Heads of HTA Agencies Group’s Post

The draft Implementing Act (IA) on Joint Clinical Assessment (JCA) for medicinal products has just been published! This is a major milestone in the journey to the new era of European Health Technology Assessment (EU HTA). What does this mean for you as you prepare a product launch for 2025? Explore the details of the Implementing Act on JCA to learn what changes have occurred, what issues remain unaddressed, and how to prepare for the upcoming final implementation of EU #HTA in 2025. https://bit.ly/3xXEnKs

With the new EU Health Technology Assessment regulations scheduled to take effect exactly one year from today (on January 12, 2025), we have a new whitepaper to guide drug developing companies. This whitepaper written by Dr Sigrid Klaar, Medical Advisor & NDA Advisory Board Member, explores the Joint Scientific Consultation. It aims to address company questions on clinical study design and other evidence generation issues from a HTA and payer perspective. The paper offers useful advice for stakeholders on making the most of this opportunity to engage with HTA agencies under the new rules. Click the link below to download the whitepaper. https://lnkd.in/dwWjacR6 #HTA #JSC #DrugAccess #EMA

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation. This Regulation replaced the voluntary network of national authorities (HTA Network), and the EU-funded project-based cooperation (Joint Actions EUnetHTA) with a permanent framework for joint work. The new framework covers joint clinical assessments, joint scientific consultations, the identification of emerging health technologies, and voluntary cooperation. The Regulation on HTA entered into force in January 2022 and applies as of 12 January 2025. Do you want to be updated regarding this New Regulation? Please contact RegPharmaClin S.L. and get latest news regarding this Regulation and its implications.

Is it time we started asking manufacturers to be bolder when incorporating patient insights as part of HTA submissions? Our poster tour at #ISPORAnnual on May 6 will examine the call for more ambitious efforts by biopharma manufacturers to ensure that the patient voice is truly central to any submission. The poster explores how health technology assessment (HTA) organizations in European markets incorporate the patient voice into their submissions. HTA agencies and regulators do not currently specify detailed study design and evidence requirements for HTA submissions for patient involvement, but should more implicit guidance be provided by HTA agencies for technology manufacturers? Authors: Mariam Bibi, Ally Robert, Abigayle Robson, and Daniella Foster, Avalere Health. Join the discussion on poster tour PT3 from 11:30-12:15. Schedule your meeting with us at Booth 413: https://lnkd.in/eAxvzZha #HEOR #MarketAccess #PatientVoice #HTA #WeAreAvalereHealth

Is it time we started asking manufacturers to be bolder when incorporating patient insights as part of HTA submissions? Our poster tour at #ISPORAnnual on May 6 will examine the call for more ambitious efforts by biopharma manufacturers to ensure that the patient voice is truly central to any submission. The poster explores how health technology assessment (HTA) organizations in European markets incorporate the patient voice into their submissions. HTA agencies and regulators do not currently specify detailed study design and evidence requirements for HTA submissions for patient involvement, but should more implicit guidance be provided by HTA agencies for technology manufacturers? Authors: Mariam Bibi, Ally Robert, Abigayle Robson, and Daniella Foster, Avalere Health Join the discussion on poster tour PT3 from 11:30-12:15. Schedule a meeting at Booth 413: https://lnkd.in/eAxvzZha #HEOR #MarketAccess #PatientVoice #HTA #WeAreAvalereHealth

📢 The European Commission has released the draft for the third Implementation Act (IA) under the EU Health Technology Assessment (HTA). This draft outlines procedural rules for the cooperation between the Member State Coordination Group on HTA, the European Medicines Agency (EMA), and other relevant expert panels. 𝐊𝐞𝐲 𝐡𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬: ‣ Coordination and information exchange between the HTA Secretariat and EMA ‣ Establishing consistency and timelines for joint clinical assessments and scientific consultations ‣ Clear guidelines for the identification and involvement of expert panels and individual experts ‣ Robust measures for protecting confidential information throughout the process The IA ensures a streamlined, transparent, and secure evaluation process for medicinal products and medical devices across the EU, facilitating better healthcare outcomes. 📅 The consultation period is open until July 24th. Read more and participate here: 🔗 https://lnkd.in/gmAnkey4 ✅ Please reach out to Kate Noble to understand the implications of this update and how we can assist you in navigating these changes. #EUHTA #HTAregulation #jointclinicalassessment #jca #healthcare #marketaccess #regulationchanges

Exploring Health Technology Assessment in Key European Countries Discover how HTA frameworks vary across the UK, France, Germany, Spain, and Italy in our latest blog post. Each country uses unique approaches to assess and integrate new health technologies, impacting national healthcare policies and patient care. Key Insights: • UK’s NICE and France’s HAS: Driving cost-effectiveness and patient outcomes. • Germany and Spain: Focus on negotiated pricing models and regional adaptations. • Italy: Integrates HTA into regional healthcare to optimize resources. Learn more about the strategic role of HTA in shaping healthcare across Europe by reading the full article on our website. https://lnkd.in/eba8PACT #HEOR #reimbursement #costeffectiveness #pharmaceuticals #HTA #marketacces #HealthEconomics

The draft Implementing Act (IA) on Joint Clinical Assessment (JCA) for medicinal products is a major milestone in the journey to the new era of European Health Technology Assessment (EU HTA). What does this mean for you as you prepare a product launch for 2025? Explore the details of the Implementing Act on JCA to learn what changes have occurred, what issues remain unaddressed, and how to prepare for the upcoming final implementation of EU HTA in 2025. https://bit.ly/4dMBICs

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation. Do you want to be updated regarding this new Regulation?, please, contact RegPharmaClin S.L. to be fully aware about this new regulation and how to proceed for its implementation,

The Regulation (EU) 2021/2282 on health technology assessment (HTAR) contributes to improving the availability for EU patients of innovative technologies in the area of health, such as medicines and certain medical devices. It ensures an efficient use of resources and strengthens the quality of HTA across the Union. It provides a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts. The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation. Do you want to be updated regarding this new Regulation?, please, contact RegPharmaClin S.L. to be fully aware about this new regulation and how to proceed for its implementation,