Margaret Murphy O'Mahony (Cork South West, Fianna Fail)
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351. To ask the Minister for Health if the clinical trial of the drug Respreeza, which treats emphysema caused by severe alpha-1, will continue to be made available to the 21 patients who are currently receiving the drug; if it will be made available to approximately 40 more patients if current assessments are favourable; and if he will make a statement on the matter. [33553/16]

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. 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 is currently conducting an assessment of Respreeza as maintenance treatment of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency. Once this assessment is completed, a summary report will be published on the NCPE website. The HSE will then consider the NCPE assessment as part of its decision-making process when considering the drug for reimbursement.

As the NCPE's assessment of Respreeza is ongoing, it is not possible to provide further details at this time.

I understand that for patients currently accessing Respreeza on a compassionate use basis, the company CSL Behring, will continue to provide and administer the drug until the end of the year. However the operation of compassionate access schemes are at the discretion of manufacturers. I have previously asked manufacturers to show compassion to reopen or maintain compassionate access schemes to patients during the assessment process by the HSE.