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- Jönsson, L, et al.
(författare)
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Analyzing overall survival in randomized controlled trials with crossover and implications for economic evaluation
- 2014
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Ingår i: Value in Health. - : Wiley: No OnlineOpen / Elsevier. - 1098-3015. ; 17:6, s. 707-713
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Tidskriftsartikel (refereegranskat)abstract
- Background: Offering patients in oncology trials the opportunity to cross over to active treatment at disease progression is a common strategy to address ethical issues associated with placebo controls but may lead to statistical challenges in the analysis of overall survival and cost-effectiveness because crossover leads to information loss and dilution of comparative clinical efficacy. Objectives: We provide an overview of how to address crossover, implications for risk-effect estimates of survival (hazard ratios) and cost-effectiveness, and how this influences decisions of reimbursement agencies. Two case studies using data from two phase III sunitinib oncology trials are used as illustration. Methods: We reviewed the literature on statistical methods for adjusting for crossover and recent health technology assessment decisions in oncology. Results: We show that for a trial with a high proportion of crossover from the control arm to the investigational arm, the choice of the statistical method greatly affects treatment-effect estimates and cost-effectiveness because the range of relative mortality risk for active treatment versus control is broad. With relatively frequent crossover, one should consider either the inverse probability of censoring weighting or the rank-preserving structural failure time model to minimize potential bias, with choice dependent on crossover characteristics, trial size, and available data. A large proportion of crossover favors the rank-preserving structural failure time model, while large sample size and abundant information about confounding factors favors the inverse probability of censoring weighting model. When crossover is very infrequent, methods yield similar results. Conclusions: Failure to correct for crossover may lead to suboptimal decisions by pricing and reimbursement authorities, thereby limiting an effective drug's potential.
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- Ramsberg, Joakim, et al.
(författare)
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The cost-effectiveness of oral triptan therapy in Sweden
- 2007
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Ingår i: Cephalalgia. - : SAGE Publications. - 0333-1024 .- 1468-2982. ; 27:1, s. 54-62
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Tidskriftsartikel (refereegranskat)abstract
- The literature suggests that triptans are cost effective compared with older types of migraine treatment. However, which of the triptans that is most cost effective has not been established. We compared the costs and effects of triptan treatment from a Swedish societal perspective, using evidence from the literature. A probabilistic cost-effectiveness model was constructed to investigate the costs and effects of treating a single attack in a typical migraine patient. The end-point used in the base-case analysis was sustained pain free without any adverse events (SNAE). We searched the scientific literature for meta-analyses reporting the efficacy of oral triptans. All treatments except rizatriptan 10 mg and eletriptan 40 mg were dominated. The incremental cost per SNAE of rizatriptan 10 mg compared with eletriptan 40 mg was approximately €100. There was substantial uncertainty concerning the results, but probabilistic analysis showed that rizatriptan 10 mg and eletriptan 40 mg had the highest probability of being cost-effective. © Blackwell Publishing Ltd.
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