OBJECTIVES: Most health technology assessment (HTA) is focused on pharmacological treatments and devices, utilising widely accepted methods. Assessments of organisational changes are less common, often requiring different approaches and types of evidence. This study outlines the key challenges to the assessment of healthcare reorganisation interventions.

METHODS: Based on over ten years’ experience of conducting HTAs of complex interventions and healthcare reorganisation, we identified consistent challenges faced for these types of analyses. To describe these challenges, we use illustrative examples from completed assessments proposing substantial healthcare reorganisation.

RESULTS: Healthcare organisation is generally tailored to a particular jurisdiction and system, with little or no applicable data on the effects of reorganisation. Relevant literature is often limited, creating a reliance on information from stakeholders who may be difficult to identify and may not be impartial. Reorganisation can also impact many clinical and patient groups who can identify barriers to implementation based on experience or anecdotal evidence. Extensive stakeholder engagement is therefore vital to inform these HTAs. Organisational changes can create geographic disparities and inequities for service users that would not typically be considered in the assessment of a treatment or device, but should be addressed. Reorganisation can also shift costs to patients, so the chosen perspective is important. Finally, reorganisation can shift responsibilities and accountability within the system, so consideration needs to be given to potential governance issues.

CONCLUSIONS: HTAs of healthcare reorganisation can be challenging to perform and require a mix of approaches that don’t neatly fit into the classic HTA methods. Flexibility is key to ensure the decision maker’s needs are adequately addressed for the safe reorganisation of services. It is critical to involve key stakeholders directly in the process because the available literature will often not give assessors the necessary understanding of the main issues.