罕病病友可更快取得健保補助 藥物審核時程大幅縮短! 大成報-2015年04月06日 下午21:40 【本報訊】有鑑於罕病治療的需求，因此食品藥物管理署針對罕病藥物審核速度流程上進行大幅度的改善。增加罕見疾病防治及藥物審議會及其相關審議小組的開會次數及縮短舉辦會議的間隔。簡化罕藥審查及藥價給付核價作業流程，及早主動通知該案申請廠商預計可縮短共計約6個月的時間。同時衛生福利部並於104年第一季公告新增認定「Elosulfase alfa」(適應症為「黏多醣症第4A型」)並預告新增認定「Teriflunomide」 (適應症為「復發型多發性硬化症; 前一年有一次復發或前二年有二次復發」)為適用罕見疾病防治及藥物法之藥物。衛生福利部向以促使罕病病人獲得完善的醫療服務為職責，於89年公布施行「罕見疾病防治及藥物法」以來，依據本法協助罕病病人取得治療所需藥物、特殊營養食品及提供相關醫療補助。未來食品藥物管理署將會同相關單位以罕病病人的醫療權益為服務目標，持續研擬加強對罕病病人的醫療照護。
Aubagio® (teriflunomide), a pyrimidine synthesis inhibitor, is an oral compound that inhibits the function of specific immune cells that have been implicated in MS. It is related to leflunomide, a drug used to treat rheumatoid arthritis. Aubagio can inhibit a key enzyme required by white blood cells (lymphocytes) – which in turn reduces the proliferation of T and B immune cells that are active in MS and also inhibits the production of immune messenger chemicals by T cells. Aubagio was approved by the U.S. Food and Drug Administration (FDA) in September, 2012 for patients with relapsing forms of multiple sclerosis.
Teriflunomide is an immunomodulator with anti-inflammatory properties. Approval is based on results of a program of phase 3 trials. Results of the Teriflunomide Multiple Sclerosis (TEMSO) trial, published in the New England Journal of Medicine in 2011, showed a significant reduction in annualized relapse rate and sustained accumulation of disability with both the 7- and the 14-mg daily doses vs placebo. A second phase 3 trial, TENERE, showed the agent was similar to interferon β-1a (Rebif, Merck Serono), a standard approved treatment for MS. A third trial, Teriflunomide Oral in people with relapsing-remitting multiple sclerosis (TOWER), showed a significant reduction in annualized relapse rates and sustained accumulation of disability with the 14-mg dose vs placebo. A second dose studied in this trial, 7 mg, showed a reduction in relapse rate but not in sustained accumulation of disability.
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