OBJECTIVES: To report the prevalence of qualitative data collection and analysis methods used within NICE appraisals of highly specialized technologies (HST).

METHODS: We systematically reviewed 20 sets of NICE HST submission guidance documents and supporting committee papers between 2005 and 2020. Data were extracted on background information and target indication, qualitative data sources, methods, evidence categories, evidence target, evidence type, analysis methods, and resulting discussions or critiques.

RESULTS: Qualitative evidence was explicitly featured within 18 submissions and 8 included evidence that was unclear if qualitative, quantitative, or mixed methods in nature. Evidence presented was predominantly patient expert reports or narratives across 15 submissions. Seven instances of interviews were discussed across 5 submissions. All submissions contained such evidence within the submission category ‘Nature of the Condition’ (N=20) including evidence for disease burden, unmet needs, and management and treatments. Most frequently discussed was evidence in support of patient health-related quality of life (HRQoL) impacts (n=20) and caregiver impacts (n=18). All submissions included at least some qualitative evidence for which the data collection or analysis methods were unclear, although two submissions reported the use of direct quotations.

CONCLUSIONS: Patient and caregiver expert reports are highly prevalent within NICE HST appraisals, with clinician evidence presented less frequently. Qualitative evidence featured heavily in discussions around HRQoL and the effect conditions can have on patients, families, and caregivers. Such evidence is presented predominantly in reference to patients, with a high prevalence also for caregivers and possible spillover effects to family. There was a notable lack of clarity regarding the data collection and analysis methods used to generate qualitative evidence, limiting any transparent critique of evidence presented. However, we acknowledge that formal evidence may not be expected for patient or caregiver narrative reports featured as these are a standardized practice for committee meetings.