The government recently made quiet, yet significant, changes to the NHS's process for assessing new medicines. On 1 December 2025, ministers confirmed an increase in the core cost-effectiveness threshold NICE uses, raising it to approximately £25,000–£35,000 per quality-adjusted life year (QALY). Two weeks later a formal consultation proposed a more contentious step: giving ministers limited power of direction to set the standard cost effectiveness threshold directly, and to require NICE not to consult when the change is made.
Political considerations and a recent UK-US pharmaceutical agreement drive this rapid change. Budgetary commitments also tie into the change, specifically an increase in medicines spending and a reduction in the medicines rebate rate. These financial adjustments aim to enhance the UK's appeal as a market for launching new drugs. According to officials, raising the cost-effectiveness threshold will allow "an extra three to five" novel therapies to be approved annually, giving patients faster access to innovative treatments.
The industry has largely applauded the new thresholds; they view them as a necessary step to encourage the adoption of new treatments that the previous limits hindered. Conversely, critics express concern about potential ramifications. They argue that the core independence of the National Institute for Health and Care Excellence (NICE); a crucial element for evidence-based decision-making that has been weakened, at least in perception.
Further complicating matters, the government's consultation extends beyond merely increasing the numbers. It proposes granting Parliament the power to allow ministers to directly set the threshold and bypass NICE's standard procedures for consulting on changes to its methods. Health policy experts caution that this move towards central control risks injecting political considerations into the decisions about which treatments the NHS will fund.
Fundamental budgetary constraints obscure the political discourse surrounding the issue. While raising the drug-approval threshold allows the NHS to sanction more or more expensive medicines without altering NICE’s established methodology, the NHS budget is ultimately limited. Even with projected increases in overall medicines spending, any additional expenditure on drugs carries a significant opportunity cost, diverting funds from essential areas like staffing, diagnostics, or other services. The Department's own impact assessment acknowledges the hard choices involved, framing the change as a public policy decision (a balance between industrial and health priorities) yet confirming that they considered and ultimately rejected non-regulatory alternatives, such as leaving the threshold decision to NICE’s board.
Whilst the Government presents this policy shift as pragmatic in a competitive global environment, a more fundamental question remains for many health policy experts: do politically accountable ministers determine the economic rules for medicine access unilaterally, bypassing standard consultative protections? The resolution of this tension will be critical in shaping the UK's future stance on innovation, patient access, and the difficult choices involved in NHS priority setting.
