Presentation (CTI)

OBJECTIVES: Manufacturers often simplify dosage terminology, using terms such as ‘monthly’ instead of the evidence-based schedule of ‘every 4 weeks.’ This discrepancy can cause confusion among healthcare professionals, resulting in unintended consequences; particularly for fixed-duration regimens where misinterpretation may lead to risk of clinical underdosing. For indefinite therapy, the issue primarily affects payers’ budgets.
To assess the impact of simplifying evidence-based dosage schedules in marketing materials on treatment duration, clinical practice, and cost, with a distinction between fixed-duration and indefinite regimens.
METHODS: Case studies of manufacturer misinterpretation of prescribing information in marketing materials were identified using Food and Drug Administration (FDA) and published promotional content. Using Excel®, differences in treatment duration and dosing frequency between evidence-based and marketing dosage schedules were modelled over a 12-months period to evaluate their impact on clinical dosing and budget implications for both fixed-duration and indefinite therapy regimens.
RESULTS: For fixed-duration regimens, misinterpretation can lead to clinical overdosing, increased cost, and deviation from trial evidence; potentially exposing patients to unnecessary risks (e.g., within oncology or immunology therapies). For indefinite therapy, this discrepancy inflates annual cost projections and may bias cost-analysis models. For instance, simplifying ‘every 4 weeks’ to ‘monthly’ can lead to 12 doses instead of 13 per year, reducing drug acquisition costs by approximately 8.3%, and potentially implying reductions in monitoring, administration, and adverse event management.
CONCLUSIONS: Clear and consistent communication of dosage schedules is essential to prevent misrepresentation of costs and resource use from manufactures to decision makers and therefore avoid biased budget impact analyses. Manufacturers should fully understand the implications of simplifying terminology before releasing promotional content to ensure compliance with local guidelines.