以條件性收載管理協議加速癌症創新藥品的可近性

Managed entry agreement to improve access to innovative cancer medicines

癌症創新藥的開發為治療帶來新契機，但高治療費用使得受惠病患侷限於少數，如何解決高價癌症新藥的普及是全球各國面臨的難題。本綜論以官方重點文件分析加上敘述型文獻回顧，重點探討澳洲與英國於其歷史背景下的變革為出發點，針對昂貴的創新藥所引進的加速審查與條件性收載給付辦法進行討論。為了有效管理醫療給付決策的風險，加速審查及以療效表現為基礎的之條件性收載給付為近年來發展的策略。澳洲政府實施的條件性藥品收載管理辦法與目前英國癌症藥品基金，都是透過藥品收載管理（Managed Entry Agreement, MEA）的方式，讓有希望前景的新治療，在進一步收集療效證據的同時，透過暫時性的過渡給付讓病人提早受惠癌症新治療。MEA雖然立意良好但也不是萬靈丹，其潛在問題例如資料收集、藥物安全性疑慮、終止給付的反彈等也需慎重考量。透過參考英澳兩國的條件性給付辦法，可以提供醫界與健保當局在討論高價藥給付困境時，以加速台灣癌症創新藥品普及的可行性。 Innovative medicines bring a promising future for cancer treatment. However, the benefit to patients is limited by its high cost. Access to these innovative cancer medicines through reimbursement is a pressing issue for government authorities around the globe to resolve. Analyses of key policy documents with a narrative literature review were conducted to provide suggestions for policy consideration. This review focused on the financial risk-sharing programs of pharmaceutical benefits in Australia and United Kingdom (UK) that have had extensive experience. Various risk-sharing arrangements for pharmaceutical benefits have been implemented to contain the risk related to reimbursement decision-making. Accelerated appraisal process and performance-based arrangement are two tactics undertaken by the developed countries to deal with the high costs of innovative medicines. The Australian Pharmaceutical Benefit Scheme and UK Cancer Drug Fund are two exemplary schemes using managed entry agreement (MEA). MEA allows conditional reimbursement to new medicines subject to its development of clinical evidence. It allows early access to new medications while new evidence are being collected. However, several barriers, such as collection of high-quality data, safety of new medicines and issues around de-listing, have been identified for a successful MEA to be implemented. Overseas experience is valuable to the Taiwanese government authorities in the context of pharmaceutical benefits policy discussion.