OBJECTIVES: The purpose of this study was to estimate the potential budget impact of the introduction and uptake of generics of Ambrisentan and Tadalafil for the treatment of Pulmonary Arterial Hypertension (PAH) in Greece.

METHODS: A Budget Impact Model (BIM) was developed over a 5-year time horizon. Epidemiological data, clinical inputs and disease management information were obtained from published literature plus expert opinion. Cost parameters included medication costs, patient monitoring, inpatient costs, outpatient visits and adverse events and derived from official pricing and reimbursement lists. Outcomes of the analysis reflected total costs over the study horizon, under two scenarios: “world with” and “world without” the generics of Ambrisentan and Tadalafil. Regarding market shares, the penetration of generics Ambrisentan and Tadalafil was illustrated by a forecasted annual increase against originators. A third-party payer perspective was employed.

RESULTS: Total 5-year costs were estimated at EUR 70,708,971 with the inclusion of generics Ambrisentan and Tadalafil in the PAH therapy mix and EUR 72,991,812 otherwise, representing an 3.13% decrease. Total savings exceed EUR 2.0 million and reach a maximum of EUR 760,947 for the 5th year, with average savings of EUR 6,199 per patient (1,240 annually). At an assumed budget of EUR 2 million, opting for generic Ambrisentan or Tadalafil allows 58 (166 vs 108) and 231 (661 vs 430) respectively, more patients to receive treatment, at an annual basis.

CONCLUSIONS: The introduction and uptake of generic versions for Ambrisentan and Tadalafil in the treatment setting of PAH could result in significant budget savings for the Greek healthcare system, demonstrating the importance of optimal resource allocation in a rare disease.