Tony McLoughlin
Question:1316. Deputy Tony McLoughlin asked the Minister for Health when the HSE will make Pembrolizumab available for NSCLC patients with a low PD-L1 expression; and if he will make a statement on the matter. [32410/18]
View answerTuesday, 24 July 2018
Questions (1316)
Written answers
The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. As Minister for Health, I do not have any statutory power or function in relation to the reimbursement of medicines.
In Ireland the majority of patients access medicines through the publicly funded community drug schemes. In line with the 2013 Act, if a company would like a medicine to be reimbursed by the HSE through the community drugs schemes, it must submit an application to have the new medicine added to the reimbursement list.
The Department has been informed by the HSE that it is currently assessing the following indication for reimbursement of pembrolizumab.
= As monotherapy for the treatment of locally advanced or metastatic NSCLC in adults whose tumours express PD-L1 with a 1% TPS and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving pembrolizumab.
The National Centre for Pharmacoeconomics (NCPE) completed a health technology assessment in May 2018 for this indication. The NCPE recommended that pembrolizumab be considered for reimbursement if cost-effectiveness can be improved relative to existing treatments. The HSE will now evaluate this application, in line with criteria laid out within the 2013 Act, before making a final reimbursement decision.