Dáil Éireann Debate, Thursday - 16 February 2023
91. Deputy Aindrias Moynihan asked the Minister for Health the process by which pregnant women experiencing extreme nausea and vomiting, hyperemesis gravidarum, can obtain the drug Cariban; the reason the drug cannot be prescribed by GPs through the drugs payment scheme; the number of Cariban prescriptions that have been processed through the drugs payment scheme to date, in tabular form; and if he will make a statement on the matter. [7436/23]
View answerExtreme nausea and vomiting can be so debilitating for a pregnant woman. There are various therapies available to support such women but having easy and affordable access to them is very important. Will the Minister outline how women can access the various therapies available?
I thank the Deputy for his question. He will be aware that I secured funding of €1.3 million in budget 2023 to provide reimbursement support for Cariban, which I think is at the heart of his question. Cariban has been available since the beginning of the year for women suffering from hyperemesis, which is a severe form of nausea and vomiting during pregnancy that affects about 1% of pregnant women. I believe the number of women who have been approved for the product is 144 as of today.
This is slightly ahead of projections in terms of the funding allocated. Because Cariban is an unlicensed it is being handled in line with the established procedures around clinical governance. This is that the initial prescriber of Cariban to the patient must be a specialist or a consultant and subsequent prescriptions can come from a GP.
It has been brought to my attention, very reasonably, that some women are saying they need access to some form of treatment, be it Cariban or something else, before the 12-week appointment with an obstetrician. There is a request it would simply be a GP who would provide the initial prescription. I have gone back to the Department with that suggestion. The initial response I got back from the Department and the HSE was for unlicensed products. Cariban is an unlicensed product and the company has never applied for it to be licensed in Ireland. Personally I think it should do this as a priority, but the company has not done so, and because of that for clinical governance reasons it falls within the established framework, which is prescription by a consultant. Nonetheless, based on the obvious issue raised concerning access and timing to see an obstetrician, I have asked that this be reviewed to see if there is a clinically appropriate formula that can be put in place to provide access quicker when pregnant women need it, rather than when they can get access to an obstetrician.
I acknowledge the different initiatives the Minister has been undertaking for women's health. The funding and access he has already been putting in place for Cariban is proof of this and demonstrates the commitment. As the Minister outlined and as so many people have been raising with me, there are these difficulties. Having timely and affordable access is so important. As the Minister is aware, many people will not expect to be seeing a consultant until they have reached about the 12-week stage and they would have a need ahead of that. Also, a GP can follow-up on issuing further prescriptions. I understand this is for approved patients. Can the Minister clarify who exactly GPs can follow up with and issue prescriptions for? Is it everybody that would be getting a prescription from a consultant or is there some subset involved?
I will get the Deputy a detailed note to ensure this information is correct. My understanding is that once a woman has a prescription from her obstetrician that the repeat prescriptions can then be filled by the GP. Under the scheme introduced this year, the product is provided completely free of charge. I will, however, get the Deputy a detailed note just in case there are some nuances involved.
What we should be doing now is looking to the company. Under the Health Act 2013, the onus is on the company to apply to the HSE to have a new medicine added to the reimbursement list. That would, in fact, solve this problem. Cariban would then be a licensed product and it would fall within the normal reimbursement scheme, which would then make it very easy for any GP to prescribe. GPs would have the comfort of knowing that this was a licensed product, with all the various clinical checks and governance associated with that. Obviously, we cannot compel the company to do this. Anecdotally, I am also hearing that Cariban is much more expensive here than it is in some other countries. If the company was to apply to have this product licensed and added to the reimbursement scheme, then the HSE would be able to negotiate, I would imagine, a much more competitive price to facilitate making it more widely available again.
For women to be able to access Cariban via their GPs would be so much more affordable, practical and accessible than going through consultants. I am glad the Minister is taking steps in this direction. It is so important that this is followed through on and this type of access is created. I understand that a number of different drugs offer the same benefits and that the market authorisation holders for those have not sought to get approval. I acknowledge that an initiative was taken with Cariban. Is the HPRA going to follow through with Cariban? Is the aim to try to get this product to a stage where it would be GP prescriptionable, if such a word exists? Given that the Minister originally took the initiative on it, is the aim to continue with this process or is there a stand-off with these market authorisation holders?
I do not know if "prescriptionable" is a word. It is now and will be forever recorded as such. My understanding is that it is up to any company to apply for market authorisation and to apply to be added to the reimbursement list. I think this would be the best solution to this. We have well established processes, clinical governance, safety reviews and contract negotiations in place, which work very well. In fact, the reason we are in this situation is because Cariban is not a licensed product and this means there was no normal mechanism to make this drug freely available. We cannot compel the company to do this. Indeed, we cannot compel any of the other companies, which the Deputy referred to, that have other products which are also seen to be very good to do this either. What we can do is to ask that there be engagement from the HSE with these companies to see if they would like to begin the process. This is certainly something I would support.
