ABSTRACT

Introduction

Ocrelizumab is the first approved drug for primary progressive multiple sclerosis. Following appraisal by health technology assessment (HTA) bodies, this medicine has not been widely covered across European countries. We have compared the HTA process in England and France.

Area covered

We undertook an analysis of relevant documents that were published by the two HTA bodies. We analyzed patients’ availability of Ocrelizumab at the different stages of the process.

Expert opinion

We identified differences in the assessment, one being the use of a different population of the pivotal trial, which has resulted in the consideration of distinct clinical effectiveness estimates. Ocrelizumab became available earlier in France as part of an early access program. However, rapid access was discontinued for newly eligible patients following an opinion concluding that Ocrelizumab yielded no additional benefit over placebo. This opinion was not compatible with the criteria allowing reimbursement in France.

In England, there was no early access program and following an appraisal that included cost-effectiveness evaluation combined with pricing agreements, medicine was finally recommended. In conclusion, differences in the HTA process may result in appreciable differences in timing and outcome from marketing authorization to the adoption of newly licensed drugs.

中文翻译：

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Ocrelizumab 在法国不推荐用于原发性进行性多发性硬化症患者，而在英国推荐：比较 HAS 和 NICE 评估的综述

摘要

介绍

Ocrelizumab 是第一个被批准用于治疗原发性进行性多发性硬化症的药物。经卫生技术评估 (HTA) 机构评估后，该药尚未在欧洲国家广泛覆盖。我们比较了英国和法国的 HTA 工艺。

覆盖面积

我们对两个 HTA 机构发布的相关文件进行了分析。我们分析了患者在该过程的不同阶段对 Ocrelizumab 的可用性。

专家意见

我们发现了评估中的差异，其中之一是使用了不同人群的关键试验，这导致考虑了不同的临床有效性估计。作为早期访问计划的一部分，Ocrelizumab 较早在法国上市。然而，在得出结论认为 Ocrelizumab 对安慰剂没有额外益处之后，新符合条件的患者停止了快速访问。该意见不符合法国允许报销的标准。

在英格兰，没有早期访问计划，经过包括成本效益评估和定价协议在内的评估，最终推荐了药物。总之，HTA 流程的差异可能会导致从上市许可到采用新许可药物的时间和结果存在明显差异。