Enda Kenny (Mayo, Fine Gael) | Oireachtas source

It is not about containment. The HSE service plan, as submitted to the Minister for Health and presented by him to the Cabinet, is based on over €800 million extra - almost €13 billion in total - being put into the health service. This means that services will be maintained and that €100 million has been left aside for new, additional and targeted services.

The Deputy makes the point that Orkambi lumacaftor-ivacaftor is a new drug that has come on the market for the treatment of cystic fibrosis. The HSE has statutory responsibility for decisions on the pricing of drugs and the reimbursement of medical products under the community drugs schemes in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Decisions on which medicines are reimbursed by the taxpayer are not political and not ministerial. They are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics, NCPE. This is a combination drug for the treatment of cystic fibrosis, with two copies of a specific CF gene mutation. The drug was approved by the Food and Drug Administration in the United States on 2 July and the European Medicines Agency three weeks ago on 19 November. On 26 November the manufacturer of Orkambi submitted a rapid review application to the NCPE. The rapid review represents the first step in making a pricing and reimbursement application. As of Friday, 4 December, the manufacturer had not submitted a full application for reimbursement to the HSE. However, based on pricing details in the rapid review file, the HSE estimates that the reimbursement could cost approximately €90 million per year. Given the significant budgetary impact, the NCPE is likely to require a full technology assessment of the drug to be carried out before making any recommendation to the HSE on reimbursement, in keeping wtih the normal procedure.

The Department and the HSE have made significant improvements to the facilities for CF sufferers around the country, particularly isolation units, which add greatly to their comfort and meet their needs. This matter is part of the application process which has a journey to travel.

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