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severe morning sickness

Health Minister insists State won't reimburse cost of drug to treat severe pregnancy sickness

When Stephen Donnelly was in Opposition he told Simon Harris that the drug called Cariban should be available on the drugs payment scheme.

DESPITE YEARS OF campaigning by pregnant women – as well as Health Minister Stephen Donnelly stating while he was in Opposition that a pregnancy sickness drug called Cariban should be available on the drugs payment scheme – it is still not being reimbursed by the State. 

Over the course of a woman’s pregnancy, the drug can cost between €1,500 and €3,000.

Between one in every 100 and one in 200 women suffers from severe vomiting, known as Hyperemesis Gravidarum or HG, which can profoundly debilitate women.

While many women suffer from regular morning sickness (which can actually occur at any time of the day) HG is a lot more serious. 

Over the years, a number of politicians, including the current health minister, have said the drug should be available through the medical card also.

Donnelly in Opposition 

In October 2018, Donnelly told the then-Health Minister Simon Harris that all costs including, appointments, specialised care, drug treatment and hospitalisation, which fall within the parameters of maternity care, should also be universally available. 

In fact, he highlighted specifically a case of women who find they suffer from an extreme cases of vomiting who cannot get the very expensive drug on the medical card. 

Cariban is prescribed and available in the Coombe, Rotunda and Holles Street maternity hospitals and has been for many years. 

Fianna Fáil Senator Catherine Ardagh raised the issue in the Seanad last week, stating that there has been a huge campaign to get the State to reimburse the costs, “but to date nothing has been done by the HSE”.

She called on the health minister to prioritise this issue and to outline what immediate actions they are taking to insure that women with hyperemesis do not face further financial hardship in accessing the basic HSE-recommended drug.

“The drug at the moment costs about €45 per week. That will need to be taken over the whole course of the woman’s pregnancy. It is therefore a huge amount of money and it adds up. It is still not available.

“Women with morning sickness have been treated in a particular way since the 1960s. We are all aware of the Thalidomide drug scandal, whereby the drug brought on malformations in 10,000 children. We are now forgetting about these women again. Although it is only 1%, we have to do much more. The HSE needs to include this drug on the refund scheme,” said Ardagh. 

TD Thomas Gould also raised the matter in the Dáil recently, stating that he was contacted by a lady suffering from very severe pregnancy sickness.

“She needed a drug called Cariban, which is used to treat severe morning sickness. Her doctor agreed that she needed it but unfortunately, this drug is not available on the medical card and she had to pay for it out of her own pocket until such time as she could no longer afford to do so.

“Unfortunately, when she had to stop taking Cariban, because she did not have the money, she ended up hospitalised due to dehydration,” he said, stating that life-changing drugs need to be accessible under the reimbursement scheme. 

Women’s experiences 

In 2016, a number of women told TheJournal.ie about their experiences dealing with HG, and how Cariban was the only treatment to work. 

A number of women spoke about the lack of understanding among the medical profession about HG, with many women stating they felt “unsupported, extremely sick and quite down”.

One woman described how she was admitted and re-admitted to hospital, getting sick up to 20 times a day, while another said when she presented to hospital she was sent home with no help. 

Another said her doctor told her to eat cold milk and Rice Krispies during her pregnancy. Later, when she presented to Holles Street Maternity Hospital emergency room, they prescribed Cariban to the woman. 

“It’s an expensive drug, but worth every penny. I took it for many weeks and then tried to come off it thinking I was through it, but as soon as I did the sickness and nausea came back. I went back on the drug and within days was perfect. The drug for me was effective and saved my sanity. I returned to work and got my life back,” she told The Journal.

It is not just women and politicians who have been calling for action to be taken on the issue, medical professionals have also called for change.  

Dr Mary Higgins from the National Maternity Hospital in Dublin previously told this website that having done training in Canada, she observed that nearly every woman suffering from this condition was on the medicine. 

She explained Cariban, a vitamin B6 antihistamine, was first developed in the 1970s.

“It is the most studied pregnancy drug,” said Dr Higgins, adding that studies have been carried out on more than 200,000 women.

‘Unethical not to give it to women’ 

She said one published paper on the medicine goes so far as to say that it is now “unethical not to give it to women”, adding that there still is a certain amount of a “put up with it” attitude out there.

“This condition can really make people miserable – it really comes down to quality of life while you are pregnant and some women simply don’t have that when they have this condition.”

The UK’s biggest study into severe sickness during pregnancy was published last year. The impact, says the study, leads many to consider terminating their pregnancy, alongside ‘suicidal thoughts’.

The report is released by King’s College London, and the research was conducted by BBC News and Pregnancy Sickness Support. 

In an answer to a recent parliamentary question on the matter from Sinn Féin’s Pa Daly, the health minister said the Health Products Regulatory Authority (HPRA) has advised that Cariban is currently not licensed for use in Ireland. 

He said two similar products, Xonvea and Navalem  have been licensed for use in Ireland.

The minister then stated that these two medicines are not readily available to women.

“The companies holding the authorisations/licences have not marketed the products in Ireland to date, and the HPRA cannot compel a company to market a medicinal product,” he said. 

“To be considered for a license in Ireland, the company marketing the product would need to make an application to the HPRA. After a thorough evaluation of all the supporting evidence, and if the benefits of the product outweigh the known and potential risks, a license may be issued,” he said. 

Drug Payment Scheme and medical card

“Where a medicine is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility, and to meet the specific needs of a patient,” said the minister. 

“The decision to prescribe or not prescribe any treatment for an individual patient is a decision for the treating clinician, in consultation with their patient,” he added. 

Donnelly said the responsibility for the clinical use of unlicensed medicines lies with the prescriber, and they must ensure as far as possible that any treatment, medication or therapy prescribed for a patient is safe, evidence-based and in the patient’s best interests.

“This applies equally to licensed and unlicensed medicinal products,” said Donnelly. 

In response to The Journal about what progress, if any, has been made in making this drug more available and affordable to women, the HSE said only licensed products are added to the reimbursement list in line with the Health (Pricing and Supply of Medical Goods) Act 2013.

“The HSE does not reimburse medicines or agree reimbursement terms in advance of the completion of the required processes… the HSE advise that Cariban (doxylamine / pyridoxine) does not have a marketing authorisation from the HPRA or the EMA.

“Therefore, as Cariban is an unlicensed product in Ireland, it is not reimbursable under the community drug schemes. However, Cariban is currently prescribed in some maternity hospitals; if prescribed to an inpatient there is no charge to that patient.”

As regards the drug Navalem, it said a pricing and reimbursement application has not been received by the HSE for this licensed product.

The HSE said it has received a pricing and reimbursement application for Xonvea, which is licensed. 

However, the HSE states that in late 2021, the company responsible for the commercialisation of this product advised that they are not in a position to launch Xonvea in Ireland at this time.

“The HSE therefore cannot currently progress this application further within the national pricing and reimbursement processes,” it said.

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