The UK's National Institute for Health and Care Excellence on Thursday disclosed plans to introduce a fast-track process for appraising new cost-effective therapies that could allow products to be made available on the NHS nearly three months earlier than under the current system. NICE chief executive Andrew Dillon remarked "we want to be more agile and flexible in the way we make decisions about new drugs, medical devices and diagnostics, so that patients can get access to them more quickly and the NHS can manage its resources fairly and efficiently."
Specifically, the agency said treatments that are estimated to have a cost per quality-adjusted life year (QALY) of no more than 10 000 pounds ($12 255) would be assessed under a "lighter touch" process. For drugs qualifying for the fast-track process, final NICE guidance would be issued immediately after marketing approval.
"NICE and NHS England believe these proposals represent a fair approach to the significant challenge of providing faster access to innovative, cost effective treatments alongside the need to safeguard future financial sustainability," Dillon stated. NICE is accepting public consultation on the proposal until January 2017.
Meanwhile, NICE also indicated it is working with NHS England to introduce a cost effectiveness level of 100 000 pounds ($125 548) per QALY for its Highly Specialised Technologies programme.NICE noted that the proposed level for the programme, which examines treatments for very rare diseases that are commissioned nationally by NHS England, is five times the usual level it uses. The agency added that drugs exceeding this amount will be considered for funding by NHS England when prioritised with other therapies for rare diseases.
Commenting on the news, the Association of the British Pharmaceutical Industry (ABPI) said the proposals would have "a significant impact on how new medicines will be brought to patients in the UK." However, the group added that while it "[shares] the objectives set out by NICE and NHS England to improve efficiency, manage affordability in the NHS and ensure decisions are reached reliably on medicines for rare diseases…we think the thresholds and methodologies proposed in this consultation can be changed and improved." The ABPI noted that it will be working with NICE and NHS England "to ensure the thresholds are set at the right levels and in a way that maximises the speed with which NHS patients can get access to those medicines."
In a previously announced plan, the UK government's Office for Life Sciences (OLS) had proposed accelerating access to innovative drugs by bypassing NICE clearance. In 2014, the government unveiled the Early Access to Medicines scheme to provide access to promising drugs for rare diseases after an initial scientific assessment by the Medicines and Healthcare Products Regulatory Agency (MHRA).
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