Patients set to lose access to a drug the State has refused to reimburse have been granted a six-month reprieve as the manufacturer says it will continue to supply it free of charge.

However the commitment extends only to the start of a new trial of the drug in the spring, and not beyond June 30, CSL Behring said.

The company is due to start a new clinical trial of Respreeza — the only therapy known to slow the progression of genetic emphysema.

Johnny Hannan, a patient on Respreeza since taking part in a previous clinical trial, said he is “alarmed at the link between the beginning of a new trial and the long-term provision of Respreeza to those of us on the original trial”.

Mr Hannan, from Mallow, Co Cork, said he would “prefer an undertaking that CSL Behring would keep us on Respreeza for as long as it takes to sort out reimbursement with the HSE”.

“I don’t want my health to be a bargaining tool for future trials,” he said.

Twenty-one patients on the island of Ireland have had compassionate access to the drug since taking part in the original Respreeza trial, the results of which led to market approval.

However, the Alpha One Foundation is concerned that not all patients currently accessing the therapy will be eligible to take part in the new trial.

“All patients, irrespective of participation in any new clinical trial, need to have continued access to this therapy. We cannot return to a situation where access to this therapy is removed,” said Foundation CEO, Geraldine Kelly. Another 40 patients who fit the prescribing criteria have no access to the compassionate use programme.

Professor Gerry McElvaney, consultant respiratory physician who treats Alpha-1 patients at Beaumont hospital in Dublin, welcomed CSL Behring’s decision at a time of year when patients are particularly vulnerable coming into the winter. However, patients not eligible for the trial will be “back to square one”.

For those who do qualify, taking part is “a reasonable option — the more people we can keep on Respreeza, the better”, Prof McElvaney said.

He said the HSE needs to make a decision to reimburse given that it involved “small numbers and a small population”.

The new trial will be non-placebo and will involve patients receiving double the dose of medication.

Eddie Owens, general manager UK and Ireland for CSL Behring said they will be “carefully reviewing all the options (including legal) open to us to review the Respreeza reimbursement decision-making process”.

In August, the HSE drugs committee endorsed the recommendation of the National Centre for Pharmacoeconomics not to reimburse the drugs on the grounds it is not cost-effective.

Alpha-1 antitrypsin deficiency is a genetic condition that can lead to lung, liver, or in rare cases, skin problems.


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