Catherine Connolly (Galway West, Independent)
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298. To ask the Minister for Health with regard to the drug payment scheme, the analysis that his Department or the HSE has carried out into removing the requirement for the original prescriber of cariban to be a consultant, in order that GPs would have the authority to be the original prescriber for this medication; and if he will make a statement on the matter. [6371/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.

This included dedicated funding for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of morning sickness, 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 Good s) 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.

However, following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of those patients with hyperemesis gravidarum, reimbursement support for Cariban® has now been made available on an individual patient basis for those patients who meet the criteria and where Consultant Obstetrician initiated.

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.

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. 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).

This arrangement has been put in place 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 indicate that the budget allocated will be used in 2023.

Paul Kehoe (Wexford, Fine Gael)
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304. To ask the Minister for Health the process in writing by which pregnant women are experiencing extreme nausea and vomiting can obtain cariban; and if he will make a statement on the matter. [6380/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 schemes eligibility – either the General Medical Services (GMS) Scheme or the Drugs Payment Scheme (DPS) – and submits the claim using the relevant administrative code in their monthly submission to PCRS.