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101 hits for »HTA «

EU HTA Task Force Meeting

This is for EUCOPE Members only. For meeting details or the agenda, please contact Matias Olsen….

https://www.eucope.org/events/eu-hta-task-force-meeting-4/

Our Work

…implementing acts. It has further commissioned EUnetHTA 21 to develop advanced HTA methodology that will lay the foundation for the methodology used in EU HTA. The EU HTA Regulation Task Force has been set up to more closely coordinate with members on the engagement with…

https://www.eucope.org/our-work/

Pharmaceutical innovators are concerned over not enough advice meetings being offered in 2025 for discussing trial designs and evidence generation plans, with serious ramifications on the ability to undergo Joint Clinical Assessments

…therapies approved by the EMA. In just three years, by 13 January 2028, these joint assessments will also be performed for all new Orphan Medicinal Products (OMPs). We welcome the new procedure and its aims to provide a transparent and inclusive framework for quality HTA,…

https://www.eucope.org/pharmaceutical-innovators-are-concerned-over-not-enough-advice-meetings-being-offered-in-2025-for-discussing-trial-designs-and-evidence-generation-plans-with-serious-ramifications-on-the-ability-to-u/

EUCOPE's Life Science Lectures - Episode Three

…(HTA) Regulation and the Pharmaceutical Package. The (EU) Regulation 2021/2282 on health technology assessment (HTA) and the revision of the pharmaceutical legislation will play a key role in patients’ access to innovative therapies in the coming decades. While the two legal reforms concern separate processes,…

https://www.eucope.org/events/eucopes-life-science-lectures-episode-three/

OD Expert Group kicks off Phase 2

…a more granular approach to the Orphan Medicinal Products (OMP) Regulation and to the EU Health Technology Assessment (HTA). Phase 2 builds on the OMP Regulation and EU HTA Regulation Phase 2 of the OD Expert Group will therefore cluster on two topics, creating content…

https://www.eucope.org/od-expert-group-kicks-off-phase-2/

EUCOPE Member Spotlight: Q&A with Sobi - Swedish Orphan Biovitrum

…in their draft proposal. Another key policy priority for Sobi is the EU HTA Regulation. Sobi´s global access & policy team partnered closely with EUCOPE to provide input to several key EUnetHTA methodologies, especially to reflect the clinical realities of rare disease therapies. It remains…

https://www.eucope.org/eucope-member-spotlight-swedish-orphan-biovitrum-sobi/

ISPOR "Missed Signals: The Economic Implications of Current Health Technology Assessment Protocols for Diagnostics"

…HTA systematically assesses value attributes and supporting evidence. However, assessing diagnostic technologies presents unique challenges due to their limited direct impact on health outcomes. This educational symposium aims to delve into the methodologies, processes, and results related to HTA assessment specifically for diagnostic imaging technologies….

https://www.eucope.org/events/ispor-missed-signals-the-economic-implications-of-current-health-technology-assessment-protocols-for-diagnostics/

EUCOPE Member Spotlight: Q&A with PTC Therapeutics

…believe it is important that: The implementation of the EU HTA Regulation ensures that the methodologies which are being developed for the joint clinical assessments are suitable for orphan medicines and ATMPs and that duplication with national HTA procedures are as much as possible, avoided….

https://www.eucope.org/eucope-member-spotlight-qa-with-ptc-therapeutics/

EUCOPE’s Life Science Lectures – Episode Five

The new EU HTA procedure: How can JCAs support access to OMPs for people living with rare diseases Episode 5 – 3 June 2024 (16:00 – 17:00 CET) The new Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) will apply from 12 January 2025, to…

https://www.eucope.org/events/the-new-eu-hta-procedure-how-can-jcas-support-access-to-omps-for-people-living-with-rare-diseases/