OBJECTIVES: To assess the budget impact of introducing adalimumab biosimilars across the Italian health system for all licensed adult adalimumab indications.

METHODS: A budget-impact model was used to estimate the cost saving potential of introducing adalimumab biosimilars in Italy over a three-year time horizon from a payer’s perspective. Current adalimumab treated population has been estimated through IMS sales data and the population was assumed to remain constant during the 3-year horizon timeframe.

Biosimilar adoption in Q4 year 1 was modelled to be 5%, rising to 40% in year 2 with a final market share of 70% in year 3 with expected discounting of approximately 50% initially with a subsequent price erosion of 47% and 33% in years 2 and 3 from the previous year. A 33% price reduction of the originator molecule was assumed in year 3. Prices of adalimumab products were obtained from published sources.

RESULTS: The introduction of an adalimumab biosimilar in the biologic treatment setting resulted in a projected total budget-saving of €324m nationally over the three-year horizon through biosimilar prescribing and price reduction of the reference adalimumab biologic during this period.

CONCLUSIONS: As anti-TNFs are the most commonly used biologics in rheumatologic, gastroenterology and dermatologic immune diseases across Italy, the introduction of adalimumab biosimilars represents a significant cost-saving opportunity. Competitive market pricing could lead to potential savings being greater than modelled. Collaborative agreements at a regional level between payers and prescribers can support biosimilar adoption generating savings while achieving better access for patients. Savings generated could be used to treat additional patients within the same therapeutic areas, meet funding requirement for new high cost therapies within high mortality risk disease areas and/or potentially support additional funding for enhanced clinical resources.