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Business Wire
4 days ago
- Health
- Business Wire
Samsung Bioepis' European Whitepaper Proposes Solutions to Bridge Policy Gaps that Hinder Healthy Market Competition and Timely Access to Biosimilar Medicines
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today published a whitepaper titled ' Solving the Biosimilar Void in Europe ' that proposes policy recommendations to fully recognize the value of biosimilars and ensure a more sustainable market in Europe. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience. Share Biosimilars have played a significant role in alleviating the financial burden on the European healthcare system, having delivered €56 billion in cumulative cost savings across Europe over the past 11 years (2013-2024). 1 However, the current policy environment in Europe, particularly the post-launch pathways, is misaligned to incentivize biosimilar competition. With post-marketing challenges, on top of high development costs, many biologics will not face biosimilar competition at the point of loss of exclusivity (LoE) within the next decade. The whitepaper proposes several measures to improve current practices that hinder healthy market competition and timely access to biosimilar medicines: Health Technology Assessment (HTA) needs to be tailored for biosimilars: With its origin in innovative medicine, HTA is a multidisciplinary process that evaluates the medical, social, economic, and ethical implications of health technologies. Some countries often have oversimplified HTA requirements for biosimilars, where reimbursement decisions are solely based on price comparisons and do not take into account biosimilars' additional benefits or where the reference biologic is not reimbursed. In many cases, HTA is relevant, but with limited guidance to properly assess the biosimilar's value. HTA can be more streamlined and tailored to speed up the entry of biosimilars to the market. In some countries, pricing and reimbursement (P&R) policies focus on achieving the lowest possible prices through mechanisms such as price linkage and reference pricing, thereby accelerating price erosion: Out of 28 European countries, 12 countries use external reference pricing methods and 17 countries mandate arbitrary discounts on biosimilar prices at an average of 28% below reference product. 2 Already set at significantly lower levels, biosimilar prices are driven further downward as competition begins, often leading to price erosion that drives players out of the market. Instead of arbitrary price-controls, free pricing will allow price discounts to be achieved naturally through free competition. Tenders often favor a single-winner system and tend to overlook broader qualitative factors such as supply stability and quality assurance: National, regional, and local tenders should support supply diversification and fair competition through multi-winner systems, with greater transparency in communication and more periodic tender reopenings so that late entrants are also given opportunities to participate. Security and stability of supply should be given higher priority in tenders to enhance demand predictability and incentivize manufacturers to secure more robust supply chains. Biosimilar uptake cannot be achieved without the support of physicians and pharmacists who prescribe and dispense these medicines: Incentives extended to healthcare professionals to encourage the prescribing and dispensing of biosimilars vary significantly across European countries. In some countries, prescriber incentives are misaligned, discouraging the use of biosimilar medicines. Incentive programs should be based on shared decision-making between physicians and patients, rather than automatic switching. Gainsharing can be introduced to stimulate biosimilar uptake while preserving competition and autonomy. Education programs for physicians, pharmacists, and patients should be continued to support wider use of biosimilars. 'Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline,' said Adam Levysohn, Vice President and Head of Commercial Strategy Europe, at Samsung Bioepis. 'It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.' Samsung Bioepis is a biopharmaceutical company that develops and manufactures high-quality biosimilars to accelerate patient access to biologic medicines. As a world leader in biosimilars, Samsung Bioepis has a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. Of the 11 biosimilars approved worldwide, eight products are available across Europe. To access the report Solving the Biosimilar Void in Europe, please visit HERE. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. 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Gulf Today
08-07-2025
- General
- Gulf Today
Tweed's youthful makeover resurrects symbol of Scottish heritage
'When you see tweed on the runway, you don't expect it to come from here,' joked 38-year-old former banker Alexander MacLeod as he set up his loom in a converted barn on the shores of a Scottish loch. MacLeod became a weaver two years ago, joining residents on the islands of Lewis and Harris, off Scotland's northwest coast, in helping to rejuvenate the tweed industry after a significant period of decline. 'It's a good thing to keep the tradition going,' he said. Tweed is a symbol of Scottish heritage and has 'always been part of the culture' on the Outer Hebrides, added Macleod, who hails from the island of Scalpay, which is connected to Harris by a bridge. It's now 'an attractive sector to be in', he explained. He left the Hebrides for seven years to work in banking but the pull of his roots proved too strong. During the day, McLeod now works for a small local cosmetics company. In the evenings, he puts on a podcast, usually about espionage, and patiently begins to weave. Only the steady hum of his machine disturbs the calm of the old stone barn. A photograph shows the weaving loom of Harris Tweed weaver Minnie Hooper at the Harris Tweed Authority building in Stornoway, on the Isle Of Lewis, in the Outer Hebrides, northern Scotland. Harris tweed, traditionally made from 100 per cent wool, is the only fabric protected by a 1993 Act of Parliament. It must be 'handwoven by the islanders at their homes in the Outer Hebrides, finished in the Outer Hebrides, and made from pure virgin wool dyed and spun in the Outer Hebrides'. The weaver spoke of his 'satisfaction' once the tweed is finished. The fabric, once associated with the British aristocracy, then goes to the spinning mill for a quality control check, where the slightest flaw is flagged up. Finally, it receives the precious 'Harris Tweed' stamp — a globe topped with a cross — certifying the fabric's provenance and authenticity, issued by the Harris Tweed Authority (HTA). The tweed then leaves the island to be purchased by discerning companies abroad, including luxury brands such as Christian Dior, Chanel, and Gucci. Several sneaker brands such as Nike, New Balance, and Converse have also used it for limited edition products. The traditional staples are jackets, caps, and bags, but the fabric can also used for furniture. There are 140 weavers, according to the HTA, which launched a recruitment campaign in 2023 and offered workshops to learn the trade following a wave of retirements. This know-how, often passed down from generation to generation, is now being nurtured by a different profile of weaver. Harris Tweed stoles displayed at the Isle of Harris Tweed shop, in Tarbert, Isle of Harris, in the Outer Hebrides, northern Soctland. 'It's nice to see younger people coming in,' said Kelly MacDonald, director of operations at the HTA. 'When I joined the industry 22 years ago, there was a severe period of decline. I was wondering: 'is there going to be an industry anymore?'' But the industry is now enjoying a 'resurgence' and 'significant growth', with more than 580,000 metres of tweed produced in 2024. 'We are always looking at new markets,' she explained, and tweed is now exported to Korea, Japan, Germany, France and other countries. It is no longer dependent on the US market, as it once was, and should be largely shielded from the tariffs imposed by President Donald Trump. Rolls of Harris Tweed line up at the Carloway Mill workshop, in Carloway, Isle of Lewis, in the Outer Hebrides, northern Scotland. Photos: AFP Tweed has 'modernised', said Cameron MacArthur, who works at Carloway Mill, one of the three spinning mills in the west of the Isle of Lewis. He is only 29, but has already worked there for 12 years. The mill, with its large machines, looks as if it hasn't changed for decades. But MacArthur has seen it evolve to embrace a younger workforce and newer fabrics, meaning it is no longer just the ultra-classic Prince of Wales check or dark colours that are on offer. 'Nowadays, we're allowed to make up our own colours... and we're just doing different things with it, modernising it, making it brighter,' he said, showing off rolls of turquoise blue and fuchsia pink. Agence France-Presse
The Sun
03-07-2025
- Health
- The Sun
M'sia sets medical milestone with conjoined twin separation in 13-hour surgery
PETALING JAYA: Malaysian surgeons have achieved another milestone in paediatric medicine by successfully separating three-month-old conjoined twins at Hospital Tunku Azizah (HTA), a government hospital in Kuala Lumpur that specialises in paediatrics and obstetrics & gynaecology. According to a statement posted on HTA's official Facebook page, the male twins were born with a rare condition known as Omphalo-Ischiopagus Tetrapus Conjoined Twin, in which the babies were joined at the abdomen and pelvis, sharing four legs. The complex and delicate procedure was led by four senior doctors—Dr Mohd Yusof Abdullah, Datuk Dr Zakaria Zahari, Dr Intan Zarina Fakir Mohamed, and Dr Phang Yee Yun. They were supported by a dedicated team of experienced paediatric surgeons from HTA and Hospital Kuala Lumpur (HKL). The 13-hour surgery began at 8:30am on June 24, with the successful separation completed at 5:43pm. The full operation concluded at 9:48pm. 'Alhamdulillah, the surgery went smoothly and both babies are now stable and receiving treatment in the Paediatric Intensive Care Unit (PICU),' the hospital reported. This remarkable operation marks the fourth successful separation of conjoined twins at HTA since 2019, and the 19th such case in the combined history of HTA-HKL surgical collaborations.
Euractiv
02-07-2025
- Health
- Euractiv
Europe's new health assessment system could be a game-changer
EU countries have begun jointly assessing new medicines under a landmark EU regulation aimed at speeding access to treatments and strengthening cross-border health cooperation. To see the new approach – in effect since January – in action, look no further than a modest but revealing spreadsheet on the European Commission's webpage. It lists the joint clinical assessments (JCAs) now underway. Currently, three new cancer drugs are being evaluated by national health authorities, with their assessments soon to be shared across all EU countries. At present, each EU member state maintains its own evaluation committees and criteria. For smaller or less affluent countries, it remains a resource-heavy challenge to assess how a new product performs compared to existing alternatives – and whether it justifies the potential cost. On Wednesday, a conference organised by the Commission's health department marked the implementation of the Health Technology Assessment Regulation (HTA) – which governs this approach – as the start of 'a new era of collaboration.' HTA typically begins after a medicine or device has been approved and provides national decision-makers with evidence on whether – and how - to offer it to their populations. While the regulation stops short of harmonising the full HTA process, it introduces a major innovation: joint clinical assessments. These evaluations review existing research on a product's clinical effectiveness. Roisin Adams, Chair of the Member State Coordination Group on HTA, underscored their importance in helping countries rein in spiraling healthcare costs. 'Many countries are still recovering from global events, not least the pandemic. We need to make smart decisions – and for that, we need solid information,' she said. In this initial phase, only new cancer drugs and advanced therapy medicinal products will trigger a joint assessment, coordinated by the Member State Coordination Group and supported by HTA experts at the European Commission. According to Adams, around 25 medicines are expected to undergo assessment in 2025. High-risk medical devices, such as implantable cardiac defibrillators, will be added in 2026, orphan drugs in 2028, and by 2030, all new medicinal products will be covered by the regulation. Hope for cancer patients Patient organisations are hopeful the new approach will deliver. 'It's meant to accelerate access and increase transparency,' said Antonella Cardone of Cancer Patients Europe. Once a joint assessment is published, patient advocates hope to put more pressure on national systems that are slow to make new treatments available. For now, though, the regulation is creating additional work for national HTA bodies. Pedro Facon, General Manager of Belgium's National Health Institute and head of the EU-wide consortium streamlining HTA procedures, likened the situation to parenting a toddler: 'As a national HTA institution, we're faced with new, complex procedures – all while continuing our regular work.' He also noted that agencies leading assessments are only reimbursed two years later – a practical hurdle for already stretched institutions. Still, many experts say the long-term gains outweigh the short-term strain. Sabine Vogler, Head of Pharmacoeconomics at Austria's National Public Health Institute, acknowledged the difficulty of aligning diverse systems, but called the initiative 'an important step forward,' especially for smaller and less resourced countries. 'Ultimately, this should save time, since countries can adapt joint assessments to fit their national context,' she said. Maya Matthews, Deputy Director and Head of HTA at the European Commission's DG SANTE, highlighted the broader potential. Her team, she stressed, is doing far more than 'niche work.' HTA could be 'the key to some of the big discussions we're having – about access, unmet needs, and reducing complexity.' One thing is certain: the future of EU health cooperation may well be built, at least in part, on carefully crafted Excel sheets. (de)
Irish Independent
28-06-2025
- Health
- Irish Independent
BreastCheck may be extended to younger and older women in plans under examination
Currently, it covers women aged 50 to 69 years and invites them for screening. Independent TD for Offaly, Deputy Carol Nolan, asked health minister, Jennifer Carroll MacNeill, if the programme could be broadened to women over 70. In response, the minister said that the Programme for Government commits to raising the age for the BreastCheck screening programme in line with updated standards from HIQA and work will shortly begin to establish whether the current age range should be extended. 'I am intent on advancing the cancer screening commitments outlined in the Programme for Government, which will be facilitated through established protocols. The National Screening Advisory Committee (NSAC) is the independent expert group that considers proposed changes to Ireland's screening programmes. 'NSAC assesses the evidence in a robust and transparent manner, and against internationally accepted criteria, before making recommendations to myself as Minister for Health. 'The rigorous processes utilised by NSAC are critical to ensure that our screening programmes are effective, quality assured and operating to safe standards, and that the benefits of screening outweigh the harms,' Minister Carroll MacNeill said. She told Deputy Nolan: "In this regard, I am pleased to report that NSAC is progressing work to consider the further expansion of our cancer screening programmes and has submitted a request to the Health Information and Quality Authority (Hiqa), which has a section dedicated to undertaking evidence synthesises on behalf of the committee, to assess the evidence for a proposed expansion to the age range eligibility of the BreastCheck programme to include those aged 45 to 49 years and those aged 70 to 74 years. 'I should highlight that Hiqa is currently focused on the conclusion of two Health Technology Assessment (HTA) processes to examine a proposed age-range expansion to the BowelScreen programme and the potential development of a screening programme for Abdominal Aortic Aneurysm (AAA). 'The evidence review for the expansion of BreastCheck remains a key priority for NSAC and is expected to commence later this year. ' She added that it would involve the assessment of relevant evidence and knowledge on the effects and consequences of healthcare technologies to guide decisions regarding the appropriate use of technology and efficient allocation of technology assessments are time-intensive and rigorous processes, she added.
