News & Commentary
July 2023 – JCAMD002 – Assessment Report
The second JCA assessment report is now available. This evaluates the relative clinical effectiveness and safety of the Evoke spinal cord stimulation (SCS) system medical device in the target patient population against relevant comparators.
The second JCA assessment report is now available. This evaluates the relative clinical effectiveness and safety of the Evoke spinal cord stimulation (SCS) system medical device in the target patient population against relevant comparators.
July 2023 – Parallel EMA/HTA body (HTAb) Scientific Advice during Interim Period post EUnetHTA 21
The Parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) under the EUnetHTA 21 service contract will have to be completed by September 2023 and all available slots have already been allocated. To bridge the interim period between the closure of EUnetHTA 21 and the full application of the HTA Regulation in January 2025, EMA and national HTAb will offer Health technology developers (HTDs) the opportunity for parallel scientific advice.
The Parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) under the EUnetHTA 21 service contract will have to be completed by September 2023 and all available slots have already been allocated. To bridge the interim period between the closure of EUnetHTA 21 and the full application of the HTA Regulation in January 2025, EMA and national HTAb will offer Health technology developers (HTDs) the opportunity for parallel scientific advice.
July 2023 – European consultations: G-BA acts as coordination contact for parallel consultations by EMA and HTA agencies in Europe in the interim period until the full implementation of the EU HTA Regulation
From September 2023, up to and including the end of 2024 (before the full application of the EU HTA Regulation), health technology developers can obtain scientific advice from the national HTA agencies and the EMA in a parallel procedure. The G-BA acts as the central HTA coordination contact: it coordinates all incoming requests for parallel scientific advice and facilitates the procedure with the national HTA agencies. This parallel scientific advice (so-called "Parallel EMA/HTA body (HTAb) Scientific Advice") can be requested by the manufacturers via the G-BA as a transitional model until the application of the EU HTA Regulation.
From September 2023, up to and including the end of 2024 (before the full application of the EU HTA Regulation), health technology developers can obtain scientific advice from the national HTA agencies and the EMA in a parallel procedure. The G-BA acts as the central HTA coordination contact: it coordinates all incoming requests for parallel scientific advice and facilitates the procedure with the national HTA agencies. This parallel scientific advice (so-called "Parallel EMA/HTA body (HTAb) Scientific Advice") can be requested by the manufacturers via the G-BA as a transitional model until the application of the EU HTA Regulation.
June 2023 – JCAMD001 – Assessment Report [updated on 16-06-2023]
The first JCA assessment report is now published assessing the relative clinical effectiveness and safety of the Optilume urethral drug-coated balloon (DCB) medical device in the target patient population against relevant comparators.
The first JCA assessment report is now published assessing the relative clinical effectiveness and safety of the Optilume urethral drug-coated balloon (DCB) medical device in the target patient population against relevant comparators.
June 2023 – The Future of HTA in Europe –The Joint Clinical Assessment (JCA)
Presentation delivered by Martin Scott, Numerus's Scientific Director, at the 2023 PSI (Statisticians in the Pharmaceutical Industry) conference in London, UK.
Presentation delivered by Martin Scott, Numerus's Scientific Director, at the 2023 PSI (Statisticians in the Pharmaceutical Industry) conference in London, UK.
Articles & Podcasts
February 2023 – Podcast interview with Dr. Elvira Müller. "EU joint HTA – decided, but how will it be executed and how should companies prepare."
In Europe, there are at least as many reimbursement assessment processes in place as European countries. Some of these are transparent and clearly defined like the German AMNOG process, others are even more complex and sometimes even unclear, dependent also on the product of interest. Anyhow, the European Commission has already decided that a European joint assessment will come into place in 2025 starting with oncology and ATMP products. Anyhow, currently, timelines and national processes to implement the outcomes of the European evaluation are still unclear and to be defined. Dr. Stefan Walzer and Dr. Elvira Mueller discuss the current status as well as issues and potential solutions for the new upcoming reimbursement start in Europe.
In Europe, there are at least as many reimbursement assessment processes in place as European countries. Some of these are transparent and clearly defined like the German AMNOG process, others are even more complex and sometimes even unclear, dependent also on the product of interest. Anyhow, the European Commission has already decided that a European joint assessment will come into place in 2025 starting with oncology and ATMP products. Anyhow, currently, timelines and national processes to implement the outcomes of the European evaluation are still unclear and to be defined. Dr. Stefan Walzer and Dr. Elvira Mueller discuss the current status as well as issues and potential solutions for the new upcoming reimbursement start in Europe.
December 2022 – The EU joint HTA procedure: a gate or barrier for access?
The joint health technology assessment (HTA) procedure was a hot topic at the World Orphan Drug Congress - Europe (WODC-EU) in Barcelona last month, and opinions were mixed.
The joint health technology assessment (HTA) procedure was a hot topic at the World Orphan Drug Congress - Europe (WODC-EU) in Barcelona last month, and opinions were mixed.
November 2022 – MedTech Europe – EU Regulation on Health Technology Assessment (HTA).
Brussels, 24 November 2022 – Ahead of the Member State Coordination Group Meeting of 28 November 2022, MedTech Europe calls for the set up of a dedicated medical and digital technologies methods subgroup to develop, in due time, “Adaptive” Joint Clinical Assessments methodologies applying the latest scientific developments.
Brussels, 24 November 2022 – Ahead of the Member State Coordination Group Meeting of 28 November 2022, MedTech Europe calls for the set up of a dedicated medical and digital technologies methods subgroup to develop, in due time, “Adaptive” Joint Clinical Assessments methodologies applying the latest scientific developments.
November 2021 – Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective.
The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by systematically comparing EU JCA and German clinical assessments (CA) based on established assessment elements for HTA and assessing the potential impact of differences on Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) ability to derive the therapeutic added value.
The transferability of the EU joint clinical assessment (JCA) reports for pharmaceuticals for the German benefit assessment was evaluated by systematically comparing EU JCA and German clinical assessments (CA) based on established assessment elements for HTA and assessing the potential impact of differences on Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) ability to derive the therapeutic added value.
