• Women who suffer with Nausea and Vomiting in Pregnancy (NVP) can now access the medicine doxylamine/pyridoxine through the Drugs Payment Scheme or Medical Card
• NVP can affect up to 80% of expectant mothers but managing it adequately in its early stages can decrease the risk of it becoming severe and patients requiring hospitalisation
• GPs can now write the initial prescription, with reimbursement available through the drug scheme

CRAIGAVON, NORTHERN IRELAND – 26/07/2024 Galen Ltd announced that from August 1^st 2024 expectant mothers in Ireland can access fully reimbursed doxylamine/pyridoxine, a medication used to alleviate the symptoms of NVP.

Around 70-80% of pregnant women experience nausea, with about 50% also suffering from vomiting¹.

Moderate to severe NVP can severely impact the patient and may also lead to hospital admission for rehydration and treatment². Evidence suggests that recognising and managing NVP early may prevent a more severe form from developing which can negatively impact women’s health and quality of life during pregnancy³.

The arrival of the first, fully reimbursed supply of the product in Ireland should mean that women can more easily access the treatment. In 2023, the Irish government allocated €1 million to facilitate the reimbursement of doxylamine/pyridoxine, ensuring free-of-charge access for women, however, to qualify for the scheme, patients needed to have received their initial prescription from a consultant obstetrician. This proved difficult as most women in early stages of pregnancy would not be registered with an obstetrician, prompting calls from Hyperemesis Ireland, which represents women experiencing a severe form of NVP, hyperemesis gravidarum, to call for simpler and quicker access to the medicine.

Expectant mothers who are not registered with an obstetrician have historically had to pay privately, costing them more than €150 a month for this medication. The total cost throughout pregnancy can reach up to €3,000, greatly impeding women's access to crucial healthcare services.

Emma Fauteux from County Cork said: “I experienced severe nausea and vomiting during my first pregnancy. I was vomiting up to 10 times per day and working a full-time job. I was sick until late into my third trimester and also suffered the same symptoms early during my second pregnancy. I am now pregnant with a third child and am delighted that this medication will now be more accessible to women in Ireland.”

Dr Dennise Broderick, Managing Director and President of Galen said: “At Galen, our purpose is to be of extraordinary service to our patients and healthcare professionals. We are thrilled to be the new exclusive provider of this medicine for pregnant women in Ireland suffering from NVP. We are delighted that it is now available by prescription from General Practitioners as well as secondary care specialists. Moreover, it is fully reimbursed under the drugs payment scheme. This is a significant step forward, which will enhance the accessibility of effective treatment for the symptoms of NVP."

Dr Sarah Short, GP from Portmarnock Family Practice said: “It's fantastic that general practitioners can now prescribe this medication, which has been a trusted option for obstetricians for many years. GPs have an effective option to offer their pregnant patients experiencing nausea and vomiting. The recent steps towards reimbursement are a significant advancement, ensuring more women have access to this important medication, improving their quality of life during pregnancy.”

-ENDS- 

References:

1. BMC Pregnancy and Childbirth. The burden of nausea and vomiting during pregnancy: severe impacts on quality of life, daily life functioning and willingness to become pregnant again – results from a cross-sectional study. Available at: https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-017-1249-0#:~:text=Most%20pregnant%20women%20experience%20pregnancy,%25%20%5B1%E2%80%933%5D. [Accessed: July 2024]
2. NICE guideline NG201. Management of nausea and vomiting in pregnancy. August 2021.
3. Campbell K, Rowe H, Azzam H, Lane CA. The Management of Nausea and Vomiting of Pregnancy. J Obstet Gynaecol Can. 2016;38(12):1127-37.
4. Hyperemesis and Nausea/Vomiting In Pregnancy Guidelines. Institute of Obstetricians and Gynaecologists, Royal College of Physicians of Ireland and the Clinical Strategy and Programmes Division, Health Service Executive. 2018
5. Cariban, ROI Summary of Product Characteristics (SPC) August 2023.
6. Saz-Leal, P., Zamorano-Domínguez, L., Frías, J. et al. Bioavailability of Cariban® Capsules: A Modified-Release Fixed-Dose Combination of Doxylamine and Pyridoxine to Relieve Nausea and Vomiting During Pregnancy.Drugs R D 23, 185–195 (2023). https://doi.org/10.1007/s40268-023-00425-7

MAT-GAL-UKI-000230. Date of preparation: July 2024