Dáil Éireann Debate, Thursday - 2 October 2025
454. Deputy Ken O'Flynn asked 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]
View answerThe 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.
