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     新藥研發過程中 經濟學研究有何作用?

      【中國制藥網 市場分析】毋庸置疑,一個新藥能成功上市,其帶來的利潤是及其可觀的,2016年恒瑞的阿帕替尼和貝達的埃克替尼銷售額分別是9億和10億,今年均已進入新醫保目錄中,這些創新藥物還將為企業帶來更多穩定的利潤增長。正是因為藥物研發具有很明顯的經濟學特征,才更需要藥物經濟學手段去輔助藥物研發的決策和道路。

      什么是新藥?2015年8月國務院印發了《關于改革藥品醫療器械審評審批制度的意見》將新藥由現行的“未曾在中國境內上市銷售的藥品”調整為“未在中國境內外上市銷售的藥品”,這一變動詮釋了新藥的兩種屬性,創新和價值。創新體現在1類新藥的物質結構在全球上都應是最新的;價值體現在新藥相較于市面上的老藥更具有臨床療效。

    新藥研發的四期臨床試驗【1】


      [1] 吳久鴻.藥物經濟學 [M].北京高等教育出版社,2017

      新藥的研發過程有著很明顯的經濟學特征

      高成本

      在新藥上市前,在藥物研發中從尋找化學實體修飾靶向藥物到選定候選藥物,到后期的開發研究進行評價試驗最后進入生產準備上市,中間的人力物力財力耗費巨大。在過去的每十年里,全球新藥的研發成本都以翻倍的速度快速增長,單個上市新藥的平均研發成本接近10億美元。不僅如此,開發一種新藥往往需要很多的時間成本,如貝達藥業的埃克替尼從2000年的探索期到2010年的III期臨床試驗順利完成,歷經了10年的風雨研發歷程。

      高風險

      新藥研發過程中技術上也會有高失敗率,上千種新化學單體中可能只有少數幾個是可以進入后期候選物質中,除了技術上,還要面臨這資金、政策、市場上的各種風險。例如新藥研發投入市場后,在本土規定的專利期內有著不錯的市場,但專利期一到,各種高質量的仿制藥蜂擁而至,競爭激烈,市場占有率急速下降。

      高回報

      毋庸置疑,一個新藥能成功上市,其帶來的利潤是及其可觀的,2016年恒瑞的阿帕替尼和貝達的埃克替尼銷售額分別是9億和10億,今年均已進入新醫保目錄中,這些創新藥物還將為企業帶來更多穩定的利潤增長。

      正是因為藥物研發具有很明顯的經濟學特征,才更需要藥物經濟學手段去輔助藥物研發的決策和道路。

      藥物經濟學最根本的目的就是為了更好的配置資源,在藥物研發中藥物經濟學研究同樣是為了更好的分配研發資源,及時在臨床階段規避研發終將失敗或者未來會虧損的藥物;幫助決策者去探討開發成功在技術上的可行性;估計臨床上對此藥品的需要程度。

      在投資理念上說,運用藥物經濟學手段去估算一個品種做下來要花多少錢,多少時間,失敗的概率有多少。上市后能獲得的最大利潤以及定價多少才算合理。

      最適合運用藥物經濟學評價的藥物研發階段是II期、III期臨床試驗,國外藥物經濟學在企業藥物研發決策中運用的很成熟,他們講究“早死早超生”,如果一種新化學實體在II期臨床研究階段中就已經顯示不出什么成本或療效優勢,決策人會果斷將它放棄掉,尋找別的新物質結構。

      但是在國內藥企中,運用藥物經濟學在藥物研發中做決策的還是很少,一是技術上的不成熟,二是不愿舍棄。能找尋到出新單體雖說不易,但是如果沒有更好的成本效益,那么后期投入的成本也終將成為先前沉沒成本的一部分。

      值得一提的是,以往在藥物研發決策分析中經濟學研究一般都在臨床后期,證實了品種的安全有效之后,再基于已有的匯總數據和結果去分析。但是這樣的經濟學研究不僅失去了它本來的決斷作用,而且因為研究的滯后致使研發和市場上策略的脫節,失去了先機。

      真正的藥物經濟學本應該在II期盡早開展,甚至是I期,站在前瞻的角度,提前分析新藥與同類藥品的優劣勢,分析研發可行性,探索評估成本效益的模型。隨著以隨機雙盲對照的大規模臨床實驗上的開展時,就應收集數據,不斷優化藥物經濟模型,利用大數據收集成本和產出的數據,模擬模型,為是否繼續進行研發提供建議。

      IV期臨床實驗的數據應該是補充和完善藥物經濟學的模型,不斷地縮小不確定性,為上市后的藥品定價,市場準入,合理用藥以及進入醫療報銷目錄打下堅定的基礎。

      所以,藥物經濟學做為輔助藥物研發決策的一種工具,不應該在后期才默默開展,而是和藥物研發一起成長。

        原標題:新藥研發過程中是否需要經濟學研究?

     

    (來源:艾美達行業研究)

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