Niall Collins (Limerick County, Fianna Fail) | Oireachtas source

I am here on behalf of the Minister for Health. I thank Senators Seery Kearney and Ahearn for raising this matter and appreciate that it will be a concern for many women in Ireland.

Hyperemesis gravidarum is a severe form of nausea and vomiting during pregnancy that affects some women and that must be diagnosed and treated appropriately. The Government is keen to ensure that anyone experiencing this condition receives the support they need. As part of budget 2023, the Minister for Health announced €32.2 million in funding for women's health this year. That includes dedicated funding for Cariban, a medicine used to treat hyperemesis gravidarum. As of January, 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 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. There are three medicines containing doxylamine or pyridoxine that are licensed in Ireland.These are listed in the reply. Two of them are gastro-resistant tablets and one is modified-release hard capsules. To date, the market authorisation holder of Xonvea has not progressed the pricing and reimbursement application further with the HSE. The market authorisation holders for Exeltis and Navalem have not submitted pricing and reimbursement applications to the HSE. Therefore, to address the unmet needs of patients with hyperemesis gravidarum, the HSE's medicines management programme was asked to review the evidence available on the unlicensed exempt medicinal product Cariban, and to make a recommendation on the appropriateness and feasibility of an exceptional patient-specific process for access to the product.

Following the recommendations of the medicines management programme, an exceptional arrangement has been put in place to support the reimbursement of Cariban. Cariban is now available under the community drug schemes on an individual patient basis for the treatment of nausea and vomiting during pregnancy where consultant obstetrician-initiated. While the initial prescription for Cariban must be issued by a consultant, further prescriptions can be issued by the patient's GP. Consultant initiation is the case for all unlicensed exempt medicinal products under the community drugs schemes. The HSE advise that where a drug is not licensed, the expertise of a specialist in the relevant field is necessary to ensure safe usage. However, if a licensed product was approved for reimbursement this arrangement could then be reviewed or revised. 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 available licensed medicinal products to progress with the formal pricing and reimbursement process in Ireland.