At the end of 2025, the Department of Health and Social Care (DHSC) held a five-week consultation on proposals to give new ministerial powers to set the value at which medicines used by the NHS are deemed affordable and made available to UK patients.
The Charity Medicines Access Coalition (CMAC), a coalition of 31 health charities representing millions of patients across the UK, is concerned about the lack of detail, potential unchecked scope of authority, and limited consultation response time provided to the public, the charity sector, and health stakeholders.
“We are concerned that the recent consultation on the proposed legislation to empower ministers to direct NICE’s cost-effectiveness threshold has not been given an appropriate consultation time and lacks detail of how UK patients will benefit from the associated policy directive. It also lacks safeguards that current or future governments may amend, upwards or downwards, the value at which UK medicines are deemed affordable without adequate consultation or evidence.
The ongoing changes in the pricing policy environment, without sufficient accompanying information on what this will mean for patients, is contributing to further uncertainty for patients as to the impact on access to next-generation innovative medications. There should be a requirement for the government to demonstrate that the positive commitment to increase expenditure on medicines will translate into UK patient benefit.
We call for further clarity from the UK government on whether the already agreed increase in the threshold will be continuously supported from existing DHSC/NHSE budgets. We seek details of how the threshold increase fits into a comprehensive access-to-medicines strategy. We ask that the government publish details on the implementation, monitoring, and patient impact of how recent headline agreements, including the VPAG rebate cap, the increase in medicine budget, and the increase in threshold, are linked, synergistic, and will lead to improved and equitable access to medicines for UK patients.”
Background
This consultation was announced as a key element of the UK-US pharmaceuticals trade agreement, which states that the NICE threshold for approving new medicines will be increased from £20,000 to £30,000 per quality-adjusted life year (QALY) to £25,000 to £35,000 per QALY.
Although CMAC members broadly support the increase in the cost-effective threshold, we are concerned by the lack of detail provided on how the increase in the threshold will significantly improve patient access. NICE has already stated that its impact assessment suggests that three to five new medicines will be made available as a direct consequence of the higher threshold. It is not clear, however, how this policy change will support a meaningful reduction in Health Technology Appraisal (HTA) non-submissions and terminations from developers of new medicines, and how the new threshold will reduce inequities in access to new medicines. Implementation and uptake variability across NHS trusts and between the devolved nations remains a concern that is not addressed by current consultations.
There is also no provision to address the scenario in which the current or future government decreases the threshold at the direction of the political party in power.
In the last two years, CMAC has responded to key government, DHSC, NICE, and NHS England consultations, which direct how medicines are valued and adopted in NHSE clinical practice. In each submission response, we have called for transparency in the decision-making process, the inclusion of people with lived experience in those decisions, and evidence-based metrics of the impact of proposed health policy changes on UK patient health. With this consultation, once again, we were given a limited time to respond with little clarity on how the proposed changes will materially affect UK patients, and we were not advised how the policy will be applied, implemented, and updated.
CMAC, representing millions of patients across the UK, is passionate about ensuring people and communities have timely access to treatment advances and that their needs and voices are shaping national medicines policy and informing decisions about the value and affordability of medicines.