Liposomal irinotecan + 5-fluorouracil/leucovorin + oxaliplatin as a first line treatment for the management of metastatic pancreatic adenocarcinoma: A budget impact analysis from a U.S. payer perspective.

e16339 Background: Metastatic pancreatic ductal adenocarcinoma (mPDAC) stands as the predominant pancreatic cancer type, affecting approximately 60, 000 individuals in the United States (US) annually and nearly 500, 000 globally. The prognosis for mPDAC is poor, with fewer than 20% of diagnosed individuals surviving beyond one year, and just 2. 9% surpassing five-years. A phase 3 trial, NAPOLI-3, demonstrated statistically significant improved efficacy outcomes for NALIRIFOX compared with nab-paclitaxel + gemcitabine (Gem-Abraxane) as a first-line (1L) therapy for the treatment of mPDAC. NALIRIFOX showed an overall survival of 11. 1 months compared with 9. 2 months with Gem-Abraxane, and a significant improvement in progression free survival of 7. 4 months compared with 5. 6 months. In light of these efficacy outcomes, the objective of this analysis was to estimate the budget impact of adding NALIRIFOX for 1L treatment to a US health plan formulary over a one-year time horizon. Methods: The model estimated the difference in total costs and resource use between a current scenario without NALIRIFOX and a proposed scenario with NALIRIFOX. The eligible population was calculated using published prevalence and incidence data and applied to a hypothetical population plan of 1 million members (includes both commercial and Medicare insurance). NALIRIFOX was compared to the current standard of care (SoC) treatments with the highest market shares; FOLFIRINOX, Gem-Abraxane and Gemcitabine monotherapy, in the first year after marketing authorization. The following costs were included: acquisition, administration, resource monitoring utilization, adverse events (AE) and granulocyte-colony stimulating factor (G-CSF). Baseline characteristics, treatment duration and adverse events for NALIRIFOX and Gem-Abraxane were taken from NAPOLI-3 and published literature for other regimens. Results are presented in terms of the incremental budget impact (BI) and per member per month (PMPM) cost. One-way sensitivity analysis was performed. Results: For a plan of 1 million members, an estimated 132 individuals were eligible for 1L treatment for mPDAC. The PMPM budget impact was < 0. 01. NALIRIFOX demonstrated notable cost savings, with reductions of 13. 6%, 7. 7%, and 1. 1% observed in the G-CSF, AEs, and resource monitoring cost categories, respectively. Results were most sensitive to the treatment duration of NALIRIFOX. Conclusions: The model results indicate that the budget impact of NALIRIFOX may be minimal from a US health plan perspective. Given the poor prognosis of mPDAC, NALIRIFOX presents itself as an important new first line treatment option for people living with an aggressive and hard to treat cancer.