Michael McNamara
Question:1669. Deputy Michael McNamara asked the Minister for Health if a person (details supplied) can be facilitated with the PCSK9 inhibitor drug; and if he will make a statement on the matter. [17662/23]
View answerTuesday, 18 April 2023
Questions (1669)
Written answers
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.
Reimbursement of PCSK9 inhibitors, alirocumab (Praluent) and evolocumab (Repatha) is supported under the High Tech Arrangement via a Managed Access Protocol overseen by the HSE-Medicines Management Programme.
Under the Managed Access Protocol for PCSK9 Inhibitors, reimbursement is supported for the following subgroups of the licensed population:
adults with a confirmed diagnosis of myocardial infarction +/- revascularisation procedures, non-haemorrhagic stroke or peripheral arterial disease (i.e. secondary prevention), or who have undergone coronary artery bypass graft, with a LDL-C persistently 3.5 mmol/L
adults with a confirmed diagnosis of heterozygous familial hypercholesterolaemia (HeFH) with a LDL-C persistently 4 mmol/L.
Both (1) and (2) would be despite optimum use of lipid-lowering therapy (atorvastatin/rosuvastatin + ezetimibe) or in the setting of confirmed intolerance to lipid-lowering therapy.
The Managed Access Protocol, which outlines in detail the criteria that must be satisfied in order for a patient to be approved for reimbursement of a PCSK9 inhibitor under the High Tech Arrangement, is available on the website of the HSE-Medicines Management Programme:
www.hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/pcsk9-inhibitors/
The medical decision to prescribe or not prescribe any treatment for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process. In addition, Section 6 of the HSE Governance Act 2013 prohibits the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.