Billy Kelleher (Cork North Central, Fianna Fail)
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226. To ask the Minister for Health the status of the negotiations between the Health Service Executive's National Centre for Pharmacoeconomics and a pharmaceutical company (details supplied) regarding the drug Orkambi; and if he will make a statement on the matter. [31265/16]

Gerry Adams (Louth, Sinn Fein)
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232. To ask the Minister for Health the position regarding the making available of Orkambi to cystic fibrosis sufferers; and if he will make a statement on the matter. [31318/16]

Gerry Adams (Louth, Sinn Fein)
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233. To ask the Minister for Health the negotiations the government has undertaken with the supplier of Orkambi (details supplied) to ensure the supply of this needed drug following the National Centre for Pharmacoeconomics recommendation that Orkambi was deemed not to be cost effective; and if he will make a statement on the matter. [31319/16]

Gerry Adams (Louth, Sinn Fein)
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234. To ask the Minister for Health if he has raised the issue of unjustified pricing of life-changing drugs such as Orkambi at EU Council level; if his attention has been drawn to the pricing of Orkambi being an issue in other countries across the EU; and if he will make a statement on the matter. [31320/16]

Alan Kelly (Tipperary, Labour)
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241. To ask the Minister for Health the reason the drug Orkambi is not being made available to cystic fibrosis patients here (details supplied). [31434/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 226, 232 to 234, inclusive, and 241 together.

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.

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

Decisions on pricing and reimbursement of pharmaceutical products within public health systems are a national competence for EU Member States. However, the issue of pricing and reimbursement of medicines and patient access to affordable medicines has been addressed at European level. In June of this year the EU Council adopted conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States. Those conclusions invited Member States to explore opportunities for cooperation on pricing and reimbursement of medicines and to identify areas for cooperation which could contribute to higher affordability and better access to medicines. I have indicated my support for these measures and I welcome the opportunity for Member States to cooperate by sharing information so that we can achieve affordable and sustainable access to medicines.