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1ISG-007 PCSK9 inhibitor prescriptions not meeting reimbursement criteria: a retrospective study

ejhpharm · 2026-03-18 · canonical JSON source

16 visible annotations · policy: published · automated confidence ≥ 75.00%

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Background and Importance Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9 inhibitors), including evolocumab, alirocumab, and inclisiran, are potent lipid-lowering agents indicated for patients at high cardiovascular risk. Clinical guidelines recommend achieving LDL-C levels below 55 mg/dL in very high risk populations. However, reimbursement in our national health service is restricted to patients with heterozygous familial hypercholesterolaemia (HeFH) or established cardiovascular disease (ischaemic heart disease, ischaemic cerebrovascular disease, or peripheral arterial disease) who are not adequately controlled (LDL-C >100 mg/dL) despite receiving maximum tolerated statin therapy (atorvastatin 80 mg or rosuvastatin 40 mg), or who are intolerant to at least two different statins.Aim and Objectives To evaluate the rate of PCSK9 inhibitor prescriptions not meeting reimbursement criteria and identify the main reasons for non-initiation treatment in a tertiary care hospital during 2024.Material and Methods A retrospective review was conducted of all PCSK9 inhibitor prescriptions submitted via the electronic prescription and dispensing system during 2024. Medical records were reviewed to collect data on lipid profiles, statin adherence, and prior prescription history. Particular attention was given to verifying high-intensity statin use and documented statin intolerance. Reasons for non-initiation were categorised as absence of high-intensity statin therapy, poor adherence, LDL-C <100 mg/dL, primary prevention without HeFH and others such as needle phobia.Results A total of 107 prescriptions were reviewed for 97 patients. After further evaluation, 20 prescriptions (18.7%) from 20 patients did not lead to treatment initiation. The mean age of these patients was 59.7 years (range: 40–77), with nine females and 11 males. Ten prescriptions came from cardiology, nine from endocrinology, and one from internal medicine. Eleven of them were for evolocumab, eight for alirocumab, and one for inclisiran. Main reasons for non-approval included absence of high-intensity statin therapy (n=7), poor adherence (n=4), LDL-C <100 mg/dL (n=3), primary prevention without HeFH (n=5) and needle phobia (n=1).Conclusion and Relevance Nearly one-fifth of PCSK9 inhibitor prescriptions did not result in treatment initiation due to non-compliance with reimbursement criteria. This result highlights the misalignment between clinical guidelines and regulatory reimbursement policies, which represents a major challenge. Strengthening interdisciplinary collaboration and enhancing prescriber awareness may facilitate appropriate use of lipid-lowering therapies and improve patient outcomes.Conflict of Interest No conflict of interest