The HSE is exploring the possibility of a ‘special arrangement’ for access to a drug for serious pregnancy conditions


THE HSE has asked a medicines management group to ‘consider the suitability and feasibility of a patient-specific arrangement’ which would make a medicine for the illnesses of pregnancy available to women who need it.

The drug, known as Cariban, is not currently available on the drug payment system or on the medical card.

Women affected by severe vomiting, known as Hyperemesis Gravidarum or HG, have asked the state to reimburse the cost of Cariban, which can cost up to €3,000 during a pregnancy.

HG can profoundly debilitate women, and although women suffer from regular morning sickness (which can actually occur at any time of the day), HG is much more serious.

Health Minister Stephen Donnelly said the state could not reimburse the cost of the drug, although Cariban was prescribed and available at maternity hospitals in Coombe, Rotunda and Holles Street, as the Commodities Regulatory Authority Health (HPRA) has indicated that the drug is currently not licensed for use in Ireland.

The newspaper has already spoken to a number of women about their experiences with HG and how Cariban was the only treatment that worked for them.

The HSE said last week that only licensed products are added to the reimbursement list under the Health (Pricing and Supply of Medical Products) Act 2013, which is why women cannot get the drug on the drug payment system or on the medical card.

“Therefore, as Cariban is an unlicensed product in Ireland, it is not reimbursable under Community Medicines Schemes,” the spokesperson said. The only way to add the drug is for manufacturers to apply for license approval, he said.

The Irish Union of Pharmacy (UIP) said The newspaper that it asks the manufacturers of Cariban to apply for product authorization on the Irish market so that the HSE will be able to reimburse it normally through the medical card and drug payment schemes.

He added :

In the meantime, pending Irish authorization of the product, the HSE should put in place exceptional arrangements to finance the drug on a case-by-case basis.

The charity Hyperemesis Ireland, which campaigns for women to have access to the drug, said several pharmacists had contacted it to say a drug may be unlicensed and reimbursed by the state.

The newspaper asked the HSE if unlicensed drugs, such as Cariban, could be reimbursed.

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In response, the HSE said it had developed a national framework for access to medicines not currently on the reimbursement list through discretionary hardship arrangements in exceptional cases.

“However, Cariban is considered a food supplement rather than a medicine in Ireland. Therefore, it cannot be considered for reimbursement as an exempt drug under GMS and community drug plans, or for reimbursement under Discretionary Hardship Agreements,” he said in a statement.

However, the HSE added that it has now ‘asked the Medicines Management Program (MMP) to consider the suitability and feasibility of a patient-specific arrangement’ for the Cariban medicine.

The MMP works with the National Medicines Information Center (NMIC) and the National Center for Pharmacoeconomics (NCPE) and the HSE Primary Care Reimbursement Service to address issues such as access to medicines and overall drug expenditure. medications.


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