Niamh Smyth (Cavan-Monaghan, Fianna Fail)
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199. To ask the Minister for Health the reason that women who suffer from hyperemesis gravidarum during pregnancy have to pay for vital medication; and if he will make a statement on the matter. [4819/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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. Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). I, as the Minister for Health, have no role in these decisions.

As part of Budget 2023, I announced €32.2 million in funding for Women’s Health Initiatives in 2023, to include dedicated funding for Cariban® (doxylamine/pyridoxine).

The dedicated funding for Cariban® will help women who experience hyperemesis gravidarum, a severe form of morning sickness, during pregnancy. Cariban® is an Exempt Medicinal Product, i.e., it is not licensed with the Health Products Regulatory Authority (HPRA) in Ireland.

Only licensed products are added to the formal HSE Reimbursement List in line with the 2013 Act. There are three products containing doxylamine/pyridoxine licensed in Ireland:

- Xonvea® gastro-resistant tablets.

- Exeltis® gastro-resistant tablets.

- Navalem® modified-release hard capsules.

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

Following the recommendations of the HSE Medicines Management Programme, and to address the unmet need of patients with hyperemesis gravidarum, an exceptional arrangement was put in place to support the reimbursement of Cariban®.

Cariban® is now available under the community drug schemes – the General Medical Services (GMS) and the Drugs Payment Scheme (DPS) – on an individual patient basis for those patients who meet the criteria for the treatment of nausea and vomiting in pregnancy.

Under the community drug schemes, Exempt Medicinal Products such as Cariban, 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.

If a licensed product was subsequently approved for reimbursement this arrangement could then be reviewed or revised.

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 the licensed medicinal products (Xonvea®, Exeltis® and Navalem®) to progress with the formal pricing and reimbursement process in Ireland.