Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
IQVIA, Solna, Sweden.
BioDrugs. 2019 Jun;33(3):285-297. doi: 10.1007/s40259-019-00345-6.
Decentralisation of healthcare budgets and issuance of local guidelines means that the use of biosimilars can vary by region within a particular country, for example between the 21 counties of Sweden.
This study aimed to analyse the county-level market dynamics of biosimilar and originator infliximab, which are hospital products, and to examine how local policy measures and practices, in addition to national policy, influenced market dynamics.
We first conducted a literature review on (biosimilar) policies in Sweden, then analysed market data provided by IQVIA™ on uptake of originator and biosimilar infliximab within the different counties (Q2 2012 to Q4 2017), including discounts from (tender) contracts. Biosimilar market shares were calculated with volume data (measured as defined daily doses [DDDs]). We then discussed our findings in semi-structured interviews with the national pricing and reimbursement agency, key experts within the county councils of Skåne, Västra Götaland, and Stockholm, and an industry representative.
Market shares of biosimilar infliximab vary widely between counties (range 18-96% in 2017). The initial uptake of biosimilar infliximab was slow and variable, with abrupt increments in biosimilar market shares coinciding with expiration of contracts for the originator product. Different approaches taken by counties to achieve a low cost per DDD of infliximab were identified, i.e., a rapid switch to the biosimilar (Skåne), a delayed switch to the biosimilar (Stockholm), or no switch to the biosimilar when a favourable price on the originator product could be obtained (Västra Götaland). Quantitative analysis showed that 59% of the variability in biosimilar market shares could be explained by the relative difference in discounted price between the biosimilar and the originator product. In addition, qualitative analysis indicated the presence of key opinion leaders, local guidelines and initiatives, and whose budget it affects as drivers in the decision-making process.
Variations in the market share of biosimilar infliximab between the Swedish counties is largely explained by the discounted price difference between biosimilar and originator product, and counties used different strategies to leverage such biosimilar competition. Additionally, the presence of key opinion leaders, local guidelines and gainsharing arrangements appeared to play a role in infliximab market dynamics in counties.
医疗预算的去中心化和地方指导方针的发布意味着生物类似药的使用在一个国家的不同地区可能会有所不同,例如在瑞典的 21 个县之间。
本研究旨在分析生物类似药和原研英夫利昔单抗(均为医院产品)的县级市场动态,并研究除国家政策外,地方政策措施和实践如何影响市场动态。
我们首先对瑞典的(生物类似药)政策进行了文献回顾,然后分析了 IQVIA™ 提供的关于不同县(2012 年第二季度至 2017 年第四季度)内原研和生物类似药英夫利昔单抗使用情况的市场数据,包括(招标)合同中的折扣。根据体积数据(以规定日剂量[DDD]衡量)计算生物类似药的市场份额。然后,我们在与国家定价和报销机构、斯科讷、西约塔兰和斯德哥尔摩县议会的主要专家以及行业代表的半结构化访谈中讨论了我们的发现。
生物类似药英夫利昔单抗的市场份额在各县之间差异很大(2017 年的范围为 18%-96%)。生物类似药英夫利昔单抗的初始使用速度缓慢且不稳定,随着原研产品合同的到期,生物类似药市场份额突然增加。确定了各县为实现英夫利昔单抗每 DDD 低成本而采取的不同方法,即快速转向生物类似药(斯科讷)、延迟转向生物类似药(斯德哥尔摩)或在获得原研产品有利价格时不转向生物类似药(西约塔兰)。定量分析表明,生物类似药市场份额变化的 59%可以用生物类似药和原研产品之间的折扣价格差异来解释。此外,定性分析表明,关键意见领袖、地方指南和举措以及影响其预算的人作为决策过程中的驱动因素存在。
瑞典各县之间生物类似药英夫利昔单抗市场份额的差异在很大程度上可以用生物类似药和原研产品之间的折扣价格差异来解释,各县使用不同的策略来利用这种生物类似药竞争。此外,关键意见领袖、地方指南和收益分享安排的存在似乎在县内英夫利昔单抗的市场动态中发挥了作用。