Rémuzat Cécile, Urbinati Duccio, Kornfeld Åsa, Vataire Anne-Lise, Cetinsoy Laurent, Aballéa Samuel, Mzoughi Olfa, Toumi Mondher
Creativ-Ceutical France, 215 rue du Faubourg Saint-Honoré, 75008 Paris, France.
University Claude Bernard Lyon I, UFR d'Odontologie, 11 rue Guillaume Paradin, 69372, Lyon, Cedex 08, France.
J Mark Access Health Policy. 2014 Jun 4;2. doi: 10.3402/jmahp.v2.23740. eCollection 2014.
With constant incentives for healthcare payers to contain their pharmaceutical budgets, modelling policy decision impact became critical. The objective of this project was to test the impact of various policy decisions on pharmaceutical budget (developed for the European Commission for the project 'European Union (EU) Pharmaceutical expenditure forecast' - http://ec.europa.eu/health/healthcare/key_documents/index_en.htm).
A model was built to assess policy scenarios' impact on the pharmaceutical budgets of seven member states of the EU, namely France, Germany, Greece, Hungary, Poland, Portugal, and the United Kingdom. The following scenarios were tested: expanding the UK policies to EU, changing time to market access, modifying generic price and penetration, shifting the distribution chain of biosimilars (retail/hospital).
Applying the UK policy resulted in dramatic savings for Germany (10 times the base case forecast) and substantial additional savings for France and Portugal (2 and 4 times the base case forecast, respectively). Delaying time to market was found be to a very powerful tool to reduce pharmaceutical expenditure. Applying the EU transparency directive (6-month process for pricing and reimbursement) increased pharmaceutical expenditure for all countries (from 1.1 to 4 times the base case forecast), except in Germany (additional savings). Decreasing the price of generics and boosting the penetration rate, as well as shifting distribution of biosimilars through hospital chain were also key methods to reduce pharmaceutical expenditure. Change in the level of reimbursement rate to 100% in all countries led to an important increase in the pharmaceutical budget.
Forecasting pharmaceutical expenditure is a critical exercise to inform policy decision makers. The most important leverages identified by the model on pharmaceutical budget were driven by generic and biosimilar prices, penetration rate, and distribution. Reducing, even slightly, the prices of generics had a major impact on savings. However, very aggressive pricing of generic and biosimilar products might make this market unattractive and can be counterproductive. Worth noting, delaying time to access innovative products was also identified as an effective leverage to increase savings but might not be a desirable policy for breakthrough products. Increasing patient financial contributions, either directly or indirectly via their private insurances, is a more likely scenario rather than expanding the national pharmaceutical expenditure coverage.
鉴于医疗保健支付方一直面临控制药品预算的压力，模拟政策决策的影响变得至关重要。本项目的目的是测试各种政策决策对药品预算的影响（该模型是为欧盟委员会的“欧盟药品支出预测”项目开发的——http://ec.europa.eu/health/healthcare/key_documents/index_en.htm）。
构建了一个模型，以评估政策情景对欧盟七个成员国（即法国、德国、希腊、匈牙利、波兰、葡萄牙和英国）药品预算的影响。测试了以下情景：将英国政策扩展至欧盟、改变市场准入时间、调整仿制药价格和渗透率、改变生物类似药的分销链（零售/医院）。
应用英国政策为德国带来了大幅节省（是基础案例预测的10倍），为法国和葡萄牙带来了大量额外节省（分别是基础案例预测的2倍和4倍）。发现推迟市场准入时间是降低药品支出的一个非常有力的工具。应用欧盟透明度指令（定价和报销的6个月流程）使所有国家的药品支出增加（从基础案例预测的1.1倍到4倍），德国除外（额外节省）。降低仿制药价格、提高渗透率以及通过医院链改变生物类似药的分销也是降低药品支出的关键方法。所有国家报销率提高到100%导致药品预算大幅增加。
预测药品支出是为政策决策者提供信息的一项关键工作。该模型确定的对药品预算最重要的影响因素是由仿制药和生物类似药的价格、渗透率和分销驱动的。即使略微降低仿制药价格也会对节省产生重大影响。然而，仿制药和生物类似药产品的激进定价可能会使这个市场缺乏吸引力，并且可能适得其反。值得注意的是，推迟创新产品的准入时间也被确定为增加节省的有效手段，但对于突破性产品可能不是一个理想的政策。直接或通过其私人保险间接增加患者的经济贡献，比扩大国家药品支出覆盖范围更有可能成为一种情景。
