Health officials are proposing to introduce a 'fast-track' appraisal system designed to accelerate patient access to new technologies most likely to offer the NHS exceptional value for money.
Under the plans - drawn up by NHS England and the National Institute for Health and Care Excellence - health technologies likely to have a cost per QALY (quality adjusted life year) of up to £10,000 would be assessed more quickly under a 'lighter touch' process.
Patients could benefit from 'fast-track' treatments much more quickly than is currently the norm, as final guidance would be published by NICE upon regulatory approval and NHS Funding made available within 30 days as opposed to the current 90 days.
A new 'budget impact threshold' of £20 million per year is also being proposed to help better manage the introduction of those treatments that are deemed cost effective but have a very high cost.
This threshold will be used to trigger discussions about potential 'commercial agreements' between NHS England and companies, as well as help determine the circumstances in which the standard 90-day requirement may be varied to so that the NHS can better absorb the impact of very high cost innovations.
The Institute also said it will consider requests where NHS England can show that the budget impact of introducing a new technology "would compromise its ability to properly fund other areas of its work".
"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," noted Sir Andrew Dillon, NICE chief executive.
Crucially, NICE and NHS England are also consulting on proposals to introduce a new cost effectiveness level of £100,000 per QALY, below which highly specialised treatments appraised by NICE will automatically qualify for NHS funding.
NICE's Highly Specialised Technology programme, which looks at treatments for very rare diseases that are commissioned nationally by NHS England, currently does not have a cost effectiveness level, which makes it difficult for companies to know how to frame their offer to the NHS.
Dr Jonathan Fielden, NHS England's director of Specialised Commissioning and deputy national medical director, said: "This new fast-track process for the most promising and cost effective new technologies will significantly speed up access, making this good news for patients, good for taxpayers and good for those pharmaceutical companies who are willing to work with us and price their products responsibly.
"Our proposals also provide clarity, for the first time, that the NHS is prepared to pay far more for effective highly specialised treatments appraised by NICE. These treatments, for patients with very rare conditions, will now qualify for automatic funding at a level that is five times higher than NICE's current limit. On top of this there will also be the added flexibility to negotiate with drug companies on those technologies which are cost effective but have a heftier price tag."
The Association of the British Pharmaceutical Industry said the consultation sets out a number of proposals "which have a significant impact on how new medicines will be brought to patients in the UK".
"We share 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. However, we think the thresholds and methodologies proposed in this consultation can be changed and improved".
