OBJECTIVES

: Liposomal irinotecan (nal-IRI; Onivyde), in combination with fluorouracil (5-FU)+leucovorin (LV), is the only category-1 NCCN recommendation for treating post-gemcitabine adult patients with mPC. Given expected increases in nal-IRI use based on guidelines, it may be valuable to understand fiscal implications to US health plans. This study estimates the budgetary consequences of increasing nal-IRI use for treating post-gemcitabine mPC adult patients from a US commercial payer perspective.

METHODS

: A Microsoft^® Excel budget impact model was developed to estimate the one-year fiscal impact for a hypothetical 1-million-member health plan. The treatment-eligible population included mPC patients receiving first-, second-, or third-line post-gemcitabine therapy. Inputs (epidemiology, dosing, direct costs [drug, administration, and monitoring]) were derived from published literature, product labels/clinical trials, Medispan PriceRx, CMS fee schedules, and a de novo real-world study of Medicare AE rates and costs (aligning to the FDA Framework for Real-World Evidence Program). Costs reflect 2018 USD. Market distributions for current and projected scenarios were provided by the manufacturer, including most common mPC treatment options and irinotecan regimens. The budget impact (total annual costs, cost per member per month [PMPM]) was calculated as the difference between current and projected markets. Sensitivity analyses examined the impact of uncertainty (±20% variation) on results.

RESULTS

: Increased nal-IRI use (1.4%, 21.5%, and 40.2% in first-, second-, and third-line therapy, respectively) in year 1 would cost $0.0001 PMPM (total cost difference of $1,132). Sensitivity analyses across all parameters did not change conclusions (+/- $0.0001 PMPM variation). AE cost offsets are achieved given the lower real-world rate of AEs for nal-IRI versus the most common regimens (FOLFIRINOX and Gemcitabine+Abraxane; e.g., anemia, fatigue, neutropenia, and thrombocytopenia).

CONCLUSIONS

: Increasing access to nal-IRI, in agreement with recent NCCN guidelines for treatment of post-gemcitabine mPC, is budget neutral given the lower real-world rate of AEs compared to common alternatives.