John Lahart (Dublin South West, Fianna Fail)
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265. To ask the Minister for Health if he will consider the reimbursement of cariban for people suffering from hyperemesis; and if he will make a statement on the matter. [9353/23]

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.

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.

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 already prescribe 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/.

Aindrias Moynihan (Cork North West, Fianna Fail)
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266. To ask the Minister for Health the reason for shortage in supply of a medication prescribed for HRT (details supplied); if he was aware that individuals currently have to go to Northern Ireland to get their prescriptions fulfilled for this product; and if he will make a statement on the matter. [9354/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Ovestin (estriol) 1mg per gram Vaginal Cream is authorised to be marketed in Ireland, however the company who holds the authorisation (Aspen Pharma Trading Ltd) does not currently market this medicinal product in Ireland and has not done so for a number of years. A company cannot be compelled to market any medicinal product in Ireland.

A number of other HRT medicinal products are authorised and marketed in Ireland. In the event that the patient’s doctor wishes to prescribe Ovestin for his/her patient, Schedule 1 of the Medicinal Products (Control of Placing on the Market) Regulations includes an exemption which enables practitioners to prescribe this as an exempt medicinal product (EMP) under that practitioners direct responsibility, in order to fulfil the special needs of that specific patient. If a valid prescription is issued for an EMP in line with the above Regulations, an appropriately authorised wholesaler can source that product from another market for supply to the patient via their pharmacy in line with that prescription.

As EMPs have not been granted a marketing authorisation in Ireland by the HPRA, they would not be assessed by the HPRA for quality, safety or efficacy. If sourced in response to a bona fide unsolicited order as a licensed product from another market these medicines will have undergone an evaluation of their safety, quality, and efficacy for the granting of their marketing authorisation in that country carried out by the respective competent authority for medicines in that state.