醫療科技評估 Health Technology Assessment
連結醫藥科技研究與政策決定的橋樑 is the systematic evaluation of properties, effects, and/or impacts of health technology

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5. CDE醫藥科技評估組如何執行評估? How does the HTA Division carry out assessments?

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點閱次數:1462

       當CDE收到健保署委託進行HTA組評估之案件時,每一案件會指定兩位評估者,相對療效評估與經濟評估各一位。評估人員除審閱建議者之申請文件資料外,同時也進行實證資料查詢及彙整,包含三國(英國、加拿大、澳洲)醫藥科技評估報告及電子資料庫(Cochrane library, PubMed, EMBASE等),整理出療效與成本效益的資料。依評估時程在第32天完成中文評估報告,CDE在42天內以正式公函將報告寄送給健保署。
       HTA所提供新藥評估報告供健保署「全民健康保險藥物給付項目及支付標準共同擬訂會議(Pharmaceutical Benefit and Reimbursement Scheme Joint committee, PBRS)」做新藥收載決定時之參考。根據二代健保法,PBRS是由來自官方(主關機關、藥物管理與保險業務單位)、醫療專家、醫療機構、雇主與消費者代表等29人所組成,為健保收載與給付決策的決定者。

 

When the CDE receives pharmaceutical reimbursement applications from the NHIA, a review team will be set up for each case. Two primary reviewers will be assigned to perform the comparative clinical efficacy evaluation and economic evaluation, respectively. Besides reviewing the documents submitted by the applicants, primary reviewers will also conduct searches and compilation of evidence data. Data regarding efficacy and cost-effectiveness are gathered from public sources such as HTA reports from the UK, Canada and Australia; and electronic databases (e.g. Cochrane Library, PubMed, EMBASE etc). After the primary reviewers’ complete assessments, their report will be confirmed by their secondary reviewers, respectively. Based on the assessment schedule, the assessment report will be completed in 32 days, and the CDE will submit the report as an official document to the NHIA within 42 days. All reports are written in Chinese. For new drug case, the assessment report of the HTA Division will be used to support the decisions on NHI listing at the Pharmaceutical Benefit and Reimbursement Scheme Joint Meeting (PBRS). By law (the second-generation NHI Act), the PBRS is a joint appraisal committee composed of 29 members from government officials, health professionals, healthcare providers and consumer representatives (employers and beneficials).