10-05-2025
What is causing delayed access to new cancer medicines?
Few areas of healthcare are as sensitive as cancer treatment.
Each year, around 44,000 cancer tumours are diagnosed here and patients may need a mix of surgery, radiotherapy and medicines.
Survival rates vary, depending on the type of cancer and how early it has been detected plus the speed of access to treatment.
This week saw claims from the organisation that represents the inventors of prescription medicines, that Ireland has the lowest availability for new cancer medicines in Western Europe.
The Irish Pharmaceutical Healthcare Association (IPHA) said that just one in four new cancer treatments licensed since 2020 is currently available here in the public system.
The HSE countered that many of the delays for approval are down to the drug firms themselves, not making a formal application for the drug to be covered for public patents, or delays by them in submitting vital paperwork on the cost and effectiveness of new drugs.
So, it is the patients that can be caught in the middle of this battle.
The State bill for medicines continues to grow rapidly, and last year it paid out over €3.4 billion for drugs.
Campaigners for patients, the United Cancer Advocates Network (UCAN) said there is no early access scheme here for new drugs, so Irish patients are forced to wait for a full assessment of the new medicines and for negotiations with drug companies to take place on price.
Miriam Staunton, Chairperson of UCAN, said there are many patients impacted by the lack of access, some of whom may not even be aware that they are missing out on life saving and life extending medications.
The group has called for an investigation of early access schemes, a review of the drugs reimbursement process and a more coordinated approach at European level.
Campaigners also want to see investment in innovative and breakthrough treatments and the implementation of the recommendations of a consultancy report by Mazars in 2023 on the HSE's drugs reimbursement process.
That report said there was room for improvement in the transparency of the process plus better communications and information to patients.
The review also recommended access to an online system for the public and industry to track the progression of medicines through the approvals process.
The HSE said that in relation to the cancer drugs cited by IPHA, around 40% have a pricing and reimbursement application ongoing, with many having significant delays on the side of the pharmaceutical company.
Oliver O'Connor, Chief Executive of IPHA, said this week that of the cancer medicines that have been authorised by the European Medicines Agency (EMA), since 2020, only one in four are now available in Ireland.
He said this is very low compared to other Western European countries and below the EU average and represents a poor performance for Ireland.
Mr O' Connor said that patients could do better if more medicines were available here faster.
The current agreement between the State and drug firms represented by IPHA on the pricing and supply of medicines runs out in September.
IPHA has been in touch with the Government about this. The industry says that a new agreement can be the vehicle to deliver faster and fairer access to new medicines.
IPHA points to a law passed in 2013 that the HSE should be making decisions on new medicines within 180 days and the industry wants to see a new system put in place so that this happens. This would mean medicines becoming available around a year earlier than they currently are.
For the State's part, it has to ensure that any new drugs that are covered under the public system are value for money, at the price sought by the drug company, and that they also represent an advance in treatment.
This is often not the case, according to Professor Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics. It does the assessments that feed into the HSE decision group that decides if new drugs should be covered.
Prof Barry said that the IPHA report this week talks of delays in access to cancer drugs of around 468 days on average.
But he pointed out that what the report does explain is where those delays occur.
Prof Barry said that over 50% of the delays are due to the pharmaceutical companies themselves for several reasons.
One of the these is that the company does not submit a pricing and reimbursement application to the HSE and the HSE cannot cover something if there is no application.
He said that when the HSE seeks an economic evaluation and dossier, it often takes over half a year to receive it. A further delay is also often due to the length of price negotiations.
"I find it interesting that a lot of the delays that are mentioned are down to the pharmaceutical industry themselves, and not to the HSE," Prof Barry explained.
He said there was no mention of value for money in the drug companies report on delayed access to medicines.
Prof Barry added that many of the drugs either do not prolong life, or do not improve the quality of life.
He also noted that the new medicines concerned are often launched earlier in larger countries, like Germany, Italy and Spain, where maximum profits are to be gained. So, he believes that the delay can also be the delay in launching in Ireland, which he says is an important point.
For this reason, Irish patients may be disadvantaged by the fact they live in a small country. There is an irony in that, given this country is such a major producer of pharmaceuticals.
IPHA argues that the European Medicines Agency (EMA) does a rigorous assessment for the licensing of medicines and that Ireland should be able to rely on that.
Oliver O'Connor said that companies are launching and making applications for medicines and IPHA would like it to be at 100% and will work towards that.
IPHA says the data from the European Pharmaceutical Industry (EFPIA) published this week shows that Irish cancer patients continue to wait almost two years or 644 days, post EMA authorisation, to access newly licensed medicines.
This it says is 55 days longer than last year, and above the EU average of 586 days.
The industry says that the overall time to make a medicine routinely available in Ireland has lengthened significantly since 2020, when it took 477 days.
In the study, other Western European countries analysed with higher rates of availability included: Germany, Switzerland, Italy, Austria, Spain, Portugal, Luxembourg, France, England, Denmark, Finland, Belgium, Scotland, Sweden, Norway, Netherlands, Iceland.
For drug firms, there are obvious commercial dynamics at play also. Patients and patient campaign groups putting pressure on the HSE and the Government for access to new cancer medicines add to the burden.
This is especially true when price talks are underway and patient case studies of people waiting desperately for perhaps life-saving drugs appear in the media.
For the State's part, health funding is not infinite, and it must manage the drugs bill. Money spent in one area of the health system, means it is not available for another area.
For example, if the new anti-obesity and weight loss drugs were made available to all who might benefit here, the annual bill faced by the State would increase by €10 billion.
Experts say that some new drugs billed by the industry as 'Gamechangers' do not live up to the hype.
They may offer a limited improvement on existing treatments or turn out to offer the same benefit as existing drugs, so-called "me too" medicines.
Often in the media, we hear of 'promising' progress in early clinical trials on potential new drugs, but after full trials on patients, the hoped-for major advance does not materialise.
Medicines are big business and many of the companies are on the stock exchange and positive reports on potential new treatments can boost share prices.
There is a lot at play in this complex health area.
However, in the end, it is only through objective clinical trials that we can know if a drug works or not, and whether the benefits for patients outweigh the side effects. Then it comes down to the price sought for the medicine.
Developing and testing potential new medicines is very costly. Many potential drugs do not make it to market. Drug firms are entitled to a reasonable return on their investment, but who decides what that should be?
Patients also benefit greatly if they can access, in good time, new drugs that can extend life and even save lives.
The State has to be mindful that new drugs are safe, effective and value for money, within a finite budget.
