Dáil debates

Thursday, 29 February 2024

Ceisteanna Eile (Atógáil) - Other Questions (Resumed)

Medicinal Products

9:50 am

Photo of Aindrias MoynihanAindrias Moynihan (Cork North West, Fianna Fail)
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8. To ask the Minister for Health if the new drug, Veoza, can be made available on the drugs payment scheme (details supplied); and if he will make a statement on the matter. [9695/24]

Photo of Aindrias MoynihanAindrias Moynihan (Cork North West, Fianna Fail)
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There are women who are cancer survivors who are not able to use hormone-based drugs during menopause. The new drug, Veoza, offers a non-hormone option to them but the cost is prohibitive. Can this drug be made available to them on the drugs payment scheme?

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I thank the Deputy very much for the question. I will start by acknowledging his ongoing advocacy in terms of new medicines, including rare diseases, but obviously, this is not one of those cases. As the Deputy is aware, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. However, it is incumbent upon all of us, as public representatives, to engage with patients and clinicians and to understand where the real opportunities are for future medicines.

Veoza is a very new development in the treatment of moderate to severe vasomotor symptoms associated with menopause. As the Deputy will be aware, the Government is prioritising women's healthcare, including through the provision of hospital-based services for menopause. He will be aware that critically, in terms of accessing new medicines for this year, we have ring-fenced €30 million with €20 million of this from new development funding and €10 million from savings from the existing substantial medicines budget of €3.2 billion.

Veoza was authorised by the European Medicines Agency in October, which was just in the last few months. The company that markets it submitted its application for reimbursement to the HSE on 8 February. The company therefore just put in its application in the last two to three weeks. It is now at the first stage of the process, which is a rapid review by the National Centre for Pharmacoeconomics, NCPE. My officials and I will obviously be following this assessment with great interest, both in terms of the benefit this drug can provide and because it fits with our push for women's healthcare and our ambitions to have the best possible women's healthcare right across the country.

Photo of Aindrias MoynihanAindrias Moynihan (Cork North West, Fianna Fail)
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I first wish to acknowledge that significant work has been done on women's health across a range of different services. That is very positive. I refer to IVF, gynaecological services, for example, in Cork, and menopause clinics. This measure would complement the great effort that has been advanced through menopause clinics. A small number of people are involved in this and they have very limited options, if any at all. This is their first opportunity to have an option available to them because it is non-hormone-based drug. Their options are limited because of their cancer treatment, which means they will not be able to use any hormone-based drugs. Can the fact that very limited alternatives are available to these people inform the decision? Can it inform and expedite the decision to put it on the drugs payment scheme at a manageable price?

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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I thank the Deputy. I will walk through the steps regarding where this is now and where it is going. As I said, the company applied for reimbursement just in the last few weeks. That application is now undergoing a rapid review at the National Centre for Pharmacoeconomics. The NCPE target for that is four weeks but it does not always meet it because it assesses many new medicines. Yet, typically, the target for a rapid review is approximately four weeks. Following the rapid review, it may recommend a full health technology assessment, HTA, which takes a bit longer. The National Centre for Pharmacoeconomics may not - but I hope it will - recommend that this goes to a full HTA. Then, it would go to the corporate pharmaceutical unit, CPU, in the HSE. As part of the budget for this year, we were asked to sanction additional staff for the CPU for exactly this reason, namely, to speed up the process so we could assess more new medicines at the same time.

I will continue my reply in my next response to the Deputy.

Photo of Aindrias MoynihanAindrias Moynihan (Cork North West, Fianna Fail)
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It is widely expected that by approximately April, this drug will become available to market and people will be able to access it. The timing on this is therefore highly sensitive. It would be great to have it available on the DPS right from the start.

There is another very significant aspect to which I wish to draw the Minister’s attention. Aside from the shock of receiving a cancer diagnosis, the difficulty in dealing with the treatment, etc., there is also a financial shock to the person. They will have lost income. Once they have put the cancer treatment behind them, they may face the possibility of having an expensive drug at menopause. It will be even more difficult for them at that stage and, therefore, the cost is hugely significant. Can a factor such as that be taken into account when the Minister is setting the price at the DPS? Let us bear in mind that people who will be using this drug will have already had this difficult, expensive time, on top of their difficult treatment.

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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These are exactly the issues that will be looked at in the rapid review and the health technology assessment. How much would it cost the State if it is on the drug payment scheme? What amount of good would the medicine do, given the amount of money that would be spent? That is how we must look at all medicines. It may be the case that it will be recommended for the drug payment scheme. The figure of €6,000 was mentioned; I am not familiar with the figure, but let us say that it is €6,000. The State would pay nearly all of that and the patient would be left with just €80 per month, or much less if they have a medical card. Certainly, if it is recommended through the process of reimbursement, the vast majority of the €6,000 would be paid for by the taxpayer. Then, the individual would pay €80 per month for the amount of time they are accessing the medicine.