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THE HSE HAS asked a medicine management group to “examine the appropriateness and feasibility of a patient specific arrangement” that would make a pregnancy sickness drug available to women who need it.
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.
Health Minister Stephen Donnelly has said the State can not reimburse the cost of the drug, despite Cariban being prescribed and available in the Coombe, Rotunda and Holles Street maternity hospitals, as the Health Products Regulatory Authority (HPRA) has advised that the drug is currently not licensed for use in Ireland.
The Journal spoke to a number of women previously about their experiences dealing 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 in line with the Health (Pricing and Supply of Medical Goods) Act 2013, which is why women cannot get the drug on the drug payment scheme or medical card.
“Therefore, as Cariban is an unlicensed product in Ireland, it is not reimbursable under the community drug schemes,” said the spokesperson. The only way the drug can be added is for the manufacturers to file an application for a licence approval, it said.
The Irish Pharmacy Union (IPU) told The Journal that it is calling on the manufacturers of Cariban to apply for a product authorisation on the Irish market so that the HSE is in a position to reimburse it in the normal way through the medical card and drug payments schemes.
It added:
In the meantime, pending an Irish product authorisation, the HSE should put in place exceptional arrangements to fund the drug in individual cases.
The charity Hyperemesis Ireland, which has been campaigning for women to get access to the drug, has stated that several pharmacists have contacted it to say a drug can be unlicensed and reimbursed by the State.
The Journal asked the HSE whether unlicensed drugs, such as Cariban, can be reimbursed.
In response, the HSE said it has developed a national framework for access to medicinal products not currently on the reimbursement list through Discretionary Hardship Arrangements in exceptional cases.
“However, Cariban is considered to be a food supplement rather than a medicinal product in Ireland. Therefore it cannot be considered for reimbursement as an Exempt Medicinal Product under the GMS and Community Drug Schemes, or reimbursement under Discretionary Hardship Arrangements,” it said in a statement.
However, the HSE added that it has now “asked the Medicines Management Programme (MMP) to examine the appropriateness and feasibility of a patient specific arrangement” for the drug Cariban.
The MMP works with the National Medicines Information Centre (NMIC) and the National Centre for Pharmacoeconomics (NCPE) and the HSE-Primary Care Reimbursement Service to deal with issues such as access to medicines and overall expenditure on medicines.
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It costs thousands of euro during a hyperemesis pregnancy to cover cariban and other anti vomiting/ nausea medication. Thousands. Viagra on the other hand is covered on the Drug Payments Scheme. Tell me you live under a male dominated government without telling me….
@Aedín: The manufactures of this drug have not applied for product authorization. That is the main reason it is not available on the DPS.
I am always amazed at how Viagra’s availability on the Drug Payments Scheme is rolled out when discussing the unavailability of other drugs.
Firstly, no-one will ever take enough Viagra in a month to hit the reimbursement level, so that just leaves medical card patients.
Secondly, Viagra is very cheap – so you really are not comparing like with like.
Lastly, the contempt that you demonstrate towards the many real medical conditions that would warrant a Viagra prescription is very odd. What has the fact that Viagra is available got to do with the unavailability of drugs that cost often cost thousands a month?
BTW – Before you come back with some low blows, I’ve never had a Viagra prescription, but the two people I know who have, did so because they had their prostate done.
@Donal McCarthy: I don’t think not being authorized is an excuse. There are people who can make that happen, specially if the demand was high enough and it would be if it was covered, and financially it actually makes sense. If it was covered it would reduce the amount of admissions to the maternity hospitals for the same illness, which would save the state in the long term. I don’t think anybody is taking away from the use of Viagra regardless of the cause. I think the argument is in the fact that not having it would not cause you to be bed bound/ incapable of functioning and potentially admitted to the hospital.
@natasha: Exactly. Without Cariban, I 100% would have been hospitalised, probably multiple times (and that treatment would have been covered by the HSE at no cost to me, including Cariban if taken as an inpatient). So the HG patients who can’t afford Cariban are likely taking up HSE beds, time, and money in hospital when they wouldn’t need to be there if Cariban was more affordable.
If our Minister for Health suffered from Hyperemesis I would imagine she would dish them out like smarties. It is much a terrible sickness. My heart goes out to anyone suffering from it.
@Ciara O Callaghan: absolutely. Cariban was the only thing that got me through after being hospitalised with severe dehydration due to vomiting. I can’t understand why this is not licensed. Wonder drug
Granted it was 43 yrs ago when my Daughter was born with severe disabilities. I was an inpatient because of High Perenisis (medical term for vomiting out of control although I’m not sure of the spelling). A drug to stop the sickness called Debendox was administered to me while in hospital. Be very careful what you take during pregnancy.
@Margaret Doyle: I appreciate your intentions might be good, but this is really not a helpful comment for anyone suffering with HG or anyone supporting them. The medications in Cariban have decades of safety data behind them – that is one of the reasons Cariban is the first-line recommended medication (the HSE guidelines go into more detail on this; the second-line drugs are *much* cheaper but have less safety data; the third-line drug may have some risks and is expensive but covered under the DPS). Women with HG can already have difficulties accessing treatment from medical professionals who are not up to date (in fact figures from the US and UK indicate 1 in 10 women with HG will terminate their pregnancy because of the condition). We also feel guilty enough for having to take medication and not being able work/function/look after our other children, we do not need well-meaning but uninformed comments like this.
My heart goes out to any woman suffering this condition. Both my pregnancies, the first 3-4 months were spent with my head constantly in the toilet all day long. It’s horrible. They do say when the mother is so sick, the healthier the baby, go figure. I was very lucky in that I wasn’t working at the time but for any working pregnant woman with this condition, my goodness, it would be impossible to do any job under those circumstances. Absolutely impossible. I sincerely hope something can be done for these women.
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