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马来西亚的卫生技术评估及其在药物政策中的应用。

Health Technology Assessment and Its Use in Drug Policy in Malaysia.

作者信息

Shafie Asrul Akmal, Chandriah Haarathi, Yong Yee Vern, Wan Puteh Sharifa Ezat

机构信息

School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia.

School of Pharmaceutical Sciences, Universiti Sains Malaysia, Malaysia; Pharmacy Practice & Development Division, Ministry of Health, Malaysia.

出版信息

Value Health Reg Issues. 2019 May;18:145-150. doi: 10.1016/j.vhri.2019.03.003. Epub 2019 May 10.

Abstract

OBJECTIVE

To describe the process and role of health technology assessment (HTA) in the context of drug policy in Malaysia.

METHODS

We summarized the HTA process through review of documents and reports available in the public domain combined with the authors' experience.

RESULTS

Health technology assessment plays an integral part in prioritizing treatment in public health facilities in Malaysia, particularly for the Ministry of Health Medicines Formulary (MOHMF). The MOHMF is the reference list of drugs allowed to be prescribed in the Ministry of Health (MOH) facilities. There are 2 organizations within the MOH that conduct HTA as their core activities, namely the Malaysian Health Technology Assessment Section and the Formulary Management Branch of Pharmacy Practice & Development Division. The assessment of pharmaceuticals for the purpose of listing medicines into the MOHMF is under the purview of the Formulary Management Branch. The evidence-based assessment focuses on safety, efficacy, effectiveness, and budget impact of the drug. Cost-effectiveness evidence is currently not mandatory but is of interest to the decision makers. The assessment outcomes are considered by the MOH Medicines List Review Panel for formulary decisions.

CONCLUSIONS

Health technology assessment has supported formulary decisions in MOH. Evidence generation needs to progress beyond efficacy or effectiveness, safety, and budget impact to incorporate cost-effectiveness. Nevertheless, there are challenges to be met to achieve this. The impact of the HTA process is currently unknown and is yet to be evaluated formally.

摘要

目的

描述卫生技术评估(HTA)在马来西亚药品政策背景下的过程和作用。

方法

我们通过查阅公共领域的文件和报告并结合作者的经验,总结了HTA过程。

结果

卫生技术评估在马来西亚公共卫生机构确定治疗优先顺序方面发挥着不可或缺的作用,特别是对卫生部药品处方集(MOHMF)而言。MOHMF是卫生部(MOH)设施中允许开具的药品参考清单。卫生部内有两个组织将HTA作为其核心活动,即马来西亚卫生技术评估科和药学实践与发展司的处方集管理处。将药品列入MOHMF的评估工作由处方集管理处负责。基于证据的评估重点关注药物的安全性、有效性、效能和预算影响。成本效益证据目前并非强制要求,但决策者对此感兴趣。卫生部药品清单审查小组在做出处方集决策时会考虑评估结果。

结论

卫生技术评估为卫生部的处方集决策提供了支持。证据生成需要超越疗效或效能、安全性和预算影响,纳入成本效益。然而,要实现这一点还面临一些挑战。目前尚不清楚HTA过程的影响,且尚未进行正式评估。

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