UK pharma slams new drug evaluation plans

The trade association for the UK pharmaceutical industry says proposals on the evaluation and funding of new medicines will have a "detrimental effect on patient care".

The proposals - developed by the National Institute for Health and Care Excellence (NICE) and NHS England - were unveiled last October and promised a "lighter touch" on appraisals that would allow patients to get access to new drugs offering "exceptional value for money" more quickly.

The fast-track - which would apply to drugs with an incremental cost-effectiveness ratio of £10,000 per quality-adjusted life year (QALY) - came alongside a pledge to automatically fund rare disease therapies up to £100,000 per QALY and a proposed budget cap of £20m to "signal the need for a dialogue with companies to agree special arrangements, to better manage the introduction of new technologies recommended by NICE".

The Association of the British Pharmaceutical Industry (ABPI) gave a guarded response to the proposals when first revealed but has now come to the conclusion that some of the elements could create "further delays in accessing medicines for a large number of NHS patients".

The group welcomes the fast-track scheme for drugs with a budget impact of less than £10,000 per QALY, a threshold which is estimated to have applied to around 15% of new drug appraisals to date. However, the £100,000 per QALY upper limit for rare diseases is "arbitrary" and will have a "detrimental impact on the development of new products for those who desperately need them".

That view was also voiced by the BioIndustry Association (BIA), which pointed out that many treatments for very rare conditions have costs per QALY of £500,000 or more and said QALY thresholds "are not appropriate for evaluating medicines for very rare diseases, due to the small patient populations, often limited data and uncertainty in the figures produced".

The ABPI is particularly scathing about the budget cap, arguing that as all new drugs approved by NICE have already gone through a process to ensure they are cost-effective and clinically beneficial, this is "both heavy-handed and unrealistic and will mean more patients face delays in accessing appropriate NHS care".

"The ABPI agrees with NHS England's objective of developing a workable solution for managing the introduction of new medicines which are likely to create significantly high costs to the NHS," said the trade group's chief executive Mike Thompson.

"Better long term planning by the health service would ensure that major breakthroughs are managed into the NHS in an appropriate and affordable way and with less disruption," he added.