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What is causing delayed access to new cancer medicines?
What is causing delayed access to new cancer medicines?

RTÉ News​

time10-05-2025

  • Health
  • RTÉ News​

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.

Irish Examiner view: Welcome and best wishes for Pope Leo
Irish Examiner view: Welcome and best wishes for Pope Leo

Irish Examiner

time09-05-2025

  • Politics
  • Irish Examiner

Irish Examiner view: Welcome and best wishes for Pope Leo

The white smoke streaming above the rooftops of the Vatican yesterday set off cheers in the waiting crowd in St Peter's Square, and little wonder. The smoke heralded the election of a new Pope, of course, an event of huge significance which goes far beyond matters of faith. The new Pope, Robert Francis Prevost, has made history already as the first American to be selected to head the Catholic Church. He is to be known as Pope Leo XIV in future, but his past will be examined closely over the coming days for indications of his papacy's direction. Having spent years as a missionary in Peru, for instance, is he likely to be attuned to the needs of the Church in the developing world? Inevitably, links and connections to Ireland will be sought in the new Pope's background. It is reasonable to expect that, as a native of Chicago, he will be familiar with that city's significant Irish heritage and population, while he is also known to be a familiar face at the Irish College in Rome. Pope Leo has considerable challenges on his hands within the Church — financial issues, declining vocations, and, notoriously, the litany of sex abuse scandals involving the Church. The wider political implications of his election will also be considered, however. US president Donald Trump was quick to congratulate his fellow American, calling his election a great honour for the country and anticipating a meeting with the new pontiff. This could be Pope Leo's first real challenge: Will he stress Christian values when meeting the guiding light of a cruel regime victimising the vulnerable? It would be naive to believe that popes are not capable of having a considerable political impact, going back to the impact of Pope John Paul II's famous visit to his native Poland in 1979, when that country was still under communist rule. That quick glimpse of responsibilities gives an idea of the challenges facing the new Pope. Best wishes to him in bearing that burden. Too long a wait for medicines Figures released by the Irish Pharmaceutical Healthcare Association (IPHA) recently make for grim reading for those dealing with cancer. There is scarcely a family on the island of Ireland which has not had loved ones affected by this disease, and the possibility that those loved ones might be missing out on vital treatment is a horrifying prospect. However, according to the IPHA, Ireland has the lowest availability of new cancer medicines in western Europe, with just one quarter of 56 new cancer treatments licensed since 2020 currently available. The IPHA has drawn on data from a study carried out on behalf of the European Federation of Pharmaceutical Industries and Associations, which shows that patients in Ireland continue to wait longer to access new medicines than patients in most western European countries. In real terms, this waiting period is significant — cancer patients in Ireland must wait almost two full years, or 644 days, to access newly licensed medicines. Of those 56 oncology medicines which were granted a European Medicines Agency licence since 2020, only 14 of them are currently available in Ireland. The HSE has put the spotlight on the pharmaceutical industry by stating that it has not received a formal pricing and reimbursement application for almost one third of the medicines from that industry. Away from the bland language, these delays are having a direct impact on people's lives. Timely treatment is a well- established principle in medical care, but according to the United Cancer Advocates Network (UCAN), not only are Irish cancer patients left waiting to access new treatments, some are not even aware they are missing out. The fact that Irish citizens must wait two years for medicines which are available in other countries is completely unacceptable. UCAN has called for a review of drug access schemes, and that should be undertaken without delay. Strong support Cliona Ward was released from detention in Washington on Wednesday evening. A green card holder resident in the US for more than 40 years, Ms Ward was arrested by US immigration and customs enforcement (ICE) officials on April 21 in San Francisco on foot of criminal convictions which she thought had been expunged from her record. She had been held at an ICE detention centre in Washington since then, but this week she was informed that all charges against her had been dropped and she was duly released from the centre. Her lawyer, Erin Hall, described Ms Ward as being 'full of gratitude' and said her client had enjoyed strong community and trade union support, while her local congressman, Jimmy Panetta, worked with the Government and the White House on her behalf. This story had a happy conclusion for Ms Ward, but it offers a glimpse of the nightmare facing those without a similar support structure. Mr Panetta said the Ward case shows 'what's possible when we come together for transparency, due process, and justice', but clearly there are many people in the ICE system suffering the lack of strong advocates. Concerns about the new immigration approach in the US means students facing into their J1 summers have been warned to scrub their social media accounts before travelling, while European academics are pulling out of planned trips to the US. Stories such as Ms Ward's are surely giving many other prospective visitors second thoughts. Read More Irish Examiner view: Common sense must prevail

Ireland found to be worst in Europe for availability of new cancer treatments
Ireland found to be worst in Europe for availability of new cancer treatments

Irish Times

time07-05-2025

  • Health
  • Irish Times

Ireland found to be worst in Europe for availability of new cancer treatments

Ireland has the lowest rate of availability for new cancer medicines in western Europe, according to a new report compiled for the European pharmaceutical body EFPIA. Only one in four of 56 new cancer treatments licensed since 2020 are available in Ireland. The survey of 36 European countries, including 27 in the EU, covers between 2020 and 2023, analysing 173 innovative medicines authorised for use by the European Medicines Agency (EMA). Of the 56 oncology medicines which were granted an EMA licence, only 14 are currently available in Ireland. Among western European countries, this is the lowest rate of availability for cancer medicines. READ MORE The Irish Pharmaceutical Healthcare Association (IPHA) said cancer patients in Ireland are having to wait almost two years after EMA authorisation to access newly licensed medicines. [ Opportunity for a new medicines playbook Opens in new window ] The association said this is 55 days longer than last year and above the EU average of 586 days. The overall time to make a medicine routinely available in Ireland has lengthened significantly since 2020 when it took 477 days while in 2024 it was 645 days. 'Lower rates of availability for cancer medicines means inferior treatment options for patients and clinicians than is routinely available in the UK and elsewhere in Europe,' it said. The Framework Agreement on the Pricing and Supply of Medicines, which outlines the principles and processes for the assessment of new medicines in Ireland, is due to expire in September. The association said the reimbursement system needed to be 'resourced, governed and designed to operate' within the legal 180-days timeline for HSE decisions set by the Oireachtas in 2013. Oliver O'Connor, chief executive of the association, said: 'Patients in Ireland deserve better, and we can do better, if the political and administrative desire is there. Pharmaceutical treatments can represent a lifeline to cancer patients, significantly enhance quality of life and change the prognosis of individual patients.' Other western European countries analysed with higher rates of availability include Germany, Switzerland, Italy, Austria, Spain, Portugal, Luxembourg, France, England, Denmark, Finland, Belgium, Scotland, Sweden, Norway, Netherlands and Iceland.

Ireland has lowest availability for new cancer medicines in Western Europe
Ireland has lowest availability for new cancer medicines in Western Europe

RTÉ News​

time07-05-2025

  • Health
  • RTÉ News​

Ireland has lowest availability for new cancer medicines in Western Europe

Ireland has the lowest availability for new cancer medicines in Western Europe, according to the Irish Pharmaceutical Healthcare Association (IPHA). Only one in four of 56 new cancer treatments licensed since 2020 are currently available in Ireland, the association said. The organisation has cited new data from a study for the European pharmaceutical body EFPIA, which shows that patients in Ireland continue to wait longer than their peers in most Western-European countries to access life-enhancing new medicines. The survey of 36 European countries, including 27 in the European Union, covers the full four years between 2020 and 2023, analysing 173 innovative medicines authorised for use by the European Medicines Agency. Of the 56 oncology medicines which were granted a European Medicines Agency (EMA) licence since 2020, only 14, or 25%, are currently available in Ireland. Almost two-year wait for access Cancer patients in Ireland continue to wait almost two years or 644 days, post-EMA authorisation, to access newly-licensed medicines. This is 55 days longer than last year and above the EU average of 586 days, according to Oliver O'Connor, the IPHA Chief Executive. He said that a new framework agreement this year with the State can be the vehicle through which to reform the reimbursement system to deliver faster and fairer access to new medicines. The current agreement is due to expire in September. The United Cancer Advocates Network (UCAN) said there is no early access scheme here, so Irish patients are forced to wait for full assessments and negotiations with drug companies to take place. It said that that many patients here are affected by the lack of access and some may not be aware they are missing out on life saving and life extending medicines. It wants an investigation of early access schemes, a review of the drugs reimbursement process and a more co-ordinated approach at European level. UCAN said the situation in Ireland had disimproved since the last data on waiting to access innovative medicines was published. Other Western European countries analysed for the study with higher rates of availability include: Germany, Switzerland, Italy, Austria, Spain, Portugal, Luxembourg, France, England, Denmark, Finland, Belgium, Scotland, Sweden, Norway, Netherlands, Iceland.

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