Alirocumab in the management of primary hypercholesterolaemia or mixed dyslipidaemia: A budget impact analysis - Italian perspective

Recent evidence suggests that adding protein convertase subtilisin/kexin type 9 inhibitors to current lipid-lowering therapies may result in unprecedented reductions in low-density lipoprotein cholesterol. The objective of this study was to assess the potential pharmaceutical financial impact of including the protein convertase subtilisin/kexin type 9 inhibitor, alirocumab, in the Italian National Health Service budget. The budget impact of adding alirocumab as a lipid-lowering therapy treatment option was assessed among the population defined by the AIFA reimbursement criteria. Data from the IMS/CEGEDIM national electronic database were used to estimate the size of the potentially eligible population. Drug costs were estimated according to dosing schedule and published prices. Alirocumab annual uptake was assumed at 7%, 9% and 10% for years 1, 2 and 3, respectively, considering a 20% treatment drop-out rate. Sensitivity analyses tested the impact of model inputs on the results. The annual estimated incremental cost of alirocumab treatment was (sic)5106/patient. Treating an eligible population of 843 patients with alirocumab in the first year resulted in a total National Health Service budget impact of (sic)4.30 million. Assuming growth of the alirocumab-treated population of 2105 and 2819 patients in the second and third years, the budgetary impact would be (sic)10.75 and (sic)14.10 million, respectively. Sensitivity analysis suggested that financial impact is most sensitive to the uptake of alirocumab in the population. The uptake of alirocumab results in an overall modest budgetary impact to the Italian National Health Service when added to conventional lipid-lowering therapies in a carefully selected population compared to the total lipid-lowering therapy pharmaceutical expenditure in Italy ((sic)1 billion).