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Compassionate use of Respreeza drug therapy discontinued

By Dermot - 08th Sep 2017 | 1 views

The therapy has been provided up until now as part of a compassionate-use programme by the drug company, CSL Behring. However, patients were today informed at a meeting with clinicians from Beaumont Hospital, Dublin, that the company has advised that it will no longer provide access to the therapy free of charge from September 30. 

The development follows the decision of the HSE on 10 August not to fund the therapy. Many of the patients involved have been on the therapy for more than ten years and have no other therapy option. Following the clinical trial, Respreeza was approved by the European Medicines Agency in 2015 and is the only therapy documented in a clinical study to slow the progression of lung disease caused by Alpha-1. Clinical trial results published in The Lancet in 2015, and in The Lancet Respiratory Medicine in 2016, conclusively demonstrated a slowing down in the progression of emphysema by 34 per cent in patients with severe Alpha-1. An Alpha One Foundation patient survey has also shown a decrease in the frequency and severity of chest infections and associated hospital admissions. 

Ms Geraldine Kelly, CEO, Alpha One Foundation, comments:”For months now, we have been campaigning for the approval of the life-changing therapy Respreeza in Ireland. It is the only approved therapy to slow progression of emphysema in these patients and, if approved, would we believe benefit up to 60 people with severe Alpha-1 in Ireland. Of that group of patients, 21 have been fortunate to have already been able to access the therapy  ̶  some for over ten years  ̶  and it has been a life-changer for them. “Last month we learned of the decision of the HSE not to fund the therapy, which was a devastating blow to the patients affected. Today, we see the fallout of that position with the decision by CSL Behring to stop the therapy for the 21 people who have been accessing it to date. “Both decisions are unconscionable.

“We have a therapy that works and that has been proven effective and it is wrong of the HSE and the Department of Health not to fund it. Equally, it is wrong for a company to discontinue a therapy that works to patients who have provided it with a rich resource of research information that has undoubtedly been of huge commercial benefit. “Patients are distraught. They have been through the most anxious time over past months, where they have been living under a constant shadow of the withdrawal of this therapy. Now, it would seem, their worst nightmare is coming true. While structures and supports are necessarily being put in place by medical staff at Beaumont Hospital to monitor patients’ health when they come off this therapy, the Alpha One Foundation still hopes these steps will not be necessary.”

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