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研究生:羅柏青
研究生(外文):Po-Ching Lo
論文名稱:骨質疏鬆症治療藥品用於骨折初級預防的成本效益分析
論文名稱(外文):Cost-effective analysis of anti-osteoporosis medications for primary prevention of fractures
指導教授:蔡憶文蔡憶文引用關係黃文鴻黃文鴻引用關係
指導教授(外文):Yi-Wen TsaiWeng-foung Huang
學位類別:博士
校院名稱:國立陽明大學
系所名稱:衛生福利研究所
學門:醫藥衛生學門
學類:公共衛生學類
論文種類:學術論文
論文出版年:2016
畢業學年度:104
語文別:中文
論文頁數:151
中文關鍵詞:骨質疏鬆症治療藥品成本效益分析藥品給付政策
外文關鍵詞:anti-osteoporosis medicationscost-effective analysisfracturesdrug reimbursement policy
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背景及目的:骨折是台灣面臨高齡化社會重要的健康議題,然而,目前台灣之全民健康保險(台灣健保)僅給付抗骨質疏鬆症(骨鬆)藥品於骨折後之次級預防,不給付於骨折前之初級預防。本研究從台灣健保署的觀點,評估台灣健保擴增抗骨鬆藥品給付至骨折初級預防的成本效益,並且估計此擴增藥品給付政策對骨鬆病人未來20年可減少之健康損失量的影響。
方法:本研究採用Markov model進行為期終身的成本效用分析。針對40歲以上新發骨鬆之男性及女性病人,比較兩種給付政策情境之成本效益:(1)現有情境:台灣健保給付抗骨鬆藥品於骨折後之次級預防;(2)擴增情境:台灣健保擴增抗骨鬆藥品之給付至骨折前之初級預防(包含次級預防)。評估之藥品包含alendronate, risedronate, zoledronate和denosumab。臨床結果指標為品質校正生活年,病人基線骨折風險參數是利用台灣健保申報資料以Weibull model估計,藥品療效、生活品質及死亡率由文獻回顧獲得。醫療資源耗用部分僅考慮健保支出的直接醫療成本。研究結果以遞增成本效益比值(Incremental Cost-Effectiveness Ratio, ICER)呈現,並針對參數及假設的不確定性進行單維敏感度分析、機率敏感度分析及情境敏感度分析。
在擴增抗骨鬆藥品至骨折初級預防可減少之健康損失量方面,本研究將前述之Markov model改成動態模型來分析。分析族群包含2017至2036年每年50歲以上新發之骨鬆病患,骨鬆病患人數的預估採用國家發展委員會之人口推計報告及經由台灣健保資料分析所獲得之國人各年齡層骨鬆發生率。健康損失包含生命年及品質校正生活年之損失,其計量等於前述之現有情境及擴增情境兩種政策情境的健康產出差異。動態馬可夫模型使用的其他參數,如病人基線骨折風險、藥品療效、生活品質及死亡率皆與前述之成本效用分析相同。

結果:在成本效用分析方面,相較於現有情境,擴增alendronate, risedronate, zoledronate和denosumab至骨折初級預防在女性的ICER值分別為2,108,990、2,684,269、1,545,940及1,749,719元;在男性的ICER值分別為1,151,401、1,523,009、891,126及1,014,925元。若以210萬台幣作為成本效益的閾值,機率敏感度分析顯示在女性擴增zoledronate,在男性擴增alendronate, zoledronate和denosumab有相當高的機率(≧85%)符合成本效益。在政策可減少之健康損失量方面,此藥品政策帶來的健康效益會隨著台灣老年人口的增長而遞增。以alendronate為例,台灣健保擴增alendronate至骨折初級預防在未來20年可減少之健康損失量,在女性病人為9,346生命年(95% confidence interval(CI)= 9,127-9,565)及44,843品質校正生活年(95% CI=43,939-45,746);在男性病人為27,086生命年(95% CI=26,452-27,719)及40,571品質校正生活年(95% CI=39,709-41,433)。

結論:台灣健保擴增抗骨鬆藥品給付至骨折初級預防可以相當程度地減緩病患因為骨鬆帶來之疾病負擔。建議健保署可針對成本效益分析結果,重新評估並調整現行抗骨鬆藥品之限縮給付政策。

Background:
The Taiwan National Health Insurance (NHI) currently reimburses anti-osteoporosis medications (AOMs) only for the secondary prevention of fractures but not for the primary prevention of fractures in Taiwanese osteoporosis patients. This study aimed to examine the cost-effectiveness of expanding reimbursement of AOMs from the secondary to primary prevention of fractures in the perspective of Taiwan National Health Insurance Administration (NHIA), and to estimate the reduction of health loss due to the expansion of reimbursement of AOMs over the next 20 years.

Method:
This study applied a cost-utility analysis to estimate the incremental costs, quality-adjusted life-years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) of expanding reimbursement of AOMs from the secondary to primary prevention of factures. AOMs including alendronate, risedronate, zoledronate, and denosumab were evaluated. A Markov model was developed to simulate long-term costs and health outcomes in both male and female osteoporosis patients in Taiwan. The model focused on only direct medical costs. The AOM’s clinical efficacy, mortality rate, and health utility were retrieved from literature review. The baseline fracture risks and osteoporosis and fractures related medical costs among Taiwanese osteoporosis patients were obtained by analyzing Taiwan’s National Health Insurance Research Database. The discount rate of 3% was used for both costs and health outcomes. The robustness of the ICER estimates was assessed in several sensitivity analyses.

Results:
The result indicated that reimbursing zoledronate in female patients, and reimbursing alendronate, zoledronate and denosumab in male patients for the primary prevention of fracture was highly likely cost-effective. The ICER of reimbursing zoledronate for the primary prevention of fractures in female patients was TWD 1545940 per QALY gained; the ICER of reimbursing alendronate, zoledronate and denosumab in male patients, TWD 1151401, TWD 891126, and TWD 1014925 per QALY gained, respectively. The reduction of health loss due to expanding AOMs reimbursement over the next 20 years will increase along with aging population in Taiwan. Using alendronate as an example, reimbursing alendronate for the primary prevention of fracture will decrease 9346 Life-Years (LYs) loss (95% confidence interval (CI), 9127, 9565) and 44843 QALYs loss (95% CI, 43939, 45746) in female patients, and decrease 27086 LYs loss (95% CI, 26452, 27719) and 40571 QALYs loss (95% CI, 39709-41433) in male patients.

Conclusion:
Expanding reimbursement of AOMs for the primary prevention of fractures will reduce the disease burden in Taiwanese osteoporosis patients. Taiwan NHIA shall consider expanding the reimbursement of AOMs from the secondary to primary prevention of factures based on the cost-effectiveness analysis.

致謝 i
中文摘要 iii
Abstract vi
目錄 viii
圖目錄 x
表目錄 xi
第一章、研究背景 1
第一節、醫療保險限縮給付病人群的藥品給付政策 1
第二節、骨質疏鬆症與台灣全民健康保險之抗骨質疏鬆藥品給付政策 6
第二章、文獻回顧 12
第一節、藥品給付限制 12
第二節、骨質疏鬆症簡介 17
第三節、抗骨質疏鬆症藥品在其他國家的藥品給付現況 27
第四節、抗骨質疏鬆症藥品對於骨折初級預防的效果 31
第五節、抗骨質疏鬆症藥品之服藥配合度對於治療效果之影響 35
第六節、抗骨質疏鬆症藥品用於骨折初級預防的成本效益 37
第三章、研究方法 44
第一節、台灣全民健康保險擴增抗骨質疏鬆症藥品給付至骨折初級預防的成本效用分析 44
第二節、台灣全民健康保險擴增抗骨質疏鬆症藥品給付至骨折初級預防在未來20年可減少的健康損失估計 58
第三節、現有情境及擴增情境下骨鬆病人發生骨折機率估計方式 64
第四章、研究結果 72
第一節、馬可夫模型使用參數綜整 72
第二節、擴增抗骨質疏鬆症藥品給付至骨折初級預防的成本效用分析結果 90
第三節、擴增抗骨質疏鬆症藥品給付至骨折初級預防於未來20年可減少的健康損失估計 110
第五章、討論 121
第六章、結論 135
參考文獻 136
附錄 145

圖 1、醫療科技給付之三個面向 13
圖 2、成本效用分析-馬可夫模型架構 46
圖 3、預估兩種政策情境不同時間點健康產出之動態馬可夫模型 59
圖 4、研究設計-骨鬆病人初發脊椎或髖部骨折機率估計 65
圖 5、研究樣本篩選流程圖-新發骨鬆病人 66
圖 6、研究設計-有骨折史病人再次發生脊椎或髖部骨折機率估計 67
圖 7、研究樣本篩選流程圖-新發脊椎骨折或髖部骨折病人 68
圖 8、台灣50歲以上各年齡男性及女性之骨鬆發生率 88
圖 9、女性骨鬆病人-單維敏感度分析 95
圖 10、女性骨鬆病人-機率敏感度分析(成本效益可接受曲線) 96
圖 11、男性骨鬆病人-單維敏感度分析 101
圖 12、男性骨鬆病人-機率敏感度分析(成本效益可接受曲線) 102
圖 13、骨鬆病人在現行台灣健保抗骨鬆藥品給付政策下,與同年齡同性別一般健康族群之健康落差 128
圖 14、擴增抗骨鬆藥品給付至骨折初級預防政策可減緩骨鬆疾病負擔的程度 129

表 1、九個已開發國家之抗骨鬆藥品給付政策 8
表 2、台灣食品藥物管理署核准之抗骨鬆藥品及其核准適應症 24
表 3、九個國家之抗骨鬆藥品給付政策及其給付金額 30
表 4、抗骨鬆藥品用於脊椎骨折初級預防之效果 33
表 5、抗骨鬆藥品用於髖部骨折初級預防之效果 34
表 6、馬可夫模型使用參數及其估計方式 48
表 7、動態馬可夫模型使用參數及其估計方式 61
表8、四個抗骨鬆藥品用於脊椎或髖部骨折初級預防之療效 71
表 9、新發骨鬆尚未骨折病人之基本特質及骨折率 73
表 10、新發骨鬆尚未骨折病人之Weibull model配適結果及各年脊椎及髖部骨折預估發生率 73
表 11、初次發生脊椎骨折樣本基本特質及再次骨折率 76
表 12、初次發生脊椎骨折樣本之Weibull model配適結果及各年預估再次骨折發生率 76
表 13、初次發生髖部骨折樣本基本特質及臨床結果 77
表 14、初次發生髖部骨折樣本之Weibull model配適結果及各年預估再次骨折發生率 77
表 15、Markov model採用之骨鬆各疾病狀態之生活品質 78
表 16、台灣50歲以上男性及女性各年齡發生髖部骨折死亡率 80
表 17、骨鬆但尚未骨折期之門診醫療支出 83
表 18、脊椎骨折期之醫療支出 84
表 19、髖部骨折期之醫療支出 85
表 20、脊椎骨折後期之門診醫療支出 86
表 21、髖部骨折後期之門診醫療支出 86
表 22、抗骨鬆藥品之每年藥費估計 87
表 23、2017~2036年每年男性及女性新發骨鬆病人人數預估 89
表 24、女性骨鬆病人之成本效用分析結果-基礎案例 91
表 25、男性骨鬆病人之成本效用分析結果-基礎案例 91
表 26、女性骨鬆病人-機率敏感度分析(各閾值下符合成本效益機率) 96
表 27、女性骨鬆病人之情境敏感度分析結果 97
表 28、男性骨鬆病人-機率敏感度分析(各閾值下符合成本效益機率) 102
表 29、男性骨鬆病人之情境敏感度分析結果 103
表 30、各年齡層骨鬆新發病人之骨折發生率 105
表 31、女性-年齡分層之成本效用分析結果 107
表 32、男性-年齡分層之成本效用分析結果 108
表 33、女性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之髖部骨折數及脊椎骨折數 112
表 34、女性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之QALYs損失 113
表 35、女性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之生命年損失 113
表 36、男性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之髖部骨折數及脊椎骨折數 114
表 37、男性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之QALYs損失 115
表 38、男性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之生命年損失 115
表 39、女性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之QALYs及生命年損失-情境敏感度分析結果:全死因死亡率下降10% 117
表 40、男性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之QALYs及生命年損失-情境敏感度分析結果:全死因死亡率下降10% 118
表 41、女性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之QALYs及生命年損失-情境敏感度分析結果:年折現率5% 119
表 42、男性-擴增抗骨鬆藥品給付至骨折初級預防在2026年及2036年可減少之QALYs及生命年損失-情境敏感度分析結果:年折現率5% 120

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