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Few Modern Drug Approvals Offer Therapeutic Value Over Older Treatments, Study Says


Healthcare stakeholders suggest system changes, proving therapeutic value.

Generative AI - Background with many different medications. Image Credit: Adobe Stock Images/nastyakamysheva

Image Credit: Adobe Stock Images/nastyakamysheva

In a study published by the BMJ, results say that although a significant number of drugs are receiving approval in the US and Europe, less than half are offering therapeutic value to patients. Examining a group of 124 first indications between 2011 and 2020, 47% in Europe and 41% in the US received high therapeutic value ratings. The authors concluded that information should be clearly communicated to patients and be reflected in the drug pricing when therapeutic value is not added over other available treatments. Healthcare stakeholders further suggested all medications must be required to provide therapeutic value in order to receive approval.

Relying on therapeutic value ratings from European health technology assessment (HTA) groups, the study acknowledged that ratings were not available in the US. Currently, the US doesn’t employ the HTA system frequently.

References: Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study, The BMJ. July 5, 2023. Accessed July 7, 2023. https://www.bmj.com/content/382/bmj-2022-074166

Less Than Half of New Drug Approvals Add Therapeutic Value Over Existing Treatments: Study. BioSpace. July 6, 2023. Accessed July 7, 2023. https://www.biospace.com/article/less-than-half-of-new-drug-approvals-add-therapeutic-value-over-existing-treatments-study-/?s=89

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