Pearse Doherty (Donegal, Sinn Fein)
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520. To ask the Minister for Health if the drug melatonin is available under the discretionary hardship scheme for a person (details supplied) in County Donegal; and if he will make a statement on the matter. [19005/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Health Service Executive (HSE) has statutory responsibility for medicine pricing and reimbursement decisions, 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 Reimbursement List. Reimbursement is for licensed 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).

The HSE advise that Melatonin (Circadin®), which is indicated for the short-term treatment of primary insomnia, has never been available under the Community Drug Schemes. Melatonin (Circadin®) underwent a review in 2008 and reimbursement was not recommended by the NCPE (see www.ncpe.ie/drugs/melatonin-circadin/).

However, the HSE advise that an application for Melatonin (Circadin®) can be made on an exceptional basis under Discretionary Hardship Arrangements for medical card holders. This is in accordance with Section 23 of the 2013 Act, which provides for the supply of items not on the Reimbursement List.

All applications under these arrangements are reviewed on an individual patient basis. The HSE must be satisfied that the patient requires the item for clinical reasons, and that there is no item on the reimbursement list which is a suitable alternative for that patient.

Paul Donnelly (Dublin West, Sinn Fein)
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521. To ask the Minister for Health when a review will be completed into the reimbursement process for cariban, the first-line treatment for hyperemesis gravidarum; and if he will make a statement on the matter. [19006/23]

Catherine Connolly (Galway West, Independent)
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559. To ask the Minister for Health the status of the review by the HSE of the current arrangement around the provision of cariban under the community drug schemes, and in particular the requirement that the initial prescriber be a consultant obstetrician; the terms of reference of the review; the timeline for the completion of the review; his plans to publish the recommendations of the review; if he will provide details of any representative groups being consulted as part of the review; and if he will make a statement on the matter. [19173/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 521, 559 and 561 together.

Dedicated funding of €1.3m was provided in Budget 2023 to provide reimbursement support for Cariban® (doxylamine/pyridoxine), for women suffering hyperemesis gravidarum, a severe form of nausea during pregnancy.

The Health Service Executive (HSE) has statutory responsibility for medicine reimbursement decisions under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

Cariban® is not licensed in Ireland. It is classed as an Exempt Medicinal Product and cannot be added to the formal reimbursement list.

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

Following a review of the available evidence, the HSE considered the potential for a time-limited, quantity-dependent reimbursement arrangement for women with hyperemesis gravidarum, to access Cariban®, when prescribed by a consultant obstetrician and in line with clear clinical criteria, as set out by the HSE.

The HSE, therefore, put in place an exceptional arrangement which requires that the initial prescriber of Cariban® must be a consultant. The HSE will thereafter accept GP prescriptions for approved patients.

Prior to finalising this exceptional arrangement, the HSE engaged with the National Women and Infants Health Programme and the Programme was in agreement that the burden of the application process was tolerable and that the peer clinical community would welcome any opportunity to progress this matter for women in their care.

Cariban® has been available under this arrangement since the beginning of the year. As of 24 April 2023, 1,074 women have been approved for the product.

However, on the recognition that women suffering hyperemesis gravidarum may need access to Cariban® before their first consultation with their specialist/obstetrician, and in light of the fact that GPs prescribe Cariban® to private patients without an initial prescription from a specialist, I asked the HSE to review the current arrangement and report back to me.

The HSE have confirmed that the review it has undertaken will involve an analysis of current arrangements and of the access to Cariban® provided to patients since January 2023. The review will also include engagement with clinical leads, the HSE Primary Care Reimbursement Service and relevant advocates. To enable meaningful analysis, the HSE advise that several months of data will be required to complete the review.

In the meantime, the HSE encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the National 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.