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BACKGROUND: Enhanced pharmacokinetic profile of albutrepenonacog alfa allows to prolong the interdose period in prophylaxis, maintaining higher trough level, and to reduce dosage needed for bleeding. This improvement could lead to a better efficiency of the hemophilia B treatment.OBJECTIVES: To estimate the impact of this new drug on the Italian National Health System (NHS).METHODS: A model was developed from the NHS perspective to assess the budget impact of treating severe hemophilia B with reimbursed recombinant factor IX over 3 years in Italy. Target population was based on data from the National Registry of Congenital Coagulopathies, which collects data from 54 Hemophilia Treatment Centers. Treatment options were: albutrepenonacog alfa (Idelvion®), eftrenonacog alfa (Alprolix®) and nonacog alfa (BeneFIX®). Annual bleeding rate, dose and infusions needed to treat an episode based on clinical trials data were considered.RESULTS: Mean costs per patient were calculated for prophylaxis and bleeding treatment by age groups. Applying age-specific costs to the expected new pattern of drugs utilization, the impact on the NHS budget was € 6 million of savings cumulated in 3 years. The model results most sensitive to drug dosages. Lower drug consumption in prophylaxis and reduced bleeding rate than the alternatives reduce expenditures. Main limitations of this analysis were the assumptions that all severe patients receive prophylaxis and the lack of consideration of positive effects of hemorrhagic complications reduction (with consequent lower need of physiotherapy/prosthetic substitution).CONCLUSIONS: The introduction of Idelvion® as therapeutic option for hemophilia B is expected to decrease pharmaceutical costs and improve patient’s quality of life due to less frequent infusions.

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The location of the center of rotation (COR) of joints is a key parameter in multiple applications of human motion analysis. The aim of this work was to propose a novel realtime estimator of the center of fixed joints using an inertial measurement unit (IMU). Since the distance to this center commonly varies during the joint motion due to soft tissue artifacts (STA), our approach is aimed at adapting to these small variations when the COR is fixed. Our proposal, called ArVE d , to the best of our knowledge, is the first real-time estimator of the IMU-joint center vector based on one IMU. Previous works are off-line and require a complete measurement batch to be solved and most of them are not tested on the real scenario. The algorithm is based on an Extended Kalman Filter (EKF) that provides an adaptive vector to STA motion variations at each time instant, without requiring a pre-processing stage to reduce the level of noise. ArVE d has been tested through different experiments, including synthetic and real data. The synthetic data are obtained from a simulated spherical pendulum whose COR is fixed, considering both a constant and a variable IMU-joint vector, that simulates translational IMU motions due to STA. The results prove that ArVE d is adapted to obtain a vector per sample with an accuracy of 6.8 ± 3.9 mm on the synthetic data, that means an error lower than 3.5 % of the simulated IMU-joint vector. Its accuracy is also tested on the real scenario estimating the COR of the hip of 5 volunteers using as reference the results from an optical system. In this case, ArVE d gets an average error of 9.5 % of the real vector value. In all the experiments, ArVE d outperforms the published results of the reference algorithms.

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