臺灣大學: 商學組江炯聰戴曉南Tai (Shannon Tai), Hsiao-NanHsiao-NanTai (Shannon Tai)2013-04-082018-06-292013-04-082018-06-292010http://ntur.lib.ntu.edu.tw//handle/246246/256533近年歐美生技製藥產業生物製劑類新藥之研發蓬勃成長快速，其中治療類風濕性關節炎之生物製劑引起相當之重視。成長因素為類風濕性關節炎流行率高，以及以往並無有效藥物，生物製劑上市後可有效改變疾病病程，解決以往所無法解決的問題。然而，國內目前僅少部份病患可使用；國內數年前尚無治療類風濕性關節炎之生物製劑，不得不讓病患忍受病程繼續惡化最終關節壞損、殘障、手術置換人工關節甚至輪椅代步。目前已有生物製劑可有效停止病程甚至讓病患完全緩解，若未能造福更多患者，以社會經濟的層面來看，可能有一些可惜。 類風濕性關節炎通常在年齡三十歲至五十歲期間發病，正值青壯可工作之黃金年齡。類風濕性關節炎病患失業或是工作能力降低之比率顯著高於一般人口，三分之二的病患平均每年減少三十九個工作天數，三分之一的病患停止工作，四分之一的病患平均所得減少。在類風濕性關節炎疾病早期關節即會快速壞損，在發病前二年的病患中，以X光檢查有百分之七十的病患發生有關節壞損，病患多在二年內即已發生中度行動障礙。 本研究方法為經由文獻探討，綜合醫療效果、疾病之社會經濟負擔，分析生物製劑可帶來之直接與潛在貢獻。 本文之主要發現為生物製劑之價值產出遠大於傳統治療、而間接成本遠低於傳統治療，至於直接成本，長期而言，病程越久，加總之直接醫療成本很有可能為生物製劑治療方式並未較高。目前世界三大風濕病醫學會與聯盟，皆在推動早期治療與治療目標應為完全康復。基於這樣的目標，越早治療並且中度疾病活動度即開始治療，越有機會完全康復。此外，歐洲風濕病醫學會聯盟治療建議指出類風濕性關節炎的標準死亡率為一般人口的將近二倍，增加的死亡率主要來自心血管疾病。患者的心血管疾病發生率亦較高。因此必須控制類風濕性關節炎的疾病活動度，以降低心血管疾病風險。治療建議指出目前有最多證據的是抗腫瘤壞死因子類生物製劑和methotrexate 治療類風濕性關節炎可以降低心血管疾病風險。有效治療類風濕性關節炎可以改善病患的身體功能，增加活動度，進而降低高血壓、高血脂、肥胖與糖尿病。美國風濕病醫學會的治療建議中包括:”如果中度疾病活動度，發病滿六個月以上，傳統疾病修飾治療藥物methotrexate單一治療效果不佳，併有預後不佳的病徵，建議使用抗腫瘤壞死因子類生物製劑…”。在英國國家健康與臨床醫學卓越研究院的治療指引所記載，生物製劑列於第一線使用與後線使用，其遞增成本效果比近似，也就是每增加一單位治療效益所需增加的成本近似。基於此點，應可推論生物製劑應可以於第一線使用。 許多醫藥先進國家均已是中度疾病活動度之病患即可使用，包括日本、美國、法國、瑞典與西班牙…等。因此中度疾病活動度患者於傳統藥物療效不佳時即應使用生物製劑治療，應是值得納入健保給付的，讓更多患者可受惠於生物製劑，減輕社會經濟負擔，創造價值，提昇整體生產力與總體經濟效益。Biologics new drugs of world biotechnology industry got substantial investment and grew fast in recent years. Biologics for rheumatoid arthritis (RA) drew the attention because of its high prevalence rate as well as unmet needs for its treatment in the past. After the first biologic against RA was launched, the unresolved problem became resolvable because it (and other biologics) can effectively modify or stop disease progression. However, only minimal patient population is benefited by biologics in Taiwan. Before biologics entering the market, rheumatoid arthritis can not be well treated so that patient suffered from disease progression to joint erosion and narrowing, disability or joint replacement surgery. Now that these effective biological disease modifying anti-rheumatic drugs are already available, it might be worth to benefit more patients that subsequently mitigates social and economic burden. Rheumatoid arthritis usually starts in people with age from 30 to 50 years old who should be at their productivity peak. The unemployment rate or reduced working ability is significantly more than that of the general population. Two-third of patients loses 39 working days a year in average; one-third of patients loses job and one-forth of patients’ income are decreased. Joint erosion starts in the early stage that 70% of patients have progressive joint erosion according to X-ray examination. The method of this research is to conduct literature review and summarize the therapeutic outcome, disease burden and the social and economic improvement with biologics. The key findings include that the values of biologics are higher than the conventional treatment and their indirect cost are also lower than the conventional treatment. As for the direct cost, if consider the long-term medical expenditure, biologics might not be higher than the conventional treatment. The rheumatoid arthritis societies and leagues worldwide are advocating early treatment and treat-to-target. Based on these concepts, RA patients not only should be treated at early stage but those who have moderate to severe diseases also be included because these patients have higher possibilities to reach the treatment target, remission. European League Against Rheumatism 2010 Recommendation points out that the standard mortality rate of RA patients is almost two times of the general population mainly because of the co-morbid cardiovascular diseases. The morbidity rate of cardiovascular diseases in RA patients is also higher. Hence, the disease activity of RA patients must be controlled in order to minimize their cardiovascular risks. Currently, a combination of any biologics of the anti-tumor necrosis factor category with methotrexate treatment showed the strongest evidence for reducing cardiovascular risks. Effective treatment of rheumatoid arthritis can improve physical function, increase mobility, decrease hypertension, hyperlipidemia, obesity and diabetes. American College of Rheumatology 2008 Recommendation recommended anti-TNF biologics for patients with moderate disease activity for 6 months or over, and for those who had inadequate response and with features of a poor prognosis that had received methotrexate monotherapy; as well as for patients with high disease activity, irrespective of the prognostic features. Many advanced countries including Japan, US, France, Sweden, Spain, etc had already approved biologics for RA patients with moderate disease activity. It is worth to consider the inclusion of anti-TNF biologics for the aforementioned patients who failed to respond to the conventional disease modifying agents in the reimbursement system. This may bring more patients back to work that reduces social and economic burden, generates productivity, creates value and raises the overall economic benefits.1481984 bytesapplication/pdfen-US生物製劑類風濕性關節炎疾病修飾治療藥物Biologicsrheumatoid arthritisDMARD[SDGs]SDG3[SDGs]SDG8http://ntur.lib.ntu.edu.tw/bitstream/246246/256533/1/ntu-99-P93748036-1.pdf