Government opens consultation to give it power over NICE thresholds

The Government is consulting on plans to give ministers the power to set cost-effectiveness thresholds for NICE decision making.

It follows a deal between the UK and US to increase the NICE cost-effectiveness threshold for new medicines in return for a 0% tariff on pharmaceuticals.

Now the Government has put forward its preferred option to give ministers a ‘limited power of direction’ to set the core cost-effectiveness threshold that NICE uses in developing guidance, including for technology appraisals.

It also wants to remove the requirement for NICE to consult on methods changes ‘where these result from a ministerial direction’.

The Government said the change was necessary to enable the threshold that NICE uses ‘to take into account a broader range of factors, such as industrial policy objectives, economic growth and investment’.

It said NICE would continue to be responsible for the wider methods and processes that it uses in the development of its guidance.

Critics of the UK-US deal have warned it could mean less money for other parts of the NHS.

But the Government said the agreement, which will see the NICE threshold rise from £20,000-30,000 per quality adjusted life year (QALY) to £25,000 to £35,000, would secure medicines access for NHS patients and boost confidence in the UK life sciences sector.

It would be the biggest change in the relationship between the Government and NICE since it was formed in 1999.

An impact assessment published alongside the consultation notes that currently the threshold can only be changed by the NICE board.

It continues: ‘It is important that decisions on critical elements of UK medicines policy which can make a strategic contribution to delivery of wider government objectives, or which need to be determined taking into account wider considerations outside health economics, such as the cost-effectiveness threshold, are subject to democratic control and accountability.’

Ministers could use the power to increase or decrease the threshold ‘to support Government objectives’ it notes.

The impact assessment cites the US medicines pricing deal as one example of how the Government may wish to use the powers to change NICE cost-effectiveness thresholds.

But there is a risk that such a move could be perceived to ‘undermine NICE’s independence’, it admits.

‘To mitigate this risk, the proposed direction-giving power would be very tightly defined, and ministers would remain unable to direct NICE as to the substance of its guidance,’ it adds.

Several health economists had been critical of the UK-US pharmaceutical deal and change to the thresholds.

Francis Ruiz, senior policy advisor at the London School of Hygiene and Tropical Medicine, said: ‘The uplift to the NICE threshold does not appear to be based on any considered technical analysis, and precedent has now been set making it an overtly political negotiation.

‘Using the threshold to support wider economic policy muddies NICE’s role as the arbiter of value for individual health technologies.’

Professor Ed Wilson, professor of health Economics and health policy at the University of Exeter, said industry will undoubtedly welcome the deal but the Government need to remember that NICE exists to think about who loses from any such decision.

‘The best evidence we have tells us the NHS generates the equivalent of one year of perfect health for every £5,000 to £15,000 spent, suggesting NICE’s threshold was already too high. 

‘Increasing it to £25,000 means we have to cut back even more on other services to pay the higher drug prices, so perversely this decision will likely end up reducing the overall health of NHS patients, not improving it.’

Professor Karl Claxton, a health economist at the University of York, said: ‘This attack on the independence of NICE is very serious for NHS costs and the health outcomes of all NHS patients.  

‘The vote on extending ministerial power to impose the ‘deal’ done with the US and the pharmaceutical industry will be the only opportunity parliament will get to indirectly vote on this deal. 

‘Despite a number of conflicting reports from Government sources this ‘deal’ will, in time, cost the NHS more than £4.6bn each year.  

‘The impact on other NHS services means that over the next 10 years (or less) this deal will cause more excess deaths than the combined consequences of the covid pandemic and the associated policy responses between 20/21 to 21/22.’

The consultation is open until 13 January.