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Belfast Telegraph
18-05-2025
- Health
- Belfast Telegraph
Cutting-edge medicines hoped to transform treatment of incurable skin condition
Debra, which supports 300 people living with epidermolysis bullosa (EB) in Ireland, said the entry of Filsuvez into the Irish market will ease the extreme pain endured by those with 'Butterfly Skin'. The disease is caused by the absence of proteins between the skin layers, making the skin ultra fragile and easy to wound. The charity insists that the expected introduction of the prescription medical gel before the end of the year could pave the way for gene therapy treatments, such as Vyjuvek. Sinead Hickey, head of research at Debra, said: 'Where Filsuvez is a promising start, as it can offer temporary pain relief, we hope it will mark the beginning for the treatment of rare disease in Ireland. 'Vyjuvek has the potential to provide life-changing wound healing for people living with Dystrophic EB, it has already proven to be very effective in the US.' The topical gel delivers new COL7A1 genes directly to skin wounds to promote wound healing. Ms Hickey said it does not have to be applied by a medical practitioner but can be done by a trained individual or family member. 'Unfortunately, Ireland is one of the slowest countries in Europe to move from recommendation to market and it could still be between seven and 12 years before we see Vyjuvek available to people here,' she said. Filsuvez, meanwhile, is applied to a sterile non-adhesive wound dressing or directly to the skin to ease the extreme pain of wounds caused by EB. Debra made submissions to the NCPE (National Centre for Pharmacoeconomics), which has recommended the HSE provides the gel once agreement is reached on pricing. A timeline has yet to be announced but Debra is optimistic a resolution will be found by the end of summer. The charity's chief executive, Jimmy Fearon, said its entry into the Irish market is a step in the right direction. 'The treatment for EB hasn't advanced much over time, so new treatments always bring hope,' he said. 'This is not a cure but it may reduce the equivalent of a bandage change every two weeks, providing some pain alleviation. 'What this primarily represents is hope, breaking through the glass ceiling would hopefully mean that others will follow. 'Debra and other EB charities around the world support and invest in important research but, ultimately, it's the pharmaceutical companies and venture capitalists that run the breakthrough.' Ireland is in the lowest quartile in Europe for introducing new drugs to the market, the chief executive said. 'It's an arduous process to bring a drug to market and this is a positive step,' added Mr Fearon. 'What we really need is faster progression from recommendation to market – time is of the essence for the 300 people in Ireland living in pain due to this condition.'


Irish Daily Mirror
18-05-2025
- Health
- Irish Daily Mirror
Entry of new medicine into Irish market to ease pain of incurable skin condition
The introduction of two new cutting-edge medicines are hoped to transform the treatment of a rare incurable skin condition, a charity has said. Debra, which supports 300 people living with epidermolysis bullosa (EB) in Ireland, said the entry of Filsuvez into the Irish market will ease the extreme pain endured by those with 'Butterfly Skin'. The disease is caused by the absence of proteins between the skin layers, making the skin ultra fragile and easy to wound. The charity insists that the expected introduction of the prescription medical gel before the end of the year could pave the way for gene therapy treatments, such as Vyjuvek. Sinead Hickey, head of research at Debra, said: "Where Filsuvez is a promising start, as it can offer temporary pain relief, we hope it will mark the beginning for the treatment of rare disease in Ireland. "Vyjuvek has the potential to provide life-changing wound healing for people living with Dystrophic EB, it has already proven to be very effective in the US." The topical gel delivers new COL7A1 genes directly to skin wounds to promote wound healing. Ms Hickey said it does not have to be applied by a medical practitioner but can be done by a trained individual or family member. "Unfortunately, Ireland is one of the slowest countries in Europe to move from recommendation to market and it could still be between seven and 12 years before we see Vyjuvek available to people here," she said. Filsuvez, meanwhile, is applied to a sterile non-adhesive wound dressing or directly to the skin to ease the extreme pain of wounds caused by EB. Debra made submissions to the NCPE (National Centre for Pharmacoeconomics), which has recommended the HSE provides the gel once agreement is reached on pricing. A timeline has yet to be announced but Debra is optimistic a resolution will be found by the end of summer. The charity's chief executive, Jimmy Fearon, said its entry into the Irish market is a step in the right direction. "The treatment for EB hasn't advanced much over time, so new treatments always bring hope," he said. "This is not a cure but it may reduce the equivalent of a bandage change every two weeks, providing some pain alleviation. "What this primarily represents is hope, breaking through the glass ceiling would hopefully mean that others will follow. "Debra and other EB charities around the world support and invest in important research but, ultimately, it's the pharmaceutical companies and venture capitalists that run the breakthrough." Ireland is in the lowest quartile in Europe for introducing new drugs to the market, the chief executive said. "It's an arduous process to bring a drug to market and this is a positive step," added Mr Fearon. "What we really need is faster progression from recommendation to market – time is of the essence for the 300 people in Ireland living in pain due to this condition."


Irish Times
26-04-2025
- Health
- Irish Times
Reimbursing weight loss drugs for all who could benefit would push State's annual medicines bill to €10bn, doctors told
The State's medicines bill would more than double to €10 billion per year if it funded weight loss drugs for all who would likely benefit from them, the head of the national pharmacoeconomics centre has warned. Prof Micheal Barry said a bill at this level was 'simply not affordable'. Weight loss jabs Mounjaro and Wegovy are currently being assessed regarding their suitability for State schemes. Weekly injections of Wegovy cost Irish users about €220 a month, which is less than the price of Mounjaro. The National Centre for Pharmacoeconomics, of which Prof Barry is clinical director, assesses the cost effectiveness of drugs and healthcare interventions to advise the Health Service Executive (HSE) on whether they should be reimbursed under State schemes. READ MORE The State currently pays out about €4 billion each year on drugs and medicines, Prof Barry told the Irish Medical Organisation's annual conference on Friday. He said an estimated one million people in Ireland have a body mass index (BMI) above 30, which puts them in the obese category. If everyone in this category, who would be expected to benefit from weight loss medication, was actually prescribed these drugs, €6 billion would be added to the State's bill. This is 'not going to happen', he said. He anticipates the assessment of Mounjaro and Wegovy will be completed by the end of this year or start of next year at the latest. 'Then the decisions will need to be made. The question is: do we fund them or fund them only for a subgroup of people?' He said State schemes cover patients prescribed a medicine called Saxenda, which is designed to regulate appetite, only if their BMI is above 35 and they have pre-diabetes or are presenting with signs of cardiovascular disease. He said a similar approach could be taken with the new drugs being assessed but, given the impact on the medicines budget, a condition could be imposed where patients only qualify for reimbursement if their BMI is above 40. These will be 'big decisions', he added. As well as assisting weight loss, the drugs being assessed have also been shown to improve cardiovascular health. Pharmaceutical companies are sure to highlight these benefits in their applications for reimbursement, he said. Separately, Prof Barry said delays in patients getting access to new cancer drugs or medications for rare diseases are 'significantly influenced' by the time taken by pharmaceutical companies in seeking reimbursement in Ireland, delays in engaging the HSE process and subsequent delays in pricing negotiations. 'That is where the delays are coming from, and no amount of oncologists jumping up and down and giving out about the HSE will change that.' He said arguments are made regularly that drugs should become available in Ireland once authorised by the European Medicines Agency (EMA). However, most EMA-approved cancer drugs enter the market 'without any evidence of overall survival and without any evidence of improving quality of life'. Cancer and rare diseases medicines account for about two-thirds of all drugs that are reimbursed by the State, Prof Barry said. 'They are invariably high-cost treatments, rarely prove cost-effective and have a significant budget impact.' The 'weak evidence/high price conundrum' associated with cancer drugs must be acknowledged, he said. Year-on-year increases in drug expenditure will continue, driven by high-cost drugs, the expanded use of existing medicines, and the increasing uptake of technologies such as continuous blood glucose monitoring. He said 60 cancer drugs were approved by the HSE in the three years leading to 2023.


Irish Independent
25-04-2025
- Health
- Irish Independent
Curbs on way for weight loss jabs Mounjaro and Wegovy to avoid €6bn drugs scheme surge
The weekly jabs were launched this year but they cost at least €200 a month and are not covered by the HSE. Michael Barry, head of the National Centre for Pharmacoeconomics, which assessed the cost effectiveness of drugs and recommended they be included in HSE schemes, said the national drugs budget is currently €4bn but if the two jabs were made available to everyone who would benefit it would jump to €10bn. It means that choices have to be made around who will be eligible. He said around one million people in Ireland are estimated to have a BMI over 30 and many of these could potentially benefit from the jabs. Making them available to this number of people 'is unaffordable and not going to happen,' he told the annual general meeting of the Irish Medical Organisation (IMO). 'These drugs are currently being assessed and anticipate it will be completed at the end of the year or the start of next year at the latest. That is when the decision making will need to be made .' It may year the jabs will only be available to people with a BMI of 40 or over, he added. He said the cardiovascular benefits will have to be taken into account when assessing the drugs. The discussion may quickly move from weight loss to cardiovascular disease prevention, he added. The advances in this area mean that an oral weight loss version has been now manufactured in the United States. Saxenda, a weight loss treatment which has been available here for some time and injected once a day, is already subject to restrictions and just 51pc of patients for whom it is recommended by doctors are approved for the drug. Around 54,000 people are currently prescribed Ozempic for diabetes, costing €7.4m a month. He also called for an honest debate around claims by pharmaceutical companies about delays in approving new cancer drugs. 'It is always portrayed that there is a delay of up to two years and it is the HSE's fault. It is not, I have no problem in saying that these are high cost drugs and we should be looking for value for money. 'I think people need to be honest and acknowledge a significant amount of the delay is due to the companies themselves and they launch in bigger markets first. That is fine – it is up to themselves. The delays are not entirely down to the HSE.' He said cancer is the most important area for the drugs industry and up to 40pc of all the assessment we do are for cancer drugs. Last year cancer drugs approved were initially priced at €490m but negotiations reduced the bill by €174m. There needs to be price negotiations, he stressed. 'When people talk about the process is broken you need to be careful because you are talking about big money and that is the saving. We are dealing with vast sums of money .'