Leo Varadkar: Drug trials or joint risk approach needed

Either trials of the drug used by cervical cancer survivor Vicky Phelan or a joint State-company risk approach to using it may be needed to ensure all women have equal access to the treatment, says Taoiseach Leo Varadkar.

Pembrolizumab (Pembro) has been offered to 221 women caught up in the CervicalCheck crisis, but not to others. A dose every three weeks costs €8,500, said Ms Phelan, adding that all women should get access to Pembro, which has improved her life.

Currently, it is not on a clinical trial and is not licensed. Oncologists say it should be made available on trial or a managed basis.

Labour leader Brendan Howlin warned yesterday that other patients may bring the State to court unless they can access the drug.

“The Government owes a duty of care to those women who are failed by our health services, but this decision risks setting a dangerous precedent if the Government does not make the same drug available to all cervical cancer patients,” he told the Dáil.

“Either a treatment is so prohibitively expensive that it cannot be provided or else it must be made available to all — there is no middle ground.”

Mr Varadkar agreed there is “inequity” here but said the lack of a licence creates “difficulties”.

“It is licensed for other cancers, but not for cervical cancer,” he said, adding that the Government would now look at solutions.

“I have sat down with [Health Minister Simon] Harris, about this issue. As the deputy can imagine, he is very aware of it. We have had contact with the manufacturer about it in the past couple of months...

“Either the Government funding a clinical trial or a cost-sharing or risk-sharing arrangement with the company, could provide a solution.

“However, we would need to have the company, and the clinicians on board to do that. That is something we will pursue in the next couple of weeks.”