The alignment of ultra-high-vacuum sample transfer systems can be problematic when there is no direct line of sight to assist the user. We present the design of a simple and cheap system which greatly simplifies the alignment of sample transfer devices. Our method is based on the adaptation of a commercial digital camera which provides live views from within the vacuum chamber. The images of the camera are further processed using an image recognition and processing code which determines any misalignments and reports them to the user. Installation has proven to be extremely useful in order to align the sample with respect to the transfer mechanism. Furthermore, the alignment software can be easily adapted for other systems.
ObjectiveS: Niraparib was recently approved for maintenance treatment of recurrent ovarian cancer patients in response to platinum-based chemotherapy. In the clinical trial, niraparib dose was adjusted to manage adverse events, resulting in a lower average dose intensity (DI) compared to the starting dose of 300mg/day. The objective was to compare the average DI in the clinical trial and real-world settings for niraparib. MethOdS: The average DI in the clinical trial setting was obtained from the Phase 3 NOVA trial. The DI was calculated as the sum of daily doses actually consumed divided by total duration. The real-world DI was derived from data obtained through specialty pharmacies on dispensing and treatment discontinuation. The analysis was performed on patients with a minimum of 4 months (127 days) of follow up. For patients who discontinued treatment, treatment duration was the time between treatment start and treatment discontinuation. For patients who were still on therapy, treatment duration was time between treatment start and analysis date. Sensitivity analysis was conducted by setting the treatment duration for these patients based on either the analysis date or date of last dispense plus 30 days, whichever was later. ReSultS: Among the 367 patients treated with niraparib in the NOVA trial the mean (95% CI) DI was 194.98mg/day (±7.10) and the median was 195.12mg/day. Data was available in the real-world setting for 907 patients. In these patients, the mean (95% CI) DI was 202.43mg/day (±8.08) and median was 186.33mg/day. In the sensitivity analysis, the mean (95% CI) DI was 197.97mg/day (±7.99) and median was 183.67mg/day. CONCLUSIONS The DI in the real-world setting for niraparib is similar to that observed in the clinical trial. Since the cost of niraparib is proportional to dose administered, it is important to consider the actual DI in estimating the real-world cost of niraparib.
is a long-lasting autoimmune disease, which is characterized by patches of abnormal skin. It is a non-curable disease; however, treatment options will help to control the disease for many patients. This study provides information on the current reimbursement situation with biological agents in various European countries, which are part of the treatment plans of middle to severe Psoriasis. MethOds: The international HTA database Prismaccess® includes all decisions by market access authorities, among others from England, Scotland, France, Germany and Sweden. All decisions on therapies for Psoriasis launched in these countries since 2011 were considered for a systematic reimbursement analysis. Results: In total, there were 57 decisions considered. France with the Transparency Committee is leading with 22 decisions, followed by Sweden's TLV with 12, the Scottish SMC with 10 and German's G-BA and IQWiG with 2 and UK's NICE with 4 recommendations. The level of added benefit differs in extent and between countries. In France, 2 subgroups obtained a ASMRs of IV, while majority reached an ASMR V, which means no added benefit. SMC recommended 2 therapies, 7 as restricted and did 1 not recommended; TLV rated 8 as recommended and 4 as restricted. NICE evaluated 3 drugs as recommended and 1 as not accepted. In Germany G-BA/IQWiG evaluated 4 drugs: 2 therapies received no added benefit and 2 received an added benefit in at least one subgroup. Overall, different decisions of the respective HTA bodies could be identified for 9 treatments. They differ in appropriate comparator therapy, patient population or economic data. cOnclusiOns: The analysis showed differences in the assessment of Psoriasis drugs between different market access authorities in Europe. Reasons vary hugely and need to be taken into account in future market access submissions. SY3 How will PaYerS Manage tHe CoSt of new, advanCed BiologiC and onCologiC agentS aS tHeraPY areaS BeCoMe Crowded witH drugS witH SiMilar MeCHaniSMS of aCtion?
ObjectiveS: Niraparib was recently approved for maintenance treatment of recurrent ovarian cancer patients in response to platinum-based chemotherapy. In the clinical trial, niraparib dose was adjusted to manage adverse events, resulting in a lower average dose intensity (DI) compared to the starting dose of 300mg/day. The objective was to compare the average DI in the clinical trial and real-world settings for niraparib. MethOdS: The average DI in the clinical trial setting was obtained from the Phase 3 NOVA trial. The DI was calculated as the sum of daily doses actually consumed divided by total duration. The real-world DI was derived from data obtained through specialty pharmacies on dispensing and treatment discontinuation. The analysis was performed on patients with a minimum of 4 months (127 days) of follow up. For patients who discontinued treatment, treatment duration was the time between treatment start and treatment discontinuation. For patients who were still on therapy, treatment duration was time between treatment start and analysis date. Sensitivity analysis was conducted by setting the treatment duration for these patients based on either the analysis date or date of last dispense plus 30 days, whichever was later. ReSultS: Among the 367 patients treated with niraparib in the NOVA trial the mean (95% CI) DI was 194.98mg/day (±7.10) and the median was 195.12mg/day. Data was available in the real-world setting for 907 patients. In these patients, the mean (95% CI) DI was 202.43mg/day (±8.08) and median was 186.33mg/day. In the sensitivity analysis, the mean (95% CI) DI was 197.97mg/day (±7.99) and median was 183.67mg/day. CONCLUSIONS The DI in the real-world setting for niraparib is similar to that observed in the clinical trial. Since the cost of niraparib is proportional to dose administered, it is important to consider the actual DI in estimating the real-world cost of niraparib.
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