NICE proposes faster process to appraise cheaper drugsBMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5592 (Published 18 October 2016) Cite this as: BMJ 2016;355:i5592
The National Institute for Health and Care Excellence (NICE) has announced proposals for a “fast track” appraisal process for drugs and other health technologies that offer “exceptional” value for money, together with clearer guidance on automatic NHS funding for any treatments it approves for very rare conditions.1
The proposals, which are part of a joint consultation by NICE and NHS England, would mean that treatments likely to have a cost per quality adjusted life year (QALY) of less than £10 000 (€11 065; $12 160) would be assessed using a “lighter touch” process.
Under the new scheme, treatments would be available on the NHS nearly three months sooner than under the current standard technology appraisal process. NICE would publish its final guidance immediately after a treatment receives its licence, without issuing draft recommendations for consultation. And approved technologies would be funded by NHS England within 30 days of NICE guidance being published, rather than the current 90 days.
Andrew Dillon, chief executive of NICE, said, “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.
“By further streamlining our processes we will ensure that treatments that clearly offer exceptional value for money will be available to the patients who need them faster than ever before.”
The new proposals also recommend a new “budget impact threshold” of £20m a year for improving how the NHS manages treatments that are considered cost effective despite having a high cost and significant impact on NHS budgets. The threshold, which NICE estimates would apply to around 20% of the drugs it currently appraises, would trigger discussions about potential “commercial agreements” between NHS England and companies.
Dillon explained, “Where the introduction of a new treatment places a large, immediate demand on NHS budgets, the impact of their introduction on other services has to be taken into account in managing their adoption.
“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.”
Further proposals suggest a new cost effectiveness level of £100 000 per QALY, below which highly specialised treatments for rare diseases approved by NICE would automatically qualify for NHS funding. NICE’s highly specialised technology (HST) programme, which looks at treatments for very rare diseases that are commissioned nationally by NHS England, does not currently have a cost effectiveness threshold.
The new proposals are available on the NICE website (www.nice.org.uk) for public consultation until 13 January 2017.