OBJECTIVES: Budget impact models (BIM) for pharmaceuticals often follow a consistent structure; however, this is often not the case for medical devices given varying stakeholders, types of devices, settings of use, and data availability. Several costing perspectives may be relevant which necessitates additional considerations for model parameters to inform a cost-offset structure. The objective of this research is to illustrate these key methodological considerations within ophthalmology given the range of device types and costing perspectives.

METHODS: The focus of this study is the design of cost-offset BIMs for a range of diagnostic, consumable, implantable, equipment, and surgical devices used in ophthalmology. Many costing perspectives were considered including practice owners, clinicians such as optometrists, ophthalmologists and technicians, patients, and both public and private payers.

RESULTS: Typically, these models are designed with a time horizon of 1 year or less, and parameters can change substantially depending on stakeholder(s) of focus. More traditional model input types include product costs, rate of complications and/or repeat procedures, operating room and staff time, follow-up visits, device failures, and repairs. Less common inputs which are essential for certain stakeholders such as practice owners, include consignment or lending fees, contracting efficiencies, re-order rates, value-added services, and risk of legal consequences. These models typically consider multiple perspectives within one structure but can often follow a traditional cost-offset BIM design with a mix of current and future product utilization and overall budget impact. Return on investment is an important result that should be considered with upfront investment of capital equipment. Furthermore, substantial gaps in the literature often necessitate estimation of resource use from clinician opinion, surveys, or Delphi panels.

CONCLUSIONS: This research illustrates the need for flexible model design considerations that incorporate less traditional parameters and results for various device types that require costing perspectives outside of traditional payers.