The medicines threshold is the benchmark NICE uses to assess whether a new treatment provides sufficient health benefit relative to its cost to justify routine NHS funding. Expressed in terms of cost per quality-adjusted life year (QALY), it underpins NICE’s recommendations and forms the basis for price negotiations between the NHS and pharmaceutical companies.

The discussion focused on how changes to this threshold could affect patient access, pharmaceutical pricing, NHS affordability, and NICE’s institutional independence.

Key discussions centred on the following: 

1. The new threshold and medicines pricing

   APPG Officers questioned whether raising the medicines threshold would accelerate access to innovative treatments and encourage companies to prioritise UK launches, particularly in rare and highly specialised diseases. 

   NICE representatives emphasised that companies typically price medicines to the prevailing threshold. Increasing it may lead to higher launch prices rather than fundamentally improved access. While the intention behind adjusting the threshold may be to expand availability, there is a risk that overall medicines expenditure would rise without proportional gains in value. 

   NICE reiterated that its cost-effectiveness evaluation is designed to serve as the foundation for price negotiation between the NHS and manufacturers, ensuring that any expansion in access remains sustainable within finite NHS resources. 

    

2. Rare diseases and personalised medicines access 

   Officers also explored whether the revised threshold would benefit patients with rare diseases or those eligible for gene and personalised therapies. 

   NICE notes that rare disease medicines historically have a relatively high approval rate, although they are often accompanied by greater uncertainty in the evidence base. NICE committees apply flexibility where appropriate, particularly when evaluating transformative or lifelong benefits. 

   However, NICE stressed that even under a new threshold, robust evidence and value for money would remain central. The Innovative Medicines Fund was highlighted as a complementary mechanism to support promising therapies while further data are generated. 

    

3. Speed of access and implementation

   Questions were raised about whether changes to the threshold would meaningfully improve the pace at which medicines reach patients. 

   NICE confirmed it is increasing capacity and working closely with the MHRA to align regulatory and appraisal timelines, aiming to reduce delays between marketing authorisation and guidance publication. However, it was also acknowledged that ensuring consistent NHS uptake of NICE-approved medicines may deliver more immediate patient benefit than adjusting the threshold alone. 

    

4. Budget impact and affordability 

   APPG Officers pressed on how a higher threshold would interact with the NHS budget impact test. It was noted that while there is political interest in increasing the proportion of NHS funding allocated to medicines, any such increase must be balanced against overall public spending constraints. 

   NICE underscored that its role remains to maximise health gain from each pound spent. A revised threshold, while potentially altering individual appraisal outcomes, does not remove the need for disciplined prioritisation across the system. 

    

   The APPG welcomed the discussion and the clarity provided by NICE on the operation of the new medicines threshold.

   Officers reaffirmed that improving patient access to medicines and medical devices remains at the heart of the APPG’s work. The APPG looks forward to continuing constructive engagement with NICE and other stakeholders to address challenges around access, affordability, and innovation, and to ensure that any changes to the threshold ultimately benefit patients.