3362. Deputy Barry Ward asked the Minister for Health further to Parliamentary Question No. 3305 of 28 July 2026, the position regarding any timeline available in relation to the negotiations related to the reimbursement status of Tucatinib (Tukysa); and if she will make a statement on the matter. [61319/26]

3369. Deputy Barry Ward asked the Minister for Health further to Parliamentary Question No. 3305 of 28 July 2026, if there is any means of expediting the process related to the reimbursement status of Tucatinib (Tukysa); and if she will make a statement on the matter. [61324/26]

3370. Deputy Barry Ward asked the Minister for Health further to Parliamentary Question No. 3305 of 28 July 2026, if she is conscious of the urgency in progressing the negotiations related to the reimbursement status of Tucatinib (Tukysa); and if she will make a statement on the matter. [61323/26]

3371. Deputy Barry Ward asked the Minister for Health further to Parliamentary Question No. 3305 of 28 July 2026, the position regarding any opportunity for submissions in relation to the reimbursement status of a medication (details supplied) ; and if she will make a statement on the matter. [61321/26]

3451. Deputy Richard Boyd Barrett asked the Minister for Health the additional measures she is considering to expedite the reimbursement decision for tucatinib, a necessary metastatic breast cancer medicine; and if she will make a statement on the matter. [60484/26]

3531. Deputy Richard Boyd Barrett asked the Minister for Health if she plans to intervene to facilitate speedy patient access to tucatinib metastatic cancer medicine for patients who have been advised by their oncology teams that this medicine is clinically appropriate; and if she will make a statement on the matter. [60501/26]

I propose to take Questions Nos. 3362, 3369, 3370, 3371, 3451 and 3531 together.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines.

Reimbursement is for licenced 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.

Further information on the progress of Tucatinib (Tukysa®) through the HSE assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at https://healthservice.hse.ie/staff/information-healthcare-workers/pcrs/corporate-pharmaceutical-unit/ .

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 wo have received at least two prior anti-HER2 treatment regimens.

The application was 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®) for this indication: https://assets.hse.ie/media/documents/HSE_Drugs_Group_-_March_2026_Minutes.pdf

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 wo 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. Representations received from the applicant remain under consideration.

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.