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Confirm NICE ICER threshold changes
NICE has announced that cost-effectiveness standards will be increased from April 2026.. This is one of the biggest changes to UK Health Technology Assessment (HTA) practice in many years and could result in three to five more medicines or indications being approved each year. An important consideration for companies is how this will impact ongoing technology assessment (TA). All assessments will continue below the current baseline until the Department of Health and Social Care (DHSC) formally publishes guidance. However, once the new threshold goes into effect, any TA in progress will immediately transition to the higher limit, regardless of when it started. Crucially, NICE will pause issuing negative draft guidance if a technology is not currently cost-effective but could become so below the new threshold. This means preventing access from being blocked prematurely and effectively “waiting” for a new threshold before some decision is completed.
However, it is important to note that for medicines that have already received negative recommendations, the impact of higher thresholds remains uncertain. NICE has made it clear that the threshold change alone will not be considered sufficient “new evidence” to justify a resubmission. However, NICE will contact companies directly to discuss the implications on a case-by-case basis.
NICE has confirmed that it has no plans to change the criteria applying to highly specialized skills (HSTs). It is currently unclear whether devolved countries will introduce similar criteria changes, although the All Wales Medicines Strategy Group (AWMSG) and the Scottish Medicines Consortium (SMC) have also joined discussions.
NICE is also preparing to introduce a new set of EQ-5D-5L values based on updated UK preference data and modern assessment methods. It is expected to be published between February and May 2026, and will undergo a 16-week consultation period before being incorporated into the NICE manual. A new set of values will change estimates of quality-adjusted life years (QALYs) and therefore may cause incremental cost-effectiveness ratios (ICERs) to change in different directions. Under some conditions, a new system may see an increase in utility gains, while under other conditions a decrease may occur. For companies preparing to file in 2026, timing is important as new value sets may require updated utility inputs and QALY and ICER results may change meaningfully.
Contact our team to discuss the impact of the ICER threshold change on your future submission plans.
EU JSC 2026 work program published
The EU Joint Scientific Consultation (JSC) 2026 work program has now been published, confirming the next consultation schedule available to companies preparing to expand into Europe in the coming years. This announcement is particularly relevant for teams seeking to optimize their evidence strategies ahead of the upcoming Joint Clinical Assessment (JCA) requirements and increasingly converging HTA expectations across the EU.
Early engagement through the EU JSC provides a unique opportunity to have a single, coordinated dialogue with both regulators and HTA authorities. This can be very useful in developing development plans and coordinating regulatory and reimbursement evidence requirements from the outset. By securing joint early feedback, companies can reduce the risk of producing data that satisfies regulators but falls short of HTA, avoiding costly post-launch evidence generation or access delays.
The consulting process also supports optimization of clinical trial design, helping companies understand payers’ expectations regarding comparators, endpoints, and patient-related outcomes. Additionally, consultations provide insight into country-specific considerations that may impact pricing and access strategies well before pivotal clinical trials are finalized.
Contact our team to discuss how Source can support your JSC process.
HEMA Initiative: A New Chapter in Global HTA
NICE, together with partners in the United States and Canada, is implementing a new collaborative initiative called the International Health Economic Methods Advisory (HEMA). HEMA’s ambition is to be an independent voice guiding best practice in international HTA. This could begin a pivotal change in the way HTA approaches itself globally.
HEMA recently published its first draft report examining whether factors other than health benefits and system costs should be formally considered in decision-making. These factors include the burden on families and caregivers, whether the treatment addresses health inequities, the degree of risk patients are willing to take on new treatments, and the value of the diagnosis. The final version of the HEMA report is expected to be published in January 2026.
HEMA is considering key questions such as whether there are reliable ways to measure these benefits. If we prioritize one treatment over another, do we really understand what the costs may be for other patients? These are questions that have real implications for patients waiting for treatment and for healthcare systems operating on limited budgets. History shows that once these frameworks are finalized, early adopters who build a broader package of evidence will have an advantage. However, the extent to which individual HTA agencies will formally adopt these broad value elements is not yet known. The HEMA initiative reminds us: The value of healthcare is more than numbers. This is about people, communities and long-term impact.
What to Watch in the Next Quarter
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- Impact and implications of NICE ICER threshold changes
- NICE method and program updates 2026
- HEMA Initiative Progress and Insights from Final Report January 2026
We will continue to track developments in this area and share insights as they arise.
