Fast-tracking drugs through streamlined collaboration
Source: NHE Nov/Dec 16
An ongoing consultation by NICE and NHS England is proposing a series of important changes to the way the bodies appraise new drugs and technologies in the country. NHE’s Luana Salles reports.
NHS England and NICE have kick-started a 12-week joint consultation on proposed changes to how the bodies evaluate and fund drugs and other health technologies, including plans to work more closely together to speed up appraisals processes.
The changes seek to overhaul and simplify the arrangements for reviewing drugs through NICE’s Technology Appraisal and Highly Specialised Technologies programmes, such as by introducing a ‘fast-track’ system for the most promising new technologies in order to get treatments to patients faster, or determining new ‘budget impact thresholds’.
The fast-track system will account for technologies that fall below an incremental cost-effectiveness ratio of £10,000 per QALY (quality-adjusted life year), meaning a “confident judgement about value for money” can be made at an early stage. This accelerated route would be a variant of the standard technology appraisal process, cutting the time it takes to make an evidence submission through to the publication of final guidance from 43 to 32 weeks. At present, around 15% of NICE’s technology appraisals fall at or below £10,000 per QALY in the final guidance.
The criteria for using this proposed route would include the availability of strong evidence that products are cost-effective, and an estimate that the new technology would fall under the proposed budget impact threshold for the full patient population relevant to the appraisal. Companies would be able to indicate that they want their products to follow a fast-track appraisal, after which NICE would analyse the submission and decide whether or not the fast route is appropriate.
Fast-tracked technologies that fall under these pre-determined goalposts would then be provided with access to NHS funding within 30 days of the publication of final guidance, rather than the current 90. NICE estimates that using this new route would result in a 25% saving in process time compared with standard appraisals.
Dr Jonathan Fielden, NHS England’s director of specialised commissioning and deputy national medical director, argued the fast-track process will “significantly speed up access”, making it good for patients, taxpayers and pharmaceutical companies “willing to work with us and price their products responsibly”.
New budget thresholds
The consultation, which closes on 13 January, also mooted a new budget impact threshold of £20m per year, which would apply to treatments deemed cost-effective but that still have a very high cost. This threshold will both trigger discussions about potential ‘commercial agreements’ between NHS England and companies, and will help decide the circumstances in which NHS England may ask NICE to consider varying the standard 90-day limit that providers have to make funding for recommended treatments available. Around 80% of treatments appraised by NICE fall below this proposed threshold.
It has also been suggested that NICE and NHS England’s separate processes for evaluating highly specialised technologies could be linked. For this, the bodies recommended automatically funding, from routine commissioning budgets, treatments for very rare conditions up to £100,000 per QALY – five times greater than the lower end of NICE’s standard threshold range – while also providing the opportunity for treatments above this range to be considered through NHS England’s own process.
Agile and flexible
Sir Andrew Dillon, NICE’s chief executive, argued that these headline proposals form part of a desire to be “more agile and flexible” in the way decisions are made about new drugs, devices and diagnostics.
“The pace and scale of innovation in the NHS require NICE and NHS England to collaborate closely to ensure patients are benefiting from faster access to the most cost effective treatments,” he added.
“By further streamlining our processes we will ensure treatments that clearly offer exceptional value for money will be available to the patients who need them faster than ever before. 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.”
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