The cost of convenience: Evaluating economic differences in SQ and IV biotherapeutic formulations.

Abstract

e23163 Background: Subcutaneous (SQ) formulations of anti-neoplastic biotherapeutics provide an alternative to intravenous (IV) administration, offering shorter administration times and eliminating the need for IV access, but also increasing the potential for injection site complications. However, adoption of SQ formulations has been mixed. We evaluated the economic differences between the IV and SQ formulations. Methods: Using publicly available, HCPCS-level utilization and cost data from the Medicare Part B Spending by Drug dataset we studied the utilization and cost of IV and SQ formulations of Rituximab, Trastuzumab, and Daratumumab between 2018 and 2022. We then modeled and compared drug administration costs based on the Medicare Physician Fee Schedule for the formulations, following the instructions in the package insert. Biosimilar options for IV Rituximab and Trastuzumab, which became available in 2019-2020, were included in the cost evaluation of the IV formulation. SQ biosimilar formulations are not currently available. Results: SQ formulations of Rituximab (Rituxan Hycela), Trastuzumab (Herceptin Hylecta), and Daratumumab (Darzalex Faspro) became available in 2017, 2019 and 2020, respectively. SQ Daratumumab was more readily adopted compared to SQ Rituximab and Trastuzumab. The cost per claim, including administration costs, for the SQ formulations was higher than their IV counterparts (brand and biosimilar) in 2022, except for brand Rituximab. Conclusions: While subcutaneous (SQ) formulations offer convenience and potential clinical and administrative benefits, they generally cost more than their IV counterparts. SQ Daratumumab was more readily adopted possibly due to fewer drug-related reactions, shorter administration duration, patient convenience, and lack of biosimilar options. Despite the higher costs, convenience and patient preference for SQ formulations may justify their use in certain clinical scenarios. Future evaluations can focus on clinical outcomes, cost-benefit ratio, manufacturer incentives, patient preferences/value perception, patent strategies, rapid infusion protocols, payer mandates for formulation choice, timing of SQ formulation market release, and the impact of biosimilar competition on formulation choices. Adoption rates and utilization/cost measures. Reference Drug SQ Formulation Adoption 2018 2019 2020 2021 2022 Daratumumab SQ - - 0% 63% 81% Trastuzumab SQ - 0% 2% 3% 4% Rituximab SQ 0% 7% 7% 6% 5% Utilization & Costs in 2022 Key Measures Daratumumab Rituximab Trastuzumab  Administration IV 4 – 7 hours 1.5 – 6 hours 30 – 90 minutes SQ 3 - 5 minutes 3 - 5 minutes 3 - 5 minutes  Claims IV 43,743 201.081 147116 SQ 182,181 10,743 5494  Average Units per Claim IV 128 82 45 SQ 180 144 60  Per Claim Cost IV Brand $7,540 $6,910 $3,917 Biosimilar - $3,889 $1,872 SQ $8,246 $5,470 $4,184  Administration Cost per Claim IV $249 - $305 $189 - $259 $119 - $189 SQ $78 $78 $78