Presentation (CTI)

OBJECTIVES: Selecting the right pricing model, particularly for products with weight-based dosing or multiple stock-keeping units (SKUs), is a common challenge for manufacturers seeking to balance patient access, commercial viability, and payer expectations. This research explores the factors influencing the choice between linear pricing (price increases with dose), flat pricing (identical price for different doses), and hybrid linear-flat models.
METHODS: We identified four orphan drugs authorised by the European Medicines Agency within the past five years with weight-based dosing or multiple SKUs, covering both adult and paediatric indications. For each analogue, we analysed the pricing model applied, Health Technology Assessment (HTA) outcomes, launch prices, and reimbursement restrictions in France, Germany, Italy, and Spain. Findings from secondary research were validated through interviews with fourteen payers across these markets. Insights were synthesised to identify key factors guiding pricing model selection.
RESULTS: The four analogues showed notable variation across markets in SKU availability, launch pricing, HTA outcomes, and reimbursement restrictions, reflecting distinct local dynamics. Payers reported greater familiarity with linear pricing, though it demands complex modelling of weight distributions, complicating budget forecasts. Flat pricing is operationally simpler and more predictable for budgeting but may result in overpayment for lower-dose patients. Hybrid models were viewed as operationally burdensome due to multiple contracting requirements. Budget impact uncertainty was a consistent concern across all models. Payers recommended collaboration with local registries to generate real-world data on patient numbers, weights, and dosing as a key mitigation.
CONCLUSIONS: No single pricing model fits all contexts. In selecting the appropriate pricing model, manufacturers should consider factors including operational complexity, payer needs, local precedents, dose variability, and revenue implications. Pricing strategies that reflect both market realities and product value will enable manufacturers to balance clinical, commercial, and access goals.