OBJECTIVES

: Prioritization of investments, equity and ethical decisions made in healthcare are of great importance for societies and governments. Forecasting future changes in drug budgets using the ART model may assist in budget prediction and planning. Many countries have policies mandating price changes of products post loss of exclusivities (LOEs) and allowing generics or biosimilars to enter the market. The ART model provides a structured analytical framework for estimating future budget headroom resulting from LOEs of drugs, highlighting areas where funds could be available to enable investment in innovation.

METHODS

: The ART model utilizes IQVIA data to inform sales values and LOE dates of pharmaceuticals. The estimations consider assumed percentage market penetration of generic/biosimilar and market expansion, mandated or expected shifts in prices for branded products and generics/biosimilars for a time period of 3 years post product LOE. Scenario analysis in Sweden, Greece, Norway and the Netherlands were conducted. The ART model does not consider introduction of new treatments.

RESULTS

: During 2020- 2022, 93, 145, 222 and 166 LOE products were identified in Sweden, Norway, the Netherlands and Greece respectively. The cumulative budget headroom during Jan 2020- Dec 2024 was estimated to 755 m € (SW), 214 m € (GR), 269 m € (NOR) and 1106 m € (NL). The average budget headroom per year during 2020 –2024 is estimated to 3,6%, 1,6%, 2,9% and 3,8% of the total annual drug budget in Sweden (4251 m €), Greece (2652 m €), Norway (1850 m €) and the Netherlands (5700 m €) respectively.

CONCLUSIONS

: The ART model analysis may support planning and preparing for introduction of value-adding innovative treatments promoting increased overall health and well-being. Budget predictability is essential for decision makers in healthcare. Estimations of future budget headroom adds to the discussion on resource allocation to fund innovation and may supports policy changes.