Caoimhghín Ó Caoláin (Cavan-Monaghan, Sinn Fein)
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467. To ask the Minister for Health the reason for the uncertainty of supply of the drug Respreeza that is critical to the continued treatment of those alpha 1 sufferers who have been in receipt of the therapy; the steps he will take to remove doubt or fear regarding continuity of supply; the steps taken and commitment to date in 2017 to ensure access to Respreeza for those persons not in receipt of the drug; and if he will make a statement on the matter. [31489/17]

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.

The HSE has considered the issue of reimbursement of Respreeza for maintenance treatment of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency.

The HSE has decided not to support reimbursement of the medicine.

The HSE in such instances is required under the Health (Pricing and Supply of Medical Goods) Act 2013 to issue a notice of proposal to the applicant company setting out that it is minded to not reimburse this medicine and the reasons why.

The company is entitled to make written representations and must be provided with at least 28 days in which to do so. The HSE is required to consider carefully any written representations it receives from the applicant company.

The notice period for applicant company representations has recently ended and the HSE is now considering the representations received from the applicant company. The HSE has also met with the company to fully understand its representations.

A final decision by the HSE can only be made after the representations received under the 2013 Health Act processes have been carefully considered.