Cost-Effectiveness of Oral Immunotherapy Treatments vs No Treatment for Peanut Allergy in Children.

Importance: The first peanut oral immunotherapy (OIT) for children was approved by the US Food and Drug Administration (FDA) in 2020. While clinical efficacy is established, evidence on cost-effectiveness-whether the benefits outweigh the costs and adverse effects-remains limited. A variant of OIT, known as probiotic and peanut OIT (PPOIT), has shown similar efficacy in trials. Objective: To compare the cost-effectiveness of PPOIT, OIT, and no treatment. Design, Setting, and Participants: This economic evaluation was conducted alongside a multicenter, randomized, placebo-controlled clinical trial in Australia between 2016 and 2019. Time horizon was 10 years, including 1.5 years of active treatment, 2 years of posttreatment follow-up, and 6.5 years of extrapolation. Data were analyzed from May 2024 to August 2025. Interventions: PPOIT and OIT. Main Outcomes and Measures: Effectiveness was measured using remission achieved and patient quality-adjusted life years (QALYs) gained. Costs were evaluated from a health care payer perspective, including active treatment and adverse event costs, and were calculated in Australian dollars. Incremental cost-effectiveness ratios were estimated. Sensitivity analyses were conducted to capture uncertainty. Results: A total of 201 children aged 1 to 10 years were recruited, 79 in PPOIT, 83 in OIT, and 39 in no treatment (mean [SD] age, 5.9 [2.8] years; 129 [64.2%] male). Over a 10-year horizon, mean (SD) cost per patient was A$3956 (A$67) for PPOIT (treatment, A$3579 [A$0]; adverse events, A$377 [A$67]), A$3582 [A$57] for OIT (treatment, A$3179 [A$0]; adverse events, A$402 [A$57]), and A$249 (A$87) for no treatment (treatment, A$0 [A$0]; adverse events, A$249 [A$87]). Mean (SD) annual remission was 34.1% (12.7%) for PPOIT, 35.1% (15.4%) for OIT, and 7.3% (8.1%) for no treatment. The total QALYs gained for PPOIIT, OIT, and no treatment were 0.096, 0.055, and 0, respectively. PPOIT was slightly more costly than OIT, achieved similar remission, and achieved better quality-of-life. Compared with no treatment, both treatments were more costly with minor risks, achieved higher remission (PPOIT, A$1384; 95% CI, A$1269-A$1415; and OIT, A$1199; 95% CI, A$1091-A$1217 per year of remission achieved, respectively), and improved quality of life (PPOIT, A$38 435; 95% CI, A$31 058-A$48 668 and OIT, A$60 840; 95% CI, A$49 479-A$86 531 per QALY gained, respectively). Conclusions and Relevance: This economic evaluation found that for remission, both PPOIT and OIT were cost-effective and good value compared with no treatment, with OIT associated with a larger effect size but no clinically meaningful difference. When QALYs are prioritized, PPOIT offers the best value. Key factors associated with cost-effectiveness were treatment product pricing and patient quality of life.