The costs incurred by patients to get eligibility to PCSK9 treatment and one-year follow-up: the results of the PRIOR Study
Keywords:Clinical pathway, Costs, Eligibility, Follow-up, Organisational impact, PCSK9
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-inhibitor 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.
AIFA. (CTS) – Ordine del Giorno 47 della Riunione Straordinaria del 24 maggio 2021 (Accessed April 22, 2022) https://www.aifa.gov.it/documents/20142/1508177/OdG_generale_CTS_straordinaria_del_24_maggio_2021.pdf.
Cortese B, Di Palma G, Lettieri C, Musumeci G. Inibitori di PCSK9: il difficile connubio fra evidenze scientifiche e limitazioni regolatorie. G Ital Cardiol (Rome). 2018;19(2):77-80. PMID:29531379
Jommi C, Cavazza M. Management of patients eligible to PCSK-9 Inhibitors: economic impact and reform proposals. Glob Reg Health Technol Assess. 2019;6:1-12. https://doi.org/10.33393/grhta.2019.460 DOI: https://doi.org/10.1177/2284240319861375
Kaufman TM, Warden BA, Minnier J, et al. Application of PCSK9 Inhibitors in Practice. Circ Res. 2019;124(1):32-37. https://doi.org/10.1161/CIRCRESAHA.118.314191 PMID:30605414 DOI: https://doi.org/10.1161/CIRCRESAHA.118.314191
Bagepally BS, Sasidharan A. Incremental net benefit of lipid-lowering therapy with PCSK9 inhibitors: a systematic review and meta-analysis of cost-utility studies. Eur J Clin Pharmacol. 2022;78(3):351-363. https://doi.org/10.1007/s00228-021-03242-6 PMID:34708270 DOI: https://doi.org/10.1007/s00228-021-03242-6
Lohr S. Sampling: Design and Analysis. 2nd ed. Brooks/Cole; 2010.
Banca d’Italia. Indagine sui bilanci delle famiglie italiane nell’anno 2016 (Accessed March 03, 2022) (https://www.bancaditalia.it/pubblicazioni/indagine-famiglie/bil-fam2016/index.html).
ISTAT – Prezzi al consumo 2020 (Accessed March 03, 2022) (https://www.istat.it/it/archivio/252604).
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