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:
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
This is the Medical Device Joint Clinical Assessment (JCA) JCAMD001 under EUnetHTA 21 on Optilume® urethral drug-coated balloon (DCB).
This 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.
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 Deliverable on medicinal JCA timelines
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.
PICO 1 Pluvicto
PICO 2 Ebvallo
PICO 3 Pombiliti
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