As such, we characterised a number of first in kinase inhibitor class drugs as moderately rather than highly innovative. However, we recognise that the criteria are qualitative rather than quantitative, requiring some value judgement to implement, and that some benefits or harms may not be apparent early in a product lifecycle, both of which could lead to misclassification (or differences in classification depending on viewpoint) that vary with time. Other commentators have further developed ideas of what constitutes therapeutic advantage and innovation to propose three axes
of pharmaceutical innovation22: context of use (including existing treatment options), product novelty (chemical, pharmacological and pharmaceutical) and impact (efficacy, safety and ease of use with respect to existing therapies). However, none of these criteria
take direct account of the public health and health service impact of a new drug (disease severity, patient group size and likely uptake); drugs in the highly innovative group include those for rare metabolic disorders and last line therapies as well as for diabetes mellitus and common malignancies. Patient group size is one factor related to commercial success,23 but the link with pharmaceutical novelty is less clear. A study of new drugs approved in the USA found a small commercial benefit for first in class as compared with follow-on drugs of the same class.24 However,
this could be overcome by demonstrating a clear therapeutic advantage, launch in a therapeutic area characterised by ‘cycling’ of different drugs as initial therapy fails, and effective marketing. Other commentators have noted the high degree of drug utilisation relating to subsequent indications rather than the initial approved indication, and suggest that much innovation and commercial productivity is not captured when considering new drug launches only,25 and this should be the focus of further study. The low levels of innovation observed in this study are of clear concern to policymakers, who have responded with a range of Entinostat initiatives to better reward innovation (including extending periods of market exclusivity in some circumstances26 27), speed access to market, increase the collaboration between commercial developers and health services (including joint scientific advice with regulators), fund basic and translational research programmes, and increase the productivity of pharmaceutical development through reducing the cost and complexity of drug development.28 In the UK, technology appraisals undertaken by NICE permit ‘the innovative nature of a technology’ to be considered as part of its deliberations, allowing a higher opportunity cost than would usually be accepted.