2018-08-012024-05-18https://scholars.lib.ntu.edu.tw/handle/123456789/707965摘要：創新新藥(innovative new drugs)的引進對藥品市場結構的改變以及藥品支出上升的顯著影響，使得如何評估創新新藥的價值(value)成為近年來各國健康照護體系所面臨到的最重大挑戰。然而，藥品的價值會受到許多內在(endogenous)及外在(exogenous)因素的影響，內在因素如藥品的創新程度、適應症以及給付規定，而外在因素則包括同一治療市場中與其他藥品間產生的競爭或取代作用等，然而，目前針對這些議題的實證研究卻是相對有限的。因此，我們將結合團隊內藥物經濟學、衛生政策管理與癌症治療的專才，利用臺灣全民健康保險資料庫與公開可取得資料，以癌症與免疫治療藥品為研究藥品，從藥品生命週期的觀點，發展與驗證新的方法學以分析內在(endogenous)及外在(exogenous)因素對於這些藥品於全民健康保險制度內藥品使用量的影響，並進行藥品動態經濟效益的評估。全民健康保險為單一保險人制度的優點，包括廣泛的處方藥給付範圍，以及全民健康保險資料庫的完整性與長達10年以上的資料長度，使得本研究能完整分析研究藥品自納入健保給付的長期使用量，並探討同一治療市場中與其他藥品間產生的競爭或取代作用等，最後可以進行藥品動態經濟效益的評估，因此本計畫的成果，不僅具有高度學術價值，對各國衛生主管機關也能提供政策規劃的重要實證資料。<br> Abstract: The adoption of innovative new drugs has continuously resulted in dramatic changes of the pharmaceutical market structure and escalating drug expenditures. Therefore, how to evaluate the “values” of these drugs has become a major challenge to health authorities worldwide. However, the value of an innovative drug can be modified by numerous endogenous (such as the expansion of indications) and exogenous factors (such as therapeutic or generic competitions). Empirical studies on this field are very scarce. Therefore, our multidisciplinary team plans to use the National Health Insurance Research Database (NHIRD) and publicly-available data to conduct a series of studies. Innovative new drugs (antineoplastic and immunomodulation agents) firstly reimbursed by Taiwan’s National Health Insurance (NHI) program between 2007 and 2016 will be our study drugs. This study aims to(1) collect key factors (endogenous and exogenous) associated with value of innovative new drugs; (2) examine the impacts of these key factors (endogenous and exogenous) on volume of study drugs consumed in Taiwan’s NHI system;(3) estimate the dynamic economic value of innovative new drugs over the drug life cycle.Taiwan’s unique NHI program and NHIRD offer several advantages for our study. Firstly, the single-payer NHI system and its comprehensive coverage of prescription drugs allows us to trace the consumption of innovative new drugs as well as their therapeutic or generic competitors. Secondly, the longitudinal NHIRD also allows us to estimate the impacts of these key factors (endogenous and exogenous) on volume of study drugs and dynamic economic value of innovative new drugs over the drug life cycle. Our study will provide significant empirical findings to future researchers and policymakers.創新新藥藥品價值藥品使用量療效競爭學名競爭經濟效益評估全民健康保險資料庫innovative new drugseconomic valuedrug volumetherapeutic competitionsgeneric competitionseconomic evaluationNational Health Insurance Research Database (NHIRD)