OBJECTIVES : Daratumumab administered via an intravenous infusion (dara-IV) is currently approved for the treatment of patients with multiple myeloma, both newly diagnosed (NDMM) and relapsed/refractory (RRMM). A daratumumab formulation for subcutaneous administration (dara-SC) was developed with the goal of shortening treatment duration without compromising safety and efficacy. Dara-SC was licensed in 2020 for the same indications as dara-IV and is expected to be reimbursed in the Italian setting. This analysis assesses the budget impact of switching Italian patients currently receiving dara-IV to dara-SC.

METHODS : A budget impact model was developed to estimate the economic impact of introducing dara-SC over a 3-year time horizon from the Italian societal perspective. The analysis included all currently reimbursed indications: DVMP and DRd for transplant-ineligible NDMM; DVTd for transplant-eligible NDMM; DRd and DVd for RRMM; daratumumab monotherapy for patients who have received at least three prior lines of therapy. In a cohort of 100 dara-IV patients per approved regimen, the model simulates the switch to dara-SC of 95% of them, in some patients (e.g. obese patients), the use of dara-IV will be preferable. The analysis included: daratumumab administration cost, adverse events cost, and productivity loss. Adverse events rates and treatment duration were taken from clinical trials. Unit costs were collected from published literature and institutional Italian data. Drug acquisition costs were assumed to be equivalent for dara-IV and dara-SC and therefore not considered in the analysis.

RESULTS : Switching 95% of patients to dara-SC results in a saving of resources for all regimens considered and in every cost category. Over 3 years, the greatest savings (€ 1.161.919) were observed for DRd in RRMM patients. Daratumumab administration cost was the main driver.

CONCLUSIONS : The introduction of dara-SC in Italy for the treatment of patients with multiple myeloma can help save resources.