Woman facing ‘imminent death’ takes case against HSE for access to cancer drug

A woman with cervical cancer has claimed before the High Court she is facing imminent death due to an alleged failure by the HSE to deal with her application for approval for further treatment with a drug which she says is keeping her alive.

Lawyers for the woman, who cannot be named, got leave from the court on Monday to judicially review the HSE’s alleged failure to answer her application for approval for the drug pembrolizumab because other treatments, including chemotherapy, have been unsuccessful.

Pembrolizumab, with a trade name Keytruda, is on the HSE’s drug reimbursement list for certain medical conditions.

The woman has been told, in view of her revised diagnosis of Stage 4b cancer, it was not listed for reimbursement for her condition.

She says she had fortunately been identified as being among a small cohort of patients suitable for treating her cancer with pembrolizumab.

Thanks to public donations, she has so far undergone four cycles of treatment with the drug and her lawyers say it has had a remarkable beneficial effect on her condition.

Those donations are now almost exhausted and she and her family are not in a position to continue to fund her future treatment, it is claimed.

“This drug is keeping her alive”, her counsel Felix McEnroy SC told Mr Justice Seamus Noonan.

The judge returned the case to Wednesday when he said the woman’s side could also apply for the drug to continue to be administered to her pending determination of her action.

Mr McEnroy said, despite an acknowledgment by the HSE’s chief executive that her case was urgent, there had been no substantive reply to her letter seeking approval for the drug.

In an affidavit, the woman said she applied on August 23rd last to be approved for pembrolizumab under the Health (Pricing and Supply of Medical Goods) Act 2013.

She says the purported consideration of her application constitutes “a refusal by silence” of the HSE to discharge its statutory functions and duties.

She was left with no option but to make the court application which was of “serious distress to me”.

She says she participated in the cervical check cancer screening programme between 2005 and 2015, was told her tests were negative, and she had no reason to be concerned for her health.

She became ill in October 2017 and, by June 2018, following a number of treatments, she was advised further surgery and radiation therapy was no longer appropriate.

She says, following the cervical check controversy, she was notified in October 2018 that her cancer screening tests had been excluded from the Minister for Health’s independent expert panel review because of the HSE’s failure to properly register her medical information in its record systems.

She says she has had her smear tests independently reviewed in the US and has been advised there were abnormalities in two of her four tests, contrary to what the HSE told her.

Had she known of that, she would have had an opportunity to seek medical assistance to better meet, or possibly avoid, the challenges of the cancer she now has.

As part of her case, she seeks a declaration the decision to exclude her records from the independent expert panel was unlawful.

She has “exhausted all other appropriate medical options ” and found herself in a situation where she cannot afford the only available medical treatment – pembrolizumab – recommended to by her doctor.

Without it, she was facing the prospect of an imminent death, she says.

She says there has been no “substantive reply” to her August letter to the HSE. An email to the HSE on September 20th last met with the reply that her letter was “receiving attention”.