Kondili Loreta A, Romano Federica, Rolli Francesca Romana, Ruggeri Matteo, Rosato Stefano, Brunetto Maurizia Rossana, Zignego Anna Linda, Ciancio Alessia, Di Leo Alfredo, Raimondo Giovanni, Ferrari Carlo, Taliani Gloria, Borgia Guglielmo, Santantonio Teresa Antonia, Blanc Pierluigi, Gaeta Giovanni Battista, Gasbarrini Antonio, Chessa Luchino, Erne Elke Maria, Villa Erica, Ieluzzi Donatella, Russo Francesco Paolo, Andreone Pietro, Vinci Maria, Coppola Carmine, Chemello Liliana, Madonia Salvatore, Verucchi Gabriella, Persico Marcello, Zuin Massimo, Puoti Massimo, Alberti Alfredo, Nardone Gerardo, Massari Marco, Montalto Giuseppe, Foti Giuseppe, Rumi Maria Grazia, Quaranta Maria Giovanna, Cicchetti Americo, Craxì Antonio, Vella Stefano
Istituto Superiore di Sanità, Rome, Italy.
Catholic University, Rome, Italy.
Hepatology. 2017 Dec;66(6):1814-1825. doi: 10.1002/hep.29399. Epub 2017 Oct 30.
We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus-infected patients: policy 1, "universal," treat all patients, regardless of fibrosis stage; policy 2, treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus-infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies' cost-effectiveness. The patients' age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post-sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis.
Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814-1825).
我们在一组感染丙型肝炎病毒的真实患者队列中评估了两种直接抗病毒（DAA）治疗方案的成本效益：方案1，“普遍治疗”，治疗所有患者，无论纤维化阶段如何；方案2，仅治疗“优先”患者，将其余患者的治疗推迟至F3期。我们将一个使用终身时间范围和医疗保健系统视角的肝病进展马尔可夫模型应用于PITER队列（代表接受治疗的意大利丙型肝炎病毒感染患者）。具体而言，8125例未接受过DAA治疗、无临床、社会人口统计学或保险限制的患者被用于评估这两种方案的成本效益。利用患者的年龄和纤维化阶段、假设的每位患者15000欧元的DAA治疗成本以及意大利肝病成本，来评估方案1与方案2的质量调整生命年（QALY）和增量成本效益比（ICER）。为了推广研究结果，我们进行了一项欧洲情景分析，对研究人群进行重新抽样，使用欧洲各国特定健康状态成本的均值以及30000欧元的平均治疗成本。对于意大利的基础案例分析，使用方案1获得的具有成本效益的ICER为每QALY 8775欧元。在10000次概率模拟中，94% - 97%的ICER仍具有成本效益。对于欧洲治疗情景，使用方案1获得的ICER为每QALY 19541.75欧元。ICER对DAA成本的变化、纤维化阶段F0 - F3患者在持续病毒学应答后的效用值变化以及从F0到F3的转移概率敏感。随着DAA价格降低，ICER下降，对于F0 - F2纤维化患者，当基础价格（15000欧元）折扣至少75%时，成本节约。
将丙型肝炎病毒治疗扩展至任何纤维化阶段的患者可改善健康结局且具有成本效益；在早期纤维化阶段降低治疗价格时，成本效益显著增加。（《肝脏病学》2017年；66:1814 - 1825）
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