Donnchadh Ó Laoghaire (Cork South Central, Sinn Fein)
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217. To ask the Minister for Health the process by which pregnant women experiencing extreme nausea and vomiting can obtain the drug cariban; the reason cariban cannot be prescribed by a GP on the drugs payment scheme given that most women do not see a consultant until after 12 weeks; the steps pregnant women can take to help with the extreme nausea and vomiting for the first 12 weeks or until the drug can be accessed; the standard practice in other EU member states; and the number of cariban prescriptions that have been processed through the drugs payment scheme to date. [8990/23]

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 of €1.3m for Cariban® (doxylamine/pyridoxine) to help women who experience hyperemesis gravidarum, a severe form of nausea during pregnancy, which 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.

I, as the Minister for Health, have no role in these decisions.

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.

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the formal Reimbursement list. 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 not licensed in Ireland and, therefore, cannot be added to the formal reimbursement list.

However, following the recommendations of the HSE Medicines Management Programme, reimbursement support for Cariban® was made available from 1st January 2023 under an exceptional arrangement for specific patients who meet the criteria and where Consultant Obstetrician initiated. However, women would only need to see a consultant in order to be initiated on the product, and thereafter it can be prescribed by their GP.

The relevant HSE circular regarding this 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 individual patient has severe nausea which requires systemic treatment, has been assessed using the appropriate assessment tool and has not responded to conservative management. The consultant also makes an Unlicensed Product Declaration and submits the application by email to the Primary Care Reimbursement Service (PCRS).

Once reviewed by the PCRS, the prescriber and dispensing pharmacy are securely emailed with the reimbursement decision. The community pharmacy then dispenses the product under the specific patient’s eligibility. While reimbursement support is offered on the basis of the patient’s eligibility under the community drug schemes (subject to the relevant patient co-payment), Cariban® is unlicensed and 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®. As of 15th February 2023, 444 women have been approved for the product.

However, I recognise that women who may benefit from Cariban® may require access to it before their first consultation with their specialist/obstetrician, and that GPs appear to already be prescribing Cariban® without an initial prescription from a specialist. Therefore, I have asked that the HSE review the current arrangement.

There are three other products containing doxylamine/pyridoxine which are licensed in Ireland (Xonvea®, Exeltis® and Navalem®), but for which the respective market authorisation holders have not progressed with a pricing and reimbursement application to the HSE under the 2013 Act.

The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National Clinical Programme for Obstetrics and Gynaecology, and other healthcare professionals, to encourage the market authorisation holders of these licensed medicinal products 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/