NICE unveils long-awaited review of methodologies

NICE has unveiled a long-awaited review of its health technology evaluation methodologies – however a re-think on its core ‘QALY threshold’ approach won’t be included.

England’s cost effectiveness watchdog has just celebrated its 20^th anniversary, and has often had a fractious relationship with the pharma industry over those years, especially when drugs have been rejected because of cost or lack of evidence. However, the sector also sees positive NICE recommendations as a way to ensure faster uptake in frontline NHS organisations, and is nowadays broadly supportive of the organisation's approach.

The new review is taking place because of commitments the government made when it agreed the 2019 Voluntary Scheme for Branded Medicines Pricing and Access. which came into force in January.

NICE says the review will explore evaluation methods in support of the NHS’ goal of providing faster access to new technologies to more patients.

This will include how it should deal with uncertainty around clinical and cost effectiveness data for new medicines at launch.

NICE says greater use of ‘data analytics and real-world evidence’ could play a part in how it might revise its methodologies.

A short-list of topics has been put forward, with any proposals for change being present for public consultation in the summer of 2020.

Topics scheduled for consideration in 2020 include:

• How quality of life is incorporated into economic analyses and considered by committees.
• Technology-specific issues (for example, addressing the challenges of evaluating the new generation of treatments that have been developed to target tumours according to their genetic make-up rather than where they originate in the body).
• The methods needed to assess the clinical and cost effectiveness of the position of technologies in the care pathway.

Sir Andrew Dillon, NICE chief executive, said the update was a regular “review and refresh of our methods to ensure that they are robust and up-to-date.”

He added: “NICE is undertaking this review at a time of unprecedented change in the healthcare system, where developments such as personalised medicine, digitalisation of health, and use of cell and gene therapy, mean products are becoming ever more challenging to evaluate.

“Keeping NICE’s methods up to date is an important contribution to managing these changes. The expanded Accelerated Access Collaboration, and the development of NHS England’s commercial framework are other important elements.

NICE has also outlined further review areas to be completed after 2020. Among these topics are the evaluation of new genomic technologies, and the reviewing of methods used to assess digital health technologies.

The review has been welcomed by the UK industry association the ABPI.

“This review is a critical opportunity to ensure NICE’s methods are fit for the future and suitable for assessing the value of medicines being launched now and in the future.

“Industry is working closely with NICE and other key stakeholder groups during the review to help deliver this ambition."

However the pharma sector will be disappointed that the review will not include NICE’s core methodology, the quality-adjusted life years (QALY).

This formula weighs up the cost of the drug for a year against the extension of life and improvement in the quality of life.

The current limit is set at around £30,000 per QALY, a threshold that was agreed to by both sides in the 2019 voluntary scheme. During negotiations, the government had threatened that it might be lowered, which would have made it more difficult for high cost treatments to gain recommendation.

Nevertheless, UK pharma will hope that the changes to other elements of the appraisal process - including a broadening of what data is considered eligible for appraisal - could help ease products to market.

The announcement coincides with a recent step-change in the speed of NICE reviews, and in the number of significant positive recommendations.  Factors behind this include the greater role for NHS England, who are able to negotiate directly on price with pharma, and with a new fast-track system recently introduced by NICE.