David Cullinane (Waterford, Sinn Fein)
Link to this: Individually | In context | Oireachtas source

519. To ask the Minister for Health if he will reconsider the inclusion of the drug Praluent for reimbursement in the drug payment scheme; if he will provide an update on same; and if he will make a statement on the matter. [44507/22]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The 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 occasion, the HSE, in stretching constrained resources, will make a decision to establish a Managed Access Protocol to identify those who would benefit most when making a decision to support reimbursement on a patient specific basis.

Alirocumab (Praluent) was added to the Reimbursement List with conditions on the 1st April 2021.

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:

1. 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

2. 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: hse.ie/eng/about/who/cspd/ncps/medicines-management/managed-access-protocols/pcsk9-inhibitors/.