I propose to take Questions Nos. 751 and 784 together.
The HSE's National Cancer Control Programme (NCCP) advise that Nivolumab and Pembrolizumab are licensed by the European Medicines Agency as monotherapy for the treatment of advanced melanoma in adults and are approved by the HSE for reimbursement in public hospitals. A Health Technology Assessment has been completed that looks at the use of these drugs as monotherapy for the adjuvant treatment of adults with Stage III melanoma and the approval process for the reimbursement of these drugs is ongoing.
The HSE has a standard assessment process in place for the approval of the reimbursement of new drugs and new indications for existing drugs. This process is intended to arrive at decisions on the funding of drugs that are clinically appropriate, fair, consistent and sustainable. The reimbursement process is underpinned by the Framework Agreement on the Supply and Pricing of Medicines (2016) and the Health (Pricing and Supply of Medical Goods) Act 2013.
Before a medicine is licensed for use in the European Union, and before it can be marketed for sale in the EU, it must receive a market authorisation from the European Medicines Agency. Once drugs are licensed, the company may apply for HSE reimbursement approval using the standard process.
The Department of Health, along with the NCCP and the wider HSE, work together in advancing the process of securing such drugs at affordable cost once the European Medicines Agency (EMA) has approved them for clinical use.
Finally, my Department cannot comment on the business decisions taken by private health insurers with regard to the medicines covered under their schemes.