The Association of the British Pharmaceutical Industry has described new proposals for evaluating medicines for NHS use as "heavy handed" and "unrealistic".
NHS England and the National Institute for Health and Care Excellence are planning a series of modifications to the appraisals system, the idea being to secure faster access to the most cost-effective medicines for patients.
Among the proposals is to automatically fund, from routine commissioning budgets, treatments for very rare conditions up to £100,000 per QALY, and provide the opportunity for treatments above this range to be considered through NHS England's process for prioritising other highly specialised technologies.
Other key changes include the introduction of a 'fast track' NICE technology appraisal process for the most promising new technologies, which fall below an incremental cost-effectiveness ratio of £10,000 per QALY, and a 'budget impact threshold' of £20 million, set by NHS England, to signal the need for a dialogue with companies to agree special arrangements to better manage the introduction of new technologies recommended by cost watchdog.
But the ABPI said it believes the proposals in their current form "will have a detrimental impact on patient care for patients with rare diseases and may create further delays in accessing medicines for a large number of NHS patients".
The Association did voice support for the fast-track programme, which, it says, should see patients benefitting from innovations much faster.
"However, given that all new drugs approved by Nice have already gone through a process to ensure they are cost-effective and clinically beneficial, the proposal to impose a £20million budget cap on these medicines is both heavy-handed and unrealistic and will mean more patients face delays in accessing appropriate NHS care," said ABPI 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".
Also, the Association has "serious concerns" that implementing an arbitrary £100,000 cost per QALY for treatments for the rarest diseases "will have a detrimental impact on the development of new products for those who desperately need them and that this this proposal should be paused while a better solution is identified".
The BioIndustry Association has also criticised the proposal, arguing that as that many treatments for very rare conditions currently funded by NHS England have costs per QALY in excess of £500,000, introducing the new £100,000 per QALY threshold would interrupt access to rare disease therapies.
It also said NHS England's prioritisation process - which would look at all rare disease therapies coming in above the threshold - is "not fit for purpose as it takes little account of unmet medical need, burden of illness and impact on patients and carers".