Dáil debates
Tuesday, 31 January 2023
Saincheisteanna Tráthúla - Topical Issue Debate
Medicinal Products
10:35 pm
Jennifer Whitmore (Wicklow, Social Democrats)
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I thank the Minister of State for coming to the House. I will raise the issue of hyperemesis. As she is aware, it is a condition whereby pregnant people suffer from severe nausea and vomiting. It is very debilitating for people and can lead to many of them ending up in hospital through dehydration or weight loss. It impacts 1% to 2% of pregnancies.
There was a campaign by Hyperemesis Ireland relating to the medication used to treat hyperemesis, Cariban, which is incredibly expensive, prohibitively so for many women in their pregnancies. It can cost up to €3,000 over the course of a pregnancy, which is a huge amount of money. Hyperemesis Ireland campaigned to make Cariban a free medication for women. It is welcome that last year the Government recognised that campaign and made that medication free and available on the drugs payment scheme. That change was brought in on 1 January this year. Unfortunately, the joy and relief that came with that was very short-lived because the reality is the system that has been set up by the HSE in order for people to avail of Cariban is causing huge problems. There are significant barriers to people getting it.
Under the current system, to get this medication, women have to register and be seen by their consultant. Their consultant has to be the one to prescribe the medication for them. As the Minister will be aware, a pregnant person will not see a consultant probably for the first 12, 13, 17 or 18 weeks of her pregnancy and, during that time, she will have to put up with hyperemesis from very early in the pregnancy and suffer greatly. 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.
I have heard from women who are not taking their full dosage because they cannot afford it. They are struggling to get to work while having other children to look after. It must be highly difficult for them to deal with. There are big problems because GPs are unable to prescribe this and you have to go to a consultant to get it. People are going to accident and emergency departments to try to get to the consultants. However, I have heard from women who have had to sit for six or seven hours in an accident and emergency department to get to a consultant. Then, when they get to the consultant, the consultant is not in a position to prescribe it for them or they may not get to see a consultant. I heard just today from someone who is 18 weeks pregnant, had her first consultant's appointment today, has had hyperemesis since her sixth week and has been paying €70 a week for that. When she went to her appointment today, she was informed that the consultants have had no contact from the HSE regarding the forms or the process by which they have to prescribe this and that they have no way of offering the hypothetical supports set out by the Government.
I think the Minister of State will appreciate that while it was a really positive thing that Cariban was made free under the drugs scheme, it is not working and there needs to be a review. Primary care and the GP should be the ones prescribing it in the absence of availability and access to consultants.
10:45 pm
Anne Rabbitte (Galway East, Fianna Fail)
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I thank the Deputy for raising this matter. She has given me the challenge of using an awful lot of words that are very complicated, but I will do my very best.
On behalf of the Minister for Health, I thank the Deputy for raising this topic and appreciate that it will be of concern to many women in Ireland. Hyperemesis is a severe form of nausea and vomiting during pregnancy that affects some women and must be diagnosed and treated appropriately. The Government is keen to ensure that anyone encountering this condition receives the support they need. As part of budget 2023, the Minister announced €32.2 million in funding for women's health. That included dedicated funding for Cariban, a medicine used to treat hyperemesis. As of January 2023, this medicine is now available to those women who need it. I take fully on board what the Deputy has just said; it comes with its own health warning.
Unfortunately, reaching this point has not been straightforward. Under the Health (Pricing and Supply of Medical Goods) Act 2013, only medicines that are licensed and have marketing authorisation from the European Medicines Agency or the Health Products Regulatory Authority can be added to the HSE's formal reimbursement list. Cariban is not licensed and therefore cannot be added to the reimbursement list. It is instead classed as an exempt medicinal product. There are three medicines containing doxylamine-pyridoxine which are licensed in Ireland. They are Xonvea, Exeltis and Navalem modified-release hard capsules.
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 not submitted pricing and reimbursement applications to the HSE. Therefore, to address the unmet need of patients with hyperemesis, the HSE's medicines management programme was asked to review the clinical evidence available on the unlicensed exempt medicinal product Cariban and to make a recommendation on the appropriateness and feasibility of an exceptional patient-specific process for access to the product.
Following the recommendations of the medicines management programme, an exceptional arrangement has been put in place to support the reimbursement of Cariban. Cariban is now available under the community drugs schemes on an individual patient basis for the treatment of nausea and vomiting during pregnancy where consultant obstetrician-initiated. That is the crux of the issue. While the initial prescription for Cariban must be issued by a consultant, further prescriptions can be issued by a patient's GP. Consultant initiation is the case for all unlicensed exempt medicinal products under the community drugs schemes. The HSE advises that where a drug is not licensed, the expertise of a specialist in the relevant field is necessary to ensure safe usage. If, however, a licensed product were approved for reimbursement, this arrangement could then be reviewed or revised.
The HSE therefore encourages clinicians, along with the Institute of Obstetricians and Gynaecologists and the national clinical programme for obstetrics and gynaecology, and other healthcare professionals to encourage the market authorisation holders of the available licensed medicinal products, Xonvea, Exeltis and Navalem, to progress with the formal pricing and reimbursement process in Ireland.
I feel there is a process being put in place but it is not solving the problem. I have to acknowledge that the Minister, Deputy Stephen Donnelly, did listen to the campaign. He worked really hard to ensure we could find a solution. Unfortunately, by the time you hit 20 weeks or 18 weeks, you are probably over the worst of your sickness and you also will not have seen your consultant, so there is a problem with waiting the 20 weeks to see the consultant.
Jennifer Whitmore (Wicklow, Social Democrats)
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There are a few things in the Minister of State's response that I find quite concerning. The first is that it is quite a hands-off response. It sort of says, "We have done what we can do and now it is up to the clinicians and the people suffering from this to lobby the drug manufacturers to get them to put the application in." That is not good enough. There is an issue. If, as the Minister of State says, the Minister, Deputy Donnelly, recognises it as an issue, he should be looking for solutions to help women in order that the supports that were put in place in January of this year are available to people, women can access the drug for free and there is not a discrepancy between people who can afford to go privately and those who are forced to suffer alone with this.
The other thing is that the response states that "the expertise of a specialist in the relevant field is necessary to ensure safe usage". GPs prescribe this - it is not that they do not - and if anyone knows a pregnant woman, it is her GP. The GP is the specialist and the person with the medical and personal knowledge of the woman to enable him or her to prescribe this. I do wonder whether the Minister had any discussions with consultants when it came to coming up with the solution because it seems to me that not only does the process not work for pregnant people but it is not working for consultants either. They have not been told what they are meant to do. No consultant would have the time to have people coming in through accident and emergency to try to get prescriptions written. Consultants do not do that. It seems completely outside their area to have people come through the hospital system, through accident and emergency, to get them to write prescriptions, particularly considering the winter we have had, when hospitals have been telling people to stay away. Now we are saying that a woman who is vomiting so much that she cannot lift her head off a chair has to go sit in an accident and emergency department, in an area where respiratory syncytial virus, RSV, and everything else is going around. We are sending these highly vulnerable women through accident and emergency to beg for prescriptions from consultants who do not have the forms, do not know how to go through the process and are not in a position to prescribe the drug. It just does not make any sense.
Anne Rabbitte (Galway East, Fianna Fail)
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I thank the Deputy again for raising this matter. I said to the Minister, Deputy Donnelly, before coming here that I did not know exactly what I would say in my closing statement. Having listened to the Deputy, however, and being a female who has been through three childbirths, and who was quite sick during two of them, I will be honest with her. A solution was found. Cariban was the drug, and the reimbursement was put in place. That is great and welcome and was well done. However, if you are at home lying on the couch and you are really ill, you need to go to your GP. You do not have the energy to get into the car to go sit in an accident and emergency department.
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.
The second thing I will do is call on the GPs and the consultants to work together, perhaps using telemedicine and so on.
It is unlicensed so we have to work within the rules of it. If a GP requested a prescription from a consultant initially and if he was to be able to prescribe that, that would assist in fast-tracking the delivery of it in the interim while the drug companies are putting in a reimbursement for it. I understand why the risk has to be held by the obstetrician but we also have to put the person at the centre at the end of the day and we have to think about that woman who needs assistance. While we welcome the work that has been done, a little bit of collaboration and pragmatic thinking are needed on how we can find a solution to this.
10:55 pm
Jennifer Whitmore (Wicklow, Social Democrats)
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Will the Minister of State ask the Minister to review this process with the HSE?
Anne Rabbitte (Galway East, Fianna Fail)
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Yes.