications. The researchers suggest that when these indications do not offer added benefits, it should be clearly communicated to patients and reflected in the price of the drugs. The study found that 48% of drugs in both regions had one supplemental indication, and a significant percentage had multiple indications. Therapeutic ratings from French and German health technology assessment bodies revealed that first indications had higher therapeutic value ratings compared to supplemental indications. The researchers suggest aligning current legislation on drug development with defined public health goals to improve patient outcomes and meet public expectations.

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