Joe Carey (Clare, Fine Gael)
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241. To ask the Minister for Health if he will re-enter negotiations with a company (details supplied), the manufacturer of the cystic fibrosis drug Orkambi, with a view to reaching an agreement and enabling persons with cystic fibrosis here to access the recognised health benefits from its use; and if he will make a statement on the matter. [34210/16]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

These decisions are made on objective, scientific and economic grounds by the HSE. In reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision and will take into account such expert opinions and recommendations which may have been sought by the HSE, including, for example, advice from the National Centre for Pharmacoeconomics.

I am informed that, following a request from the HSE, the NCPE carried out an assessment of the manufacturer's economic dossier submitted in March 2016 on the cost effectiveness of lumacaftor/ivacaftor (Orkambi). This dossier included details on all relevant costs and relevant cost offsets including hospitalisation, disease management costs, intravenous antibiotics, adverse events and any additional costs arising in patients not taking Orkambi.

The NCPE has completed its HTA and submitted it to the HSE in June 2016. The NCPE determined, following an evaluation of the economic dossier, that the manufacturer failed to demonstrate cost-effectiveness or value for money from using the drug. The NCPE have confirmed that all relevant costs were included in the analysis. A summary of the HTA has been published on the NCPE website and is available at: .

The HSE has since had further engagements with the manufacturer in an effort to secure significant price reductions for Orkambi. This process is ongoing The HSE will consider the outcome of these engagements and any other, together with the NCPE recommendation, in making a final decision on reimbursement.