Cencora | Pharma solutions’ Post

The new EU Health Technology Assessment (EU HTA) framework is now in force! As the landscape transforms with the introduction of Joint Clinical Assessments (JCAs) in 2025, we’ve pulled together key insights and resources from Phastar experts to help you navigate these changes. 📹 Watch our webinar on the upcoming changes to EU HTA regulations and learn how to prepare for successful HTA submissions. 📖 Read our articles to uncover the challenges of the new framework and discover strategies to streamline compliance. Stay ahead of the curve and ensure your clinical development strategy is aligned with the new EU HTA requirements. Access the resources here: https://lnkd.in/eDW4CyT9 #EUHTA #ClinicalDevelopment #RegulatoryChanges #HealthcareInnovation #Phastar

New Call from European Commission! The European Commission has opened a new call for applications to expand the Health Technology Assessment (HTA) Stakeholder Network, which plays a crucial role in the implementation of the HTA Regulation (EU) 2021/2282. This is a key opportunity for organisations involved in EU HTA to engage directly with the HTA processes shaping the future of healthcare technology in Europe. Key Information: ‣ Application Deadline: 9 October 2024, 17:00 (CEST) ‣ Target Audience: European patient associations, health technology developers, consumer groups, health professional organisations, and other health-related NGOs ‣ How to Apply: Submit the required documents to SANTE-HTANETWORK@ec.europa.eu ‣ Link to application form: https://lnkd.in/eTK_8dps FIECON Joint Clinical Assessments (JCA) experts can provide cutting-edge insights and up-to-date knowledge on HTA developments to support your organisation. Stay informed by reading our latest Article related to HTA Stakeholder Network: Stakeholders meet to feedback on #JCA and shape the implementation of the 2025 #HTA Regulations: https://lnkd.in/exHm_t3a #HTA #EURegulation #FIECON #Pharma

🔟 - 9️⃣ Attended ISPOR Philippines Chapter as part of HTAC. The challenges of approving health technologies at a faster pace and including medicines in the formulary have always been the main topics of discussion when it comes to HTA. Additionally, the power of LGUs to purchase their own health technologies without needing to follow the Philippine National Formulary has been a point of debate in HTA discussions. The way I see it is that: 1️⃣ We need to accept more topic nominations, and the only way for HTA PH to handle this is by increasing its manpower and have more external assessors. 2️⃣ Improve health information systems, data gathering, sharing, and analysis in the Philippines and across the region. 3️⃣ Harmonize the efforts of the FDA, DOH, PhilHealth, and HTA PH to ensure that each agency is aligned and supports one another. 4️⃣ Build the capacity of individuals interested in working in the field of HTA. 5️⃣ Strengthen health systems. 6️⃣ Include patients within health systems, making them partners rather than mere subjects. After all, what is important is not the number of technologies being approved, but the health outcomes for those receiving the technology.

On our #BusinessBlog, we have just posted a new article regarding the Adoption of the European Health Data Space (EHDS) Regulation and its implications for Clinical Research in the EU! ✅👏   ✨ Last week the Council of the EU adopted this pioneering regulation, a giant leap in the way we tackle health data across European borders. In the article, we discuss the impact of the EHDS on clinical research in the EU from different perspectives, such as data availability, regulatory compliance, and following steps. While we transition through these changes, all stakeholders in clinical research must continue to adapt to leverage the potential of this powerful initiative.💻🚀   👍To find out how EHDS will affect clinical research and what it means for the future of health care in Europe, read the full article on our Business Blog https://lnkd.in/d2iCZUg6.   #EHDS #HealthcareInnovation #ClinicalResearch #DataManagement #HealthData 

🌐 Each EU member state submits #PICO criteria for new products to improve the HTA process 🌐 Jarmo Hahl, Kalle Aaltonen, and Tuomas Oravilahti discussed PICO criteria (Patient, Intervention, Comparator, Outcomes) at Emma Event on April 10, 2024. Each member state is expected to deliver PICO criteria for new products during the process, possibly grouped into subgroups.   According to Aaltonen, the number of PICOs is intended to be reduced to a reasonable level. Mechanisms for reduction are to be found before 2025.  📌 What is PICO? ✔ P = Population, Patient, Problem: The health issue and patient group being studied   ✔ I = Intervention: The intervention or method being studied to address the health issue   ✔ C = Comparator: The method against which the studied method is compared ✔ O = Outcomes: The health outcomes the method produces, which are to be investigated In the #EU, the #HTA Directive has also made the concept of #JCA (Joint Clinical Assessment) relevant. It aims to harmonise the assessment methods for medicines and other health technologies among member states.  JCA aims to provide a joint assessment report on the clinical efficacy and safety of a medicine or treatment method, which different countries can utilise in their national decision-making processes.  This procedure is designed to promote transparency, objectivity, and uniformity in assessing medicines, which may help speed up the availability of new, effective, and safe treatments across the EU. A joint clinical assessment can reduce overlapping work and enhance the use of resources in health care. ➡ Read the whole article here: ➡ In English ➡ https://lnkd.in/dhZq9Jqg In Finnish ➡ https://lnkd.in/d88d7k5v #Medaffcon #JointClinicalAssessment

Manufacturers will not be able to predict the questions they will be asked during their clinical assessments in the upcoming EU HTA Regulation. However, they can formulate a proactive approach by performing PICO simulation exercises. VP of Market Access & Healthcare Consulting Europe Herbert Altmann and EU HTA Lead Ruairi O’Donnell explain how manufacturers can expect the unexpected in a recent Citeline article: https://ow.ly/KFF450THmVX #HTA #EUHTA

Collaborations among agencies are becoming more and more important in the access landscape. See this blog with Tina Wang providing a framework to navigate current initiatives and discuss to what extent they can deliver on the many promises. We conclude that collaborations in regulatory and HTA are progressing, but to deliver they need to be better linked with vertical initiatives along the access pathway. #HTAcollborations #ILAP #HTA

🚀 EU’s HTA Regulation Set to Transform Access to Rare Disease Treatments by 2025! 🌍 On January 12, 2025, Europe will implement a groundbreaking Health Technology Assessment (HTA) Regulation aimed at revolutionizing the evaluation of new medicines and health technologies. 🔑 Key Highlights: - Accelerated access to life-saving treatments for rare disease patients. - Harmonized evaluation methods ensure consistent and comparable outcomes. - Enhanced patient involvement fosters informed healthcare decisions. - Reduction in national delays for timely reimbursement of new therapies. This monumental shift introduces Joint Clinical Assessments (JCAs), centralizing evaluations and aligning them with European Medicines Agency (EMA) timelines. The result? Quicker access to innovative treatments for those who need them most! Transparency is a cornerstone of this new framework, ensuring patient perspectives are integral in the assessment process. While challenges remain in adapting national HTA systems, collaboration with EURORDIS aims for seamless implementation. 💡 This regulatory change promises a more efficient and equitable healthcare system across Europe—benefiting patients with rare diseases significantly! 👉 Click the link to learn more about this pivotal development! #EUCare #HealthTech #InnovationInHealthcare #PatientCenteredCare #RareDiseases #RegulatoryAgencies #ResearchConsultantCompanies #MarketAccess #MarketAccessToday

Are you responsible for your organization’s HEOR activities in Europe? Are you getting ready for EU Joint Clinical Assessment (JCA) from January next year? Stop by our booth at #ISPOR2024 to meet with our EU HTA Regulation experts to find out how we can help you prepare for the new Regulation and navigate your product through the JCA. Stop by our booth (231) to find out more and visit our website to set up a meeting with our experts. https://buff.ly/44n6yi8 #HEOR #HealthEconomics #OutcomesResearch #HTA #ISPORAnnual #JCA #EUHTARegulation

Health technology assessment and regulatory methodologists and assessors came together for a webinar titled “Understanding evidence challenges, managing uncertainties, and exploring potential solutions”. There was huge interest from the community with over 350 participants registered and balanced representation from HTA and EMA. The webinar was hosted by the NCPE - National Centre for Pharmacoeconomics in collaboration with the HTA Coordination Group Methodology and Procedures Subgroup, the Heads of HTA Agencies Group and the EMA CHMP and Methodology Working Group. Presentations described the distinct remit of HTA and EMA but also where the synergies lie and how through discourse on the challenges, uncertainty can be better understood in the context of these remits. A common understanding will allow for more successful employment of methodologies and solutions to manage uncertainty.  This is the part of an ongoing scientific collaboration between HTA and regulators and we look forward to more fruitful discussions in Autumn. Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)KCE - Federaal Kenniscentrum voor de Gezondheidszorg - Centre Fédéral d'Expertise des Soins de Santé INFARMED, I.P. European Medicines Agency Michael Berntgen @european commission dg