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 and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must apply to have the new medicine added to the reimbursement list.
Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE).
Pembrolizumab has market authorisation in Ireland/the EU for a number of indications.
The HSE has approved the reimbursement of Pembrolizumab for the following indications:
- as monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults;
- as monotherapy for the first-line treatment of metastatic non-small cell lung carcinoma (NSCLC) in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations;
- as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
It should be noted that the first part of the last indication is not reimbursed because the HSE is already reimbursing another immunotherapy with similar efficacy (nivolumab) at lower cost. Patients who are transplant-ineligible and have failed BV can receive reimbursement support for pembrolizumab, as nivolumab does not have market authorisation for this sub-group of patients.
Pembrolizumab is currently being assessed by the HSE, using the criteria as set out in the Health (Pricing and Supply of Medical Goods) Act 2013, for a number of other indications for which it has received marketing authorisation.