The first year of generic NOACs: implications for patients and the healthcare system

Abstract Introduction Non-vitamin K antagonist oral anticoagulants (NOACs) have become standard of care in the management of non-valvular atrial fibrillation (NVAF). Generic versions of NOACs were introduced in Portugal in September 2023 for apixaban, followed by dabigatran in January 2024 and rivaroxaban later in April 2024. Our study describes the adoption of generic NOAC versions and the economic impact on patient and healthcare spending. Methods We reviewed data from the public database on medications commercialized and their associated expenses in Portugal. We analyzed the number of NOAC pills sold - branded and generic - and their costs to patients (out of pocket) and the national healthcare system (co-payment) between July 2023 and June 2024. We have divided the study period in trimesters where appropriate. Results In the study period, €142 million (M) NOAC pills – branded and generic - were sold in Portugal corresponding to a total expense of €167.4M. The total out of the pocket expense – patient’s costs – was €51.9M and the total co-payment was €115.5M. Among NOACs – branded and generic - sold during the study period, apixaban accounted for 53.2%, rivaroxaban 23.5%, edoxaban 13.2% and dabigatran 10.2%. Generics corresponded to 33.2% of all NOACs sold. There was a strong trend towards the adoption of generic NOACs representing 0.1% in the first trimester, 26.5% in second trimester, 45.9% in third trimester and 59.3% in the last trimester. By the last trimester, 84.0% of apixaban pills sold were generics. A similar pattern was seen with dabigatran and rivaroxaban. Despite being introduced later, generic versions of dabigatran and rivaroxaban accounted for 68.3% and 33.9% respectively (Figure 1). In 2023, the national healthcare system allocated €1 593.8M to medications, with patients contributing €859.8M. Anticoagulants ranked as the second-highest drug class in terms of total costs, with apixaban and rivaroxaban being the second and third active substances associated with the highest expenses, respectively. In the first trimester of the study period, expenses for NOACs amounted to €13.7M for patients and €30.5M for public healthcare co-payment. By the final trimester, patient costs had decreased to €12.1M and public healthcare co-payment to €27.0M, reflecting reductions of 11.7% and 11.4%, respectively. Conclusion Generic have been widely adopted by patients in Portugal leading to a significant decrease in costs for patients and the public healthcare system. Economic factors and previous experience with generic drugs likely influenced patient choice.