• Cariban is an effective first-line pharmacological treatment indicated for the symptomatic treatment of nausea and vomiting during pregnancy (NVP) in adults who do not respond to conservative management

• GPs can now write the initial prescription, with reimbursement available through the drug scheme

• 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

CRAIGAVON, NORTHERN IRELAND – 25/07/24 Galen Ltd announced today that it is the new, exclusive distributor of fully reimbursed Cariban in Ireland, ensuring reimbursement for women in Ireland suffering from nausea and vomiting in pregnancy as of August 1^st 2024.

This is an important milestone for pregnant women in Ireland, up to 80% of whom can be affected by the condition⁴. 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 Cariban, 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 essential medication. The cumulative burden throughout pregnancy can reach up to €3,000, greatly impeding women’s access to crucial healthcare services.

The Department of Health had also previously stated that the medicine could not be eligible for reimbursement as an Exempt Medicinal Product. Now, Cariban has attained official inclusion in the reimbursement list, allowing patients to access it through the Drugs Payment Scheme or Medical Card, with authorisation for prescription by a General Practitioner. Previously, the only way in which reimbursement was granted, was via completion of a 4-page form via a consultant in the hospital. This process is no longer required and the product can be prescribed via a GP or specialist. Ensuring reimbursement under the drugs payment scheme will result in easier access for patients to the medicine, leading to improved health outcomes for pregnant women suffering from NVP.

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 Cariban for pregnant women in Ireland suffering from NVP. We are delighted that this medicine 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.”

Moderate to severe nausea and vomiting is characterised by intractable vomiting which can be associated with electrolyte abnormalities (causing fatigue and dizziness), acid-based disturbance and weight loss⁴. NVP can impact on the pregnant woman’s physical and mental health, leading to hospital admission for rehydration and treatment⁴.

Evidence suggests that recognising and managing NVP early may prevent a more severe form from developing. Early recognition and management of NVP can reduce the impact on women’s health and quality of life during pregnancy, as well as the financial impact on the health care system⁶.

Dr Sarah Short, GP from Portmarnock Family Practice said: “With Cariban now available for prescription, 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.”

Find out more about Cariban by clicking here.