Agreement in Qualitative and Quantitative Assessments of Disease Severity: Evidence from Pharmaceutical Reimbursement in Sweden

BACKGROUND AND OBJECTIVES: Publicly funded healthcare systems that consider a trade-off between efficiency and equity by allowing a higher cost per patient benefit in patients with more severe conditions must somehow assess disease severity. Some countries employ quantitative measures of shortfall, whereas others rely on qualitative assessments. Despite its importance in pharmaceutical reimbursement and pricing, the operationalisation of disease severity in real-world decision making has rarely been scrutinized. The aim of this study was to investigate the relationship and agreement between qualitative disease severity assessments and quantitative measures of disease severity in Swedish pharmaceutical reimbursement. METHODS: Information from 36 pharmaceutical reimbursement decisions made by the Dental and Pharmaceutical Benefits Agency (TLV) in Sweden from 2018 to 2023 was extracted, including the qualitative assessment of disease severity (moderate, high, or very high). Based on publicly available decision documents from the agency, we calculated absolute QALY shortfall (AS) and proportional QALY shortfall (PS). Linear regression was used to describe the mean shortfall across severity classifications. Ordinal logistic regression was used to analyse the role of AS and PS as predictors of TLV's qualitative disease-severity assessments and the predictive ability of both measures was compared using the coefficient of discrimination (D'). RESULTS: = 61.0%) and overlaps in observed shortfall across different severity classifications. CONCLUSION: Proportional QALY shortfall agrees more closely than AS with qualitatively assessed disease severity applied in the Swedish reimbursement system but there are large variations in the qualitative assessments that cannot be explained by either measure. Further investigation is warranted to understand if this is an intended and desired outcome.