Maes Ingrid, Kok Eline, De Torck Pieter-Jan, Mestre-Ferrandiz Jorge, Simoens Steven
Inovigate, Wilrijk, Belgium.
Independent Economics Consultant, Madrid, Spain.
Front Pharmacol. 2023 Sep 28;14:1199253. doi: 10.3389/fphar.2023.1199253. eCollection 2023.
Current pricing and reimbursement models that focus on one indication at a time are not suited to address the market access of multi-indication medicines. Therefore, the aim of this study is to co-create with Belgian stakeholders a multi-indication pricing model and procedural pathway, to identify conditions for implementation, and to illustrate the multi-indication pricing model with a case study. Different multi-indication pricing models were identified from the literature, case studies and pilots in other countries. Semi-structured interviews were conducted with 21 representatives from the National Institute for Health and Disability Insurance, insurance funds, clinicians, patients, the policy cell of the Minister of Health, pharmaceutical industry and academia. These provided insight in the opinions of stakeholders about possible multi-indication pricing models and their feasibility in the Belgian context. Agreement on the preferred multi-indication pricing model and procedural pathway was reached in a multi-stakeholder round table. The international review generated four main multi-indication pricing models that vary in terms of whether a uniform price or differential prices are applied, whether prices are adjusted for the volume and/or value of the medicine in each indication, and whether a proactive or retroactive dynamic pricing approach is used. However, Belgian stakeholders preferred a fifth model, which sets a single price as the volume- and value-weighted average price across all indications at launch. Over time, the price is adapted based on volume and value of the medicine in real-life practice for each indication. To implement this model, a legal framework, horizon scanning and early dialogue, data infrastructure, an evidence plan for the medicine, technical expertise and governance model need to be developed. Although the multi-indication pricing model preferred by Belgian stakeholders raises the administrative burden, it allows for the price of a medicine to vary during the lifecycle based on its initial and real-life performance in multiple indications.
当前一次只关注一种适应症的定价和报销模式并不适合解决多适应症药物的市场准入问题。因此，本研究的目的是与比利时的利益相关者共同创建一种多适应症定价模式和程序路径，确定实施条件，并通过案例研究来说明多适应症定价模式。从文献、其他国家的案例研究和试点中确定了不同的多适应症定价模式。对来自国家健康与残疾保险研究所、保险基金、临床医生、患者、卫生部长政策小组、制药行业和学术界的21名代表进行了半结构化访谈。这些访谈深入了解了利益相关者对可能的多适应症定价模式及其在比利时背景下的可行性的看法。在多利益相关者圆桌会议上就首选的多适应症定价模式和程序路径达成了一致。国际审查产生了四种主要的多适应症定价模式，这些模式在是否应用统一价格或差异化价格、是否根据每种适应症中药物的数量和/或价值调整价格以及是否采用主动或追溯动态定价方法方面存在差异。然而，比利时的利益相关者更喜欢第五种模式，即在上市时将单一价格设定为所有适应症的数量和价值加权平均价格。随着时间的推移，根据每种适应症在实际应用中的药物数量和价值来调整价格。为了实施该模式，需要制定法律框架、趋势扫描和早期对话、数据基础设施、药物证据计划、技术专长和治理模式。尽管比利时利益相关者首选的多适应症定价模式增加了行政负担，但它允许药物价格在其生命周期内根据其在多种适应症中的初始和实际表现而有所不同。
