The National Institute for Health and Care Excellence (NICE) and NHS England have proposed changes to NICE’s drug appraisal process so that some treatments become available more quickly to patients.
The proposals, announced on 13 October 2016 as part of a joint consultation by NICE and NHS England, involve the introduction of a new “fast track” process for treatments deemed to offer “an exceptional value for money”.
NICE says this means that technologies with a quality-adjusted life year (QALY) of up to £10,000 will be dealt with more quickly under a “lighter touch” process.
NHS England will make funding for such drugs and devices available within 30 days compared with the existing 90-day requirement.
Sir Andrew Dillion, chief executive of NICE, England’s health technology body, says: “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.
“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,” he adds.
NICE says it will also sync its approval process for fast-track treatments with the European Medicines Agency. It will aim to publish final guidance for the NHS immediately after the drug receives its European marketing authorisation.
The proposals also introduce a ‘budget impact threshold’ of £20m per year. This means that technologies that receive a positive NICE opinion but exceed this threshold would trigger negotiation between NHS England and the drug’s manufacturer to bring the annual cost down.
The plans also suggest that NHS England should have the scope to ask NICE to vary the standard funding requirement and allow a longer period of phased introduction for treatments whose costs exceed the budget impact threshold. NICE estimates that 80% of technologies approved between June 2015 and June 2016 would have been unaffected by this threshold.
The proposals also include plans for automatic funding for treatments for rare diseases that cost under £100,000 per QALY — five times higher than NICE’s standard lower threshold of £20,000. Manufacturers of treatments that surpass this threshold would still have the opportunity to apply to NHS England’s prioritisation process for treatments for rare conditions.
Diana Jupp, acting chief executive at blood cancer charity Bloodwise, says the charity welcomes this aspect of the proposals to improve access to therapies for rare diseases but says the consultation does not address some of the wider concerns around the NICE appraisal process.
“There are highly effective blood cancer drugs that are struggling to get approved by NICE, and proposals in this consultation don’t respond to the problems in the current system,” she says.
“In addition, whilst it is right that affordability is managed in the NHS, we are concerned that the budget impact threshold could provide another barrier in the [health technology assessment] process to patients accessing effective medicines.”
Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, says the proposed changes will have a major impact on the way treatments are approved and it is important to ensure the thresholds involved are set at the right level.
“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,” says Thompson. “However, we think the thresholds and methodologies proposed in this consultation can be changed and improved.”
He adds: “Medicines in the UK are already subject to rigorous value assessment by NICE and cost controls through a deal with the government that already caps NHS medicines spend. Any decision to implement further restrictions needs to be appropriate, in the best interest of patients, and needs to support the future investment in medicines of the future.”
The consultation is open until 13 January 2017.