Presentation (CTI)

OBJECTIVES: Subcutaneous (SC) formulations offer reduced administration time, improved convenience and healthcare system (HCS) efficiency. However, real-world adoption varies dramatically despite clinical equivalence, suggesting clinical efficacy alone does not drive successful implementation of alternative formulations. This research aimed to summarise the barriers to adopting SC formulations of approved products, and proposed solutions to support real-world adoption.
METHODS: IV oncology drugs with approved equivalent SC formulation were identified through targeted searches of regulatory and technology appraisals in the UK, France, Germany, Canada and the US. The Consolidated Framework for Implementation Research (CFIR) was applied to systematically map barriers and enablers of transitioning to SC formulations across five domains: Intervention Characteristics, Outer Setting, Inner Setting, Characteristics of Individuals, and Implementation Process.
RESULTS: Nine products with IV and SC formulations were identified. Real-world adoption varied dramatically: >95% for some agents within 4 weeks of implementation versus restricted access for others despite clinical equivalence. Using the CFIR, adoption barriers spanned five domains: Individual (prescriber inertia, clinician knowledge gaps); Organizational (electronic medical record/formulary delays, workflow complexity); System-level (restrictive reimbursement policies); Intervention (perceived loss of clinician oversight); and Process (inadequate training infrastructure). Key enablers of transitioning to SC included multidisciplinary leadership engagement, structured education programs, quantified operational benefits (chair time reduction), and patient preference (up to 92% preferring SC over IV). Critically, adoption success correlated with formal implementation frameworks rather than clinical efficacy alone, suggesting system-level factors are a key determinant of real-world adoption.
CONCLUSIONS: Transitioning patients to SC formulations in oncology represent opportunities for patient-centred care and system efficiency. Tailored implementation strategies are critical for maximizing adoption. Incorporating CFIR-guided frameworks into clinical practice decisions could accelerate adoption, reduce equity gaps, and ensure consistent access to formulation innovations across diverse HCS worldwide.