OBJECTIVES: The proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) alirocumab and evolocumab are reimbursed in Ireland for specified sub-populations of the licensed population, due to concerns regarding their cost-effectiveness and budget impact:

(1) adults with established atherosclerotic cardiovascular disease with a low-density lipoprotein (LDL)-C persistently ≥ 3.5 mmol/L (i.e. secondary prevention cohort), and

(2) adults with a confirmed diagnosis of heterozygous familial hypercholesterolaemia with a LDL-C persistently ≥ 4 mmol/L (i.e. primary prevention cohort).

Reimbursement is subject to a Managed Access Protocol (MAP), introduced on 1^st July 2019, which outlines the eligibility criteria that must be satisfied for reimbursement support. This study provides a summary of applications under the MAP and describes the utilization of PCSK9i.

METHODS: All reimbursement applications for PCSK9i submitted to the HSE-Medicines Management Program (MMP) between 1 July 2019 and 30 April 2024 were reviewed. Data was extracted from the HSE-Primary Care Reimbursement Services (HSE-PCRS) national pharmacy claims database, from 1 July 2019 to 30 April 2024. Analysis was performed using R Studio.

RESULTS: A total of 447 reimbursement applications were submitted in the study timeframe. Reimbursement was approved for 66% (n= 295) of applications submitted, of which 116 (39%) were for secondary prevention and 178 (60%) were for primary prevention. The mean age of applicants was 59.9 years.

Two hundred and eighty-eight approved patients accessed treatment with a PCSK9i during the study timeframe; the majority were male (n= 157, 54.5%).

In April 2024, 229 patients accessed a PCSK9i under the MAP.

Evolocumab (Repatha®) has the largest market share (91%, n=209).

CONCLUSIONS: When used in conjunction with health technology assessment, MAPs, an example of health technology management, enable access to new drug treatments for patients likely to derive most clinical benefit, while providing budgetary oversight and certainty for the payer.