Steven Matthews (Wicklow, Green Party)
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263. To ask the Minister for Health if his attention has been drawn to the concerns of Hyperemesis Ireland regarding the current reimbursement policy in respect of medication to treat this condition; if he proposes to meet the group to discuss its concerns; and if he will make a statement on the matter. [6253/23]

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. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.

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 Good s) 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 (EMP), 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 those patients with hyperemesis gravidarum, reimbursement support for 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. 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). This arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®.

There are three other products containing doxylamine/pyridoxine, which are licensed in Ireland:

- Xonvea® gastro-resistant tablets.

- Navalem® modified-release hard capsules.

- Exeltis® gastro-resistant tablets.

The market authorisation holder of Xonvea® has not progressed the pricing and reimbursement application further with the HSE at this stage. The market authorisation holders for Exeltis® and Navalem® have not submitted pricing and reimbursement applications to the HSE.

The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, and other healthcare professionals to encourage the market authorisation holders of the licensed medicinal products (Xonvea®, Exeltis® and Navalem®) to progress with the formal pricing and reimbursement process in Ireland.