Dáil Éireann Debate, Tuesday - 7 July 2020
751. Deputy Peter Burke asked the Minister for Health if he will examine the standard treatment plan and drug use for those suffering with stage III melanoma; if he will authorise the use of nivolumab and pembrolizumab for this condition in the public system in view of the fact it is currently the authorised treatment for this condition in the private health system; and if he will make a statement on the matter. [14146/20]
View answer784. Deputy Niamh Smyth asked the Minister for Health if patients diagnosed with melanoma in the public health system here are only offered immunotherapy when in stage IV of the illness; the reason such treatment is not offered at stage III in view of the fact that half of patients at this stage advance to the next; his views on whether more lives would be saved if persons were offered such treatment earlier; if his attention has been drawn to the fact that adjuvant immunotherapy nivolumab, pembrolizumab and targeted therapy are available to some with private health insurance here but the public health service is not funding the medications; his further views on whether this is consistent with the goals of the National Cancer Strategy; and his plans to improve stage III melanoma treatments. [14210/20]
View answerI 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.
