21 We aim to establish the most up to date description of the order innovativeness of new drugs launched in the UK, and to understand whether the recent increase in drug launches represents increasing numbers of highly innovative new drugs being made available, or whether the apparent recovery in launch volumes is due to increasing numbers of drugs of limited additional therapeutic value. We adopted the criteria proposed by Aronson et al1 to define the degree of innovation based on an assessment of clinical usefulness and the nature of the innovation (table 1). Table 1 Criteria for determining clinical
usefulness and nature of pharmaceutical innovation, adapted from Aronson et al1 and Ferner et al10 Methods Data collection and definition of new drugs We obtained data on the numbers and characteristics of new drugs (NCEs and new biological agents) launched in
the UK each year from relevant editions of the British National Formulary (BNF). The BNF lists all preparations available for prescribing and/or dispensing in the UK, including prescription only and over-the-counter medicines. Information on the active ingredient and BNF chapter heading (organised into broad therapeutic areas) for every item in the ‘new preparations’ section of each BNF from edition 41 in 2001 to edition 64 in 2012 was obtained and entered onto a spreadsheet. The BNF also includes non-drug products (nutraceutical and medical foods, natural products, devices and diagnostic products), new salts and esters of existing chemical compounds, and generic or biosimilar preparations; these products
were excluded to leave only new drugs (full details given in online supplementary file 1).19 In addition, active and passive immunisations were excluded from the data as these typically follow different development and National Health Service (NHS) market access pathways to other drugs. Commercial pharmaceutical databases (Pharmaprojects, Informa Healthcare; and Adis R&D Insight, Springer International Publishing) were also used to determine whether a substance was a new drug at the date of UK launch. Different dosages of the same product were counted only once; different formulations of the same product, Entinostat for example, oral tablet and intramuscular injection, were counted once if they contained the same active ingredients, and multiple times if they contained different active ingredients. Different indications for the same product were counted once. Determination of innovation level The criteria proposed by Aronson et al1 (table 1) were used to determine the degree of innovation at the time of launch for all new drugs identified as entering the UK market between 2001 and 2012 (inclusive). Clinical usefulness and the process through which the innovation arose (nature of the innovation) were determined by simple searches of online sources, including the NHS Evidence web portal (http://www.evidence.nhs.