3286. Deputy Paul Lawless asked the Minister for Health if she will provide an update on the National Centre for Pharmacoeconomics' assessment of a drug (details supplied) for the treatment of progressive pulmonary fibrosis; when the manufacturer submitted the medicine for reimbursement consideration and the expected timeline for completion of the assessment and subsequent HSE reimbursement decision. [61106/26]

3289. Deputy Paul Lawless asked the Minister for Health if she will consider measures to expedite the assessment and reimbursement process for a drug (details supplied) recently authorised by the European Commission for the treatment of progressive pulmonary fibrosis, in view of the serious and progressive nature of the condition and the lack of time sensitive treatment options available to patients. [61108/26]

3291. Deputy James Lawless asked the Minister for Health if she is aware of the significant financial burden facing patients who may seek access to a drug (details supplied) privately while awaiting reimbursement decisions; and if her Department or the HSE is examining options to support eligible patients who cannot afford such treatment costs. [61113/26]

3292. Deputy James Lawless asked the Minister for Health whether her Department and the HSE have commenced engagement with a company regarding pricing and reimbursement negotiations for a drug (details supplied); and if she will outline the current status of those discussions. [61114/26]

3293. Deputy James Lawless asked the Minister for Health if she will outline the Government's strategy to improve access to innovative therapies for patients living with progressive pulmonary fibrosis; and if she recognises the need for accelerated pathways where new medicines demonstrate significant potential to reduce disease progression and mortality. [61116/26]

I propose to take Questions Nos. 3286, 3289, 3291, 3292 and 3293 together.

The Government is committed to investing in new medicines. Supported by €158 million of funding in Budgets 2021-2025, the State delivered access to 250 new medicines. 70 of these were for rare diseases. Budget 2026 allocated €217 million additional investment in medicines, including €30 million in funding for new medicines. This has, as of August 2026, delivered access to 30 new medicines, including 7 for rare diseases.

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines, in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The Minister has no role in decisions on pricing and reimbursement.

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.

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. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

To begin the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.

Ireland is ‘open for business’ and all pharmaceutical companies are encouraged to submit applications for reimbursement for new medicines that are granted marketing authorisation in Europe.

Further information on the progress of assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at www.sspcrs.ie/portal/rdt/pub/application/home.

As of the 25th August 2026, no pricing and reimbursement application has been received by the HSE for nerandomilast (Jascayd®).