Model inputs.

Background
Evidence supports the long-term efficacy of Nucleos(t)ide Analogs (NAs) therapy in improving chronic hepatitis B (CHB) prognosis. However, determining the most cost-effective first-line NAs remains unclear. China’s implementation of the New Volume-Based Procurement Policy (NVBP Policy) in 2019 led to substantial price reductions for entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF). This study assesses the cost-effectiveness of ETV, TDF, and TAF, both with and without NVBP, for CHB in China.
Methods
A state-transition model, parameterized using data from published literature, was utilized to compare treatment strategies encompassing non-NAs best support care (BSC), ETV, TDF, and TAF, with or without NVBP. A simulated lifetime cohort was employed, measuring outcomes such as predicted liver-related deaths, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
Results
In comparison to Non-NAs BSC, TAF yielded an additional 2.68 QALYs per person, with an ICER of 7,853.22 USD/QALY. Subsequently, TDF generated an additional 2.61 QALYs/person at an ICER of 7,153.39 USD/QALY, and ETV produced an additional 2.01 QALYs/person with an ICER of 9,366.74 USD/QALY without NVBP. Incorporating NVBP, the ICERs for TAF, TDF, and ETV decreased to −745.62 USD/QALY, −729.33 USD/QALY, and −871.11 USD/QALY, respectively, compared to non-NAs BSC. At willingness-to-pay (WTP) thresholds ranging from 12,500 USD/QALY to 37,500 USD/QALY, TAF with NVBP showed an increased probability (51.15–52.47%) of being the optimal treatment strategy, followed by TDF and ETV with NVBP exhibiting a reduced likelihood 43.09–42.45% and 6.40–4.48% in the iterations.
Conclusions
Our analysis suggests that TAF with NVBP represents the most cost-effective long-term therapy for CHB. Both TDF and ETV, with or without NVBP, and TAF without NVBP were considered cost-ineffective.

背景
现有证据表明，核苷酸（类）似物（Nucleos(t)ide Analogs，NAs）治疗可改善慢性乙型肝炎（CHB）患者的长期预后，但目前仍未明确最具成本效益的一线NAs治疗方案。中国于2019年实施国家带量采购政策（New Volume-Based Procurement Policy，NVBP政策）后，恩替卡韦（ETV）、富马酸替诺福韦二吡呋酯（TDF）及替诺福韦艾拉酚胺（TAF）的价格大幅下降。本研究旨在评估中国境内，在实施与未实施NVBP政策两种场景下，ETV、TDF及TAF用于慢性乙型肝炎治疗的成本效益。

方法
本研究采用基于已发表文献数据参数化的状态转换模型，对比包括非NAs最佳支持治疗（BSC）、ETV、TDF及TAF在内的多种治疗策略（分别联合与不联合NVBP政策）。研究纳入模拟终生队列，评估结局指标包括预测的肝脏相关死亡人数、治疗成本、质量调整生命年（QALYs）及增量成本效果比（ICERs）。

结果
相较于非NAs最佳支持治疗，TAF可使每位患者额外获得2.68个质量调整生命年，增量成本效果比为7853.22美元/质量调整生命年。未实施NVBP政策时，TDF可使每位患者额外获得2.61个质量调整生命年，增量成本效果比为7153.39美元/质量调整生命年；ETV可使每位患者额外获得2.01个质量调整生命年，增量成本效果比为9366.74美元/质量调整生命年。实施NVBP政策后，相较于非NAs最佳支持治疗，TAF、TDF及ETV的增量成本效果比分别降至-745.62美元/质量调整生命年、-729.33美元/质量调整生命年及-871.11美元/质量调整生命年。在支付意愿（WTP）阈值为12500美元/质量调整生命年至37500美元/质量调整生命年的场景下，实施NVBP政策的TAF成为最优治疗策略的概率升高（51.15%~52.47%）；其次为实施NVBP政策的TDF与ETV，其成为最优策略的概率分别为43.09%~42.45%与6.40%~4.48%，呈逐步下降趋势。

结论
本研究分析表明，实施NVBP政策的TAF是慢性乙型肝炎患者最具成本效益的长期治疗方案。无论是否联合NVBP政策的TDF与ETV，以及未实施NVBP政策的TAF，均被视为成本效益不足的治疗方案。