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Ireland’s two-tier cancer drug system: ‘I can give one drug to one lot of patients, not to another’

Public patients face ‘huge delays’ on cancer drugs, a poorer quality of life and a poorer chance of survival

According to figures from the Irish Pharmaceutical Healthcare Alliance (IPHA), the average time between EMA and HSE approval for cancer medicines was 651 days in 2023
According to figures from the Irish Pharmaceutical Healthcare Alliance (IPHA), the average time between EMA and HSE approval for cancer medicines was 651 days in 2023

Public patients are facing “huge delays” in accessing potentially life-saving cancer drugs that have been available to all private patients since last year, resulting in poorer chances of survival, oncologists have said.

This has created a “two-tier system” for treatment, doctors have said. They feel that their “hands are tied” and that they sometimes must prescribe less effective drugs for public patients.

Since last summer, Irish health insurers – VHI, Laya and Irish Life – have covered the cost of novel intravenous cancer drugs that have been approved by the European Medicines Agency (EMA).

The decision by Laya and Irish Life to pay for these medicines followed reports in The Irish Times highlighting disparities between the levels of coverage between the three insurers, with VHI covering them since 2019.

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However, the drugs are not available to public patients until after the HSE completes an extensive reimbursement approval process.

According to figures from the Irish Pharmaceutical Healthcare Alliance (IPHA), the average time between EMA and HSE approval for cancer medicines was 651 days in 2023, meaning it is almost two years before these drugs are available to patients in the public system.

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Prof Janice Walshe, a consultant oncologist in St Vincent’s hospital, works in both private and public care: “I could have a situation where I go to work in two wards and I would be able to give one drug to one lot of patients, but not to another.”

Prof Michaela Higgins, a consultant oncologist at St Vincent’s University Hospital, and current president of the Irish Society of Medical Oncology (ISMO), said: “It means we know we are prescribing medication for our patients that are proven to be less effective and to provide them with a poorer chance of survival and, in some cases, a poorer quality of life.”

One drug available to private patients is Trastuzumab deruxtecan (Enhertu), shortened to tdxd, which is effective on certain subtypes of breast cancer. It was approved by the EMA in January 2021, but is not yet available to public patients in Ireland.

Now they [manufacturers] know it’s going to take longer than a year for HSE approval so they’re not opening as many compassionate release programmes

—  Prof Cathy Kelly - consultant medical oncologist

Another example is the use of Pembrolizumab, or pembro, for endometrial cancer. Though available under the public system for other disease types, it is not available for this purpose, doctors said, despite EMA approval for this indication in April 2022.

Prof Cathy Kelly, UCD clinical professor and consultant medical oncologist at the Mater Private Hospital, said some pharmaceutical companies have “compassionate release programmes”, allowing public patients access at a cost to the company.

“But now they [manufacturers] know it’s going to take longer than a year for HSE approval so they’re not opening as many compassionate release programmes, or they’re more reluctant, because they know they could be funding it for several years.”

The HSE did not respond to a request for comment by the time of publication. Minister for Health Stephen Donnelly recently said recommendations for improving transparency of the reimbursement process were being advanced.

Separately, the health service is to introduce a national electronic healthcare record (EHR) system that would allow healthcare workers to view patients’ medical information digitally, under plans being brought to Cabinet this week.

The State has consistently been criticised for its lack of progress in digitising the health service. In 2021, the Health Information and Quality Authority (Hiqa) highlighted “major deficiencies” in the current information system, with data on patient health usually being managed on different electronic systems or on paper-based systems, affecting people’s safety.

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On Tuesday, it is understood the Minister will bring a memo to Cabinet outlining the Digital Framework, a significant overhaul of the current health service information system.

It will include a national patient app, the conclusion of a community health-based record system, and concluding procurement of a national shared care record, which would allow healthcare workers to quickly view a patient’s medical information.

Costs for the new system are not outlined but a 10-year business plan in 2016 said rolling out a national EHR system would amount to up to €875 million. Costs have risen since then, meaning the figure is likely to be much higher.

Shauna Bowers

Shauna Bowers

Shauna Bowers is Health Correspondent of The Irish Times