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Thursday 7 December 2023 Dublin: 10°C
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hyperemesis gravidarum

Govt one step closer to giving severe illness during pregnancy drug free of charge

U-turn on calling Cariban a food supplement as HPRA says such classification is not appropriate.

A U-TURN ON the classification of an expensive drug used to combat severe illness during pregnancy means the Government is now one step closer to giving the drug to women free of charge.

The drug, known as Cariban, is currently unavailable on the drugs payment scheme or medical card.

Women impacted by severe vomiting, known as Hyperemesis Gravidarum or HG, have called for the State to reimburse the costs of Cariban, which can cost up to €3,000 over the course of a pregnancy.

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

The Department of Health previously said that it had been advised that Cariban was considered to be a food supplement, rather than a medicinal product.

Therefore, the department maintained that it cannot be considered for reimbursement as an Exempt Medicinal Product under the medical card, Community Drug Schemes, or reimbursement under Discretionary Hardship Arrangements.

This is something a number of pharmacists, as well as Hyperemesis Ireland, a charity that has campaigned tirelessly for years for reimbursement, have taken issue with.

The Journal has now confirmed that there has been a u-turn in the matter. 

A spokesperson for the Department of Health said in a statement:

“The Department had been advised that Cariban was considered to be a food supplement. The Minister of Health Stephen Donnelly asked the Women’s Taskforce to explore funding options.

“The Department subsequently contacted the Health Products Regulatory Authority (HPRA).

“The HPRA has advised that while Cariban does contain pyridoxine hydrochloride which, as per Directive 2002/46/EC, is permitted for use in the manufacture of food supplements, it also contains doxylamine succinate which is an antihistamine and therefore it would not be appropriate to classify Cariban as a food supplement.”

Such a clarification brings the possibility of reimbursement of the drug one step closer as such an explanation as to why the State cannot fund the drug under such schemes is now void.

The Journal also understands that a HSE medicines group tasked with carrying out an “urgent” review on reimbursing the expensive drug has now completed its report.

The HSE Medicines Management Programme were asked to undertake an urgent, exceptional clinical review of Cariban, with a view to finding an alternative pathway for making it available free of charge.

The Journal understands that the HSE has advised that this review has been completed and recommendations have been submitted to the HSE Corporate Pharmaceutical Unit (CPU) for consideration. 

However, because the cost is not insignificant, any decisions on making the product available will require sign off by senior HSE management, it is believed.

No timeline has been given as to when a final decision on reimbursing the drug will be made.

Asked about the matter yesterday in the Dáil, Public Expenditure Minister Michael McGrath said he understood the issue was very important for so many pregnant women all over the country.  

“I am aware the matter has been raised with the Minister, Deputy Stephen Donnelly on a number of occasions. He and his officials in the Department have been working with the HSE to bring about a solution.  

“I believe he is optimistic that a solution can be implemented. I anticipate that he will have something to say publicly about that very shortly,” he confirmed.

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