Brendan Howlin (Wexford, Labour)
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613. To ask the Minister for Health further to Parliamentary Question No. 302 of 7 July 2022, if he will provide an update on the results of the deliberation of the HSE of the medicines management programme assessment for the use of the medication, following the reply received from the HSE in relation to the provision of affordable cariban medication for women suffering from hyperemesis; and if he will make a statement on the matter. [6644/23]

Jackie Cahill (Tipperary, Fianna Fail)
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631. To ask the Minister for Health when he expects an outcome of the review he requested from the HSE and his Department on the current approach to the reimbursement of cariban; and if he will make a statement on the matter. [6689/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 613 and 631 together.

As part of Budget 2023, funding of €32.2 million was announced for Women’s Health Initiatives in 2023.

This included dedicated funding of €1.3m for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a 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 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.

Within the European Union (EU), the pricing and reimbursement of medicines is a national competence. As Member States operate different pharmaceutical reimbursement systems across the EU, a direct comparison of the reimbursement of products is not possible. The competent authority for pricing and reimbursement in Ireland is the HSE.

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.

This exceptional 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 is in line with expectations and indicates that the budget allocated will be used in 2023. As of 10th February 2023, the number of applications received by the Primary Care Reimbursement Service (PCRS) stands at 384.

There are three other products containing doxylamine/pyridoxine, which are licensed in Ireland:

- Xonvea® gastro-resistant tablets.

- Navalem® modified-release hard capsules.

- Exeltis® gastro-resistant tablets.

The market authorisation holder of Xonvea® has not progressed the pricing and reimbursement application further with the HSE at this stage. The market authorisation holders for Exeltis® and Navalem® have not submitted pricing and reimbursement applications to the HSE.

The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, other healthcare professionals, and relevant representative bodies to encourage the market authorisation holders of the licensed medicinal products (Xonvea®, Exeltis® and Navalem®) to progress with the formal pricing and reimbursement process in Ireland.

Finally, the HSE provides general advice on treatments for hyperemesis gravidarum at:

/www2.hse.ie/conditions/hyperemesis-gravidarum/treatment/

Peadar Tóibín (Meath West, Aontú)
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614. To ask the Minister for Health if he will list the drugs and medications which are currently in short supply in the State; the public relations and communication practices adopted by the HSE at times when drug and medicine supplies run low or end; and if he will make a statement on the matter. [6650/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Products Regulatory Authority (HPRA) publishes a list of medicines currently in short supply on its website with the reason for the shortage and expected dates for the return of supply. This information is dynamic and changes depending on the current information the HPRA has to hand, including removal from the list when a shortage has been resolved.

The list of shortages in tabular form is publicly available and can be found here: www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages