A shipment of Respreeza, the only therapy shown to slow the progress of genetic emphysema, arrived into the country yesterday but will remain warehoused in a row over who should pay distribution and administration costs.
In the meantime, the 21 patients in receipt of the drug will have to forego upcoming doses until a resolution is reached. It has been claimed a further 40 patients could benefit from this drug.
Up until now, the drug company, CSL Behring, has covered these costs — €120,000 per annum — for the 21 patients.
The company claims that it was agreed with the Alpha One Foundation, the research group which lobbies for the patients, and their doctor, that “alternative arrangements would be found” to administer the infusions from mid-October.
Foundation chief executive Geraldine Kelly said they are struggling to put these arrangements in place and have put a number of proposals to the HSE, including that patients be allowed receive the infusions at a primary care centre or local hospital.
The HSE told the Irish Examiner the problems for the patients “are being caused entirely by the decisions of the pharmaceutical company”.
A spokesperson said: “The answer to this quite simply is for CSL to continue the arrangements as they have existed for many years and to stop this persistent manipulation of patients in pursuit of corporate interests.”
The HSE said it had requested on October 19 to meet CSL, but it is unavailable until November 13.
CSL argues it has already provided Respreeza to patients free of charge for more than a decade, initially via participation in a clinical trial and then on a compassionate-use basis while they awaited market approval for the drug.
That approval came in September 2015 but the HSE then decided it would not fund the drug because it was not cost-effective.
Patients were due to lose access at the end of September this year, but CSL — which is planning another trial next year and will need to recruit some of the same patients — decided to extend the availability of Respreeza until a new trial commences, “ie for about six months or until June 30th 2018 (if earlier)”.
One of the patients, Johnny Hannon from Mallow, Co Cork, who has genetic emphysema, said both the drug company and the HSE have a duty of care to patients under the Declaration of Helsinki.
Paragraph 34 of the declaration states that: “In advance of a clinical trial, sponsors, researchers, and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.”