Simon Harris (Wicklow, Fine Gael)
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The HSE assessed the application for the pricing and reimbursement of Respreeza and in August 2017, the manufacturer, CSL Behring, was notified that the HSE did not recommend reimbursement.

A number of patients were on an access scheme for this product, operated by the manufacturer, for the treatment of Alpha-1 Antitrypsin Deficiency. That scheme was being run independently by the manufacturer without reference to the HSE.

The company notified the HSE that it had decided to terminate the access scheme from 30 September 2017. Following interventions by the HSE, the company modified its decision and agreed to continue to supply the medication free of charge for the patients on the access scheme. Due to the critical and exceptional circumstances, the HSE agreed to fund the provision of the necessary nursing service to ensure that patients could continue to receive the medicine

The HSE is continuing to liaise with the treating Consultant and the company and has drafted the terms of an agreement for the long term care of the 19 alpha one clinical trial patients. This proposal is being reviewed by CSL Behring and it is hoped that a final agreement can be reached shortly.

In so far as the provision of Respreeza to other patients is concerned, it is open to the company to submit a new reimbursement application which will be assessed by the HSE in line with the Health (Pricing and Supply of Medical Goods) Act 2013. As the Deputy will appreciate, the Minister for Health has no statutory role in such matters.