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Last week it was reported that the HSE was unlikely to reimburse the drug Respreeza, following a decision by the National Centre for Pharmacoeconomics (NCPE) in late 2016 not to approve funding for the therapy. Yesterday, HSE Director General Mr Tony O’Brien said HSE management would not be recommending the reimbursement of Respreeza but that the Executive never closes the door to further discussions.
“Our patients with AAT [Alpha-1 antitrypsin] deficiency are very upset at this decision and the way it has been imparted to the public,” Prof Gerry McElvaney, Consultant in Respiratory Medicine in Beaumont Hospital, Dublin, and Head of the Department of Medicine, RCSI, told the <strong><em>Medical Independent</em></strong> (<strong><em>MI</em></strong>) on 16 February.
“Our patients and the Alpha One Foundation have been kept in the dark throughout this process. They have requested a meeting with the Minister and the NCPE, which have been refused.”
Since a clinical trial of Respreeza — known as the RAPID study — began in Ireland in 2006, some 21 people have been offered access to the therapy by maker CSL Behring on a “compassionate” basis, with some patients receiving the treatment for almost a decade. It is also estimated that a further 40 patients would benefit.
The RAPID study, published in <em>The Lancet</em> in 2015, conclusively found that Alpha-1 patients treated with Respreeza saw a significant slowing-down by 34 per cent in the progression of emphysema, as measured by CT scan.
“The NCPE casts doubts about the efficacy of the medication,” said Prof McElvaney. “They are incorrect. The data on the effectiveness of this medication is unequivocal. What is at question is whether the effectiveness warrants the cost. In that regard, I would have reservations about the costings put out by the NCPE in [<em>The Irish Times</em>] newspaper report today [16 February] as they seem far too high and in any case, I think that is the area where sensible negotiation would lead to a lower price.”
In December 2016, approval for funding reimbursement was declined by the NCPE at the €84,364.80 cost (excluding VAT) submitted by CSL Behring.
“Ccompassionate” access to the drug was due to cease at the end of this month. However, the company has announced a further two-month extension.
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