Journal
ESMO OPEN
Volume 7, Issue 5, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.esmoop.2022.100569
Keywords
reimbursement; health technology assessment; decision making; cancer drugs
Categories
Funding
- Jan Wallanders and Tom Hedelius stiftelse & Tore Browaldhs stiftelse [P21-0018]
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This study describes the clinical and cost-effectiveness evidence supporting reimbursement decisions of new cancer drugs in Sweden and analyzes the influence of trial characteristics and cost per quality-adjusted life years (QALYs) on the likelihood of reimbursement. The results show substantial uncertainties in the evidence underlying reimbursement decisions and emphasize the importance of cautious decision-making considering limited evidence on patient-centered outcomes and the implications of allocating resources to expensive treatments with uncertain value for money.
Background: This study aimed to describe the clinical and cost-effectiveness evidence supporting reimbursement decisions of new cancer drugs and analyze the influence of trial characteristics and the cost per quality-adjusted life years (QALYs) on the likelihood of reimbursement in Sweden. Patients and methods: Data were extracted from all appraisal dossiers for new cancer drugs seeking reimbursement in Sweden and claiming added therapeutical value between the years 2010 and 2020. The data were analyzed using descriptive statistics, and logistic regression models were also used with the cost per QALY, study design, comparator, and evidence on final outcomes in the clinical trials as predictors of reimbursement. Results: All 60 included appraisals were based on trial evidence that assessed at least one final outcome (overall survival [OS] or quality of life [QoL]), although rarely as a primary outcome. Of the appraisals with a final decision (n = 58), 79% were approved for reimbursement. Among the reimbursed drugs, only half had trial evidence demonstrating improved OS or QoL. Only one drug had trial evidence supporting improvements in both OS and QoL. The average cost per QALY for reimbursed cancer drugs was estimated to be 748 560 SEK ((sic)73 583). A higher cost per QALY was found to decrease the likelihood of reimbursement by 9.4% for every 100 000 SEK ((sic)9830) higher cost per QALY (P = 0.03). For cost-effectiveness models without direct evidence of improvements in final outcomes, a larger QALY gain was observed compared with those with evidence mainly relying on intermediate and surrogate outcomes. Conclusions: There are substantial uncertainties in the clinical and cost-effectiveness evidence underlying reimbursement decisions of new cancer drugs. Decision makers should be cautious of the limited evidence on patient-centered outcomes and the implications of allocating resources to expensive treatments with uncertain value for money.
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