US Medical Affairs Outcomes Research, Takeda Pharmaceuticals U.S.A., Inc., Lexington, Massachusetts, USA.
Health Economics and Outcomes Research, Anlitiks, Inc., Windermere, Florida, USA.
Transpl Infect Dis. 2024 Apr;26(2):e14216. doi: 10.1111/tid.14216. Epub 2024 Jan 14.
Cytomegalovirus (CMV) infections among hematopoietic stem cell transplant (HSCT) and solid organ transplant (SOT) recipients impose a significant health care resource utilization (HCRU)-related economic burden. Maribavir (MBV), a novel anti-viral therapy (AVT), approved by the United States Food and Drug Administration for post-transplant CMV infections refractory (with/without resistance) to conventional AVTs has demonstrated lower hospital length of stay (LOS) versus investigator-assigned therapy (IAT; valgancilovir, ganciclovir, foscarnet, or cidofovir) in a phase 3 trial (SOLSTICE). This study estimated the HCRU costs of MBV versus IAT.
An economic model was developed to estimate HCRU costs for patients treated with MBV or IAT. Mean per-patient-per-year (PPPY) HCRU costs were calculated using (i) annualized mean hospital LOS in SOLSTICE, and (ii) CMV-related direct costs from published literature. Probabilistic sensitivity analysis with Monte-Carlo simulations assessed model robustness.
Of 352 randomized patients receiving MBV (n = 235) or IAT (n = 117) for 8 weeks in SOLSTICE, 40% had HSCT and 60% had SOT. Mean overall PPPY HCRU costs of overall hospital-LOS were $67,205 (95% confidence interval [CI]: $33,767, $231,275) versus $145,501 (95% CI: $62,064, $589,505) for MBV and IAT groups, respectively. Mean PPPY ICU and non-ICU stay costs were: $32,231 (95% CI: $5,248, $184,524) versus $45,307 (95% CI: $3,957, $481,740) for MBV and IAT groups, and $82,237 (95% CI: $40,397, $156,945) MBV versus $228,329 (95% CI: $94,442, $517,476) for MBV and IAT groups, respectively. MBV demonstrated cost savings in over 99.99% of simulations.
This analysis suggests that Mean PPPY HCRU costs were 29%-64% lower with MBV versus other-AVTs.
巨细胞病毒(CMV)感染在造血干细胞移植(HSCT)和实体器官移植(SOT)受者中造成了显著的医疗资源利用(HCRU)相关经济负担。马拉韦罗(MBV)是一种新型抗病毒疗法(AVT),已被美国食品和药物管理局批准用于治疗对常规 AVT 具有抗药性(有/无)的移植后 CMV 感染,在 3 期试验(SOLSTICE)中与研究者指定的治疗(IAT;缬更昔洛韦、更昔洛韦、膦甲酸钠或西多福韦)相比,显示出较低的住院时间(LOS)。本研究估计了 MBV 与 IAT 相比的 HCRU 成本。
开发了一个经济模型来估计接受 MBV 或 IAT 治疗的患者的 HCRU 成本。使用(i)SOLSTICE 中每年平均住院 LOS 和(ii)已发表文献中的 CMV 相关直接成本,计算每位患者每年(PPPY)的平均 HCRU 成本。蒙特卡罗模拟的概率敏感性分析评估了模型的稳健性。
在 SOLSTICE 中接受 MBV(n=235)或 IAT(n=117)治疗 8 周的 352 名随机患者中,40%有 HSCT,60%有 SOT。MBV 和 IAT 组的总体医院 LOS 的总体 PPPY HCRU 成本分别为 67205 美元(95%置信区间[CI]:33767 美元,231275 美元)和 145501 美元(95%CI:62064 美元,589505 美元)。MBV 和 IAT 组的 PPPY ICU 和非 ICU 住院费用分别为:32231 美元(95%CI:5248 美元,184524 美元)和 45307 美元(95%CI:3957 美元,481740 美元)和 82237 美元(95%CI:40397 美元,156945 美元)MBV 与 228329 美元(95%CI:94442 美元,517476 美元)MBV 与 IAT 组。在超过 99.99%的模拟中,MBV 显示出节省成本。
本分析表明,与其他 AVT 相比,MBV 的平均 PPPY HCRU 成本降低了 29%-64%。