No abstract

structural change. Since 2016, only two pharmaceuticals (both in oncology) have undergone both European JA and national assessment in Germany. This is the first time that the methodology applied in the different assessments is compared based on concrete examples. METHODS: Differences between the JA and the corresponding German assessment report were analyzed for Midostaurin in the indication of FLT3-positive acute myeloid leukemia (JA published November 2017) and Alectinib in the indication of ALK-positive advanced non-small cell lung cancer (JA published January 2018). The comparison features five key items previously identified: body of evidence, comparators, endpoints, evidence synthesis, and subgroups. RESULTS: While in Germany only RCT data with a specific comparator was accepted in each case, non-RCTs and multiple comparators were included in the JA leading to a larger body of evidence (1 study vs. 3 studies in each example). Indirect comparisons were considered only in the JAs (e.g. Alectinib vs. Ceritinib). Furthermore, some endpoints not regarded as relevant in Germany, such as progression-and disease-free survival, were presented within the JAs. The methodology used to evaluate the certainty of results differed significantly. However, there were also similarities between JA and the German assessment: both approaches follow the principles of evidence-based medicine; central endpoints were overall survival, health-related quality of life, and safety; subgroups investigated were consistent. CONCLUSIONS: The examples reviewed confirm that the outcome of European JAs and their German equivalent can be expected to differ for methodological reasons. In general, JAs offer a broader spectrum of possibilities in terms of suitable evidence and analytical methods. Nevertheless, a high degree of consensus was observed in the final evaluations suggesting a strong potential for future harmonization of the different procedures.

in a test with the National Medicines Verification Organisation to evaluate possible strategies, compatible with legislation, for the implementation of serialisation. Purpose The aim of the first test is to evaluate the feasibility of decommissioning of each unique identifier at the reception of medicinal products in the pharmacy. Material and methods During 14 days (summer 2018), the pharmacy technician scanned the data-matrix of each box received with an Optel certa tabletop (possibility of switching between vertical and handheld scanner). Quantitative indicators (number of boxes received, number of serialised drugs in circulation, products with a non-compliant data matrix) were recorded. The scanning time of each carton was measured and the equipment's ergonomics evaluated. Results During the study, the pharmacy received an average of 822 boxes/day (min: 273; max: 1737), of which 90% were in the scope of the FMD and the RD. The average scanning time per pack was 5 s, totalling an average of 56 minutes/day to scan all boxes. Only 3/530 medications displayed a serial number, while three of them (nicardipine, pemetrexed, midazolam) had a non-readable data-matrix (colour inversion) on their packaging and thus could not be scanned. The Optel certa tabletop and its software are considered easy to use. But the manoeuverability and malfunctions of the handheld scanner contributed to inflate the scanning time. Conclusion This first test demonstrated the technical feasibility of decommissioning boxes on their reception in real working conditions. The connection to the National Medicines Verification System was not effective during the test, so the upload time between interfaces could not be evaluated. The imposing equipment leads to opting for mobile and compact scanning devices. Decommissioning at reception confronts us with repeated interruptions of tasks (deliveries, phone calls …) but avoids the storage of non-authentic and non-conforming boxes. A second decommissioning test just before dispensing to patients is planned to assess the feasibility of this scenario. REFERENCES AND/OR ACKNOWLEDGEMENTSFalsified Medicines Directive. Delegated Regulation 2016/161. No conflict of interest.