The UK government is proposing to take direct control over the cost-effectiveness thresholds used by the National Institute for Health and Care Excellence (NICE), which assesses medicines and medical technologies. This change could have significant effects on how medical devices are evaluated, priced, and adopted within the National Health Service (NHS).
For more than twenty years, NICE has operated with a cost-effectiveness threshold of £20,000 to £30,000 per quality-adjusted life year (QALY). This standard helps determine if treatments provide enough health benefit compared to their cost. The proposed change would raise this threshold to £25,000–£35,000 per QALY.
According to Chris Whitehouse, a political consultant specializing in medical technology policy at Whitehouse Communications and advisor to MedTech suppliers: "Under the new arrangement, the threshold will rise to £25,000 – £35,000 per QALY. On the surface, this change may appear beneficial for device manufacturers, as higher thresholds increase the likelihood that their products will be deemed cost-effective. Devices that previously struggled to meet NICE’s strict criteria could now gain approval more easily."
Whitehouse also points out concerns about potential impacts on NICE's independence: "But, there is concern in other quarters about the potential erosion of NICE’s independence. Traditionally, NICE has balanced clinical evidence, patient outcomes, and economic evaluation to ensure impartiality. Removing the requirement for consultation when thresholds are altered by ministerial direction could risk politicising the process. For medical devices, this could mean that greater weight in future is given to industrial policy objectives, such as attracting investment in the UK life sciences sector."
Medical device companies may find it easier for their products—especially innovative diagnostics or implants—to be approved under these new guidelines. Start-ups might benefit from increased access to NHS markets.
However, there are concerns that allowing ministers rather than an independent board to set these standards might undermine trust in how decisions are made about which devices reach patients.
Whitehouse concludes: "Ultimately, the government’s intervention represents a trade-off: greater flexibility to align health policy with industrial strategy, but at the cost of NICE’s independence and methodological rigor. For medical devices, the impact will be twofold. On one hand, higher thresholds may stimulate innovation and broaden patient access to cutting-edge technologies. On the other, some are arguing, the politicisation of cost-effectiveness decisions could erode trust in the evaluation process, compromise patient safety, and destabilise the market environment."
He adds: "As the consultation unfolds, stakeholders in the medical device sector – clinicians, patients, and industry leaders – must weigh these competing priorities. The challenge will be balancing economic ambitions with the fundamental goal of medical devices: delivering safe, effective,and value-driven care to patients."
MedTech developers and suppliers interested in participating can contribute feedback through an online survey.
Questions regarding this article can be directed to chris.whitehouse@whitehousecomms.com.
