OBJECTIVES : Estimate budget impact on US commercial payers adopting fixed-dose combination therapy of lesinurad and allopurinol (L/A) as second-line urate-lowering therapy in gout patients for whom allopurinol (ALLO) therapy has failed.

METHODS : This budget impact model used a Markov model to estimate costs, survival, and discontinuation in a 1-million-member health plan. Model parameters were derived from CLEAR 1 and CLEAR 2 Phase III trials of lesinurad, published literature, and market share estimates. The model population included patients failing first-line ALLO monotherapy; the time horizon is 5 years. A scenario based on ALLO therapy was compared with a future scenario in which L/A is provided to a portion of ALLO patients not meeting sUA goal. The uptake of L/A population was assumed to increase from 1.2% to 5.2% over 5 years. Annual and cumulative incremental costs were reported as total cost, per-member per-month (PMPM) cost, and cost-per-treated patient per year. One-way sensitivity analysis, to identify parameters that most influence the model, was conducted (±10% variation for each model parameter). US payer perspective for commercial health care plans is modeled.

RESULTS : A total of 8205 patients would be treated with second-line therapy in treatment mixes with and without L/A, respectively. The budget impact of L/A is estimated to be $231,451 in the first year and $1,049,637 in the fifth year, for a cumulative 5-year incremental cost of $3,473,891. Cumulative 5-year cost-per-treated gout patient per year was $107, and cumulative incremental 5-year PMPM was estimated at $0.06. Sensitivity analysis indicated the model was most sensitive to L/A cost and L/A market shares, each affecting PMPM by approximately $0.01.

CONCLUSIONS : From the commercial payer perspective, adding L/A as a second-line gout therapy to a hypothetical 1 million–person health plan over a 5-year time horizon results in cumulative total incremental PMPM costs of approximately $0.06.