Olivares José M, Rodriguez-Martinez Alfonso, Burón José A, Alonso-Escolano David, Rodriguez-Morales Alexander
Department of Psychiatry, Hospital Meixoeiro, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
Appl Health Econ Health Policy. 2008;6(1):41-53. doi: 10.2165/00148365-200806010-00004.
The availability of long-acting injectable risperidone may increase adherence to antipsychotic treatment and lead to improved clinical and economic outcomes for patients with schizophrenia.
To investigate the cost effectiveness of treatment with long-acting injectable risperidone compared with previous antipsychotic regimens in patients with schizophrenia enrolled in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) in Spain.
e-STAR is an international, long-term, ongoing, observational study of schizophrenia patients who, during their routine course of clinical practice, are started on a new antipsychotic treatment. In e-STAR, data are collected at baseline, retrospectively over a minimum period of 12 months and up to a maximum of 24 months, and prospectively at 3-month intervals for 24 months after the start of a new antipsychotic drug. For the purpose of this study, patients who started treatment with long-acting injectable risperidone during their routine clinical management and were enrolled in the e-STAR study in Spain were eligible. The effectiveness of long-acting injectable risperidone compared with previous antipsychotic treatment, defined as the absence of hospitalizations or relapses, was assessed at 12 and 24 months of treatment. Acquisition costs of antipsychotic drug therapy were based on the official registered price. Drug prices from source were in euro, year 2005 values; hospital costs from source were in euro, year 2001 values, and were inflated to reflect 2005 costs. Complete follow-up data were available for 788 patients at 12 months after starting long-acting injectable risperidone and for 757 patients at 24 months.
In terms of effectiveness, at 12 months after switching to long-acting injectable risperidone, there was a higher percentage of patients who did not require hospitalization (89.1%), did not relapse (85.4%) or neither required hospitalization nor relapsed (82.4%) as compared retrospectively with the same period for the previous treatment (67%, 47.8% and 59.8%, respectively). The corresponding figures at 24 months also favoured treatment with long-acting injectable risperidone (85.2% vs 60%, 88.5% vs 47.4% and 77% vs 53.6%, respectively). Treatment with long-acting injectable risperidone was associated with higher medication costs per month compared with previous antipsychotic medication after 12 (euro 405.80 vs euro 128.16) and 24 months (euro 407.33 vs euro 142.77) of follow-up. Cost effectiveness per month per patient was lower for risperidone than previous antipsychotic medication in the three patient scenarios: without hospitalization (euro 539.82 vs euro 982.13), without relapse (euro 519.67 vs euro 1242.03) and without hospitalization and without relapse (euro 597.22 vs euro 1059.39).
Treatment with long-acting injectable risperidone compared with previous antipsychotic medications resulted in a higher number of patients not requiring hospitalization, not relapsing, and not requiring hospitalization and not showing relapse, resulting in risperidone being more cost effective per month per patient.It is important to note that real-world variations in adherence would automatically be controlled from within a randomized control trial, and hence, any evaluation of variations in adherence inevitably requires a real-world focus. On the basis of these findings, which were obtained in real-world clinical practice, long-acting injectable risperidone is predicted to be the dominant strategy because it results in effective symptom control and direct medical cost savings. However, because of limitations in methodology, any conclusions should, at this stage, be treated as tentative, and confirmation in more detailed follow-up studies is required. Cost-effectiveness comparisons based on experimental evaluations of relapse minimization strategies are also required. In order to avoid estimation biases in the future, a prospectively designed study is needed.
长效注射用利培酮的可获得性可能会提高抗精神病治疗的依从性，并为精神分裂症患者带来更好的临床和经济结果。
在西班牙电子精神分裂症治疗依从性登记处（e-STAR）登记的精神分裂症患者中，研究长效注射用利培酮与先前抗精神病治疗方案相比的成本效益。
e-STAR是一项针对精神分裂症患者的国际、长期、持续进行的观察性研究，这些患者在其常规临床实践过程中开始接受新的抗精神病治疗。在e-STAR中，在基线时收集数据，回顾性收集至少12个月、最长24个月的数据，并在开始使用新的抗精神病药物后每3个月前瞻性收集24个月的数据。为了本研究的目的，在常规临床管理期间开始使用长效注射用利培酮并参加西班牙e-STAR研究的患者符合条件。在治疗12个月和24个月时，评估长效注射用利培酮与先前抗精神病治疗相比的有效性，定义为无住院或复发。抗精神病药物治疗的获取成本基于官方注册价格。来源的药品价格以欧元计，为2005年的值；来源的医院成本以欧元计，为2001年的值，并进行了通胀以反映2005年的成本。在开始使用长效注射用利培酮12个月后，有788名患者可获得完整的随访数据，在24个月时有757名患者可获得完整的随访数据。
在有效性方面，在改用长效注射用利培酮12个月后，与先前治疗同期相比，不需要住院（89.1%）、未复发（85.4%）或既不需要住院也未复发（82.4%）的患者百分比更高（分别为67%、47.8%和59.8%）。24个月时的相应数据也有利于长效注射用利培酮治疗（分别为85.2%对60%、88.5%对47.4%和77%对53.6%）。与先前的抗精神病药物相比，在随访12个月（405.80欧元对128.16欧元）和24个月（407.33欧元对142.77欧元）后，长效注射用利培酮治疗每月的药物成本更高。在三种患者情况下，利培酮的每位患者每月成本效益均低于先前的抗精神病药物：无住院（539.82欧元对982.13欧元）、无复发（519.67欧元对1242.03欧元）以及无住院且无复发（597.22欧元对1059.39欧元）。
与先前的抗精神病药物相比，长效注射用利培酮治疗使更多患者不需要住院、未复发以及既不需要住院也未复发，从而使利培酮的每位患者每月成本效益更高。需要注意的是，随机对照试验会自动控制现实世界中依从性的差异，因此，对依从性差异的任何评估都不可避免地需要关注现实世界。基于在现实世界临床实践中获得的这些发现，预计长效注射用利培酮将成为主导策略，因为它能有效控制症状并直接节省医疗成本。然而，由于方法学上的局限性，现阶段的任何结论都应视为初步的，需要在更详细的后续研究中进行确认。还需要基于复发最小化策略的实验评估进行成本效益比较。为了避免未来的估计偏差，需要进行前瞻性设计的研究。
