Johansson Erin, Giovannitti Massimo, Mezzetti Maurizio, Lu Na, Sabatino Silvia
Eli Lilly and Company Ltd, Indianapolis, IN, USA.
Eli Lilly Italy S.p.A, Rome, Italy.
J Med Econ. 2023 Jan-Dec;26(1):1155-1166. doi: 10.1080/13696998.2023.2255495. Epub 2023 Sep 7.
To assess, within the Italian healthcare system, the cost-effectiveness of baricitinib versus dupilumab, both in combination with topical corticosteroids (TCS), in adults with moderate to severe atopic dermatitis (AD) who are eligible for but have failed, have contraindications to, or cannot tolerate ciclosporin.
Using the perspective of the Italian healthcare payer, direct medical costs associated with each intervention were estimated over a lifetime horizon. A Markov cohort model utilized the proportions of patients with ≥75% improvement Eczema Area and Severity Index obtained from clinical trials. Health outcomes were evaluated in quality-adjusted life years (QALYs) to assess the cost effectiveness of baricitinib against a willingness-to-pay threshold of €35,000 per QALY gained.
In the base case, with secondary censoring applied, patients treated with dupilumab or baricitinib, in combination with TCS, accumulated total costs of €135,780 or €129,586, and total QALYs of 18.172 or 18.133, respectively. The incremental cost-effectiveness ratio of dupilumab versus baricitinib was estimated at €160,905/QALY.
Core assumptions were needed to extrapolate available short-term clinical trial data to lifelong data, adding uncertainty. Benefits of baricitinib seen in clinical trials and not assessed in dupilumab clinical trials were not included. Discontinuation rates for each treatment were derived from different sources potentially introducing bias. Results may not be generalizable to other populations.
This cost-effectiveness analysis shows that, from the Italian healthcare payer perspective, in the treatment of patients with moderate to severe AD who have experienced failure on, are intolerant to, or have contraindication to ciclosporin, dupilumab cannot be considered cost-effective when compared with baricitinib. Given its oral administration, favorable risk/benefit profile and lower acquisition cost compared with dupilumab, baricitinib may offer a valuable, cost-effective treatment option-after failure on conventional systemic agents-for patients with moderate to severe AD in Italy.
在意大利医疗保健系统中,评估巴瑞替尼与度普利尤单抗在联合外用糖皮质激素(TCS)治疗中度至重度特应性皮炎(AD)成人患者中的成本效益,这些患者符合使用环孢素的条件但治疗失败、有禁忌证或无法耐受环孢素。
从意大利医疗保健支付方的角度出发,估算了每种干预措施在患者终身期间的直接医疗成本。马尔可夫队列模型利用了从临床试验中获得的湿疹面积和严重程度指数改善≥75%的患者比例。健康结局采用质量调整生命年(QALY)进行评估,以根据每获得一个QALY支付意愿阈值35,000欧元来评估巴瑞替尼的成本效益。
在基础病例中,应用二次审查后,接受度普利尤单抗或巴瑞替尼联合TCS治疗的患者累计总成本分别为135,780欧元或129,586欧元,总QALY分别为18.172或18.133。度普利尤单抗与巴瑞替尼的增量成本效益比估计为160,905欧元/QALY。
需要核心假设将可用的短期临床试验数据外推至终身数据,这增加了不确定性。巴瑞替尼在临床试验中显示的益处但未在度普利尤单抗临床试验中评估的未被纳入。每种治疗的停药率来自不同来源,可能会引入偏差。结果可能不适用于其他人群。
该成本效益分析表明,从意大利医疗保健支付方的角度来看,在治疗中度至重度AD且对环孢素治疗失败、不耐受或有禁忌证的患者时,与巴瑞替尼相比,度普利尤单抗不具有成本效益。鉴于其口服给药方式、良好的风险/效益概况以及与度普利尤单抗相比更低的采购成本,巴瑞替尼对于意大利中度至重度AD患者在传统全身用药失败后可能提供一种有价值的、具有成本效益的治疗选择。