Réada Cronin (Kildare North, Sinn Fein)
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211. To ask the Minister for Health if he will meet with a group (details supplied) at his earliest convenience; and if he will make a statement on the matter. [8933/23]

Michael Lowry (Tipperary, Independent)
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240. To ask the Minister for Health if his attention has been drawn to the concerns of an organisation (details supplied) regarding the current reimbursement policy for cariban in respect of medication to treat hyperemesis gravidarum; if he will pursue the HSE to have this medication licensed with the Health Products Regulatory Authority in order that it can be to be prescribed through a GP; and if he will make a statement on the matter. [9216/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 211 and 240 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 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.

In line with the 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

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.

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 unlicensed and is not on the formal reimbursement list.

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/