Stephen Donnelly (Wicklow, Fianna Fail)
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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. Over the last 3 years the State has invested €98 million in new medicines, providing 148 new medicines or extended uses for medicines, including 39 medicines with an orphan designation. €98 million represents only the initial cost of these medicines. The spending on these medicines is estimated at €327.5 million to the end of 2023.

The HSE will have €30 million to spend on new drugs in 2024. This comprises €20 million of new development funding and a further €10 million, to be generated through HSE efficiencies, which will also be re-invested in new drugs. 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 will deliver 34 new staff, and an online tracker which will allow patients and industry to follow the progress of an application through the assessment process. I am keen to provide this transparency for patients and I appreciate their important role in this 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 has undertaken 756 Health Technology Assessments (HTAs) in the period 2019-2023, rising from 92 in 2019 to 238 in 2023.

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.

The NCPE have taken a leading role in the development of cross-country guidelines for comparative clinical effectiveness which will be used across Europe under the new HTA Regulation, under which many medicines for rare diseases will be assessed from 2025 onwards. In particular, Ireland has worked closely with other countries, via the Beneluxa Initiative, in trying to identify and address the challenges that this has posed for healthcare systems.