臺灣博碩士論文加值系統

背景：中央健康保險署於2020年5月修正DPP-4/SGLT2抑制劑之複方製劑的給付規定。此類複方製劑從限用於糖化血色素未低於8.5%者，修改為糖化血色素高於7.5%者即可使用。
目的：本研究以中央健康保險署的觀點，分析DPP-4/SGLT2抑制劑之複方製劑在給付規定修正後與修正前之成本效果。
方法：本研究使用馬可夫模型，針對第二型糖尿病患者，模擬在糖化血色素高於7.5%時得以服用DPP-4/SGLT2抑制劑之複方製劑（早期使用組）與在糖化血色素未低於8.5%時方能服用複方製劑（延遲使用組）的終身醫療費用和健康結果。模型使用參數取自全民健康保險研究資料庫2010年200萬人世代追蹤抽樣檔與已公開發表之文獻，醫療費用和健康結果採用3%的年折現率。研究結果以遞增成本效果比值呈現，並進行單因子敏感度分析、情境敏感度分析及機率性敏感度分析以瞭解不同參數對於研究結果之影響。
結果：早期使用組的終身醫療費用為新臺幣1,379,697.72元，生活品質校正生命年為9.07年；延遲使用組的終身醫療費用為新臺幣1,355,022.44元，生活品質校正生命年為8.79年。與延遲使用組相比，早期使用組的終身醫療費用較高，但也有較長的生活品質校正生命年。計算遞增成本效果比值後，可以得知每多得到一個生活品質校正生命年需多花的成本為新臺幣87,096.42元，早期使用組具有成本效果。從敏感度分析來看，早期使用組在絕大多數情況下也具有成本效果。
結論：對身處臺灣健康照護體系的第二型糖尿病患者而言，早期使用DPP-4/SGLT2抑制劑之複方製劑（給付規定修正後），相較於延遲使用（給付規定修正前）具有成本效果。

Background: In Taiwan, reimbursement of fixed-dose combination (FDC) products containing dipeptidyl peptidase-4 (DPP-4) inhibitors and sodium-glucose cotransporter-2 (SGLT2) inhibitors had been approved to treat people with type 2 diabetes and glycated hemoglobin ≥ 8.5% before May 2020. In May 2020, this regulation was modified to treat patients with glycated hemoglobin > 7.5%. The present study sought to evaluate the cost-effectiveness of SGLT2 inhibitor/DPP-4 inhibitor fixed-dose combination therapy for type 2 diabetes mellitus before and after the implementation of the modified reimbursement regulation.
Methods: A Markov model was developed to simulate the costs and health outcomes of patients receiving SGLT2 inhibitor/DPP-4 inhibitor FDC products with glycated hemoglobin levels > 7.5% (early use group) compared with those receiving FDC products with glycated hemoglobin levels ≥ 8.5% (delayed use group) over a lifetime horizon. Transition probabilities, costs, and health state utility values were obtained from published sources and the 2010 longitudinal generation tracking database of Taiwan's National Health Insurance. All costs and health outcomes were discounted at a rate of 3% per year. One-way sensitivity analyses, scenario analyses, and probabilistic sensitivity analyses were performed to explore the impact of changes in key data inputs.
Results: The early use group resulted in higher total lifetime costs (NT$1,379,697.72 vs NT$1,355,022.44) while yielding greater quality-adjusted life-years (QALYs) (9.07 vs 8.79) compared with the delayed use group. This translated to an incremental cost-effectiveness ratio of NT$87,096.42 per QALY gained. Sensitivity analyses verified the robustness of the model.
Conclusion: Compared to delayed treatment with SGLT2 inhibitor/DPP-4 inhibitor FDC products in patients whose HbA1c levels are ≥ 8.5%, early treatment with FDC products in patients whose HbA1c levels are > 7.5% is likely to be a cost-effective method for the management of patients with type 2 diabetes in a Taiwanese healthcare setting.

口試委員會審定書 i
謝辭 iii
中文摘要 iv
Abstract v
Table of Contents vii
List of Figures xii
List of Tables xiii
Chapter 1: Introduction 1
1.1 Background 1
1.1.1 Cardiovascular Disease 1
1.1.2 Cardiovascular Disease and Diabetes Mellitus 2
1.1.3 Sodium-Glucose Cotransporter-2 Inhibitors and CVD Prevention 3
1.1.4 National Health Insurance Reimbursement Criteria 4
1.2 Objective and Importance 5
Chapter 2: Literature Review 7
2.1 Cardiovascular Disease and Diabetes Mellitus 7
2.1.1 Cardiovascular Disease 7
2.1.2 Diabetes Mellitus 9
2.1.3 Cardiovascular Disease in Diabetes Mellitus 11
2.1.4 Prevention of Cardiovascular Disease in Diabetes Mellitus 12
2.2 Treatment of Type 2 Diabetes Mellitus 14
2.2.1 Lifestyle Management 14
2.2.2 Oral Anti-Diabetic Drugs 15
2.2.3 National Health Insurance Reimbursement Criteria in Taiwan 16
2.3 Clinical Effectiveness of Pharmacologic Interventions 18
2.3.1 DPP-4 Inhibitors 19
2.3.2 SGLT2 Inhibitors 22
2.3.3 Combination of DPP-4 Inhibitors and SGLT2 Inhibitors 24
2.4 Methods of Economic Evaluation 25
2.4.1 Different Types of Economic Evaluation 26
2.4.2 Economic Evaluation Using Modeling Approaches 27
2.5 Economic Studies of SGLT2 Inhibitors for Type 2 Diabetes Mellitus 29
2.5.1 General Characteristics of the Included Studies 35
2.5.2 Types of Interventions and Comparators 36
2.5.3 Health States 37
2.5.4 Costs 38
2.5.5 Utilities 39
2.5.6 Cost-Effectiveness of SGLT2 Inhibitors 39
2.5.7 Summary of the Included Studies 40
2.6 Summary 40
Chapter 3: Methods 43
3.1 Study Design 43
3.2 Model Assumptions and Description 44
3.3 Transition Probabilities 46
3.4 Treatment Effects 49
3.5 Costs 51
3.5.1 Data Sources 51
3.5.2 Data Analysis Using the LGTD 2010 53
3.6 Utilities 54
3.7 Statistical Analysis 55
Chapter 4: Results 57
4.1 Cost Data from the LGTD 2010 57
4.2 Base-Case Analysis 58
4.3 One-Way Sensitivity Analyses 59
4.4 Scenario Analyses 60
4.5 Probabilistic Sensitivity Analysis 62
Chapter 5: Discussion 65
5.1 Major Findings 65
5.2 Strengths 67
5.3 Limitations 68
Chapter 6: Conclusions 71
6.1 Conclusions 71
6.2 Recommendations 72
6.2.1 Recommendations to the NHIA 72
6.2.2 Recommendations for Future Research 72
Reference 75
Appendix: Research Ethics Committee Approval Letter 101

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