OBJECTIVES: This study aimed to evaluate the environmental impact of the early development of the subcutaneous (SC) formulation of daratumumab within the Italian healthcare context.

METHODS: Following Life Cycle Assessment (LCA) principles, we developed an Environmental Impact Model to estimate the annual carbon footprint of SC and intravenous (IV) formulations of daratumumab, expressed in carbon dioxide equivalents (CO2eq). We identified key factors differentiating the two formulations across every phase of the product life cycle, including packaging, transportation, administration, and disposal. Data on resource consumption and emissions were collected from local and European sources, supplemented by expert opinions where data were lacking. The analysis considered both worst-case and best-case scenarios to estimate the range of the environmental impact of the early development of the SC formulation.

RESULTS: Life cycle emissions per administration of IV and SC daratumumab were estimated at 23.8 kg CO2eq and 10.6 kg CO2eq, respectively. Key factors influencing these results included the allocation of overhead emissions, emissions per euro spent on medical supplies, reduction in delivery trips, and emissions related to drug packaging. On a national scale, total emissions savings depended on the number of patients treated with the SC formulation and the timing of its development. The early development of the SC formulation resulted in annual emissions savings for Italy ranging from 123 to 3.192 tonnes CO2eq. Considering the SC formulation was introduced 10 years before IV patent expiration, overall savings were projected to range from approximately 1,000 to 32,000 tonnes of CO2eq.

CONCLUSIONS: The early development of daratumumab SC formulation promises significant CO2eq savings, reducing environmental burdens and benefiting patients, families, and the National Health Service (NHS). Introducing the SC formulation 10 years before IV patent expiration demonstrates the potential for long-term environmental sustainability and emphasizes the need for environmental considerations in pharmaceutical development.