Balmaceda Carlos, Espinoza Manuel A, Diaz Janepsy
Departamento de Asuntos Científicos, Instituto de Salud Pública, Santiago, Chile.
Departamento de Salud Pública, Pontificia Universidad Católica de Chile, Santiago, Chile.
Value Health Reg Issues. 2015 Dec;8:43-48. doi: 10.1016/j.vhri.2015.04.003. Epub 2015 Jun 14.
Bioequivalence has become a standard request for drug commercialization in most high income countries, and significant efforts have been made to implement it in many low and middle income countries. In Chile, the requirement of bioequivalency has been gradually implemented since 2008, associated to a communicational campaign to inform the general population about its scope and importance. The objective of this study is to estimate the effect of the implementation of bioequivalence on the prices of products that have been affected by this policy. We conducted a difference in difference study in a set of 30 chronic use drugs, selected from the eighty clinical guidelines published by the Chilean Ministry of Health. The effect was assessed according to the date when the corresponding ministerial decree was published. A control drugs was selected for each analyzed medication in order to estimate the effect of implementation independently of other factors of the market. We identified three groups of drugs: (i) those which experimented a significant increment of price due to bioequivalence; (ii) those where prices decreased; and (iii) those where prices did not (significantly changed) decrease. A sensitivity analysis complemented the study results and identified the significant effect of the date when the bioequivalence was implemented. It is concluded that the implementation of bioequivalence in Chile had a significant effect on prices of some medications. However, the magnitude and direction of such effect depends on the characteristics of the particular market defined by each drug.
在大多数高收入国家，生物等效性已成为药品商业化的一项标准要求，并且许多低收入和中等收入国家也已作出重大努力来实施这一要求。在智利，自2008年以来逐步实施了生物等效性要求，并开展了宣传活动，向公众宣传其范围和重要性。本研究的目的是评估实施生物等效性对受该政策影响产品价格的影响。我们对从智利卫生部发布的80份临床指南中选出的30种慢性使用药物进行了双重差分研究。根据相应部长令发布的日期评估其影响。为每种分析的药物选择一种对照药物，以便独立于市场的其他因素来评估实施的效果。我们确定了三组药物：（i）因生物等效性而价格大幅上涨的药物；（ii）价格下降的药物；以及（iii）价格未（显著）下降的药物。敏感性分析对研究结果进行了补充，并确定了实施生物等效性的日期的显著影响。得出的结论是，智利实施生物等效性对某些药物的价格产生了重大影响。然而，这种影响的程度和方向取决于每种药物所定义的特定市场的特征。
