I propose to take Questions Nos. 633 and 680 together.
As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.
This included dedicated funding of €1.3m for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea during pregnancy, which 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 not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
However, following the recommendations of the HSE Medicines Management Programme, reimbursement support for Cariban® was made available from 1st January 2023 under an exceptional arrangement for specific patients who meet the criteria and where Consultant Obstetrician initiated. However, women would only need to see a consultant in order to be initiated on the product, and thereafter it can be prescribed by their GP.
The relevant HSE circular regarding this arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
This exceptional arrangement has been put in place to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. As of 15th February 2023, 444 women have been approved for the product.
While 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), Cariban® is unlicensed and is not on the formal reimbursement list.
There are three other products containing doxylamine/pyridoxine which are licensed in Ireland (Xonvea®, Exeltis® and Navalem®), but the respective market authorisation holders have not progressed with a pricing and reimbursement application to the HSE under the 2013 Act.
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 these licensed medicinal products to progress with the formal pricing and reimbursement process in Ireland.
Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at:
www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/.
