OBJECTIVES:

Pembrolizumab plus enfortumab vedotin (Pem+EV) showed encouraging activity in first-line (1L) cisplatin-ineligible (cis-IE) patients with locally advanced or metastatic urothelial cancer (la/mUC) in the KEYNOTE-869/EV-103 trial. The objective is to estimate the budget impact of including Pem+EV to a US health plan formulary as a 1L therapy in cis-IE la/mUC.

METHODS:

A cohort-based budget impact analysis (3-year time horizon) was performed to estimate the incremental cost of adding Pem+EV from an overall US payer perspective. Comparators included pembrolizumab, gemcitabine plus carboplatin with/without avelumab maintenance (GC w/wo avelumab), gemcitabine, gemcitabine plus paclitaxel, and atezolizumab based on NCCN guideline. Costs included drug acquisition, administration, monitoring, Grade 3-5 adverse event management, and subsequent treatments. Population and cost inputs were obtained from SEER and other public information. Market shares were estimated from market research and claims data for comparators, and assumed a constant 25% for Pem+EV over 3 years. Sensitivity analyses were conducted to assess model uncertainty.

RESULTS:

In a hypothetical 1,000,000-member health plan, it was estimated that 17 cis-IE la/mUC patients in the 1L setting would be eligible for Pem+EV annually. The inclusion of Pem+EV resulted in an annual budget increase of $289,487, $678,807, and $788,138 in year 1-3 ($585,477 on average) and per-member per-month (PMPM) budget impact of $0.0486. Total costs per patient per treatment course were $488,666 and $402,225 for Pem+EV and GC w/wo avelumab, followed by pembrolizumab ($286,284). The model results remained robust in sensitivity analyses, and most sensitive to subsequent treatment costs, time horizon, 20% cost-sharing, and EV’s relative dose intensity.

CONCLUSIONS:

The introduction of Pem+EV for 1L cis-IE la/mUC patients in a healthcare plan of 1 million members is projected to lead to a modest budget impact. Pem+EV can be an affordable and valuable treatment option for la/mUC patients in the 1L setting.