Takeda Pharmaceuticals U.S.A., Inc., Lexington, Massachusetts, USA.
Infectious Diseases Division, Massachusetts General Hospital, Boston, Massachusetts, USA.
J Med Virol. 2024 Apr;96(4):e29609. doi: 10.1002/jmv.29609.
This study evaluated the cost-effectiveness of maribavir versus investigator-assigned therapy (IAT; valganciclovir/ganciclovir, foscarnet, or cidofovir) for post-transplant refractory cytomegalovirus (CMV) infection with or without resistance. A two-stage Markov model was designed using data from the SOLSTICE trial (NCT02931539), real-world multinational observational studies, and published literature. Stage 1 (0-78 weeks) comprised clinically significant CMV (csCMV), non-clinically significant CMV (n-csCMV), and dead states; stage 2 (78 weeks-lifetime) comprised alive and dead states. Total costs (2022 USD) and quality-adjusted life years (QALYs) were estimated for the maribavir and IAT cohorts. An incremental cost-effectiveness ratio was calculated to determine cost-effectiveness against a willingness-to-pay threshold of $100 000/QALY. Compared with IAT, maribavir had lower costs ($139 751 vs $147 949) and greater QALYs (6.04 vs 5.83), making it cost-saving and more cost-effective. Maribavir had higher acquisition costs compared with IAT ($80 531 vs $65 285), but lower costs associated with administration/monitoring ($16 493 vs $27 563), adverse events (AEs) ($11 055 vs $16 114), hospitalization ($27 157 vs $33 905), and graft loss ($4516 vs $5081), thus making treatment with maribavir cost-saving. Maribavir-treated patients spent more time without CMV compared with IAT-treated patients (0.85 years vs 0.68 years), leading to lower retreatment costs for maribavir (cost savings: -$42 970.80). Compared with IAT, maribavir was more cost-effective for transplant recipients with refractory CMV, owing to better clinical efficacy and avoidance of high costs associated with administration, monitoring, AEs, and hospitalizations. These results can inform healthcare decision-makers on the most effective use of their resources for post-transplant refractory CMV treatment.
本研究评估了 maribavir 与研究者分配治疗（IAT；缬更昔洛韦/更昔洛韦、膦甲酸或西多福韦）用于移植后难治性巨细胞病毒（CMV）感染的成本效益，包括有或无耐药性的情况。使用 SOLSTICE 试验（NCT02931539）、多国真实世界观察性研究和已发表文献中的数据，设计了两阶段 Markov 模型。第 1 阶段（0-78 周）包括有临床意义的 CMV（csCMV）、无临床意义的 CMV（n-csCMV）和死亡状态；第 2 阶段（78 周-终身）包括存活和死亡状态。为 maribavir 和 IAT 队列估计了总费用（2022 美元）和质量调整生命年（QALY）。为了确定相对于 100000 美元/QALY 的支付意愿阈值的成本效益，计算了增量成本效益比。与 IAT 相比，maribavir 的成本更低（139751 美元对 147949 美元），QALY 更高（6.04 对 5.83），因此具有成本效益。与 IAT 相比，maribavir 的药物获得成本更高（80531 美元对 65285 美元），但药物管理/监测成本更低（16493 美元对 27563 美元）、不良事件（AE）成本更低（11055 美元对 16114 美元）、住院成本更低（27157 美元对 33905 美元）和移植物丢失成本更低（4516 美元对 5081 美元），因此 maribavir 的治疗具有成本效益。与 IAT 治疗的患者相比，接受 maribavir 治疗的患者无 CMV 时间更长（0.85 年对 0.68 年），导致 maribavir 的再治疗成本更低（成本节约：-42970.80 美元）。由于 maribavir 具有更好的临床疗效，并且避免了与药物管理、监测、AE 和住院相关的高昂成本，因此与 IAT 相比，maribavir 对移植后难治性 CMV 的治疗更具成本效益。这些结果可以为医疗保健决策者提供有关如何最有效地利用资源治疗移植后难治性 CMV 的信息。
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