D5.4 Production of JCA on medicinal products and medical devices
This EUnetHTA 21 deliverable (D5.4) focusses on the planned clinical assessments during EUnetHTA 21, in accordance with the tender specifications.
The objectives of this deliverable are to:
- Produce JCA for medicinal products (at least 1, maximum 2) and medical devices (at least 2, maximum 4), to continue to improve quality, consistency and national uptake of the JCA and further standardize the production process.
- During the JCA production, test the methodological convergence paths defined at the end of EUnetHTA JA3 (i.e. PICO concept paper and the GRADE framework paper).
- During the JCA production, test the new methodological guidelines that will be developed by EUnetHTA 21 as well as the revised templates and guidelines, responding to identified challenges in EUnetHTA JA3.
For any questions regarding this deliverable, please contact JCA_Secretariat@zinl.nl
Below you can find the published documentation:
D5.4 Production of JCA/CA on medicinal products and medical devices – Project Plan |
JCAMD001This is the Medical Device Joint Clinical Assessment (JCA) JCAMD001 under EUnetHTA 21 on Optilume® urethral drug-coated balloon (DCB). The aim of this JCA is to assess the relative clinical effectiveness and safety of the Optilume urethral drug-coated balloon (DCB) medical device in the target patient population against relevant comparators. In accordance with the requirements of EUnetHTA 21 members, the target patient population and relevant comparators were defined before the start of the assessment in the assessment scope according to a Population, Intervention, Comparator, Outcome (PICO) framework. The assessment scope is presented in Section 3 of the final JCAMD001 report. The assessment was based on the submission dossier submitted by the health technology developer (HTD) of this medical device, Laborie Medical Technologies. Below is the documentation provided by the JCA authoring team (assessment report and responses to the factual accuracy check performed by Laborie Medical Technologies); and the Core Submission Dossier prepared by Laborie Medical Technologies, the Health Technology Developer of the technology under assessment.
For any questions regarding the assessment, please contact EUnetHTA@zinl.nl |
JCAMD002This is the Medical Device Joint Clinical Assessment (JCA) JCAMD002 under EUnetHTA 21 on Evoke Spinal Cord Stimulation (SCS) System. The aim of this JCA is to assess the relative clinical effectiveness and safety of the evoke Spinal Cord Stimulation (SCS) System. In accordance with the requirements of EUnetHTA 21 members, the target patient population and relevant comparators were defined before the start of the assessment in the assessment scope according to a Population, Intervention, Comparator, Outcome (PICO) framework. The assessment was based on the submission dossier submitted by the health technology developer (HTD) of this medical device, Saluda Medical. Below is the documentation provided by the JCA authoring team (assessment report and responses to the factual accuracy check performed by Saluda Medical); and the Core Submission Dossier prepared by Saluda Medical, the Health Technology Developer of the technology under assessment. |
D5.4 deliverable on medicinal JCA timelines
The D5.4 deliverable on medicinal JCA timelines are published below. Please note, that this is a draft document and may be revised by August 2023. |
D5.4 JCA without HTD submission (PICO exercise)
The documents describe a test run for the definition of PICOs for an assessment of a medicinal product. This exercise aimed at testing and improving the process developed within EUnetHTA21. As such, it has no relevance and no consequences for national assessments of medicinal products. Furthermore, heterogeneity in terms of wording and presentation between the 3 exercises was expected. |
