The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister I have no role in this statutory process.
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 submit an application to the HSE to have the new medicine added to the reimbursement list.
Reimbursement is provided for licenced indications which have been granted a market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.
Pembrolizumab has been granted marketing authorisation for a number of indications and is included on the HSE reimbursement list for some of those indications. In addition, a number of other indications are currently being assessed for reimbursement.
Clinical trials for various immunotherapies, including pembrolizumab, are ongoing globally for a range of other possible indications which may receive marketing authorisation in the EU over the next number of years. Each of those indications will be considered for reimbursement as market authorisations are granted and applications received.