抗癌新藥之健保給付藥價申請策略之研究

Abstract

癌症為目前主要的醫療照護課題，不但疾病發生率急劇升高，治療的狀況也未臻理想，因此各大大藥廠無不卯足全力開發抗癌的新藥，從化學治療、免疫治療、荷爾蒙製劑以至標靶治療。而隨著抗癌新藥的價格節節上升，也造成各國醫療沉重的負擔，因此抗癌新藥在各國的藥價申請也面臨越來越多的挑戰。 本研究整理各國醫療給付機構相關的規定和個案，歸納出兩個抗癌標靶新藥申請藥價時的關鍵因素：藥物本身的臨床顯著性和給付限制，針對這兩個因素進行了可能性假設和權重後，建立藥價申請的決策樹模型。藉由這個決策樹模型，可以看到一個標靶抗癌新藥在不同臨床數據和不同給付限制組合下，會有不同的藥價申請策略和期望值，從而由其中選擇出最佳的藥價申請策略。 國際藥物給付包括中央健保局的健保給付制度一直在進行許多變革，對於新藥藥價的影響將非常深遠，廠商必須及早擬訂出所有可能的對策以因應未來的變局。本研究以標靶抗癌新藥藥價策略為研究主題，在實務上試圖能提供一個較客觀可行的策略模型，使藥廠在評估其藥價申請時，可以有較客觀全面性的參考。

Cancer is one of the major healthcare concerns not only due to the high growth rate of incidence, but also the unsatisfied treatment outcomes. Therefore most major pharmaceutical companies are focusing on development of anti-cancer agents from chemical therapy, immunology therapy, hormonal therapy to target therapy. The increasingly high cost of these new anti-cancer agents is getting to be a big burden to each country’s healthcare system, posing more and more challenges to the reimbursement price application. This study overviewed the regulations and cases of each country’s reimbursement system and identified two critical factors for price application of new anti-cancer target agent: Clinical significance and Reimbursement restriction. A decision tree model was established based on these factors with assumed possibility and weight. Using this decision tree model, different combination of clinical significance and reimbursement restrictions can lead to different scenarios with expected values, respectively. The best price application strategy could be identified from these scenarios. The international reimbursement including Taiwan’s BNHI is evolving, therefore pharmaceutical companies have to set countermeasures in advance to meet this changing reimbursement environment. This study applied an anti-cancer target agent as an example to introduce a practical and objective model as a reference for pharmaceutical companies to evaluate their price application strategy.