Background and importance Hyperlipidaemia is the main risk factor for the early manifestations of atherosclerosis and related complications. In recent years, new monoclonal antibodies have become available in clinical practice (evolocumab and alirocumab), termed PCSK9 inhibitors (PCSK9i). Web based monitoring register was used to monitor the access to therapy.
Aim and objectives The objectives of the study were to determine the direct healthcare costs in the 3 year period 2017–2019, as well as the incidence of adverse events reported by clinicians related to PCSK-9i therapy at the regional level.
Material and methods A retrospective study was conducted. Real data (prescription, dispensed units) were derived from informatics administrative databases. Expenditure incurred for the purchase of pharmacological therapies was instead calculated considering the ex factory price net of the SSN discounts. Adverse reactions (ADRs) were extrapolated from the National Pharmacovigilance Network (RNF) and evaluated using Naranjo’s algorithm.
Results In 2017, the first year PCSK9i became available, 96 patients were treated (78.5% evolocumab; 21.5% alirocumab) for a total of 587 units dispensed, and expenses were 141 396.34€. In the period under study, there was a growing trend in units dispensed. In 2018, an increase of +429% was seen compared with 2017, probably due to the conclusion of some clinical trials. Evolocumab was preferred to alirocumab (delta 2018–2019=+163.70%). In particular, one of the five local health authorities appeared to have dispensed 46.81% of the total units. Only three ADRs occurred in regional patients. Patients (men:women=2:1), with a mean age of 64.33±15.27 years, had been in treatment for 45 days. 75% of ADRs were attributable to evolocumab. Naranjo’s algorithm revealed that 25% of ADRs related to evolocumab were classified as possible and 75% as likely (distributed equally between the two active ingredients).
Conclusion and relevance Although the analysis showed an increase in the use of evolocumab, the incidence of use remained too low compared with potential patients eligible for treatment (n=637).1 The clinical pharmacist, because of his knowledge and skills, is able to take up the challenge that the new paradigm of real world data is posing and generating ‘real data for real tests’.
References and/or acknowledgements
Nicholls SJ. doi:https://doi.org/10.1007/s11886-019-1103-2.
Conflict of interest No conflict of interest