Holly Cairns (Cork South West, Social Democrats)
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468. To ask the Minister for Health if he will ensure that a medication for hyperemesis (details supplied) is made available through the drugs payment scheme with a prescription from a GP. [6184/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023. This included dedicated funding for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of morning sickness, during pregnancy.

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. Only licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.

Cariban® is an Exempt Medicinal Product, i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.

However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, Cariban® has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.

The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.

Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated.

However, whilst the original prescriber of Cariban® must be a Consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.

Finally, reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS).