More than half of new drugs entering the German healthcare system have failed to demonstrate any added benefit.

A recent analysis published in The BMJ examines the process and policy surrounding the development of new drugs and their introduction into the German healthcare system. The authors debunk the myth of innovation - the fallacy that something new is necessarily an improvement on what existed before. 

'the rhetoric of novelty and innovation creates an assumption that new products are better than existing ones'

Researchers from IQWiG (The Institute for Quality and Efficiency in Health Care) argue “the rhetoric of novelty and innovation creates an assumption that new products are better than existing ones” but research on drug approvals since the ‘70s demonstrates that only a miniscule number of new drugs offer any advantage to or significant improvement on drugs already in circulation. 

IQWiG, a German body governing advances in health technologies, classifies new drugs according to their increased benefit as minor, considerable, or major. Their assessment of 216 drugs entering the German market between 2011 and 2017 revealed nearly 75% of these drugs were shown to have either minor or no added benefit to consumers. Furthermore, a lack of sufficient studies, and in some cases plainly erroneous studies, lead to inconclusive evidence of drug efficacy in over 100 drugs examined. 

Moreover, post-approval studies rarely happen. In the instance of this 2011-2017 German study, none of the post-approval studies requested by the assessment body were completed. 

This lack of information and research available on newly developed drugs makes it difficult, if not impossible, for doctors and patients to gauge how treatments will affect them. 

The authors from IQWiG argue a new approach to decision and policy making is necessary. Regulatory agencies need to demand more robust evidence and become less tolerant of shortened development programs. Information gaps need to be closed with mandatory requirements for controlled trials of new drugs. And, pricing and reimbursement decisions should avoid ‘incentivising marginal outcomes’. Expected benefits should be determined at the outset of development and research, and drug pricing be set at a level that directly correspond to patient results. 

The paper concludes that policy-makers need to take a more ‘proactive’ approach rather than waiting to see what drug manufacturers decide to develop, and how. Drugs ought to be developed based on urgent needs identified within the health system rather than based on the assumption that newness necessitates advancement.