With the aim of streamlining access across medical conditions and optimising NHS resource use, NICE has outlined the process to integrate their technology appraisals into NICE treatment guidelines. These processes are open for consultation until the 14th March 2024. Ultimately, this NICE update will have ramifications on market access in the UK.
At present, NICE’s interim statement describes two approaches: 1) ‘incorporation’, which presents unchanged technology appraisal recommendations within guidelines, and 2) Integration, which involves comparative analyses of treatments in guidelines that are over three years old. Interim guideline integration recommendations highlight that if a NICE appraisal is integrated into a guideline, the committee may change how a technology is recommended, which could alter the sequence or priority of treatment options. This could impact the market access and positioning of a pharmaceutical product. Evidence supporting benefits and cost-effectiveness could lead to recommendations for wider or more restricted use of a technology. This could potentially open up new markets or restrict existing ones. On the contrary, if deemed no longer cost-effective, the technology could be negatively recommended, leading to the withdrawal of the guidance, impacting the product’s NHS funding and use.
NICE technology appraisal recommendations are to be integrated into guidelines when there are several treatments within a decision space, lacking clear selection rationale. This typically will not occur until three years post the initial appraisal. A prioritisation board using a framework assesses whether to integrate, considering clinical and system factors. Methods align with the NICE guidelines manual, taking into account surveillance, scoping, stakeholder engagement, and evidence gathering. Cost-effectiveness, VAT exclusion, and quantitative decision modifiers will be considered, along with the potential for guideline committees to revise technology use based on clinical practice and marketing authorisation.
Navigating the integration of technology appraisals into treatment guidelines will be crucial for companies in order to maintain access for their products. Manufacturers will have to demonstrate the unique value of their drugs within a competitive landscape and anticipate a three-year wait before integration. While cost-effectiveness remains a central focus, broader benefits should not be overlooked. Positive integration may secure NHS funding, but the window for commercial discussions appears limited. Additionally, companies must be aware of potential changes in the appeals process for unfavourable decisions to maintain optimal market access in the UK. The open consultation for these processes concludes on 14th March 2024.
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Source:
NICE. Interim methods and processes statement for including NICE technology appraisal recommendations in guideline topic areas. Retrieved from https://www.nice.org.uk/consultations/2495/8/integrating-nice-technology-appraisal-recommendations. Last accessed 7 February 2024