New drugs: where did we go wrong and what can we do better?BMJ 2019; 366 doi: https://doi.org/10.1136/bmj.l4340 (Published 10 July 2019) Cite this as: BMJ 2019;366:l4340
- Beate Wieseler, head of department of drug assessment,
- Natalie McGauran, researcher,
- Thomas Kaiser, head of department of drug assessment
- Institute for Quality and Efficiency in Health Care, Cologne, Germany
- Correspondence to: B Wieseler
Medicines regulators around the world are pursuing a strategy aimed at accelerating the development and approval of drugs.12 These approaches are based on the assumption that faster access to new drugs benefits patients. The rhetoric of novelty and innovation creates an assumption that new products are better than existing ones.
But although gaps in the therapeutic armamentarium undoubtedly exist, research covering drug approvals since the 1970s suggests only a limited number of new drugs provide real advances over existing drugs.3456789 Most studies put the proportion of true innovation at under 15%, with no clear improvement over time.
No evidence of added benefit for most new drugs
By law, the German health technology assessment agency IQWiG (Institute for Quality and Efficiency in Health Care) must investigate the added benefit of new drugs compared with standard care. The classification of added benefit—as minor, considerable, or major—depends on the importance of the outcome and magnitude of the treatment effect, and the information affects pricing and treatment decisions (box 1).
Early assessment of benefit of new drugs in Germany
On 1 January 2011, Germany introduced early benefit assessment (Frühe Nutzenbewertung) of new drugs through the reform of the market for medicinal products act (AMNOG). Its aim is to determine whether a new drug has any added benefit over standard care. The Federal Joint Committee (G-BA), the main decision making body within the German statutory health insurance system, is responsible for the assessment procedure and ultimately decides on the added benefit.
The G-BA specifies the standard care based on criteria laid down in the law. According to these criteria, standard care is an approved and reimbursed intervention that …RETURN TO TEXT