Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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454. To ask the Minister for Health the average time taken by the National Centre for Pharmacoeconomics and her Department to complete health technology assessments and reimbursement decisions on oncology drugs in the past three years; and whether target timelines exist to expedite access for public patients. [52825/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The State is committed to providing timely access to new and innovative medicines to all patients. Work is ongoing and consideration is being given to various measures to address access to medicines, including to ensure faster access. Budgets 2021 to 2025 allocated an additional €158 million for new medicines, which has facilitated the introduction of 238 new medicines, 97 of which are for the treatment of cancer.

The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. This arises from the Health (Pricing and Supply of Medical Goods) Act 2013. The Act provides a rigorous process for the assessment of new medicines for reimbursement. This enables taxpayers to be confident that the right medicines are chosen, at a sustainable price.

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

HSE decisions on which medicines are reimbursed by the State via public funds are made on objective, scientific and economic grounds, and having regard to the advice of the National Centre for Pharmacoeconomics (NCPE).

The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the NCPE for assessment. The NCPE may advise that a full Health Technology Assessment (HTA) is recommended, which would then be commissioned by the HSE as per the agreed processes. The NCPE endeavours to issue a Rapid Review Assessment report within four weeks of receipt and issue the formal pharmacoeconomic assessment (i.e. HTA report) within 90 days (allowing for the ‘stop-clocks’ process). The timeline for the full HTA process is variable as this is a “stop-clock process”.

The NCPE uses a decision framework to systematically assess whether a medicine is cost-effective. This includes clinical effectiveness and health-related quality-of-life benefits, which the new treatment may provide and whether the cost requested by the pharmaceutical company is justified. The potential budget impact of a medicine is also assessed.

Following the recommendation from the NCPE, the HSE examines all the evidence which may be relevant for the decision; the final decision on reimbursement is made by the HSE. In the case of cancer drugs, the NCPE recommendation is also considered by the National Cancer Control Programme (NCCP) Technology Review Group. The time from HTA completion to reimbursement decision is variable as it depends on the outcome of price negotiations with pharmaceutical companies.

Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). Pharmaceutical companies must apply to the HSE for reimbursement.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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455. To ask the Minister for Health if her Department has entered into outcomes-based or risk-sharing agreements with pharmaceutical companies in respect of new cancer drugs; and if so, to provide details of the drugs concerned, the duration of the agreements, and the outcomes being measured. [52826/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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456. To ask the Minister for Health the projected level of additional annual funding required over the next five years to ensure that all newly approved cancer drugs are made available to public patients in a timely manner; and whether ring-fenced oncology funding is being considered within her Department. [52827/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for pricing and reimbursement of new medicines.

The State has committed very substantial amounts of funds to the HSE to support new medicines (and new use of medicines) and continues to do so on an ongoing basis. Budgets 2021-2025 allocated dedicated funding for new drugs totalling €158 million. This allowed the HSE to approve 238 new medicines including 97 new oncology drugs in that period. Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

The HSE in its decision making considers the 5-year budget impact of each new medicine notwithstanding that the budget of the HSE is set on an annual basis. The year 1 costs of most medicines represent a fraction of the overall costs of those medicines when fully introduced.

In any single year there will be substantial uncertainty around the costs that will emerge in the year in question at the time that the budget is set.

On occasion, medicines expected to reach the market in a particular year at time of budget planning will not ultimately reach the market as they may fail to demonstrate that they satisfy the safety, efficacy and / or quality standards required to receive a market authorisation from the European Medicines Agency (EMA). In addition, any application from a market authorisation holder, may not occur in the year forecast in the horizon scan.

The full cost of new medicines (or new use of medicines) approved will never emerge within the first calendar year of reimbursement approval, given some of those approvals will be effective in Q1, some in Q2 (i.e. partial year costs), some in Q3 (i.e. less than half year costs) and some in Q4 (with little or no costs in that calendar year but substantial and growing costs in the next year).

In addition, the HSE undertakes commercial negotiations for new drugs on behalf of the State to deliver substantial savings in the medicines budget, thereby creating financial headroom to maximise budget utilisation.

The HSE is committing all resources as allocated to the provision of new medicines over time, notwithstanding any inter-year variations. Given the uncertainties outlined, the estimation and allocation of required budgets is conducted on an annual basis. This ensures optimal use of State funds to provide care for patients in Ireland.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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457. To ask the Minister for Health whether her Department has carried out any equality or impact assessment on disparities in access to oncology drugs between public and private patients; and if so, to publish those findings. [52828/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The State is committed to providing timely access to new and innovative medicines to all patients. Budgets 2021 to 2025 allocated an additional €158 million for new medicines, which has facilitated the introduction of 238 new medicines. 91 of these are for treating cancer as well as 55 for rare diseases.

In 2024, the HSE launched an application tracker to increase transparency in the medicines assessment process. In addition, the 34 staff allocated in Budget 2024, have been hired across the pricing and reimbursement process. These measures will enable the assessment of a greater number of medicines at a quicker pace and ensure patients can easily remain informed of progress.

The timing of company applications for new medicine reimbursement in different countries can vary for several reasons, not least the available market share in each country.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation from the European Medicines Agency (EMA), it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.

The Minister for Health regulates the community rated private health insurance market in Ireland. This is a voluntary market, which operates under principles including minimum benefits, requiring insurers to offer a minimum level of cover in every insurance policy. Health insurance companies may exclude or include certain services and providers in their policies, provided they remain in compliance with the Minimum Benefit Regulations. Beyond Minimum Benefits regulations, the Minister has no role to play in the commercial decisions of any health insurer.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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458. To ask the Minister for Health to provide comparative data on the time from European Medicines Agency approval to reimbursement for new oncology medicines in Ireland versus other EU member states; and to indicate whether Ireland is above or below the EU average. [52829/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. This arises from the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for licensed indications which have been granted marketing authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). Pharmaceutical companies must apply to the HSE for reimbursement.

Once a company responsible for the commercialisation of a new medicine receives marketing authorisation, it can apply for reimbursement in the country (or countries) of its choice. Ireland, by virtue of its size and market share, may not always be prioritised by a company in the first stages of marketing a new product. This is an important factor affecting the timelines for reimbursement from EMA approval to HSE reimbursement approval, as statutorily, the HSE cannot add a new medicine to the reimbursement list until an application is received.

Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor and misrepresent the process, as statutorily the HSE is not able to add a new medicine to the reimbursement list until an application is received. Additionally, the initial commercial offering from manufacturers for medicines can have significant implications for the negotiation process, including its duration. In the context of a finite health budget, it is vital that the State ensures good value for money for public expenditure, and to ensure that the available budget maximises as much access as possible to medicines and other healthcare services for patients.

Ireland encourages all pharmaceutical companies to apply to the HSE to have their medicines added to the reimbursement list once granted marketing authorisation by the European Medicines Agency. Reimbursement timelines vary by country due to market size and company strategy.

An external review of the pricing and reimbursement process, the Mazars Review, was published in 2023. The Mazars Review determined that the pricing and reimbursement process operated in line with international norms and made a number of recommendations to improve the process, resulting in:

1) the implementation of an application tracker for the medicines assessment process which was launched by the HSE in 2024.

2) the hiring of 34 staff across the pricing and reimbursement system in 2024.

These measures will enable the assessment of a greater number of medicines at a quicker pace and provide transparency to all stakeholders including patients around the status of the pricing and reimbursement application of a new treatment.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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459. To ask the Minister for Health if she will publish in full the rationale, minutes, and assessments underpinning reimbursement decisions on oncology drugs since 2020; and if not, the reason for the continued confidentiality. [52830/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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460. To ask the Minister for Health whether a national registry of oncology patients treated with newer cancer therapies is maintained; and if so, to outline how this real-world data informs reimbursement and future access decisions. [52831/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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There is no dedicated national registry for oncology patients receiving new cancer therapies.

The National Cancer Registry Ireland (NCRI) collects, classifies, and analyses data on cancer incidence and prevalence across the country. It tracks newly diagnosed cancer cases and related tumours, including some subsequent tumours if they meet registration criteria. However, its focus is primarily on initial diagnoses and does not comprehensively track relapses or long-term treatment outcomes, including newer therapies.

In terms of the reimbursement of medicines, the HSE has advised it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available to it.

The HSE robustly assesses applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds. 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 first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The NCPE may advise that a full Health Technology Assessment (HTA) is recommended, which would then be commissioned by the HSE as per the agreed processes.

The NCPE uses a decision framework to systematically assess whether a technology is cost-effective. This includes clinical effectiveness and health related quality-of-life benefits, which the new treatment may provide and whether the cost requested by the pharmaceutical company is justified.

Following the recommendation from the NCPE, the HSE examines all the evidence which may be relevant for the decision; the final decision on reimbursement is made by the HSE. In the case of cancer drugs, the NCPE recommendation is also considered by the National Cancer Control Programme (NCCP) Technology Review Group.

Ken O'Flynn (Cork North-Central, Independent Ireland Party)
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461. To ask the Minister for Health the steps being taken to accelerate the availability of oncology generics and biosimilars to reduce cost barriers for the public health system; and whether legislative or regulatory reform is being considered in this regard. [52832/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Government recognises the importance of timely access for patients to new medicines. The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines is the focus of a number of workstreams across my Department.

Budgets 2021-2025 allocated an additional €158 million for new drugs, which facilitated the introduction of 238 new medicines in that period. 97 of these are for use in oncology. The HSE in its decision making considers the 5-year budget impact of each new medicine notwithstanding that the budget of the HSE is set on an annual basis. The year 1 costs of most medicines represent a fraction of the overall costs of those medicines when fully introduced.

In 2023 a review of the drug reimbursement process was published. It found that the process was operating as intended and within international norms. Recommendations from the review have now been implemented. A pricing and reimbursement application tracker has been launched to improve transparency. In 2024 an additional 34 staff were recruited to enhance capacity across the pricing and reimbursement system.

Access to medicines requires industry and the State to work together, through timely assessment, and reasonable pricing with fully completed HTAs (Health Technology Assessments). The Government encourages pharmaceutical companies to submit timely applications for reimbursement.

My Department is looking at reimbursement systems across the European Union and working closely on access to medicines with Beneluxa partners, where we have had previous success.

As outlined in the Programme for Government, consideration will be given to early access mechanisms for medicines. These mechanisms and their effects are complex and must be evaluated carefully.

Donna McGettigan (Clare, Sinn Fein)
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462. To ask the Minister for Health the number of patients precluded from accessing CAR T-cell treatment due to the current age restriction on the treatment, per county, in tabular form; and if she will make a statement on the matter. [52849/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this is a service matter, I have asked the Health Service Executive to respond to the deputy directly, as soon as possible.