Aindrias Moynihan (Cork North-West, Fianna Fail)
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Veoza offers an alternative to HRT for women at menopause. It is a game-changer for so many, especially those for whom HRT is contraindicated. These are typically cancer survivors for whom hormone therapies are just not an option.

Veoza was introduced into Ireland early last year and costs approximately €80 per month for the women using it. The pharmacoeconomic assessment has been ongoing since last spring. The Minister of State will be aware that Ireland has one of the slower processes across Europe for approving qualifying new drugs. Many other countries have approved the use of Veoza, and GPs are currently prescribing Veoza in Ireland as well. At €80 per month that is a difficult cost. When it is not included in the drugs payment scheme, DPS, that €80 is over and above any other medical cost the person may have. Many of these people have already fought cancer and may have other medication costs associated with that. The €80 payment for Veoza each month is over and above the costs of those medicines.

Some people may choose to take a non-hormone option, but for a limited number of people it is the only option. It is the only route available to them. When there is only a limited number of people, that means a limited cost to the State on the DPS. Studies have shown the dramatic quality of life improvement for those who are using Veoza. Symptoms reduced as quickly as within the first week. Since the pharmacoeconomic assessment commenced last spring, there has been a significant policy advancement for women with menopause care with the introduction of the free HRT in the this year's budget and implemented last week. That made a drug option available from the State to people for menopause care. Is this policy decision feeding into the pharmacoeconomic assessment? Surely it is, as it would be a significant change in policy since the assessment commenced. It would surely add to the case for approving Veoza on the drugs payment scheme.

I mentioned that in Ireland we would have a slower process for approving new drugs under the DPS. Is there an indicative timeline for the pharmacoeconomic assessment? If there is not, will the Minister of State's officials raise it with the National Centre for Pharmacoeconomics to get a direction? Each month this goes on, this is an added cost for the women who are waiting. Has the Minister of State also examined the possibility of Veoza being included in a variant of the free HRT scheme?

Kieran O'Donnell (Limerick City, Fine Gael)
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I thank the Deputy for raising this issue, which I am taking on behalf of the Minister for Health, Deputy Carroll MacNeill. I will provide some background and then address the Deputy's question.

Fezolinetant, marketed under the trade name Veoza by Astellas Pharma is a medicine used to treat moderate to severe vasomotor symptoms such as hot flushes and night sweats associated with menopause. The European Medicines Agency granted marketing authorisation for this product in December 2023. The company marketing this medicine made an application for addition to the HSE reimbursement list in February 2024. The HSE has statutory responsibility for medicine pricing and reimbursement decisions, under the Health (Pricing and Supply of Medical Goods) Act 2013. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds on the advice of the National Centre for Pharmacoeconomics, NCPE. Formal processes govern applications for the pricing and reimbursement of medicines and new uses of existing medicines to be funded or reimbursed, or both. In March 2024, the NCPE completed a rapid review of Veoza. Factors that are evaluated during rapid review include the cost of the drug relative to potential comparators, uncertainty in comparative clinical effectiveness, uncertainty in cost effectiveness and the potential drug budget impact. On this occasion, the NCPE recommended a full health technology assessment, HTA, of Veoza to assess its clinical effectiveness and cost effectiveness compared with the current standard of care. Subsequently, the HSE commissioned a full HTA and a pre-submission consultation took place between the NCPE and the company in April 2024. The next step in the agreed process is for the applicant to submit a full HTA dossier to the NCPE. To date, a full HTA dossier has not been received by the NCPE. Given the substantial budgetary impact of the funds sought by the applicant, the company must engage with the pricing and reimbursement process in order for the application to progress.

The State acknowledges the importance of access to medicines and has made considerable investments in new medicines in recent years. A record of more than €3 billion, almost €1 in every €8 of public funding spent on health in 2023 was spent on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines. Between budget 2021 and budget 2024, an additional €128 million was allocated for new medicines, which facilitated the introduction of 194 new drugs for reimbursement by the HSE, including 74 for treating cancer and 46 for treating rare diseases. For 2025, funding of €30 million has been allocated to enable access to new medicines. This will come directly from efficiencies to be achieved by the HSE. Throughout this year and over the coming years, we will continue to focus on investment in medicines including through the maximisation of the considerable budget available, to ensure patients can access medicines in as timely a way as possible.

Aindrias Moynihan (Cork North-West, Fianna Fail)
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While the assessment is ongoing, this is costing €80 each month for women who do not an alternative option available to them. It has been a constructive move to get free HRT available to people. However, it is almost like it is dangling out there and there is a cohort of women who are not able to avail of it and damn it they have already had a hell of a challenge seeing off their cancer. It does not make to have a game-changer drug available and just not made available. We have what appears to be one of slowest processes for approving new drugs under the DPS. There must be some way of improving that and making drugs available in a more timely manner, especially when we see that the same drugs are being approved in other states across Europe. These women have seen off their cancer but because of their medical condition, they do not have the option to go for HRT. This other option is almost available to them. It is available to women who can afford to pay the €80 over and above the DPS threshold. Is there a way of prioritising it? Is there any indication of a timeline for approval? Will the Minister of State raise that with his officials and give some guidance to women across the country who would avail of Veoza?

Kieran O'Donnell (Limerick City, Fine Gael)
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I once again thank the Deputy for his interest in this important area. I will bring his comments to the attention of the Minister for Health and the officials in the Department. As the initial reply stated, the next step in the agreed process is for the applicant company to submit a full HTA dossier to the NCPE. To date, a full HTA dossier has not been received by the NCPE, which awaits that submission from the applicant company.

As stated, I will bring the points the Deputy raised to the attention of the Minister and her officials. The Deputy made a very cogent point on a particular issue for women.