Peter Burke (Longford-Westmeath, Fine Gael) | Oireachtas source

I thank the Deputy for raising this very important issue. Again, I must give apologies for the Minister for Health, who obviously would be more aware of this topic and the review at the moment.

Hyperemesis gravidarum is a severe form of nausea and vomiting during pregnancy, which the Deputy articulated very well. It affects approximately 1% of the pregnant population and must be diagnosed and treated appropriately. The Government is keen to ensure that anyone encountering this condition receives the support they need.

As part of budget 2023, the Minister announced €32.2 million in funding for women’s health in 2023. This included general dedicated funding for Cariban, a medicine used to treat hyperemesis gravidarum. As of January 2023, this medicine is now available to those women who need it. Unfortunately, reaching this point has not been straightforward. Under the Health (Pricing and Supply of Medical Goods) Act 2013, only medicines that are licensed and have marketing authorisation from the European Medicines Agency or the Health Products Regulatory Authority can be added to the HSE’s formal reimbursement list. Cariban is not licensed and, therefore, cannot be added to the reimbursement list. It is instead classed as an exempt medicinal product.

Three medicines containing doxylamine pyridoxine are licensed in Ireland: Xonvea, Exeltis and Navalem. The respective market authorisation holders of these three products have not, however, 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, 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.

Following the recommendations of the HSE medicines management programme, reimbursement support for Cariban to women suffering with hyperemesis gravidarum was made available from 1 January 2023 under an exceptional arrangement. The exceptional arrangement requires that treatment be consultant initiated, which is a long-standing governance practice in respect of exempt medicinal products. 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. This exceptional arrangement has been put in place to ensure that women suffering from hyperemesis gravidarum have access to Cariban.

As of 27 March 2023, 847 applications for Cariban had been received and 825 women had been approved for the product. As the Minister recognises that women suffering from hyperemesis gravidarum may need access to Cariban before their first scheduled consultation with their specialist obstetrician, and in light of the fact that GPs prescribe it for private patients without an initial prescription from a specialist, the Minister has asked that the HSE review the current arrangement and report back to him.

I will raise the Deputy's issue about the timing of the review. She said that she had raised it with the Minster prior to this. I will ask him to also revert to her urgently with an update on the review. I do not have that information to hand.

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