WOMEN, GPs AND Consultant obstetricians should not have to lobby drug manufacturers in order to gain easy access to a drug that helps with severe sickness during pregnancy, according to Social Democrats TD Jennifer Whitmore.
The Wicklow TD said in the Dáil last night that the system set up by the HSE in order for people to avail of the drug Cariban is causing “huge problems” for women.
Under the current system, in order to get this medication, women have to register and be seen by their consultant, who is the only person who can prescribe the medication.
Whitmore said a pregnant women often does not see a consultant until weeks into her pregnancy, and will therefore have to “put up” with hyperemesis gravidarum (HG).
“We are talking about people who cannot get off the sofa because they are so sick. They potentially have to look after other children, are not able to work and are not able to afford to go the private route for this medication,” she said.
Budget 2023 set aside funding of €1 million to facilitate reimbursement of the drug, Cariban, from January 2023.
Health Minister Stephen Donnelly said he would inquire as to why an initial prescription from a consultant would be required.
This situation has also been criticised by women, campaigners, pharmacists and doctors and then-Tánaiste Leo Varadkar, who queried the move last year.
Although women impacted by severe vomiting welcomed the State reimbursement of Cariban, which can cost up to €3,000 over the course of a pregnancy, they also criticised the need for a consultant prescription.
In a statement to The Journal, the Department of Health said that the HSE is calling on clinicians, the Institute of Obstetricians and Gynaecologists, the National Clinical Programme for Obstetrics and Gynaecology, and other healthcare professionals to encourage drug companies to progress with the formal pricing and reimbursement process in Ireland.
The health minister was not present for questioning on the matter last night, with junior minister Anne Rabbitte instead tasked with responding to Whitmore.
The minister said that reaching this point has not been straightforward, and explained that Cariban is an Exempt Medicinal Product (EMP) and therefore is not licensed with the Health Products Regulatory Authority (HPRA) in Ireland.
Only licensed products are added to the formal HSE Reimbursement List in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
Currently there are three products containing doxylamine/pyridoxine, which is contained in Cariban, licensed in Ireland:
However, the Dáil was told that to date, the market authorisation holder of Xonvea has not progressed the pricing and reimbursement application further with the HSE.
The market authorisation holders for Exeltis and Navalem have also not submitted pricing and reimbursement applications to the HSE to date.
The department said if the circumstances surrounding the three licensed drugs changes, so too could the situation with Cariban, adding:
Of course, if a licensed product was subsequently approved for reimbursement this arrangement could then be reviewed or revised.
Speaking in the Dáil, Rabbitte said:
“I will call on the drug companies that have the licences for Xonvea, Exeltis and Navalem to put in an application. I am not leaving it to the HSE; I am asking the drug companies to start that process.”
The junior minister said the HSE had advised her that where a drug is not licensed, the expertise of a specialist in the relevant field is necessary to ensure safe usage of it.
If, however, a licensed product, such as the three drugs mentioned above, were approved for reimbursement, the arrangement with Cariban could then be revised, she said.
In a statement to The Journal, the department said the HSE has no agreement in place with the manufacturers of EMP’s in terms of pricing and supply under the Health (Pricing and Supply of Medical Goods) Act 2013.
Rabbitte told the Dáil: “I feel there is a process being put in place but it is not solving the problem.”
Cariban is the solution for most women with HG, but women do not have the energy to go into a maternity hospital emergency department in order to get a prescription, said the minister.
“I will do one thing first. I will call on the drug companies that have the licences for Xonvea, Exeltis and Navalem to put in an application. I am not leaving it to the HSE; I am asking the drug companies to start that process. That needs to happen,” said Rabbitte who also urged GPs and consultants to find a way to share prescriptions easily in the interim.
“We need to introduce emergency measures that will allow GPs to prescribe Cariban, as they already can, but then allow these women to be reimbursed for it under the drugs payment scheme. The women now impacted by this deserve it, their families deserve it, and it is the least we can do to help them,” she said.
Whitmore said the Minister of State’s response was “quite a hands-off response’, stating that it can’t be left to the clinicians and the people suffering from HG to lobby the drug manufacturers to put in a reimbursement application.
That is not good enough,” she said, adding that if the health minister recognises there is an issue with licensing and applications being submitted by the drug companies, then the minister should be looking for solutions to help women.
To embed this post, copy the code below on your site
have your say