Patrick Wincy Reyes, Lara Alyssa Liban, Ma. Cecilia Victoria Arellano, Joshua Santillan, Sheena Jasley Samonte, Anne Julienne Marfori, Anna Melissa Guerrero, Marc James delos Santos, Catherine Manuela Lee-Ramos, Agnette Peralta, Department of Health – Medical Device Unit, Health Technology Assessment Council
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引用次数: 0
Abstract
Introduction
Pursuant to the Universal Health Care Act of 2019, the Health Technology Assessment Council (HTAC) in the Philippines was mandated to make recommendations for government financing of health technologies, including medical devices. The development of a Philippine Essential Medical Device List (PEMDL) will serve as a guide for the procurement of medical devices and supplies in government health facilities and as the basis for creating a price reference index.
Methods
The HTAC and a team of medical device experts (the Expert Advisory Committee) developed a streamlined pathway and guidelines using a Delphi technique with the Philippine Food and Drug Administration (FDA) and the Department of Health (DOH) to determine the necessary criteria for fast tracking the inclusion of medical devices. The pathway was also revised throughout a pilot processing of commonly procured medical devices (e.g., consumables) that were either already covered by existing national health insurance packages or funded by DOH programs, among others.
Results
The final pathway consisted of validating whether the device was already approved by the Philippine FDA and whether it was already part of standard of care. Similar to the usual HTA nomination requirement, the local FDA approval attested to the safety and quality of the device. Meanwhile, the inclusion of the device in the standard of care guaranteed that it was essential in the healthcare setting. This can be written in the World Health Organization technical documents and databases such as the Medical Devices Information System, health facility listing requirements, or locally adopted clinical practice guidelines. The initial PEMDL for release contained a total of 307 medical devices across 16 categories.
Conclusions
Unlike the mandate for the Philippine National Formulary, government health facilities are not yet required to base their procurement on the PEMDL because the list is still in its infancy. Moving forward, the list will include big ticket items and will be updated through consultations with specialty centers and hospitals.
导言根据 2019 年《全民医疗保健法》,菲律宾卫生技术评估委员会(HTAC)的任务是就政府对医疗技术(包括医疗器械)的资助提出建议。菲律宾基本医疗器械清单(PEMDL)的制定将作为政府卫生机构采购医疗器械和用品的指南,并作为创建价格参考指数的基础。方法菲律宾卫生技术评估委员会和医疗器械专家团队(专家咨询委员会)采用德尔菲技术,与菲律宾食品药品管理局(FDA)和卫生部(DOH)共同制定了简化路径和指南,以确定快速纳入医疗器械的必要标准。结果最终的路径包括验证设备是否已经获得菲律宾 FDA 的批准,以及是否已经成为医疗标准的一部分。与通常的 HTA 提名要求类似,当地 FDA 的批准证明了设备的安全性和质量。与此同时,将该设备纳入医疗标准则保证了它在医疗环境中的重要性。这可以写入世界卫生组织的技术文件和数据库(如医疗器械信息系统)、医疗机构列表要求或当地采用的临床实践指南。结论 与《菲律宾国家处方集》的规定不同,政府卫生机构尚未被要求根据《菲律宾国家处方集》进行采购,因为该清单仍处于起步阶段。今后,该清单将包括大型项目,并将通过与专科中心和医院的协商进行更新。
期刊介绍:
International Journal of Technology Assessment in Health Care serves as a forum for the wide range of health policy makers and professionals interested in the economic, social, ethical, medical and public health implications of health technology. It covers the development, evaluation, diffusion and use of health technology, as well as its impact on the organization and management of health care systems and public health. In addition to general essays and research reports, regular columns on technology assessment reports and thematic sections are published.