After two decades, NICE begins consultation on drug assessment methods

The UK’s drug cost-effectiveness body NICE has launched a public consultation, presenting the case for change about how it assesses medicines, medical devices and diagnostics.

NICE has been assessing medicines for 21 years using the Quality Adjusted Life Year (QALY) – the cost to ‘buy’ a patient a year of quality life – as its main methodology.

Big pharma was never going to be happy about the existence of a body like NICE, which is designed to drive down prices paid by the taxpayer-funded NHS, by far and away the largest payer in the UK.

While industry has begrudgingly found ways to work with NICE to get drugs to the UK market, there have been numerous occasions where manufacturers have felt short-changed by the process and in some cases seen drugs failing to get funding on technicalities.

It’s still true that most drugs are eventually funded after a NICE assessment.

But the consensus is that despite tweaks to the system over the years, reform is needed to keep apace with developments in fields such as cancer.

NICE uses the Cancer Drugs Fund to provide interim reimbursement for cancer drugs that require more survival data and allows more flexibility for drugs used at the end of life.

And the cost-effectiveness threshold of £30,000 per QALY has not moved since NICE began, meaning that manufacturers’ wiggle-room on pricing has been constantly squeezed by inflation.

NICE’s consultation will ask whether additional factors should be included in decision-making, such as the severity of a condition and how health technologies can reduce health inequalities.

It is also asking whether there should be more flexibility in rare diseases, where generating evidence is difficult.

NICE wants feedback on how it assesses highly innovative technology, or those with potentially large benefits where risks could be managed.

The consultation will cover the role of evidence gathered outside clinical trials, such as real-world evidence and how NICE could refine its approach to measuring health-related quality of life in different circumstances.

NICE’s consultation follows an internal review of its number-crunching following commitments made in the voluntary pricing scheme that the government agreed with industry last year.

Steve Bates, chief executive of the Bioindustry Association said: "The proposed changes to NICE's methods published today send an important signal to the innovative biotech sector that the UK is serious about ensuring access to new medicines.

"We are very encouraged by the focus on removing significant barriers to access, which puts the UK on a new footing, setting the benchmark for health technology appraisals - particularly around modifiers, uncertainty and discounting. It will help ensure both that industry can continue to deliver innovative medicines and that patients can access them."