Analysis of the prescription process of PCSK9 inhibitors in the cardiology departments of Spanish hospitals and optimization proposal. The IKIGAI study.

Aims: To ascertain the formalities and procedures required for the prescription of PCSK9 inhibitors in the cardiology departments of Spanish hospitals, making proposals for improvement to optimize the prescription process.

Methods: A first phase of collecting information about the variables and administrative procedures required for the prescription of PCK9 inhibitors and the elaboration of a specific questionnaire and a second phase of collecting data with an online self-administered questionnaire.

Results: A total of 88 hospitals participated in the study (mean number of beds 625; mean number of cardiologists 18 ± 10; 78% university hospitals). There was underuse of PCSK9 inhibitors (real prescription of 30 treatments/year; potential prescription of 80), mainly because of not fulfilling the therapeutic positioning report (52%) and application refusal (31%). Beyond the requirements of the therapeutic positioning report, 1.2 ± 0.4 applications are required with 8.5 ± 4.2 variables. Only 21% of hospitals did not require a previous authorization process and in the remaining hospitals, approval from a committee was necessary. The accumulated time of the prescription process was 6 weeks. Discontinuation rates during follow-up were 9% ± 12%.

Conclusions: Treatment with PCSK9 inhibitors is clearly underused in Spain. This is mainly due to both inappropriate identification of patients, and complex administrative procedures that could inhibit/discourage prescription by cardiologists and consequently, limit their use. In addition, there is a substantial delay from drug approval tadministration.