Dáil Éireann Debate, Thursday - 29 June 2023
422. Deputy Jennifer Whitmore asked the Minister for Health for an update on the HSE review of the availability of medication for hyperemesis; when the review will be completed; what will happen upon completion of the review; and if he will make a statement on the matter. [31781/23]
View answer423. Deputy Jennifer Whitmore asked the Minister for Health the number of women who have been approved for cariban on a month-by-month basis to date in 2023; the cost accrued by the State to date for the provision of this medication via the community drug scheme; and if he will make a statement on the matter. [31782/23]
View answerI propose to take Questions Nos. 422 and 423 together.
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.
Budget 2023 provided funding of €1.3m to allow reimbursement support for Cariban® (doxylamine/pyridoxine), for women suffering hyperemesis gravidarum, a severe form of nausea during pregnancy. Cariban® is not licensed in Ireland. It is classed as an Exempt Medicinal Product and cannot be added to the formal reimbursement list.
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. This arrangement has been in operation since 1 January 2023.
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 have asked the HSE to review the current arrangement and report back to me.
The HSE have confirmed that the current review involves an analysis of the exceptional arrangement and of the access to Cariban provided to patients since January 2023. The review also includes engagement with clinical leads, the HSE Primary Care Reimbursement Service and relevant advocates.
The HSE have advised that this review will be completed by July 2023. The Department will then consider the findings of the review.
As of 31 May 2023, expenditure on the reimbursement arrangement for Cariban® is €0.23 million. The number of women approved for the product at that time was 1,376. The full cost associated with these approvals will depend on the dosage prescribed and the length of use.
The below table sets out the number of approvals for Cariban on a month-by-month basis. As of 27 June 2023, 1,621 women have been approved for reimbursement support for Cariban.
|
Month |
Number of women approved for Cariban® |
|
January |
250 |
|
February |
331 |
|
March |
329 |
|
April |
204 |
|
May |
262 |
|
June* |
245 |
|
Total* |
1,621 |
*As of 27 June 2023
