The Cost-Effectiveness and Budget Impact of Ibalizumab-uiyk for Adults with Multidrug-Resistant HIV-1 Infection in the United States

Background Ibalizumab-uiyk (ibalizumab) is a first-in-class, long-acting, postattachment HIV-1 inhibitor for adults with multidrug-resistant (MDR) HIV-1 infection. This analysis examines the cost-effectiveness and budget impact of ibalizumab treatment for this difficult-to-treat population in the United States. Methods A Markov model followed cohorts of adults with MDR HIV-1 infection through two final lines of antiretroviral therapy: ibalizumab + optimized background therapy (OBT) or OBT alone followed by nonsuppressive therapy. Model inputs were based on ibalizumab clinical trial data, market uptake projections, and published literature, with costs in 2019 dollars. The cost-effectiveness analysis assessed costs and health outcomes from a health care sector perspective for individuals receiving ibalizumab + OBT versus OBT alone over a lifetime time horizon. The budget-impact analysis estimated the impact on payer budgets of the introduction of ibalizumab over 3 years for a hypothetical commercial health plan. Results Compared with individuals receiving OBT alone, individuals receiving ibalizumab + OBT incurred higher costs but lived longer, healthier lives, with an incremental cost of $133,040 per QALY gained. For a hypothetical commercial health plan with 1 million members, the introduction of ibalizumab + OBT was estimated to increase budgets by $217,260, $385,245, and $560,310 ($0.018, $0.032, and $0.047 per member per month) in years 1, 2, and 3, respectively. These results were found to be robust in sensitivity and scenario analyses. Conclusions Ibalizumab may represent a cost-effective and affordable option to improve health outcomes for individuals with MDR HIV-1 infection.