An article published in the British Medical Journal by IQWiG has argued that over half of new drugs entering the German healthcare system demonstrate no new benefit, and called for reform.
The article’s lead author heads drug assessment at IQWiG – Institut for Quality und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Healthcare), Germany’s HTA body, therefore the article accurately covers the workings of the system. However, the overall argument of the piece gives little space to the reality that drugs showing no additional benefit will not gain reimbursement beyond existing standard of care.
The piece notes that despite 58% of medicines not being found to have added benefit, only 1% are found to be inferior to standard of care. Of the medicines found to be unproven, most were not assessed because their trial data did not use IQWiG’s preferred comparator (51%), or treatment regimen/dose (34%). Only 15% were rejected because they failed to show sufficient evidence of efficacy.
The article is highly critical of early-stage assessment for new drugs, challenging the recent trend for accelerated assessment methodologies, for example NICE’s commitments as part of the UK’s 2019 VSBMPA pricing scheme, or its Cancer Drugs Fund model.
It is unclear how the arguments made in the article would be reconciled with various classes of innovative new drugs, for example gene therapies, which tackle very long-term diseases, where mature evidence of long-term effectiveness cannot be feasibly collected within practical timeframes.
The article also criticises so-called “me-too drugs” for diverting R&D resources away from more substantial innovation. While this may be a legitimate criticism of some manufacturers, the authors do not consider the value of a diverse range of therapies in ensuring healthy market competition, which may down prices and benefit patients’ access to new medicines.
See the full publication here.