Posted by Michael Wonder on 06 Jul 2023
Extension of indications in drug approval: often without proof of additional benefit
6 July 2023 - In a comment in the BMJ, the head of the IQWiG Department for drug assessment advocates approval regulations that promote drugs with proven additional benefits instead of me-too preparations.
A study by a research team from Harvard published in the BMJ, based on health technology assessments from Germany and France, confirms a trend that has been apparent for some time: while at least every second new drug in its first area of application has a proven effect on those affected additional benefit compared to standard treatment, this proportion decreases with each additional indication for which approval is subsequently granted.
