By Toby Hobbs
Changes to NICE ICER thresholds confirmed
NICE has announced that from April 2026 there will be an increase to its cost-effectiveness threshold. This marks one of the biggest shifts in UK Health technology assessment (HTA) practice in years and could enable an additional three to five medicines or indications to be approved each year. An important consideration for Companies is how this will impact ongoing technology appraisals (TAs). Until the Department of Health and Social Care (DHSC) formally issues its direction, all appraisals will continue under the current threshold. But once the new threshold is applied, every ongoing TA will immediately transition to the higher limit, regardless of when it began. Crucially, if a technology is not cost-effective today, but could become so under the new threshold, NICE will pause publication of any negative draft guidance. This avoids blocking access prematurely and means some decisions will effectively “wait” for the new threshold before being finalised.
However, it should be noted that for medicines that have already received a negative recommendation, the impact of the higher threshold remains uncertain. NICE has clarified that the threshold change alone will not count as sufficient “new evidence” to justify a resubmission, but NICE will contact Companies directly to discuss case-specific implications.
NICE has confirmed that there are no plans to change the thresholds applied to Highly Specialised Technologies (HST). Additionally, the All Wales Medicines Strategy Group (AWMSG) and Scottish Medicines Consortium (SMC) have been involved in discussions, but it is currently unclear whether the devolved nations will introduce similar threshold changes.
NICE is also preparing to introduce a new EQ-5D-5L value set, based on updated UK preference data and modern valuation methods. Publication is expected between February and May 2026, followed by a 16-week consultation before integration into the NICE Manual. The new value set may shift quality-adjusted life year (QALY) estimates, and therefore incremental cost-effectiveness ratios (ICERs) in different directions; some conditions may show increased utility gains under the new system while others may see reductions. For Companies preparing submissions in 2026, the timing will be important, as the new value set may require updated utility inputs and could meaningfully shift QALY and ICER results.
To discuss the implications of changes to the ICER threshold on plans for any upcoming submissions, please get in touch with one of our team.
EU JSC 2026 work programme published
The EU Joint Scientific Consultation (JSC) 2026 work programme has now been published, confirming the next set of consultation slots available for Companies preparing to launch in Europe over the coming years. This announcement is particularly relevant for teams looking to optimise their evidence strategies ahead of the upcoming Joint Clinical Assessment (JCA) requirements and increasingly convergent HTA expectations across the EU.
Engaging early through an EU JSC provides a unique opportunity for a single coordinated dialogue with both regulators and HTA bodies. This can be highly valuable for shaping development plans, ensuring that regulatory and reimbursement evidence needs are aligned from the outset. By obtaining joint early feedback, Companies can reduce the risk of generating data that satisfies regulators but falls short for HTA, avoiding costly post-launch evidence generation or delayed access.
The consultation process also supports optimisation of clinical trial design, helping Companies understand payer expectations around comparators, endpoints, and patient-relevant outcomes. In addition, consultation offers insight into country-specific considerations that may influence pricing and access strategy well before pivotal trials are finalised.
To discuss how Source can support in the JSC process, please get in touch with our team.
The HEMA initiative: A new chapter for global HTA
NICE, along with partners in the US and Canada, is implementing a new collaborative initiative, the international Health Economics Methods advisory (HEMA). HEMA’s ambition is to be an independent voice that guides best practice in international HTA. This could kick start a pivotal shift in how HTA is approached globally.
HEMA has recently published the first draft report that examines whether factors other than health benefits and costs to the system should be formally considered in decision-making. These factors include the burden on families and carers, if treatments address health inequalities, how much risk patients are willing to accept on novel treatments, and the value of a diagnosis. The final version of the HEMA report is due to be published in January 2026.
HEMA is considering key questions, such as do we have reliable ways to measure these benefits? Can we properly understand what it might cost other patients if we prioritise one treatment over another? These are questions with real-world impacts for patients awaiting treatments and health care systems working with restricted budgets. History tells us that once such frameworks are finalised, early adopters who build broader evidence packages will be at an advantage. But the extent to which individual HTA bodies will formally adopt these wider value elements remains to be seen. The HEMA initiative is a reminder that value in healthcare is more than a number; it is about people, communities, and long-term impact.
What to watch next quarter
-
- Impact and implications of NICE ICER threshold changes
- NICE methods and programme updates for 2026
- Progress on the HEMA initiative and insights from the final report in January 2026
We will continue to track developments in this area and share insights as they arise.
