Consultation on the new Late Stage Assessment approach by NICE is open in England

NICE is currently developing methods and processes for a new type of guidance called Late Stage Assessment (LSA) in HealthTech. 

On February 29, 2024, NICE published an interim statement for LSA methods and processes for consultation. The document defines the objectives of the LSA, stakeholders involved, timelines, topic selection, approach to assessing the evidence, economic evaluation, and outcomes (recommendations). Some of the key points are provided below:

• LSA aims to assess technologies that are in widespread or established use in the NHS to inform commissioning and procurement decisions. Over time, technologies in use often undergo continuous or incremental innovation and adaptation, but there is limited consistency in how these are valued and recognized. LSA will assess which technologies in a category represent value for money and whether price variations are justified by the incremental differences and advancements;
• The topics will be selected in collaboration with the Department of Health and Social Care (DHSC). The technologies considered for LSA include those that have: 1) high annual cost to the NHS (based on the technologies being procured at high cost and low volume or low cost and high volume); 2) existing procurement framework for the category in the NHS; 3) price variation between technologies in the market; and 4) incremental innovation and performance claims that have led to incremental price increases;
• The LSA timelines are expected to range between six and nine months;
• LSA will follow the standard approach to assessing the evidence for a NICE evaluation as outlined in NICE's health technology evaluation manual. The approach to economic evaluation may vary by topic depending on the available data and previous technology evaluations;
• LSA guidance will recommend technologies or features of technologies that are considered value for money based on whether they are within the price range that represents the best options for patients and value for money for the NHS. Technologies or features of technologies that are in a higher price range will be recommended if this is justified by improved clinical or non-clinical outcomes and user preferences. The potential net budget impact of the higher price range can be considered in the recommendations.

The deadline for submitting comments is March 28, 2024.

See the full details here.

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