Clare Daly (Dublin Fingal, Independent)
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425. To ask the Minister for Health the factors in his decision not to recommend the Orkambi drug for cystic fibrosis patients. [15543/16]

Clare Daly (Dublin Fingal, Independent)
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429. To ask the Minister for Health if he recommends the use of Orkambi drug for cystic fibrosis patients. [15585/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 425 and 429 together.

I understand that this is a matter of great concern for many Cystic Fibrosis patients and their families and would like to clarify that the process of assessing Orkambi is not yet complete. I would also like to clarify the process, as the premise of your question is incorrect, and have set out the factual position below for your information.

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. Prior to deciding whether to reimburse a medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness and the resources available.

The 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 (NCPE). The NCPE conducts health technology assessments (HTAs) of pharmaceutical products for the HSE, and can make recommendations on reimbursement to assist the HSE in its decision-making process. The NCPE used a decision framework to systematically assess whether the drug is cost-effective as a health intervention.

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. 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 will now enter into negotiations with the manufacturer, to seek very significant price reductions. The HSE will then consider the outcome of these negotiations, together with the NCPE recommendation, in making a final decision on reimbursement.