臺灣中重度異位性皮膚炎使用杜避炎或口服JAK抑制劑相較於常規治療之成本效用與財務影響分析

Abstract

背景：異位性皮膚炎(Atopic Dermatitis, AD)是一種慢性發炎性皮膚疾病，在台灣盛行率約1.28％，其中 26.7％ 為中重度的患者，不少的患者生活品質不佳，同時也對健保造成龐大的醫療支出。傳統治療方式對這些患者的療效往往有限，近年問世的生物製劑和口服小分子鏢靶藥物，為患者帶來全新的治療選擇，包括：Dupilumab(杜避炎)與 JAK 抑制劑(如 Abrocitinib、Baricitinib、Upadacitinib)。本研究從台灣全民健康保險觀點，評估這些新療法相較於最佳支持治療(Best Supportive Care, BSC)之成本效用與財務影響。 方法：本研究之成本效用分析，建構一個結合決策樹與馬可夫模型之混合模型，評估短期與長期(1–20 年)之臨床與經濟結果，參數來源包含臨床試驗療效、健保直接支付的醫療成本，以及 EQ-5D 效用值。所有治療均包含外用類固醇或鈣調磷酸酶抑制劑(Calcineurin)為基礎療法。研究結果以品質調整生命年(QALY)與增量成本效益比(ICER)表示，並以每 QALY 新台幣 200 萬元為支付意願閾值，所有結果均以 3％ 折現率計算。亦進行敏感度分析測試模型的穩健性。財務影響分析(Budget Impact Analysis, BIA)則以健保署觀點，估算 2026–2030 年，比較現行之BSC 以及新藥，包括： Dupilumab 與JAK 抑制劑(Upadacitinib、Abrocitinib、 Baricitinib)，針對中重度異位性皮膚炎(AD)新療法納入台灣全民健康保險體系後，所產生的財務影響。 結果： 在所有療法中，每日口服 Upadacitinib 30 毫克為最具成本效益選項(11.0782 QALYs；相較於 BSC 其ICER 為NT$1,250,903/QALY)，其次為Upadacitinib 15 毫克(NT$1,376,435/QALY)。Dupilumab 在成本效益上遭到排除(被支配)，Baricitinib 的 ICER 超出 NT$2,000,000/QALY 閾值。敏感度分析顯示結果具有穩健性，其中療效效用值提升、藥品價格與中止治療率為主要影響因子。財務影響分析預估五年總增額支出達 NT$117 億元，主因為藥費支出，單位病人之年均增額成本由 NT$339,000 下降至 NT$265,000。 結論： 每日服用 Upadacitinib 30 毫克為治療台灣中重度異位性皮膚炎成人患者之最具成本效益選項。然而，其高昂的總體財務衝擊顯示未來須配合合理定價與 給付策略，方能兼顧健保可負擔性與病患可近性。

Background: Atopic dermatitis (AD), a chronic inflammatory skin disease, affects 1.28 of Taiwan’s population, with 26.7％ having moderate-to-severe cases, causing significant healthcare costs and quality-of-life impairments. Conventional treatments often fail these patients, necessitating novel therapies like Dupilumab and Janus kinase (JAK) inhibitors (Abrocitinib, Baricitinib, Upadacitinib). This study evaluates the cost-utility and budget impact of these therapies versus best supportive care (BSC) for adults with moderate-to-severe AD from Taiwan’s NHI perspective. Methods: A hybrid decision tree-Markov model assessed short- and long-term (Years 1–20) outcomes using trial efficacy, NHI costs (2022 NT$), and EQ-5D utilities.Interventions included topical corticosteroids/calcineurin inhibitors. Outcomes were quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs), discounted at 3％, with a NT$2,000,000/QALY threshold. Sensitivity analyses tested robustness. A five-year (2026–2030) budget impact analysis (BIA) included epidemiology and market uptake. Results: Upadacitinib 30 mg was most cost-effective (11.0782 QALYs, ICER NT$1,250,903/QALY vs BSC), followed by Upadacitinib 15 mg (NT$1,376,435/QALY). Dupilumab was dominated; Baricitinib’s ICERs exceeded NT$2,000,000/QALY. Sensitivity analyses confirmed robustness, with utility gains, medication costs, and discontinuation rates as key drivers. The BIA estimated a NT$117 billion incremental impact, driven by drug costs, with per-patient increments falling from NT$339,000 to NT$265,000. Conclusion: Upadacitinib 30 mg was the most cost-effective option for moderate-to-severe atopic dermatitis in Taiwan, but its high budget impact underscores the need forstrategic pricing and reimbursement policies to ensure long-term affordability and access.