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.
% - Benefit - % - Benefit - Drugs
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.
People - Information - Time - Approval - Use
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 authors.
The reality, however, looks quite different. For instance, an evaluation of cancer drugs approved by the EMA between 2009 and 2013 showed that most had been approved with no evidence of clinically meaningful benefit on patient relevant outcomes (survival and quality of life), and several years later little had changed.
Studies - Regulators - Companies
What's more, postmarketing studies often do not happen and globally, regulators do little to sanction non-compliant companies, they write.
Evidence also suggests that many of the investigated drugs add benefit only in subgroups of patients. "For the overall patient population, the current output of drug...
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