ArticleESMO open2022
Assessment of the clinical and cost-effectiveness evidence in the reimbursement decisions of new cancer drugs.
Article in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed.
- European Network on Optimizing Treatment With Therapeutic Antibodies in Chronic Inflammatory Diseases: Overview, Progress and Perspectives.Clinical and translational science · 2026Review
- Factors influencing the reimbursement decisions of cancer drugs in Spanish National Health System.Health economics review · 2026Article
- Clinical and economic impact of the availability of innovative therapies for advanced lung cancer in men in Latin America: a population-based secondary data study.Lancet regional health. Americas · 2025Article
- Observational
- Article
- Impact of competition on reimbursement decisions for cancer drugs in China: an observational study.The Lancet regional health. Western Pacific · 2024Article
- Analyses of quality of life in cancer drug trials - a review of measurements and analytical choices in post-reimbursement studies.BMC cancer · 2024Review
- Quantifying societal burden of radiation-induced small bowel toxicity in patients with rectal cancer.Frontiers in oncology · 2024Article
- Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?Clinical drug investigation · 2023Review
- The reimbursement decision speed for oncology new drugs in China and its determinant factors.Frontiers in public health · 2023Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis 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
methodsData 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.
resultsAll 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 (€73 583). A higher cost per QALY was found to decrease the likelihood of reimbursement by 9.4% for every 100 000 SEK (€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.
conclusionsThere 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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