Holly Cairns
Question:1938. Deputy Holly Cairns asked the Minister for Health his views on making a medication (details supplied) for hyperemesis gravidarum to be reimbursed on the drugs payment scheme and medical card. [43800/22]
View answerThursday, 8 September 2022
Questions (1938)
Written answers
The 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 Goods) Act 2013.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed. Only licensed products are added to the formal GMS Reimbursement List in line with the Health (Pricing and Supply of Medical Goods) Act 2013. It is a matter for the Marketing Authorisation Holder to apply for licensing in Ireland through the Health Products Regulatory Authority (HPRA).
The HPRA have advised that Cariban is currently not licensed for use in Ireland. There are three similar products, Xonvea (doxylamine 10 mg and pyridoxine 10 mg), Navalem (doxylamine 10 mg and pyridoxine 10 mg) and Doxylamine/Pyridoxine Exeltis 10 mg/10 mg gastro-resistant tablets (doxylamine 10 mg and pyridoxine 10 mg) that are licensed for use in Ireland. However, the companies holding the authorisations/licences have not marketed the products in Ireland to date, and the HPRA cannot compel a company to market a medicinal product.
The HSE asked the Medicines Management Programme to examine the appropriateness and feasibility of a patient specific arrangement for the product. The HSE Medicines Management Programme assessment for Cariban has now been completed and its recommendation is under deliberation with the HSE at present.