CERMES, IFR, INSERM U, National Institute of Health and Medical Research, Villejuif, France.
BMC Health Serv Res. 2011 Jun 25;11:151. doi: 10.1186/1472-6963-11-151.
During the last decade, oral bisphosphonates (BP) became the most widely prescribed pharmacologic class for post-menopausal osteoporosis. However, many surveys revealed the important issue of poor persistence with those drugs resulting in a failure of treatment to reduce fracture risk sufficiently. Using a published Markov model, this study analyses the economic impact of non-persistence with bisphosphonates in the context of the introduction of generics in France.
Direct costs of vertebral, hip and wrist fracture were assessed and included in an existing 10-year Markov model developed to analyse consequences of non-persistence. Three alternatives of comparison were set: no treatment, real-world persistence, and ideal persistence. Simulated patients' characteristics matched those from a French observational study and the real-world adherence alternative employed persistence data from published database analysis. The risk of fracture of menopausal women and the risk reduction associated with the drugs were based on results reported in clinical trials. Incremental cost-effectiveness ratios (ICERs) were calculated first between real-world adherence and no treatment alternatives, and second between ideal and real-world persistence alternatives. The cost of non-persistence was defined as the difference between total cost of ideal and real-world persistence alternatives.
Within fractured women population, mean costs of 10-year management of fracture were significantly different between the three alternatives with €7,239 (± €4,783), €6,711 (± €4,410) and €6,134 (± €3,945) in the no-treatment, the real-world and ideal persistence alternatives, respectively (p < 0.0001). Cost-effectiveness ratio for real-world treatment persistence compared with no-treatment alternative was found dominant and as well, alternative of ideal persistence dominated the former. Each ten percentage point of persistence gain amounted to €58 per patient, and extrapolation resulted in a global annual cost of non-persistence of over €30 million to the French health care system, with a substantial transfer from hospital to pharmacy budgets.
Within term, improving persistence with oral bisphosphonates should be economically dominant on levels currently known in real-world. Given this potential savings, ambitious adherence-enhancing interventions should be considered in osteoporotic patients.
在过去十年中,口服双膦酸盐(BP)已成为绝经后骨质疏松症最广泛使用的药物治疗方法。然而,许多调查显示,患者对这些药物的持续用药依从性较差,导致治疗未能充分降低骨折风险,这是一个重要问题。本研究使用已发表的 Markov 模型,分析在法国引入仿制药的情况下,不持续使用双膦酸盐对经济的影响。
评估了椎体、髋部和腕部骨折的直接成本,并将其纳入现有的 10 年 Markov 模型中,以分析不持续治疗的后果。设定了三种比较方案:不治疗、真实世界的持续治疗和理想的持续治疗。模拟患者的特征与法国观察性研究相匹配,真实世界的持续治疗方案采用已发表的数据库分析中的用药依从性数据。绝经后妇女的骨折风险和药物相关的骨折风险降低率基于临床试验的结果。首先在真实世界的持续治疗与不治疗之间计算增量成本效益比(ICER),然后在理想的持续治疗与真实世界的持续治疗之间计算。不持续治疗的成本定义为理想的持续治疗与真实世界的持续治疗之间的总治疗成本差异。
在骨折女性人群中,三种方案 10 年骨折管理的平均成本存在显著差异,无治疗、真实世界的持续治疗和理想的持续治疗方案的 10 年管理成本分别为 7239 欧元(±4783 欧元)、6711 欧元(±4410 欧元)和 6134 欧元(±3945 欧元)(p<0.0001)。与不治疗方案相比,真实世界的持续治疗方案的成本效益比具有优势,而理想的持续治疗方案则优于前者。每提高 10%的持续治疗率,每位患者的成本增加 58 欧元,由此推算,法国医疗保健系统每年因不持续治疗而产生的费用超过 3000 万欧元,这将导致医院和药店预算之间的大量转移。
在短期内,提高口服双膦酸盐的持续治疗率在经济上应优于目前真实世界中已知的水平。鉴于这种潜在的节省,应考虑在骨质疏松症患者中实施提高用药依从性的积极干预措施。