School of Pharmacy, Faculty of Science, University of Waterloo, 10A Victoria Street S, Kitchener, ON, N2G1C5, Canada.
Pharmacoeconomics. 2020 Feb;38(2):181-192. doi: 10.1007/s40273-019-00852-y.
BACKGROUND/AIM: Tenofovir alafenamide (TAF) has been approved for treating chronic hepatitis B (CHB) due to a proposed better safety profile in comparison with current therapies. We evaluated the cost effectiveness of TAF and other available treatment options for hepatitis B envelope antigen (HBeAg)-positive and HBeAg-negative CHB patients from a Canadian provincial Ministry of Health perspective.
A state-transition model based on the published literature was developed to compare treatment strategies involving entecavir (ETV), tenofovir disoproxil fumarate (TDF), and TAF. It adopted a lifetime time horizon. Outcomes measured were predicted number of liver-related deaths, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).
For HBeAg-positive patients, TAF followed by ETV generated an additional 0.16 QALYs/person at an additional cost of Can$14,836.18 with an ICER of Can$94,142.71/QALY compared with TDF followed by ETV. Of the iterations, 28.7% showed that it is the optimal strategy with a Can$50,000 willingness-to-pay threshold. For HBeAg-negative patients, ETV followed by TAF would prevent an additional 13 liver-related deaths per 1000 CHB patients compared with TDF, followed by ETV. It generated an additional 0.13 QALYs/person at an additional cost of Can$59,776.53 with an ICER of Can$461,162.21/QALY compared with TDF, followed by ETV. TAF-containing strategies are unlikely to be a rational choice in either case. The results were sensitive to the HBeAg seroconversion rates and viral suppression rates of the treatments.
Our analysis suggests that TAF is not cost effective at its current cost. A 33.4% reduction in price would be required to make it cost effective for HBeAg-positive patients with a Can$50,000 willingness-to-pay threshold.
背景/目的：替诺福韦艾拉酚胺（TAF）已获批准用于治疗慢性乙型肝炎（CHB），因其与现有疗法相比具有更好的安全性。我们从加拿大省级卫生部的角度评估了 TAF 和其他可用的乙型肝炎表面抗原（HBeAg）阳性和 HBeAg 阴性 CHB 患者治疗方案的成本效益。
我们开发了一个基于已发表文献的状态转换模型，以比较涉及恩替卡韦（ETV）、富马酸替诺福韦二吡呋酯（TDF）和 TAF 的治疗策略。它采用了终生时间范围。测量的结果是预测的与肝脏相关的死亡人数、成本、质量调整生命年（QALYs）和增量成本效益比（ICERs）。
对于 HBeAg 阳性患者，TAF 序贯 ETV 可使每人额外获得 0.16 个 QALY，额外成本为 14836.18 加元，与 TDF 序贯 ETV 相比，ICER 为 94142.71 加元/QALY。在迭代中，有 28.7%的情况表明，这是一个最佳策略，对于 50000 加元的意愿支付阈值。对于 HBeAg 阴性患者，与 TDF 序贯 ETV 相比，ETV 序贯 TAF 可使每 1000 例 CHB 患者额外预防 13 例与肝脏相关的死亡。与 TDF 序贯 ETV 相比，它可使每人额外获得 0.13 个 QALY，额外成本为 59776.53 加元，ICER 为 461162.21 加元/QALY。在这两种情况下，包含 TAF 的治疗方案都不太可能是合理的选择。结果对治疗的 HBeAg 血清转换率和病毒抑制率敏感。
我们的分析表明，TAF 目前的价格并不具有成本效益。如果价格降低 33.4%，对于 HBeAg 阳性且愿意支付 50000 加元的患者来说，TAF 才具有成本效益。
