EU Joint Clinical Assessment after the first reports: How should companies interpret the findings?
The first completed EU Joint Clinical Assessments are revealing how the new process is settling in. Three assessments have been completed, one procedure has been withdrawn, two have been discontinued because the required information and analyses were not provided, and a further 12 assessments are ongoing. [1] At this stage, it remains too early to assume that these cases are representative of future JCAs. All three completed reports concern orphan medicines in rare cancers, and cover different technologies, development programmes and evidence settings. They are nevertheless useful because they demonstrate a range of findings that can emerge at the PICO level and raise important issues for national HTA, pricing and reimbursement. A practical way to review progress is therefore to consider the case for each PICO rather than trying to assign one overall interpretation to each medicine. Some findings may support a relatively straightforward national assessment. Others may require additiona...
