The costs incurred by patients to get eligibility to PCSK9 treatment and one-year follow-up: the results of the PRIOR Study

Abstract
Background. Several health care services are required to get eligibility to PCSK9-inhibitors medicines and the follow-up of patients being treated. The ultimate goal is making prescriptions appropriate and monitoring the effects of these drugs. Some recent papers (opinion / consensus documents) highlighted the necessity to make simpler this clinical pathway. Our paper illustrates the cost of this pathway incurred by patients (direct healthcare and non-healthcare costs, productivity losses by patients and their possible care-giver due to the time dedicated to healthcare services). Methods. The study relied on a retrospective data collection through a structured questionnaire administered to 240 patients, being on treatments with PCSK9-inhibiotrd drugs for at least one year. Patients were recruited in 4 Italian healthcare centres from June 2020 to July 2021. Results. Recruited patients are 64 years old on average. 64% of patients are males and 36% are actively employed and working. Mean cost incurred by patients amounts to € 926,1. Direct healthcare costs, direct non-healthcare costs and productivity losses equal to € 463,5 (50%), € 136,7 (15%) and € 325,9 (35%) respectively. Healthcare services fully covered by the National Health Service account for 56% of the total. Co-payments are applied to 26% of healthcare services, whereas patients pay the full price for 18% healthcare services. Discussion. Getting eligibility to PCSK9-inhibitors and managing patients’ follow-up generate important costs incurred by patients. Furthermore, these costs are very different across healthcare centres. We are fully aware that appropriateness of prescriptions and patients’ follow-up are very important. However, simplifying the clinical pathway would bring economic advantages and could make more homogenous the way this pathway is managed by healthcare centres.