More than half of new drugs entering the German healthcare system have not been shown to add benefit, argue researchers in The BMJ today.
Beate Wieseler and colleagues at the German health technology assessment agency IQWiG (Institute for Quality and Efficiency in Health Care) say that international drug development processes and policies are responsible and must be reformed.
Between 2011 and 2017, IQWiG assessed 216 drugs entering the German market following regulatory approval, they explain. Almost all of these drugs were approved by the European Medicines Agency for use throughout Europe.
Yet only 54 (25%) were judged to have a considerable or major added benefit. In 35 (16%), the added benefit was either minor or could not be quantified. And for 125 drugs (58%), the available evidence did not prove an added benefit over standard care in the approved patient population.
The situation is particularly shocking in some specialties, they add. For example, in psychiatry/neurology and diabetes, added benefit was shown in just 6% (1/18) and 17% (4/24) of assessments, respectively.
Some people have argued that limited information at the time of regulatory approval (and thus widespread use by patients) is the price to be paid for early access to innovative drugs, explain the […]
