Purpose: We analyse the barriers to the prescription of PCSK9i in a public tertiary hospital in Spain.
Methods: In our hospital a multidisciplinary committee reviews all PCSK9i prescriptions. Eligible patients include those with LDL-c>100mg/dl in secondary prevention or with proven familial hypercholesterolemia despite optimal therapy (maximum tolerated statin dose and ezetimibe) or proven statin intolerance. Once accepted, patients are randomly assigned to receive evolocumab or alirocumab which they retrieve from the hospital pharmacy every two months. We reviewed all requests for PCSK9i administration between October 2016 and May 2018.
Results: We recorded demands for PCSK9i prescription in 91 patients during a 20-month period. Baseline characteristics are shown in table 1. Seventy-four PCSK9i solicitudes (81.3%) were accepted and 17 (18.7%) were denied (13 did not meet clinical criteria, 2 had LDL-c<100mg/dl and 2 were not under optimal therapy). Among the accepted patients, 12 (16.2%) did not start or discontinued treatment (4 reached LDL<100 mg/dl without PCSK9i administration, 3 had adverse events, 5 did not wish to start a subcutaneous treatment). Baseline LDL-c levels were 151±55mg/dl. In patients receiving PSCK9i, LDL-c levels after 3-6 months decreased to 64.8±34.8mg/dl, with a mean reduction of 79.6±42.4mg/dl (p<0.001).
Conclusion: Despite the body of evidence supporting the use of PCSK9i, different barriers make it difficult to incorporate this treatment to the therapeutic arsenal. An optimal and responsible selection of patients and a correct follow-up is needed in order to take advantage of these novel therapies.