Assessment of Patient Reported Outcomes in Health Technology Assessment Submissions of Key Rheumatological Indications Across the UK, Germany, and France

OBJECTIVES: The focus on patient-reported outcomes (PROs) in rheumatology is intensifying, in line with a worldwide shift towards greater emphasis on 'patient-centered care'. The objective of the study was to assess the frequency and types of PROs in HTA submissions for key rheumatological indications

METHODS: 72 HTA assessments were studied for 13 drugs approved between 2014 and 2024 across three rheumatological indications: Rheumatoid Arthritis, Psoriatic Arthritis, and Systemic Lupus Erythematosus (SLE). These HTA evaluations were gathered from publicly accessible resources for France (FR), Germany (DE), and the UK

RESULTS: The findings of this study suggest that 83% of assessments between 2014 and 2024 incorporated PROs across FR, DE, and the UK, with 79%, 84%, and 90% respectively. Rheumatoid Arthritis had the highest number of assessments (89%) with PROs incorporated, followed by Psoriatic Arthritis (85%) and SLE (64%). Across geographies and indications, 50% of the PROs incorporated were disease-specific, focusing on disease activity and quality of life, while the other 50% of assessments included generic PROs focusing on physical function, fatigue, and pain.

CONCLUSIONS: Rheumatological conditions have significant impact on a patient's physical function, mood, and quality of life. Therefore, the patient's perspective is crucial for a thorough evaluation of rheumatologic diseases, encompassing their effects on everyday living and the success of therapeutic interventions. Manufacturers need to integrate more disease-specific PRO data for rheumatological conditions to ensure that the evidence package for drugs is comprehensive.