OBJECTIVES: This landscape assessment aimed to evaluate and highlight differences in the value placed on clinical and economic evidence provided to HTA bodies, used to gain reimbursement.

METHODS: Data from HTA decisions published 2009–2024 were extracted for the following agencies: IQWiG/G-BA (Germany), NICE (England), SMC (Scotland), HAS (France), AIFA (Italy), AEMPS (Spain), TLV (Sweden), CADTH (Canada), PBAC (Australia), HIRA (South Korea), NHSA (China), CHUIKYO (Japan). Analysis primarily focussed on the clinical data evaluated by these HTA bodies and the final reimbursement decision.

RESULTS: The main clinical decision drivers (CDDs) of reduction in asthma exacerbations and corticosteroid use were highly rated across most HTA bodies; however, AEMPS, AIFA, G-BA, HIRA, NICE and SMC considered quality of life (QoL) and patient-reported outcomes (PROs) improvements to be key CDDs. Lung function improvement, based on FEV₁ and FeNO score, was a secondary CDD, considered by AEMPS, CADTH, HIRA, CHUIKYO, NHSA, TLV and SMC. Acceptable safety profile was considered key by HAS, PBAC, CHUIKYO and TLV; hospitalization rate and asthma symptom control were considered supporting CDDs by CADTH and HAS.

By drug, clinical value by demonstrating a reduction in exacerbations was high for all biologics, and in steroid use for mepolizumab, benralizumab and tezepelumab. Clinical value of improved lung function was high for reslizumab and tezepelumab, and QoL and PRO improvements for benralizumab, dupilumab and tezepelumab.

By country, key CDDs were reduction in oral corticosteroid use in all markets; asthma exacerbation rate in all markets except Germany; and improved QoL in all markets except France, Sweden, Canada, Australia and China.

CONCLUSIONS: These findings show that the most valued CDDs across most HTAs were reductions in asthma exacerbations and corticosteroid use, with some HTAs also prioritizing QoL and PROs. These results can guide evidence-generation strategies, aiding in reimbursement and optimizing outcomes for biologics in asthma.

Funding: GSK (GSK ID 222239)