OBJECTIVES

: As autoimmune diseases are typically chronic conditions yet not necessarily fatal, both the suppression of symptoms and improvement in quality of life are important clinical outcome measures. Clinical outcome assessments (COAs) include outcomes reported by patients (PROs), clinicians (ClinROs) and observers (ObsROs). The objective of this study was to review health technology assessments (HTA), for five autoimmune diseases (lupus, psoriasis, arthritis, Crohn’s disease and ulcerative colitis) to understand the role played by COAs.

METHODS

: HTA reports (original assessments, resubmissions and extensions of indications) by five agencies (HAS, G-BA, IQWiG, NICE and SMC) from 2011-2017 for the five autoimmune diseases were included in the analysis. All COAs (classified as PROs, ClinROs, PerfROs, or ObsROs and composite measures [CM]) included in the submissions were identified. The data was analysed quantitatively for inclusion and impact of COA data on HTA decision-making.

RESULTS

: CONCLUSIONS

: The proportion of HTA submissions containing COA evidence have increased in the period 2011-2017 for the five autoimmune diseases. As in many cases the COA data is a primary endpoint, ClinROs, PROs and, notably, CM play an important role in the assessment of the symptoms and impacts of these conditions. However, the specific impact of COAs on HTA decision-making is less clear.