HTA Monthly – October 2025

Kiera Lander

October brought real movement across the Health Technology Assessment (HTA) landscape, not just in health technology, but also across pharmaceuticals, strategies and international collaborations. From the National Institute for Health and Care Excellence (NICE) expanding its mission to include digital tools, to the Scottish Medicines Consortium (SMC) improving first-orphan processes, to NICE International expanding its global reach, the message is clear. Evidence expectations are evolving and integration between systems is accelerating. This month’s update is as follows.

Have you seen the NICE x HealthTech expansion coming?

One small step for medical technology, one giant leap for healthcare, is it possible anywhere? wonderful It officially placed medical technology on equal footing with pharmaceuticals. Devices, diagnostics and digital tools will now be evaluated with the same rigor as new drugs, bringing about a dramatic change in the way innovation enters the National Health Service (NHS).

• • Why is it important?: This expansion will help address disparities in healthtech adoption across regions and end the zip code lottery that has hindered promising technologies such as wearable diabetes monitors and artificial intelligence (AI)-based diagnostics. And as we know, AI is dominating dinner table discussions and will inevitably see greater use in healthcare settings, from the dawn of robotic surgery to preventative medicine becoming a central goal in the global landscape.
  • What this means: For digital health innovators, this means a shift to more rigorous and transparent evidence expectations. Companies must develop a strong economic model, a clear value system, and an early strategy for stakeholder engagement similar to those used to evaluate pharmaceuticals. We focus on demonstrating real-world value beyond clinical efficacy, demonstrating how technology improves patient outcomes, workflow efficiency, and system sustainability. That is, applying the same Health Technology Assessment (HTA) principles to different types of interventions.

NICE’s first Impact Topics will begin evaluation in February 2026 and be published in December. In the early stages, you will already be preparing your submission to benefit from this route. This is something worth discussing!

‘Rare’ SMC Update: Ultra-Orphan Drugs

SMC has improved processes to: Ultra-orphan drugsInitial evaluation has been underway since 2019.

• • change: The New Drug Committee still participates in the initial evaluation, no longer needed This step involves full SMC committee discussion. Patient and clinical expert input remains central and has no impact on the publication schedule.
  • influence: This update is a minor improvement to help streamline the initial evaluation phase.
  • What this means: Real-world evidence (RWE), scenario analysis and economic models that address uncertainty remain. essential. Companies must ensure that their evidence generation plans are methodologically sound and strategically aligned to withstand scrutiny during reassessment.

The NHS gives us a 10-year plan.

NICE has set itself the role of communicating the government’s requirements. 10 Year Health and Care Plan. As the NHS continues to minimize its reliance on reactive care, there is motivation to improve access to home care, shift administrative burdens to digitally designed care processes, and further explore preventive medicine.

• • What does this mean? Some headline priorities include:

1. 1. Faster, fairer launch of high-impact HealthTech – Building on expanded HealthTech program
   2. Updated guidance to encourage smarter spending – A “full life cycle” approach that keeps guidance in real time and responsive to new evidence and costs.
      • First example: updated chronic heart failure guidelines, providing patients with life-saving drugs up to a year earlier and expanding GP prescribing.
   3. Parallel decisions with the Medicines and Healthcare products Regulatory Agency (MHRA) – By April 2026, regulatory and HTA decisions will be aligned, aiming to get new drugs to patients three to six months sooner.

• • What this means: The shift to continuous evidence review means that modeling and systematic literature reviews (SLRs) must be designed as living assets rather than static artifacts. The push for parallel regulatory/HTA submissions raises the bar for early integrated evidence strategies. This means early engagement with evidence planning and close collaboration between regulatory, clinical and Health Economics and Outcomes Research (HEOR) teams to stay ahead.

NICE International: a global success story

NICE International continues to expand its impact by working with 11 countries (and a further seven from 2026) through its Regulatory Partnership for Growth Funds.

• • Why This Matters: This initiative will strengthen overseas HTA capacity while providing £5 billion of export opportunities for the UK life sciences sector. NICE (dare I say it)that‘?) Leader of HTA. I think we will be in a better place if we roll out this expertise globally. For example, following NICE’s partnership with Kenya, an independent HTA committee was launched and a wave of new recruitment began.

• • What this means: As HTA systems mature globally, the demand for evidence generation and strategic guidance from experienced partners will increase. For companies expanding into international markets, this change may mean working with experts who can explore a wider range of HTA requirements and ensure that their global evidence strategy is ready for a variety of assessment frameworks. If this is an area you would like to explore, please contact us to discuss our capabilities for country launch support and HTA strategy insight!

What to Watch in the Next Quarter

Please contact us to discuss the impact of these updates on your market access strategy and how we can assist.