3305. Deputy Barry Ward asked the Minister for Health the position regarding negotiations ongoing in relation to the approval for reimbursement status of a drug (details supplied), which is used as part of the wider treatment of some cancers; and if she will make a statement on the matter. [55769/26]

3306. Deputy Barry Ward asked the Minister for Health the action she will take to engage with the HSE to expedite delays in relation to the approval for reimbursement status of a drug (details supplied) which is used as part of the wider treatment of some cancers; and if she will make a statement on the matter. [55770/26]

3307. Deputy Barry Ward asked the Minister for Health if she will consider facilitating a meeting with a person diagnosed with cancer and their supporters in relation to adding a cancer treatment to the list of approved drugs for reimbursement (details supplied); and if she will make a statement on the matter. [55771/26]

3308. Deputy Barry Ward asked the Minister for Health the reason that a drug used in the treatment of cancer (details supplied) is not available for reimbursement status for patients in Ireland in spite of its widespread use in the EU and approval for use by the European Medicines Agency; and if she will make a statement on the matter. [55772/26]

3309. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to a detailed submission in relation to adding a cancer treatment to the list of approved drugs for reimbursement (details supplied); and if she will make a statement on the matter. [55773/26]

3359. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to the case of a person (details supplied); the steps she will take to ensure that they have access to the level of treatment required; and if she will make a statement on the matter. [56012/26]

I propose to take Questions Nos. 3305 to 3309, inclusive, and 3359 together.

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.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA). In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list.

Applicants must continue to engage throughout the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Act. The Act specifies nine criteria which must be considered. These include the health needs of the public and the clinical need for the medicine. All these factors, taken together, allow the HSE to make an informed decision on new medicines.

In terms of the specific details of the application for pricing and reimbursement of tucatinib (Tukysa®):

The HSE received an application for pricing and reimbursement on the 23rd of August 2022 from Seagen, since acquired by Pfizer (the applicant), for tucatinib (Tukysa®) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.

• 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 HSE commissioned the Rapid Review process on the 23rd of August 2022.

• The NCPE Rapid Review assessment report was received by the HSE on the 20th of September 2022. The NCPE advised the HSE that a full health technology assessment (HTA) is recommended to assess the clinical effectiveness and cost effectiveness of tucatinib compared with the current standard of care.

• The HSE commissioned a full HTA on the 28th of September 2022 as per agreed processes.

• The NCPE HTA Report was received by the HSE on the 25th September 2025. The NCPE recommended that tucatinib not be considered for reimbursement unless cost effectiveness can be improved relative to existing treatments: www.ncpe.ie/tucatinib-tukysa-hta-id-22058/ .

• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. The HSE CPU has met with the applicant to discuss this application.

• The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Management Team. The totality of clinical and economic evidence for tucatinib (Tukysa®) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens was comprehensively and extensively reviewed by the Drugs Group at the March 2026 meeting. The Drugs Group, by majority, did not recommend in favour of reimbursement of tucatinib (Tukysa®) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens: assets.hse.ie/media/documents/HSE_Drugs_Group_-_March_2026_Minutes.pdf.

• The decision-making authority in the HSE is the HSE Senior Management Team. The HSE Senior Management Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE Senior Management Team supported the Drugs Group recommendation not to reimburse tucatinib (Tukysa®) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens.

• In line with the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE provided formal written notice to the applicant of the HSE Senior Management Team’s proposed decision not to reimburse tucatinib (Tukysa®) in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens on the 8th May 2026.

The applicant has submitted representations on the proposed decision to the HSE, which remain under consideration. The HSE cannot comment on potential outcomes pending the notice of proposal and representation process.