Budget Impact Analysis of Introducing Elotuzumab in Combination with Lenalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: A US Payer Perspective

Background: Despite advances in the treatment of multiple myeloma (MM), patients with this high-burden disease continue to be at an high risk of relapse and progression. This underscores the considerable unmet need for new agents that can provide durable disease control in patients with relapsed/refractory MM (RRMM). Elotuzumab is a SLAMF7-directed immunostimulatory antibody recently approved by the US Food and Drug Administration, in combination with lenalidomide and dexamethasone (ELd), for the treatment of patients with MM who have received 1-3 prior therapies. This approval was based on the results from ELOQUENT-2, a randomized, open-lable, Phase 3 study, showing a 30% reduction in the risk of disease progression or death with minimal additional toxicity, over the combination of lenalidomide and dexamethasone.

Objective: To determine the budgetary impact of adding ELd to the formulary of a health plan in the United States.

Methods: A budget impact model was developed to estimate the 3-year costs of adding ELd to a plan's formulary. Key regimens approved for use in the United States as of November 2015 were included. The model flows from the incidence of RRMM (8 per 100,000) and distribution of these patients into the various competing regimens, estimated with market research data. The number of patients under treatment each year was based on treatment starts with the regimen, progression-free survival and duration of treatment. In Years 1, 2 and 3, ELd was projected to have a share of 9.7%, 8.9% and 9.6% of patients with incident RRMM, respectively. Costs related to MM medications, concomitant medications, adverse-event management, laboratory tests and disease monitoring were accounted for, and were adjusted to 2016 values using the medical component of the Consumer Price Index. In the second and third years, costs incurred by incident patients of the previous years were also evaluated. Model results were expressed in terms of absolute annual budget impact and budget impact per plan member per month (PMPM) and per year (PMPY).

Results: For a hypothetical plan of 1 million members, 29 patients with RRMM received treatment in Year 1, 70 in Year 2 and 96 in Year 3. Estimated budget increase associated with adding ELd to a heath plan's formulary was $379,507 in Year 1, $853,950 in Year 2 and $1,282,792 in Year 3. In Years 1, 2 and 3, the PMPM budget impact was $0.032, $0.071 and $0.107, respectively, while the PMPY budget impact was $0.380, $0.854 and $1.283.

Conclusion: Based on this evaluation, the introduction of ELd should only have a gradual and marginal budget impact on US health plans.

Study funding: Bristol-Myers Squibb