Dáil Éireann Debate, Thursday - 7 December 2023
326. Deputy Mairéad Farrell asked the Minister for Health how the accessibility to the medication cariban in Ireland differs to the international standard practice; and if he will make a statement on the matter. [54348/23]
View answerThe 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 Good s) Act 2013. Only licensed 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.
However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, reimbursement support for Cariban® (doxylamine/pyridoxine), an unlicensed Exempt Medicinal Product, has now been made available on an individual patient basis for those patients who meet the criteria and 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.
The relevant HSE circular regarding the exceptional arrangement for Cariban® is available at:
www.hse.ie/eng/staff/pcrs/circulars/pharmacy/pharmacy-circular-001-23-cariban.pdf.
In order to obtain reimbursement support for Cariban® under this exceptional arrangement, the prescribing consultant must confirm whether the following apply:
• The individual has nausea and vomiting of pregnancy (NVP) which requires systemic treatment.
• The individual has been assessed using the pregnancy unique quantification of emesis and nausea (PUQE) assessment tool and the appropriate treatment algorithm has been followed.
• The individual has not responded to conservative management.
The consultant must also make an Unlicensed Product Declaration and submit the completed application form by email to the Primary Care Reimbursement Service (PCRS).
Once reviewed by the PCRS, the prescriber and dispensing pharmacy are emailed (via secure email) with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s community drug schemes eligibility and submits the claim using the relevant administrative code in their monthly submission to PCRS.
While reimbursement support is offered on the basis of the patient’s eligibility under the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS), Cariban® is not on the formal reimbursement list.
Within the international community, the pricing and reimbursement of medicines is a national competence. As different nations operate different pharmaceutical reimbursement systems across the world, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.
