Pearse Doherty (Donegal South West, Sinn Fein)
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389. To ask the Minister for Health if a decision has been made by the Health Service Executive to include the drug Daxas in the community drugs scheme; and if he will make a statement on the matter. [5456/15]

Kathleen Lynch (Cork North Central, Labour)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013.

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. They are not political or ministerial decisions.

The HSE received an application for the inclusion of Roflumilast or Daxas® to give it its brand name in the GMS and community drugs schemes. The National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of Daxas in 2010.

The assessment report concluded that the manufacturer had not demonstrated the cost effectiveness of Roflumilast. The HSE considered this report and other evidence but was unable to support reimbursement as the available evidence submitted by the pharmaceutical company was insufficient. In these circumstances, Roflumilast, was not added to the HSE Reimbursement List.

I understand that the pharmaceutical company Takeda have a multinational clinical trial on-going in an attempt to develop sufficient evidence to allow the HSE and other international reimbursement agencies to re-consider reimbursement. To date there is no evidence of publication of the results of the new clinical trial by Takeda, however, it is expected that the company will re-submit a pricing and reimbursement application when the results of this trial are available to it.