ECONOMIC IMPACT OF ALIROCUMAB IN THE MANAGEMENT OF PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA- AN ITALIAN PERSPECTIVE
Author(s)
Marocco A1, Stanisic S1, Fanelli F2, Damele F2, Colivicchi F3
1Analytica Laser, Milan, Italy, 2Sanofi, Milano, Italy, 3Azienda Complesso Ospedaliero “S. Filippo Neri”, Rome, Italy
OBJECTIVES: Current evidence suggests that adding proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitors to current lipid lowering therapies (LLTs) may favor achievement of unprecedented reductions in LDL-Cholesterol (LDL-C). This study assessed potential budgetary impact of PCSK9 inhibitor alirocumab in the context of the Italian National Health Service (INHS). METHODS: The addition of alirocumab to LLTs was assessed in a population strictly defined as per AIFA prescribing criteria. Data from the national electronic medical report Cegedim was used to estimate the size of the potentially eligible Italian population (i.e. patients not reaching predefined LDL-C levels despite treatment with high-potency statins and ezetimibe or who are statin-intolerant). Alirocumab annual uptake of 15%, 19% and 20% was assumed for year 1, 2 and 3, respectively, considering a treatment drop-out rate of 20%. Calculations were made on full year treated (FYT) patients. Drug unit costs were applied in line with dosing schedule and published prices. Sensitivity analyses were conducted, altering annual therapy uptake (±20%), treatment drop-out rate (±10%) and drug price (-5%,-10%). RESULTS: This analysis suggests that 1,887 FYT patients could be treated with alirocumab in the first year, with a respective yearly impact of € 9.66mil on the INHS. Estimated annual cost of treatment per patient is €5,118. Alirocumab treated population is estimated to increase to 4,863 and 6,287 FYT patients in Year 2 and Year 3, respectively with a consequent budgetary impact of €24.72mil and €31.96mil. Sensitivity analysis suggested that treatment uptake variation has the highest financial impact with potential variation in range of €7.73mill to €11.59mill in the first year after treatment introduction. CONCLUSIONS: Alirocumab, used as an add-on to statin therapy and ezetimibe showed a moderate budgetary impact on INHS. An update of this analysis is anticipated once the results of the ODYSSEY OUTCOMES cardiovascular outcomes trial become available.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PCV35
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
Cardiovascular Disorders