Many of those who need the drug have to stop taking it because of its high cost.
Minister for Health Stephen Donnelly has said a drug used to treat Hyperemesis Gravidarum (HG) will not be reimbursed by the State, though he himself called for it to be when he was in Opposition.
Advocates have been campaigning for years to make the drug Cariban available on the drugs payment scheme for those suffering with HG, an extreme form of vomiting and nausea throughout pregnancy that can severely debilitate the sufferer.
Studies into the condition have suggested it is so severe that it can lead to suicidal thoughts or the desire to terminate the pregnancy to bring an end to the suffering.
Over the course of pregnancy, the drug can cost those suffering from HG between €1,500 and €3,000,
the Journal reports.
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A number of politicians, including Donnelly, have said the drug should also be available through the medical card over the years.
In October 2018, when Donnelly was in Opposition, he told then-Health Minister Simon Harris that all maternity costs should be universally available. This included appointments, specialised care, drug treatment and hospitalisation.
He even specifically highlighted the fact that those suffering from extreme cases of vomiting throughout pregnancy cannot get the expensive drug on the medical card.
Fianna Fáil Senator Catherine Ardagh raised the issue in the Seanad last week as despite campaigns to get the State to reimburse the cost of the HSE-recommended drug, “to date nothing has been done”.
“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,” she said, adding that the HSE “needs to include this drug on the refund scheme”.
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The issue was also recently raised in the Dáil by TD Thomas Gould, who said he was contacted by a woman suffering from very severe pregnancy sickness and had to stop taking Cariban purely because she couldn't afford it.
“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,” he said. “When she had to stop taking Cariban, because she did not have the money, she ended up hospitalised due to dehydration.”
Responding to Sinn Féin TD Pa Daly's recent parliamentary question on the issue, Donnelly said the Health Products Regulatory Authority (HPRA) has advised that Cariban is currently not licensed for use in Ireland.
He said two similar drugs, Xonvea and Navalem, have been licensed for use in Ireland but are not readily available.
“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 continued: “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. 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.”
Cariban has been prescribed and available in the Coombe, Rotunda and Holles Street maternity hospitals for years.
In a statement to the Journal, the HSE said only licensed products can be reimbursed in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
“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,” it said.
“However, Cariban is currently prescribed in some maternity hospitals; if prescribed to an inpatient there is no charge to that patient.”
For support and resources on coping with Hyperemesis Gravidarum, visit hyperemesis.ie.
