Hot topic: NICE opens the purse strings – a bit

In a few weeks’ time NICE – England and Wales’s drugs cost regulator – is set to make it a little easier for drugs to be approved for NHS use on cost grounds. 

Specifically, the cost ceiling is going to rise. This ceiling – the so-called “QALY threshold” – is actually a range. And that range is going to go up from £20 – £30,000 for a year’s supply to £25,000 to £35,000. 

This is the first time the threshold will have risen since the National Institute for Health and Care Excellence (NICE) was created in 1999. 

Why is this happening now? Pressure from two sides. 

Pharma firms have made it clear they’ll dial back investment in the UK if the NHS doesn’t pay more for their meds.  

And the Trump administration has been blunt in using trade tariff talks as a lever to raise what the NHS pays for US drugs. 

Interestingly, when NICE confirmed back in December that it would be raising the thresholds, it explicitly stated that the reason for the change was “to improve the operating environment for pharmaceutical companies in  the UK” and “to support the sector”. 

The question is: which drugs are likely to get green-lighted for NHS use now, that wouldn’t have before? 

One. New cancer drugs could benefit, as they often sit a bit above NICE’s existing threshold. Here, all eyes are on whether AstraZeneca’s ADC Enhertu will be green-lit in more breast cancer indications. There’s been considerable disappointment that NICE has only approved it in narrow indications so far. 

Two. Drugs for severe chronic conditions like automimmune, cardiac or lung diseases. 

Three. Drugs for certain rare diseases – although not those for ultra-rare indications. 

NICE estimates raising the threshold will allow it to recommend another three to five medicines a year, which it would not have done previously. 

Raising the QALY threshold isn’t the only significant change being made though. 

There’s also going to be more weight placed on how a drug improves quality of life, such as improving function or reducing pain. This comes after NICE conducted an exercise asking thousands of people what they valued in medicines.  

All in all, these changes are going to make it a little easier for a drug to be approved for use on the NHS in England and Wales. A modest but significant change. 

Watch this week’s hot topic below!

Further reading: 

https://www.thevesey.co.uk/blog/evaluating-the-cost-effectiveness-of-medical-treatments 

https://www.nice.org.uk/news/blogs/should-nice-s-cost-effectiveness-thresholds-change- 

https://www.abpi.org.uk/media/blogs/2025/october/why-the-government-must-urgently-raise-the-nice-cost-effectiveness-threshold/ 

https://www.nice.org.uk/news/articles/changes-to-nice-s-cost-effectiveness-thresholds-confirmed