Joan Collins (Dublin South Central, Independent)
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18. To ask the Minister for Health the status of the negotiations between the HSE, Health Service Executive, and NCPE, National Centre for Pharmacoeconomics, and a pharmaceutical company (details supplied) regarding Orkambi for cystic fibrosis, in view of the fact it is 24 weeks since the original decision was made not to recommend Orkambi based on cost; and if he will make a statement on the matter. [37780/16]

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.

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 Orkambi. This dossier included details on all relevant costs and relevant cost offsets including those associated with hospitalisation, disease management costs, intravenous antibiotics, adverse events and any additional costs arising in patients not taking Orkambi.

The NCPE has completed its Health Technology Assessment and this is available on its website. It was submitted 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.

The HSE has recently completed its most recent round of negotiations with the manufacturer. On foot of this, the HSE’s Drugs Committee, having considered the NCPE recommendation and other expert advice, is in the process of sending its latest recommendation on the cost-effectiveness of Orkambi to the HSE Directorate. The HSE Directorate will then make a decision taking into consideration the manufacturers latest price offer. This decision will be made on objective, scientific and economic grounds in line with the 2013 Act.

I share the HSE's disappointment that the manufacturer in this case has maintained a very high price in the course of negotiations in relation to the potential reimbursement of Orkambi for Irish patients.

I appreciate that this is a very stressful time for Cystic Fibrosis patients and their families. However, I want to assure them that I do not consider this to be the end of the process. I would strongly urge Vertex, as the manufacturer in this case, to fundamentally reconsider its position and to table a pricing proposal which can facilitate the provision of Orkambi at a price that will represent value for money for the Irish health service, patients and the taxpayer.

I would also like to inform the Deputy that I have written to the Health Ministers in England, Scotland, Canada and Australia asking them to collaborate to try and make progress on accessing Orkambi at a cost effective price for cystic fibrosis patients in each of their countries.