Cormac Devlin (Dún Laoghaire, Fianna Fail)
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639. To ask the Minister for Health if he is aware of the difficulties women are facing when trying to access vital medicines for hyperemesis gravidarum; if he will provide an update on the efforts that are being made to resolve the situation; and if he will make a statement on the matter. [22611/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for medicine reimbursement decisions under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

Dedicated funding of €1.3m was provided in Budget 2023 to provide reimbursement support for Cariban® (doxylamine/pyridoxine), for women suffering hyperemesis gravidarum, a severe form of nausea during pregnancy.

Cariban® is not licensed in Ireland. It is classed as an Exempt Medicinal Product and cannot be added to the formal reimbursement list.

There are three other products containing doxylamine/pyridoxine which are licensed in Ireland. These are Xonvea®, Exeltis® and Navalem®. However, the respective market authorisation holders have not progressed with a pricing and reimbursement application to the HSE under the 2013 Act.

Following a review of the available evidence, the HSE considered the potential for a time-limited, quantity-dependent reimbursement arrangement for women with hyperemesis gravidarum, to access Cariban®, when prescribed by a consultant obstetrician and in line with clear clinical criteria, as set out by the HSE.

The HSE, therefore, put in place an exceptional arrangement which requires that the initial prescriber of Cariban® must be a consultant. The HSE will thereafter accept GP prescriptions for approved patients.

Prior to finalising this exceptional arrangement, the HSE engaged with the National Women and Infants Health Programme and the Programme was in agreement that the burden of the application process was tolerable and that the peer clinical community would welcome any opportunity to progress this matter for women in their care.

Cariban® has been available under this arrangement since the beginning of the year. As of 9^thMay 2023, 1,190 women have been approved for the product.

However, on the recognition that women suffering hyperemesis gravidarum may need access to Cariban® before their first consultation with their specialist/obstetrician, and in light of the fact that GPs prescribe Cariban® to private patients without an initial prescription from a specialist, I asked the HSE to review the current arrangement and report back to me.

The HSE have confirmed that the review it has undertaken will involve an analysis of current arrangements and of the access to Cariban® provided to patients since January 2023. The review will also include engagement with clinical leads, the HSE Primary Care Reimbursement Service and relevant advocates. To enable meaningful analysis, the HSE advise that several months of data will be required to complete the review. It is envisaged that this review will be completed by July 2023.

In the meantime, the HSE encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Programme for Obstetrics and Gynaecology, other healthcare professionals, and relevant representative bodies 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.