Grace Boland (Dublin Fingal West, Fine Gael)
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1869. To ask the Minister for Health if she intends to review how orphan medicinal products are assessed and reimbursed as part of the Programme for Government's commitment to conduct a review into Ireland's reimbursement process; and if she will make a statement on the matter. [12557/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My ambition is to deliver greater access for patients, including patients with a rare disease, to the latest innovative medicines.

In 2023, over €3.2 billion was spent on medicines by the State. This represents nearly €1 in every €8 of public funding being spent on health. The State has made an additional €128 million available for new drugs between 2020 and 2024. Up to November 2024, this has seen 194 new medicines approved for reimbursement by the HSE including 74 oncology drugs and 46 orphan medicines for rare diseases.

For 2025 an additional €30m will be made available for new drugs funding, through efficiencies identified by the joint DOH-HSE Medicines Sustainability Taskforce. The Department of Health, the HSE and all relevant agencies and stakeholders place a priority focus on achieving the most efficient and effective use of available resources. This ensures that the substantial investment in medicines is maximised to treat even more patients with new innovative therapies in the years to come.

This funding is in addition to a substantial investment in resources to enhance the HSE’s medicines pricing and reimbursement process. This includes 34 new staff now in post across the pricing and reimbursement system, and an online tracker which will allow patients and industry to follow the progress of an application through the assessment process.

Building this capacity will support agencies to operate to the fullest of their ability, providing timely and efficient evaluation of medicines for reimbursement. This will provide greater certainty to industry and incentivise timely applications for reimbursement.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to nine criteria including efficacy, the health needs of the public, cost-effectiveness and potential or actual budget impact -

(1) The health needs of the public,

(2) The cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

(3) The availability and suitability of items for supply or reimbursement,

(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,

(5) The potential or actual budget impact of the item or listed item,

(6) The clinical need for the item or listed item,

(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,

(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and

(9) The resources available to the HSE

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). There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and/or reimbursed.

The NCPE assess the information provided by health technology developers on the relative clinical effectiveness, cost effectiveness and budget impact of the new medicine compared to existing available treatments. In addition, the NCPE identify the key areas of uncertainty associated with these estimates. They do this in accordance with scientific rigour used in many other countries throughout Europe. It is recognised that there are limitations with the clinical evidence available to inform HTAs at the time of reimbursement application and this leads to a high level of uncertainty in the cost-effectiveness estimates.

Grace Boland (Dublin Fingal West, Fine Gael)
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1870. To ask the Minister for Health if the upcoming Rare Disease Strategy will provide recommendations/actions on how to improve Ireland's reimbursement process for innovative treatments for rare disease patients; and if she will make a statement on the matter. [12558/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The National Rare Disease Steering Group was established in December 2023, and was tasked with developing a new National Rare Disease Strategy for Ireland. The Steering Group are expected to finalise the Strategy in the coming weeks, following which it will be presented to me for consideration before the Strategy is officially launched.

I understand that the Steering Group has given consideration to a wide variety of areas including, but not limited to, research and innovation, genetics and genomics and orphan medicinal products as part of the development of this Strategy and that the Group's recommendations will reflect these important areas.