Dáil Éireann Debate, Tuesday - 3 March 2026
933. Deputy James O'Connor asked the Minister for Health if she will outline the approach adopted when processing medicine reimbursement applications for combination therapies for cancer patients in the public system; and if she will make a statement on the matter. [16984/26]
Amharc ar fhreagra938. Deputy Colm Burke asked the Minister for Health the approach adopted when processing medicine reimbursement applications for combination therapies for cancer patients in the public system; and if she will make a statement on the matter. [17031/26]
Amharc ar fhreagraI propose to take Questions Nos. 933 and 938 together.
The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess 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.
Once a medicine is approved by the European Medicines Agency, the HSE is dependent on a pharmaceutical company making an application to Ireland for its drug or new indication to be assessed for reimbursement.
All medicines are considered for pricing of reimbursement in order of application from companies including combination therapies for treating cancer.
While many companies engage proactively with the HSE, Ireland, by virtue of its size and market share, may not always be prioritised by some companies in the first stages of marketing a new medicine. Reports describing timelines for reimbursement from EMA approval to HSE reimbursement approval do not consider this important factor, as statutorily the HSE are not able to add a new medicine to the reimbursement list until an application is received.
The National Centre for Pharmacoeconomics (NCPE) conducts the Health Technology Assessment (HTA) of drugs for the health service in Ireland in collaboration with the HSE's Corporate Pharmaceutical Unit (CPU). They assess comparative clinical effectiveness and cost-effectiveness of drugs compared to current standard of care. The NCPE engages with stakeholders, including patients and clinicians, throughout the assessment process.
The HSE’s CPU is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
The HSE Drugs Group is a national committee that makes recommendations on the pricing and reimbursement of drugs in Ireland using the criteria set out in the 2013 Act to the HSE Senior Leadership Team.
The decision-making authority in the HSE is the HSE Senior Leadership Team.
