背景:心血管疾病(CVD)連續幾十年來為台灣十大死因之一,這不僅是一項重要的公共衛生議題,同時也對台灣醫療體系帶來沉重的經濟負擔,特別是在老年人口。研究已證實,Statin 類藥物能有效預防心血管疾病,為臨床上普遍使用的降膽固醇治療藥物。隨著CVD盛行率的快速成長,2013年台灣全民健康保險署修訂降膽固醇藥物給付規定,擴大降膽固醇藥物的用藥標準。因此,在政策修訂後,接受降膽固醇治療的患者和藥品支出將會大幅增加。 目的:本研究探討台灣全民健康保險修訂降膽固醇藥物給付規定後, statin 類降膽固醇治療的成本效果(cost-effectiveness) 。 方法:本研究使用馬可夫決策模型(Markov decision model),目標族群針對65歲以上之心血管疾病(心絞痛、心肌梗塞、中風)或糖尿病患者,且低密度膽固醇介於100-130 mg/dL 的新符合健保用藥族群。本研究採用台灣全民健康保險署觀點,醫療費用與健康結果採用3% 折現。模型使用參數取自台灣全民健保資料庫、statin 藥物大型臨床試驗與統合分析研究,與已發表文獻。研究結果以遞增成本效果比(incremental cost-effectiveness ratio, ICER)進行分析。 結果:心絞痛、心肌梗塞、中風與糖尿病患者,接受終身 statin 類降膽固醇治療的 ICER 分別為新台幣 91,739 元、121,356 元、131,694元與227,938 元。因此,以國際衛生組織建議之成本效果指標為閾值,statin 類降膽固醇治療具有成本效果。敏感度分析顯示,研究結果會受到研究時間水平影響;然而,整體而言,statin 類降膽固醇治療仍具有高度成本效果。 結論:以台灣全民健康保險觀點,台灣全民健康保險修訂降膽固醇藥物給付規定後, statin 類降膽固醇治療對於心血管疾病的預防,具有成本效果。本研究結果顯示,早期和長期持續接受statin 類降膽固醇治療,具有較佳的臨床效果和成本效果。
Background: In Taiwan, cardiovascular diseases (CVD) are the leading causes of death for over 10 years in succession, and it is a crucial health issue and additionally impose an heavy economic burden on health care systems, particularly among the older patients. Statin is commonly used in cholesterol-lowering therapy to prevent CVD. With the rapid growth of CVD prevalence, in 2013, Taiwan’s National Health Insurance (NHI) reimbursement criteria for cholesterol-lowering therapy was modified to expand the use of cholesterol-lowering medicine. The new policy would contribute to an increase in both the number of eligible patients and statin medicine expenditures considerably. Objective: This study aims to evaluate the benefits and the cost-effectiveness of statin therapy for the newly eligible patients over 65 years old with CVD or diabetes under the modified NHI reimbursement criteria for cholesterol-lowering therapy in 2013, and to provide the evidence-based information for future research and decision-makers in Taiwan. Methods: We designed a Markov model to evaluate the cost-effectiveness of statin therapy for a hypothetical 65-year-old cohort with LDL cholesterol levels of 100-130 mg/dL having a history of CVD (angina, MI, stroke) or type 2 diabetes in Taiwan. The model used a lifetime time horizon, Taiwan’s NHI healthcare payer perspective, and 3% discount rate for costs and health outcomes. Data sources for model parameters included Taiwan’s National Health Insurance Research Database (NHIRD), large clinical trials and meta-analyses for the statin treatment, and other published sources. Main outcomes were incremental costs per quality-adjusted life-year (QALY) gained. Results: In the base-case analysis, cost-effectiveness results for the lifetime statin therapy in patients with a history of angina, MI, stroke or diabetes was NT$ 91 739, NT$ 121 356, NT$ 131 694 and NT$ 227 938 per QALY gained, respectively. In the one-way sensitivity analysis, the disutility caused by daily medication use was found to have a moderate impact on the cost-effectiveness of statin treatment, particularly for diabetic patients. Cost-effectiveness results were sensitive to changes in time horizons modeled. In Monte Carlo probabilistic sensitivity analysis, there was always had a high likelihood of being highly cost-effective at the thresholds of NT$ 700 000. Conclusion: This economic evaluation from Taiwan’s NHI perspective demonstrates that under the modified NHI reimbursement criteria, statin therapy would be effective and highly cost-effective for prevention of CVD for the newly eligible patients over 65 years old with CVD or diabetes. Early intervention with statins has better effectiveness and cost-effectiveness results among CVD patients. Importantly, the time horizon of the models plays a significant role in the cost-effectiveness of statin treatment. This finding also raises the importance of early and continuing treatment for a longer duration to achieve the optimal benefit of the investment in statins.