今年醫保目錄調整即將進入申報階段 一批國產創新藥有望進入醫保談判
據《經濟參考報》報道,隨著6月30日可參審藥品獲批截止時間到來,2021年國家醫保藥品目錄調整工作即將進入申報階段。報道引述不完全統計,2020年8月18日至2021年6月30日獲批的創新藥或新適應症約有40個,意味著一批國產創新藥有望進入醫保談判。市場對於創新藥納入醫保帶來的機會高度關注,機構普遍認為,醫保目錄調整常態化助力創新藥快速放量。
報道指出,尤其是今年創新藥上市節奏進一步加快,僅6月就至少有七個國產1類創新藥獲批上市,涉及恆瑞醫藥、艾迪藥業、海正藥業、澤璟製藥、榮昌生物等多家上市公司。而國家藥監局最新發布的報告顯示,2020年全年,藥審中心審評通過創新藥新藥上市申請(NDA)20個品種。當中,6月23日,翰森製藥披露1類創新藥艾米替諾福韋片獲批上市,該產品為抗感染藥物,適用於慢性乙型肝炎成人患者的治療。
業內人士分析稱,符合2021年醫保目錄調整範圍的創新藥品種或適應症包含PD-1單抗、PARP抑製劑、ADC等。
值得注意的是,在此前兩輪醫保談判中進入醫保目錄的四款國產PD-1產品,均增加了新的適應症。 6月28日,信達生物宣布,信迪利單抗獲批第四項適應症,聯合貝伐珠單抗注射液(達攸同)用於既往未接受過系統治療的不可切除或轉移性肝細胞癌的一線治療。 6月23日,百濟神州宣布替雷利珠單抗再獲兩項新適應症。6月10日,恆瑞醫藥披露卡瑞利珠單抗獲批第六個適應症。此前,君實生物特瑞普利單抗用於既往接受過二線及以上系統治療失敗的複發/轉移性鼻咽癌患者治療的新適應症上市申請獲得附條件批准。
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