Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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72. To ask the Minister for Health if he is aware of the drug Nivolumab, an immunosuppressant drug treatment for cancers that experts have described as a game-changer; if he will license this drug once the clinical trials are completed; and if he will make a statement on the matter. [3936/16]

Kathleen Lynch (Cork North Central, Labour)
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The cancer drug Nivolumab (trade name Opdivo) was authorised by the European Medicines Agency in June 2015; this means that it is approved for use in all EU Member States.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available to the HSE.

Decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. They are not political or ministerial decisions. The National Centre for Pharmacoeconomics conducts the health technology assessment of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process.

Nivolumab is currently being considered by the HSE under the national medicines pricing and reimbursement assessment process. As the assessment process is ongoing, it would not be appropriate for me to comment further on this process, which is an independent function of the HSE.