Dáil Éireann Debate, Tuesday - 14 February 2023
641. Deputy Jackie Cahill asked the Minister for Health if he is aware that pregnant people affected by hyperemesis gravidarum are currently forced to present at emergency departments in order to obtain consultant prescriptions for Cariban; if his Department has identified the unnecessary delays and additional cost burden this has caused in emergency departments; and if he will make a statement on the matter. [6722/23]
Amharc ar fhreagraAs part of Budget 2023, I announced €32.2 million in funding for Women’s Health Initiatives in 2023, to include dedicated funding for Cariban® (doxylamine/pyridoxine). The dedicated funding for Cariban® will help women who experience hyperemesis gravidarum, aa severe form of nausea and vomiting, during pregnancy. Hyperemesis gravidarum is expected to affect about 1% of the pregnant population.
The Health Service Executive (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. Only licenced indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA) can be added to the formal reimbursement list.
Cariban® is an Exempt Medicinal Product (EMP), i.e., it is not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.
Following the recommendations of the HSE Medicines Management Programme, Cariban® is now available on an individual patient basis for those patients who meet the criteria under the community drug schemes – the General Medical Services scheme (GMS) and the Drugs Payment Scheme (DPS) – where Consultant Obstetrician initiated.
Under the community drug schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber of Cariban® must be a consultant and specialist in the relevant field, the HSE will accept a GP prescription subsequent to the initial hospital prescription for approved patients.
This exceptional arrangement has been put in place since 1st of January 2023 to ensure that those patients suffering from hyperemesis gravidarum have access to Cariban®. The dedicated funding that has been allocated is based on 1% of the pregnant population requiring treatment for hyperemesis gravidarum. The number of approved applications to date is in line with expectations and indicates that the budget allocated will be used in 2023. Any potential additional costs arising from patients presenting at emergency departments to access this arrangement were not included in the estimates.
