Personalised medicines account for 60% of the over 5,600 active products currently in the global pharmaceutical industry’s R&D pipeline, but the UK healthcare system is at risk of failing to adapt to this new challenge, new research warns.

For the UK’s commercial environment to respond to this challenge, a fundamental shift in Health Technology Assessment (HTA) approaches is needed, says the report, which has been published by the Association of the British Pharmaceutical Industry (ABPI).

The UK has made good progress in stratified medicine with the assessment processes set up by the National Institute for Health and Care Excellence (NICE) for diagnostics, says the study. However, using the incremental cost-effectiveness ratio (ICER) threshold approach in technology appraisals, many oncology drug are not being recommended by NICE, even with the supplementary end-of-life criteria introduced by NICE in 2009, it adds, and points out that the Cancer Drugs Fund (CDF), which will now run until 2016, has helped many NHS patients gain access to new cancer medicines not appraised or recommended by NICE.

It also notes that the Scottish Medicines Consortium (SMC)’s recent review of its processes for rare diseases and end-of-life care recommends more flexible approaches for their assessment, while NICE’s Highly Specialised Technology (HST) programme has the potential to make a big difference as to how specialist medicines for very rare diseases are evaluated.

The report also highlights further challenges, including the increasing costs of drug development and difficulties with patient recruitment for clinical trials; around 80% of trials do not meet patient recruitment timelines and trials last, on average, 30%-42% longer than companies initially plan for, it says. To remedy these problems, the authors call for trial performance in the UK to be improved by enabling faster patient enrolment, encouraging the use of electronic health records and streamlining the research governance process.

“Whilst companies are refocusing their pipelines towards specialised and stratified medicines, a gap is opening up between the commercial environment the industry currently operates in and the new R&D environment the industry is moving towards. If we don’t address this gap soon, patients will be unable to access the best treatments and the UK economy will suffer,” warns the ABPI’s chief executive, Stephen Whitehead.

“It is vital that our industry continues to work closely with the NHS and academia to ensure that we become a world leader in stratified medicine, as well the location of choice for pharmaceutical R&D from across the globe,” he emphasises.