Respreeza patients have to wait on next dose

Patients in receipt of a drug that slows the progression of genetic emphysema do not know when they will receive their next dose because of confusion over who is to administer the drug.

CSL Behring, the company which manufacturers Respreeza, said it was “anticipated” that the patients’ representative group, the Alpha-1 Foundation, together with the patients’ physician, would put individual arrangements in place so they could continue to receive weekly infusions.

However, the company said yesterday: “We cannot clarify if arrangements are in place yet.”

One of the patients, Johnny Hannan from Mallow, Co Cork, said GPs were, in general, unhappy to take on the task of administering Respreeza because they had neither the equipment nor the nurses to do it.

“Understandably the GPs don’t want to do it,” said Mr Hannan. “As of now, the drug is coming into the country, but it will just be sitting there because there is no one to administer it.”

Previously, nurses from Point of Care healthcare company were paid by CSL Behring to administer Respreeza to the 21 patients in receipt of it.

Those patients had access to the drug for a number of years, initially for participating in a clinical trial, and then via a compassionate access programme operated by CSL Behring while they awaited market approval for Respreeza.

The company had anticipated that the HSE would fund the drug once it got market approval in 2015. The HSE refused on the grounds that it was too expensive — about €84,000 per patient per annum.

Patients continued to have access as negotiations with the HSE dragged on, with a final deadline of September 30 set for reaching a deal.

Subsequently, CSL Behring offered to provide Respreeza until June 30, 2018, or until a new study testing the long-term efficacy of Respreeza begins, “whichever comes first”.

When this newspaper asked the HSE to clarify its position vis-a-vis the ongoing supply of Respreeza, it said: “The HSE contacted the company on October 19 seeking a meeting to discuss their proposals and to ensure that the company was fulfilling its obligations to the patients they had recruited.

“The company has indicated its availability to meet on November 13, following which we should know more about its intentions. However, our expectation is that the company will fulfil all of its obligations to this patient group.”

Kerry Fianna Fáil TD John Brassil, who has lobbied on behalf of Alpha-1 patients, said patients were “back in limbo”.