Costello Medical, London, United Kingdom.
Costello Medical, Singapore.
J Manag Care Spec Pharm. 2024 Sep;30(9):1001-1012. doi: 10.18553/jmcp.2024.30.9.1001.
Heavily treatment-experienced (HTE) people with HIV (PWH) have limited treatment options owing to multidrug resistance (MDR). Lenacapavir (LEN) is indicated, in combination with other antiretrovirals, for the treatment of adults with MDR HIV-1 experiencing failure of their current antiretroviral regimen because of resistance, intolerance, or safety considerations.
To evaluate the cost-utility of LEN in combination with an optimized background regimen (OBR) vs alternative recently approved treatments for HTE PWH, fostemsavir (FTR)+OBR and ibalizumab (IBA)+OBR, for the treatment of PWH with MDR, from a mixed US health care payer perspective.
A Markov state-transition model with a lifetime time horizon was developed. Transition probabilities between viral load categories were based on individual participant data from the CAPELLA trial for LEN+OBR and on relative efficacy parameters obtained from indirect treatment comparisons for comparators. Health state utilities were sourced from the literature. Costs included drug acquisition costs, drug administration costs, disease management costs, adverse event costs, AIDS-related event costs, and treatment switching costs and were sourced from red book costs, Medicare and Medicaid fees, and the literature. Costs and outcomes were discounted at 3% annually. The model was used to estimate total and incremental costs, life-years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. A deterministic and a probabilistic sensitivity analysis, as well as scenario analyses, were performed to address elements of uncertainty in the model and to explore the robustness of the results.
Over a lifetime time horizon, LEN+OBR was associated with the highest absolute QALYs (9.41) and the greatest number of LYs (12.09) compared with FTR+OBR (QALYs: 8.75; LYs: 11.26) and IBA+OBR (QALYs: 8.36; LYs: 10.78). LEN+OBR was also associated with the lowest total lifetime costs of the 3 interventions (LEN+OBR: $1,441,122 [US dollars]; FTR+OBR: $1,504,986; IBA+OBR: $1,524,396) and therefore was dominant over both comparators in the base case. LEN+OBR remained dominant vs FTR+OBR and IBA+OBR across the range of scenarios tested and LEN+OBR had a 99% probability of being cost-effective compared with FTR+OBR and IBA+OBR in the probabilistic sensitivity analysis at a willingness-to-pay threshold of $50,000/QALY.
This economic evaluation demonstrated that LEN+OBR provides meaningful increases in QALYs and LYs, and is dominant over a lifetime time horizon, compared with FTR+OBR and IBA+OBR for the treatment of PWH with MDR in the United States.
由于多重耐药性（MDR），大量接受过治疗（HTE）的艾滋病毒（HIV）感染者（PWH）的治疗选择有限。Lenacapavir（LEN）与其他抗逆转录病毒药物联合使用，适用于因耐药性、不耐受或安全性考虑而导致当前抗逆转录病毒方案治疗失败的 MDR HIV-1 成人患者。
从美国混合医保支付者的角度出发，评估 LEN 联合优化背景方案（OBR）与最近批准的用于治疗 MDR HTE PWH 的替代方案，即 fostemsavir（FTR）+OBR 和ibalizumab（IBA）+OBR，治疗 MDR PWH 的成本效用。
开发了一个具有终生时间范围的马尔可夫状态转移模型。病毒载量类别之间的转移概率基于 CAPELLA 试验中每个参与者的数据，以及通过间接治疗比较获得的比较剂的相对疗效参数。健康状态效用来源于文献。成本包括药物获得成本、药物管理成本、不良事件成本、艾滋病相关事件成本和治疗转换成本，并来源于红皮书成本、医疗保险和医疗补助费用以及文献。成本和结果以每年 3%的贴现率进行贴现。该模型用于估计总成本和增量成本、生命年（LYs）、质量调整生命年（QALYs）和增量成本效益比。进行了确定性和概率敏感性分析以及情景分析，以解决模型中的不确定性因素，并探讨结果的稳健性。
在终生时间范围内，与 FTR+OBR（QALYs：8.75；LYs：11.26）和 IBA+OBR（QALYs：8.36；LYs：10.78）相比，LEN+OBR 与最高的绝对 QALYs（9.41）和最大数量的 LYs（12.09）相关。LEN+OBR 还与 3 种干预措施中最低的总终生成本相关（LEN+OBR：1441122 美元；FTR+OBR：1504986 美元；IBA+OBR：1524396 美元），因此在基础情况下，它在所有比较中均占主导地位。在测试的所有场景中，LEN+OBR 仍然优于 FTR+OBR 和 IBA+OBR，并且在概率敏感性分析中，与 FTR+OBR 和 IBA+OBR 相比，LEN+OBR 在 50000 美元/QALY 的支付意愿阈值下具有 99%的成本效益概率。
这项经济评估表明，与 FTR+OBR 和 IBA+OBR 相比，LEN+OBR 为治疗美国 MDR PWH 提供了有意义的 QALYs 和 LYs 增加，并且在终生时间范围内具有优势。
