Dáil debates

Thursday, 10 December 2020

Ceisteanna Eile - Other Questions

Medicinal Products

11:30 am

Photo of David CullinaneDavid Cullinane (Waterford, Sinn Fein)
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85. To ask the Minister for Health if the drug dupilumab for the treatment of severe atopic eczema will be approved; and if he will make a statement on the matter. [42338/20]

Photo of Richard Boyd BarrettRichard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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452. To ask the Minister for Health when dupilumab for persons with eczema will be made available in Ireland; and if he will make a statement on the matter. [42807/20]

Photo of David CullinaneDavid Cullinane (Waterford, Sinn Fein)
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I am raising with the Minister the issue of dupilumab, which is a drug for people with severe eczema. I know that the drug approval process is an apolitical one, and so it should be and I fully support that, but my understanding is that this drug was discussed at a meeting on Tuesday of this week within the HSE. Can the Minister provide an update to the House on this drug?

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 85 and 452 together.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the Health (Pricing and Supply of Medical Goods) Act 2013.

I am informed that the HSE received two applications for the reimbursement of dupilumab for the treatment of moderate to severe atopic dermatitis in patients who are candidates for systemic therapy: first in November 2017, for treating adult patients, and then in December 2019, for treating adolescents 12 years and older. The National Centre for Pharmacoeconomics, NCPE, conducted a full health technology assessment of the application for the adult population and in December 2019 recommended that dupilumab be considered for reimbursement if cost-effectiveness could be improved relative to existing treatments. The NCPE conducted a rapid review of the application for the adolescent group and in January of this year advised that a full health technology assessment was not proposed and that the drug should not be considered for reimbursement at the submitted price.

Having reviewed the NCPE's recommendations, the patient group submission and the outputs of commercial negotiations, the HSE drugs group recommended that the HSE executive management team not support the reimbursement of the drug for either the adult population or the adolescent population. On 21 August the applicant was notified of the proposed decision not to support reimbursement. On 18 September the applicant submitted representations concerning this proposed decision. Last month the HSE reviewed the applicant's representations and met with representatives from the company.

The HSE has advised that the process is still ongoing and that the matter will be included on the agenda for the HSE drugs group's meeting in January 2021. The HSE executive management team is the decision-making body for the reimbursement of medicines under the Health Act 2013 and will, on receipt of the outcome of the drugs group's deliberations, make the decision as to whether the drug will be reimbursed.

Photo of David CullinaneDavid Cullinane (Waterford, Sinn Fein)
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I hope we will see movement on this issue in January. The drug is a treatment for severe eczema, which causes inflamed, dry and broken skin, which is exhausting to treat, painful and intensely itchy. I have met many people who suffer from this unfortunate disease and many healthcare professionals who are campaigning on the issue. While the issue is apolitical, we all get lobbied on these issues from time to time and I am very clear as to what our role is. Equally, however, when I listen to healthcare professionals who say there is something profoundly wrong with the drug approval process in this State, and very often we find ourselves the last EU state to approve drugs, I believe it is an area we need to review on an ongoing basis. I have asked the Oireachtas health committee to examine this and to work with Deputy Donnelly as Minister for Health. If we can make improvements in this area while still keeping in place the apolitical process that is in place, we should consider doing so.

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I agree with everything the Deputy has said. The health committee of the previous Dáil spent a lot of time considering this. The good news is that there are some amazing, life-changing and lifesaving new drugs out there. A lot of them are so-called high-tech drugs, which are very expensive, and the HSE has been paying a lot more for such drugs. In recent years, for example, the amount spent on the high-tech drugs alone has gone up from €400 million to €700 million per year, a very significant increase. Part of the frustration for this calendar year is that there was no allocation in the service plan for new drugs. That has been part of the reason that some of the drugs have been held up. I say this without prejudice to this particular drug because, as the Deputy says, this is an independent assessment process. What I can say is that I have allocated €50 million for 2021 to new drugs. I agree with the Deputy that Ireland in some cases is behind the curve and he and I have been given evidence that sometimes we are late to the party in allocating new drugs. We are all the time trying to balance making as many of the new and exciting drugs available as possible for as many people in Ireland as possible with the very real cost constraints. As the Deputy will be aware, negotiations take time and, in fairness to the HSE, at least in several examples I have seen, it does succeed in securing a lower unit price for the drugs which, given any budget, means we can make more and more drugs available.

Photo of David CullinaneDavid Cullinane (Waterford, Sinn Fein)
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I thank the Minister for his response. I recently met with Professor John Crowne. We had a good discussion on cancer care and one of the issues he raised with me was, again, these high-tech drugs to which the Minister referred in the field of cancer. He was very supportive of and enthusiastic and excited about a lot of these new drugs.

However, he pointed out that many of them are not available to patients in this State because, as he and many others who work in this area have observed, the unfortunate slowness of the drug approval process.

I wish to also raise the issue of the drug, Patisiran, which is a life-saving treatment for hereditary ATTR amyloidosis. As the Minister will be aware, that is a disease that is peculiar to people on this island. The drug is available in the North but it is not available to patients in the South, which is problematic.

My point is that we can all celebrate these drugs when they come on stream. Significant advances are being made all the time. However, if patients cannot access the drugs in a timely manner, then we have a difficulty. I genuinely believe it is an area in which we can make improvements. I certainly wish to work constructively with the Minister, as does the Joint Committee on Health, to make advances in this area.

11:40 am

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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There have been several conversations and representations about Patisiran, the second drug the Deputy referenced, and I will revert to him and colleagues with an update on it.

Any opportunity we can find to accelerate access to these new and exciting drugs should be taken. I had a conversation with medical oncologists just this week on access to new cancer drugs. On the €50 million that has been allocated for new drugs, although there is no set amount yet and the budget does not get sliced up per care pathway, it would be quite reasonable to think that €15 million or up to one third of that €50 million will end up being allocated towards some of the really exciting new drugs. I asked the medical oncologists whether there is an opportunity for us to save money within the existing amount. We should remember that we spend €2 billion per year on drugs. Their clear view was that there is an opportunity to make savings in biosimilars and prescribing practices. What I would love to do is to protect the drugs budget, add the €50 million to it, and find ways of reducing costs within that €2 billion and reinvesting the saved money back into further drugs. That certainly seemed to be something the medical oncologists wished to discuss further. I will be delighted to continue the discussion with the Deputy and the joint committee on the issue.