TÁNAISTE LEO VARADKAR has said he does “not understand the rationale” of not allowing GPs to initially prescribe a drug which helps women with extreme sickness during pregnancy.

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 Cariban, which can cost up to €3,000 over the course of a pregnancy. 

HG can profoundly debilitate those who suffer with it. While a majority of women experience regular morning sickness (which can actually occur at any time of the day), HG is a lot more serious and can often mean multiple hospitalisations.

This year’s budget set out that funding of €1 million would be set aside to facilitate reimbursement of the drug, with women set to given free-of-charge access from January 2023. 

The budget announcement in September detailed how Cariban would be fully reimbursed when prescribed by a consultant obstetrician. 

Consultant prescription 

However, questions were asked by campaigners as to why their GP cannot provide the prescription. Currently, GPs write prescriptions for their patients which are filled as usual in pharmacies. 

Health Minister Stephen Donnelly told The Journal in September that what was recommended to him is that the drug be made available on prescription from a treating consultant obstetrician.

However, the minister said he wanted to investigate that further given what he said were “legitimate questions” as to why a GP could not prescribe the drug.

Hyperemesis Ireland, a group that has been tirelessly campaigning for women to get access to the drug, has said women should not have to wait until a hospital appointment (where they could see a consultant) before they get the prescription.

They said many women experience the extreme sickness months before their initial appointment with a consultant, adding that involving a consultant at all is a waste of their time and the patient’s time.

HSE proceeding with original recommendation

However, despite comments made by the Tánasite and health minister, The Journal can confirm that the HSE plans to proceed with the original recommendation that the “original prescriber” must be a “consultant and specialist in the relevant field” and not a GP.

The HSE said in a statement that it “will accept a GP prescription further to the initial hospital prescription for approved patients”.

When asked about the issue by People Before Profit TD Gino Kenny today, the Tánaiste, who is also a qualified doctor, said hyperemesis gravidarum is a “serious and debilitating illness in pregnancy if someone has the misfortune to experience it”.

“I do not know the rationale for not allowing GPs to prescribe it. GPs routinely deal with pregnancies of all kinds, especially early pregnancies. I am not sure whether there is a good reason for it,” he said, but without additional information, Varadkar said he was reluctant to comment further.

He said his office would take the matter up with the health minister. 

The HSE statement to The Journal on the reasoning said that as Cariban is an Exempt Medicinal Product i.e. not licensed with the Health Products Regulatory Authority (HPRA) in Ireland, the condition for how it should be initially prescribed was necessary. 

“Following the recommendations of the HSE Medicines Management Programme, this product will be made available on an individual patient basis for those patients who meet the criteria under Community Drug Schemes (GMS, DPS) from January 2023 where Consultant Obstetrician initiated,” it said. 

The HSE said that under the Community Drug Schemes, Exempt Medicinal Products must be consultant-initiated, which is why the original prescription must come from a consultant doctor, it said.

Women experiencing sickness in early pregnancy

Kenny said that constituents had been in touch with him to state that the condition generally begins in the first few weeks of pregnancy and most women will only see a consultant after they are 12 weeks pregnant. (Some women also choose midwifery-led clinics at Ireland’s maternity hospitals.) 

Fine Gael’s Neale Richmond also raised concerns this week about women having to wait until they see a consultant before being able to avail of a prescription, stating the HSE has discretion in the area of exceptional patient-specific processes.

“The important point is that the condition is extremely time-sensitive. Women do not know if they are going to get hyperemesis gravidarum before they get pregnant. Often, the patient does not present with symptoms until the eighth or ninth week of pregnancy,” he said. 

There is a need to work quickly to treat the condition, so having to attend a consultant appointment not only delays treatment by up to three or four weeks but puts a massive cost on the women who simply have to get access to this drug.

He called for a system to be put in place whereby there is no requirement for women to attend a consultant appointment in order to get a reimbursement.

“They should be able to get access to the drug through a GP because this is a time-sensitive exceptional need. I think all of us agree that Cariban is recognised as a safe drug. It is seen as such. We must ensure that we put in place the process to get ahead of the delay on a wider regulatory matter,” he said.

Minister of State at the Department of Health Mary Butler said if a woman is eight or nine weeks pregnant and extremely sick, the last thing she wants to do is to get up and try to make a consultant appointment.

She said she is hopeful that the medicine will make a meaningful difference to the well-being of pregnant women, but acknowledged there seemed to be “one small barrier that we need to overcome”.