Dáil Éireann Debate, Tuesday - 14 February 2023
540. Deputy Pádraig O'Sullivan asked the Minister for Health if he will clarify the cost of cariban; the reason only consultant prescriptions for cariban are reimbursable; if reimbursement can also be given if prescribed by someone’s GP; and if he will make a statement on the matter. [6490/23]
Amharc ar fhreagraAs 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 nausea and vomiting, 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 licensed 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 HSE's formal reimbursement list. Therefore, there is currently no formal pricing agreement in place for Cariban®.
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.
The HSE circular sets a reimbursement price for a pack of 24 Cariban 10mg/10mg modified release hard capsules at €34.90.
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).
