新一代抗精神病藥長效型針劑之訂價與給付策略探討

Abstract

研究目的 藉由實務實習計畫參與，了解在二代健保制度下，台灣新藥上市的藥價政策和未來趨勢、全民健康保險藥品核價原則及作業流程、藥品價格調整原則及作業流程、藥品與特殊材料費用有關之總額支付制度與藥物核價資訊、與健保新藥使用有關的醫療科技評估及成本效益分析，以及新藥上市可能對健保預算產生的財務衝擊預估等。 方法 本研究以一尚未在台灣上市的新一代抗精神病藥長效型針劑做研究標的，配合實習計畫的進度採用相關的研究方法: 一、在擬定給付價格的階段，將採內容分析法(content analysis)，針對英國、澳洲及加拿大三國醫藥科技評估(HTA)的結果做探討，並分析健保署參照的世界先進十國藥品給付現況，提出台灣給付價格可行區間假設。 二、利用深度訪談(in-depth interview) 疾病治療與健保給付相關專家，了解台灣的流行病學資訊、本土的臨床照顧模式以及醫療利用情形，以便最佳化健保預算衝擊模型的考量因子。 三、在經濟效益評估的階段，利用回溯性世代(retrospective cohort) 分析2010-2013年健保資料庫百萬歸人檔中思覺失調症患者的相關處方用藥與其他醫療成本，將相關參數導入財務影響分析中(budget impact analysis)，評估新的治療是否可以減少相關的健保支出；再利用基準情境(base-case scenario)與敏感度分析(sensitivity analysis)，檢視如果改變重要假設(key assumptions)中的參數，會對分析結果產生的影響 結果 台灣針對本研究藥物給付區間可能落在新台幣7,665元至9,257元間，而此新藥定位為取代現有治療方式，本經濟評估採較保守的9,257元依健保署觀點、直接成本進行財務影響分析。基礎分析結果，以健保「藥費」預算觀點，第一年到第五年分別為新台幣0.6萬、-46萬、34萬、-40萬及-135萬元。同樣的分析方式下，以健保「藥費」預算觀點，第一年到第五年分別為新台幣-137萬、-509萬、-583萬、-873萬及-1,251萬元。情境分析顯示所測試的參數皆不改變節省健保支出之結論。 結論 本研究藥物與其他藥物相比，在療效、安全性與耐受性方面有相當或較優越的表現，此新一代長效針劑納入給付亦能為健保節省整體醫療支出，綜合各項分析，將此新藥列於健保給付治療選擇中，除了帶給醫師與病患新的選擇外，也能與國際接軌，讓台灣在思覺失調症治療能更進一步。

Objective By means of practicum, we are capable of understanding the pricing and reimbursement policy for the new treatment launch Taiwan. A holistic economic evaluation, including Health Technology Assessment report, cost-effectiveness analysis, and budget impact analysis will bring comprehensive picture for the novel treatment. Method This study aims for a long-acting injectable antipsychotic which has not launched in Taiwan. Stepwise methods are applied according to the process: 1. Content analysis will be applied to HTA reports discussion issued by UK, Australia, and Canada. The assumption of possible reimbursed interval will come up after putting advanced 10 countries price into consideration. 2. Conduct in-depth interview with key opinion leaders to confirm the prevalence, clinic practice, and treatment algorithm for schizophrenia. 3. At economic evaluation phase, utilize retrospective cohort of Normalized Million People File from 2010 to 2013 (National Health Insurance Research Database) to analyze medication and other medical cost for schizophrenic patients. The parameters will be applied into budget impact analysis; meanwhile, base-case scenario and sensitivity analysis will be conduct to check the budget impact under different assumed circumstances. Results According to the policy, the possible reimbursed price interval of this novel long-acting injectable may fall between TWD 7,665 and TWD9,257. To be modest, we took TWD 9,257 as the assumed reimbursement price which is positioned to replace exited long-acting injectables. The economic evaluation is based on perspective of national health insurance and direct cost to conduct budget impact analysis. In base-case analysis, the novel long-acting injectable will save TWD 12.51 million in fifth-year after reimbursement, including 1.35 million in drug expenditure and 11.16 million in OPD and IPD cost. Whilst, in scenario analysis, the conclusion of cost saving remains the same no matter which parameter varies. Conclusion The novel long-acting injectable in this study is non-inferior or superior to the other existed long-acting injectable in efficacy, safety, and tolerability. From the perspective of economic evaluation, the reimbursement of this novel treatment will not only save drug expenditure but also all medical cost for national health care insurance.