OBJECTIVES: This landscape assessment evaluated submissions and HTA evaluation outcomes for specified biologics for CRSwNP aiming to understand the difference in clinical value/clinical decision drivers (CDDs) across HTA bodies and inform future evidence generation.

METHODS: Data from HTA decisions published between 2009 and 2024 were extracted for the following bodies: IQWiG/G-BA (Germany), NICE (England), SMC (Scotland), HAS (France), AIFA (Italy), AEMPS (Spain), CADTH (Canada), PBAC (Australia) and CHUIKYO (Japan). The report summarises the manufacturers’ clinical submission information and reimbursement decision (including benefit level ratings, imposed restrictions to label and/or entry agreements), and key HTA body commentary.

RESULTS: 13 HTA decisions were included in this assessment. When evaluating the effectiveness and clinical value of biologics for severe CRSwNP, the main CDDs were the improvement in nasal polyp (NP) score, relief of nasal obstruction and related symptoms. Additional meaningful CDDs included reduced time to or need for NP surgery and/or corticosteroid use for NP (G-BA, HAS, PBAC). A low serious adverse event rate (≤10%) was strongly considered by HTA bodies when recommending CRSwNP biologics for reimbursement.

By drug, key CDDs were NP and SNOT-22 scores for omalizumab, NP and nasal obstruction VAS scores for mepolizumab and dupilumab. Reduced time to surgery and corticosteroid use were also considered for mepolizumab. Quality of life was an important supplemental CDD, with SNOT-22 being the preferred patient-reported outcome. SNOT-22 showed statistically significant results in multiple evaluations, influencing positive reimbursement decisions for mepolizumab and dupilumab. SF-36, EQ-5D, and NPQ were also mentioned as exploratory endpoints or for comparison.

CONCLUSIONS: The findings demonstrate that HTA bodies value interventions in CRSwNP differently, with certain CDDs being more important to some than others. These results can guide evidence-generation strategies and data collection on CDDs, aiding in reimbursement and optimising biologic treatment outcomes in CRSwNP.

Funding: GSK (GSK ID 222239)