Cancer doctors have warned they cannot prescribe the drugs they feel are appropriate to one-in-four patients due to shortcomings in the system for approving new medicines.
The warning is contained in a presentation made by four senior cancer doctors to a group working on a new plan to overhaul the State’s system for approving new drugs, set up earlier this year.
While survival rates for Irish cancer patients have improved in recent years, the doctors say they are “telling patients daily that treatment they should get is not available – and may never be available”.
The presentation outlines a “frontline reality” for cancer patients where Ireland “no longer provides standard of care for 25 per cent of cancer patients” when it comes to drug availability.
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New drugs are subject to an extensive approval process in Ireland after they are given the green light by the European Medicines Agency, following which the pharmaceutical company producing a drug applies to the HSE for “reimbursement” – which, when granted, allows doctors to prescribe the drug on the public system.
Access to cancer drugs is a complex topic, which places demands on clinicians and policymakers who have to balance multiple factors.
One of the authors of the presentation, consultant oncologist Michael McCarthy, told The Irish Times that “a system like this is very important, and it’s important we have a robust means of evaluating new treatments and ensuring the taxpayers get value for money”.
While Dr McCarthy said “basic features” of the Irish system are good, he argued there is need for reform – and that a wider process to future-proof the system as the nature of cancer care evolves is needed.
“This is a growing challenge for oncologists and cancer patients regarding ability to access new standard of care cancer treatments,” Dr McCarthy said. “I have lists of people that I’m trying to keep going with second rate therapies, awaiting reimbursement of better treatment options.”
Earlier this year, Minister for Health Stephen Donnelly published a report by consultancy firm Mazars into the system which found the health service was operating in line with legislation and results were in keeping with international norms, but that there was scope for improvement.
In their presentation to the working group which is looking to implement the report, the four doctors warned that the current process is slow, with approval taking two years or more, compared to one in “most other countries”.
Dr McCarthy says he is optimistic that the implementation of the Mazars report will improve matters, but warned beyond that, “there is more work to be done to rectify the drug access problem”.
As cancer care evolves beyond chemotherapy, when it was easy to implement the recommendations of new trials examining dosage and combinations because the cost of those drugs was low, the majority of new cancer treatments that are emerging are all high-cost drugs.
The presentation also criticises the current system which relies on drug companies applying to the HSE to enter the process, as opposed to clinicians being able to identify drugs they want and have them brought into the system.
Dr McCarthy said the HSE and others are working hard to get drugs available but there was a need for greater resourcing, transparency and structural changes.
A spokeswoman for the HSE said its decisions are made on “objective, scientific and economic grounds” including the health needs of he public, cost-effectiveness, proposed costs, benefits and risks, clinical need and how effective the drug is – as well as the HSE’s resources.
It said the rate of approval of new medicines has accelerated in recent years, with 26 new approvals for cancer drugs in 2021 and 18 in 2022, and a further 11 this year.
The HSE said it is working on improvements to the application process for drugs, including further transparency, and is planning to introduce an online “application tracker” for drugs and indicative timelines for completing the process.
It said it is engaging with the working group and has “already identified and made the Department of Health aware of the additional resources and investment that will be required to ensure the necessary capacity is in place to bring about certain process improvements”.
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A spokesman for the Department of Health said it has already put in place policy changes to improve the system.
“The Government is committed to providing timely access to new and innovative medicines to all patients. Under Minister [Stephen] Donnelly, there has been a significant increase in the medicines budget,” the spokesman said.
“Additional funding of €98 million in the past three Budgets has enabled the HSE to approve over 130 new drugs, 55 of which are for cancer.”
