Initiate

A lot more is happening in EUHTA.... Enhanced Procedural Guidance for JCAs published today. Key Takeaways and Insights 🖋️ Streamlined Timelines: The scoping process duration was reduced by 38 days. Administrative efficiency improves overall timelines while maintaining quality. 🖋️ Increased Stakeholder Involvement: Extended time for PICO surveys and subgroup reviews enriches the assessment process. Patients and experts provide critical inputs throughout the JCA lifecycle. 🖋️ Transparency Improvements: All HTD submissions are accessible to the JCA subgroup. Factual accuracy check comments and responses are published online. 🖋️ Flexibility Amid Rigid Timelines: No clock stops, even for therapeutic indication changes, emphasizing procedural continuity. 🖋️ Learning Opportunities: Optional watcher roles introduce an educational aspect to the subgroup, enhancing capacity-building. Full publication can be found here: https://lnkd.in/eFQWvG2b If you want to know more the Initiate team can help support you. We are actively preparing clients for JCA and JSC submissions and would be pleased to share our experience with you.

🚀Don't miss tomorrow's masterclass!🚀 ⬇️ Market Access and the Celtic Nations 📅Date: Thursday 5th December 🕐Time: 1 - 2PM (GMT) 👉LSAA members register here: https://lnkd.in/ehsb2tJ5 👈 🌐Find more masterclasses here: https://lnkd.in/eVJWfGih 🎯Key learning objectives: 📈 Specific country by country Market Access insight 📈 Highlighting opportunities and understanding the challenges across the Devolved Nations as we enter 2025 📈 Recent Market Access developments across Wales, Northern Ireland and Scotland 🗣️Speaker: Andrew Mumford 🎙️Host: Ian Chamberlain ⏰Can't make it tomorrow? ⬇️ Register and we'll send you the recording so you can watch it in your own time! #nhs #lifesciences #pharma #marketaccess #celticnations

EU HTA Updates: The 2025 Annual Work Programme for the Health Technology Assessment Coordination Group (HTACG) outlines key priorities under Regulation (EU) 2021/2282, effective January 2025. It focuses on joint clinical assessments (JCAs) for cancer treatments and advanced therapy medicinal products (ATMPs) and introduces joint scientific consultations (JSCs) for medical devices. Subgroups will address emerging health technologies and refine methodological guidance. The HTACG plans 17 JCAs for cancer-related new active substances and 8 for ATMPs. Developers can request JSCs for medicinal products from February 3 to March 3, 2025, and for both medicinal products and medical devices from June 2 to June 30, 2025 via the HTA IT Platform. The HTACG anticipates 5-7 JSCs for medicinal products and 1-3 for medical devices during 2025. Subgroup activities include monthly meetings (except August) to coordinate assessments and improve methodologies. While JCAs for medical devices will not begin in 2025, processes for future implementation will be developed. Stakeholders, including patient organizations and health professionals, will contribute to JCAs and JSCs through expert involvement and disease-specific input. The HTA IT Platform will ensure secure and transparent interactions, while webinars, conferences, and the European Commission’s HTA website will facilitate communication and stakeholder engagement. Preparations for the 2026 work program will incorporate insights from ongoing JCAs and stakeholder feedback on emerging health technologies, ensuring the framework evolves to meet future needs.