Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Department of Hepatology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
PLoS One. 2019 Aug 29;14(8):e0221769. doi: 10.1371/journal.pone.0221769. eCollection 2019.
We undertook this study to assess the incremental cost per quality adjusted life year (QALY) gained with the use of pan-genotypic sofosbuvir (SOF) + velpatasvir (VEL) for HCV patients, as compared to the current treatment regimen under the universal free treatment scheme in Punjab state.
A Markov model depicting natural history of HCV was developed to simulate the progression of disease. Three scenarios were compared: I (Current Regimen)-use of SOF + daclatasvir (DCV) for non-cirrhotic patients and ledipasvir (LDV) or DCV with SOF ± ribavirin (RBV) according to the genotype for cirrhotic patients; II-use of SOF + DCV for non-cirrhotic patients and use of SOF+VEL for compensated cirrhotic patients (with RBV in decompensated cirrhosis patients) and III-use of SOF+VEL for both non-cirrhotic and compensated cirrhotic patients (with RBV in decompensated cirrhosis patients). The lifetime costs, life-years and QALYs were assessed for each scenario, using a societal perspective. All the future costs and health outcomes were discounted at an annual rate of 3%. Finally, the incremental cost per QALY gained was computed for each of scenario II and III, as compared to scenario I and for scenario III as compared to II. In addition, we evaluated the lifetime costs and QALYs among HCV patients for each of scenario I, II and III against the counterfactual of 'no universal free treatment scheme' scenario which involves patients purchasing care in routine setting of from public and private sector.
Each of the scenarios I, II and III dominate over the no universal free treatment scheme scenario, i.e. have greater QALYs and lesser costs. The use of SOF+VEL only for cirrhotic patients (scenario II) increases QALYs by 0.28 (0.03 to 0.71) per person, and decreases the cost by ₹ 5,946 (₹ 1,198 to ₹ 14,174) per patient, when compared to scenario I. Compared to scenario I, scenario III leads to an increase in QALYs by 0.44 (0.14 to 1.01) per person, and is cost-neutral. While the mean cost difference between scenario III and I is-₹ 2,676 per patient, it ranges from a cost saving of ₹ 14,835 to incurring an extra cost of ₹ 3,456 per patient. For scenario III as compared II, QALYs increase by 0.16 (0.03 to 0.36) per person as well as costs by ₹ 3,086 per patient which ranges from a cost saving of ₹ 1,264 to incurring an extra cost of ₹ 6,344. Shift to scenario II and III increases the program budget by 5.5% and 60% respectively.
Overall, the use of SOF+VEL is highly recommended for the treatment of HCV infection. In comparison to the current practice (scenario I), scenario II is a dominant option. Scenario III is cost-effective as compared to scenario II at a threshold of one-time GDP per capita. If budget is an important constraint, velpatasvir should be given to HCV infected cirrhotic patients. However, if no budget constraint, universal use of velpatasvir for HCV treatment is recommended.
本研究旨在评估泛基因型索磷布韦（SOF）+维帕他韦（VEL）用于 HCV 患者的增量成本效益，与旁遮普邦全民免费治疗方案下的现行治疗方案相比。
建立了一个描述 HCV 自然史的 Markov 模型，以模拟疾病的进展。比较了三种方案：I（现行方案）-非肝硬化患者使用 SOF+达卡他韦（DCV），肝硬化患者根据基因型使用利迪帕韦（LDV）或 DCV 联合 SOF±利巴韦林（RBV）；II-非肝硬化患者使用 SOF+DCV，代偿期肝硬化患者使用 SOF+VEL（失代偿期肝硬化患者用 RBV），III-非肝硬化和代偿期肝硬化患者均使用 SOF+VEL（失代偿期肝硬化患者用 RBV）。从社会角度评估了每种方案的终身成本、寿命年和 QALYs。所有未来的成本和健康结果均按 3%的年利率贴现。最后，比较方案 II 和 III 相对于方案 I，以及方案 III 相对于方案 II 的增量成本效益比（ICER）。此外，我们评估了方案 I、II 和 III 中每个 HCV 患者的终身成本和 QALYs，以及在不存在全民免费治疗方案的情况下，即患者从公共和私营部门的常规医疗服务中购买治疗的情况。
方案 I、II 和 III 均优于无全民免费治疗方案，即具有更高的 QALYs 和更低的成本。仅将 SOF+VEL 用于肝硬化患者（方案 II），与方案 I 相比，每位患者的 QALYs 增加 0.28（0.03 至 0.71），每位患者的成本降低 5946 卢比（1198 卢比至 14174 卢比）。与方案 I 相比，方案 III 使每位患者的 QALYs 增加 0.44（0.14 至 1.01），且成本不变。方案 III 与方案 I 的平均成本差异为-2676 卢比/患者，但范围从节省 14835 卢比到增加额外成本 3456 卢比/患者不等。与方案 II 相比，方案 III 使每位患者的 QALYs 增加 0.16（0.03 至 0.36），每位患者的成本增加 3086 卢比，范围从节省 1264 卢比到增加额外成本 6344 卢比不等。方案 II 和 III 的采用分别使项目预算增加 5.5%和 60%。
总体而言，SOF+VEL 非常推荐用于 HCV 感染的治疗。与现行做法（方案 I）相比，方案 II 是一个主要的选择。与方案 II 相比，方案 III 在人均一次 GDP 的阈值下具有成本效益。如果预算是一个重要的约束，应给予 HCV 感染的肝硬化患者维帕他韦。然而，如果没有预算限制，建议对 HCV 患者进行普遍的维帕他韦治疗。
