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PRO59 ANALYSIS OF THE G-BA BENEFIT ASSESSMENTS OF ORPHAN DRUGS AND GERMAN PAYER OPINIONS ON THE NEW "LAW FOR THE IMPROVEMENT OF SAFETY IN DRUG SUPPLY"

Since 2011, manufacturers of orphan drugs with sales exceeding €50m have been required to undergo assessment by the Joint Federal Committee(G-BA). Currently, an “additional benefit” is assumed for orphan drugs by the G-BA; however, the “Law for improvement of safety in drug supply”, expected to be implemented in Jul-2019, is likely to impact the assessment. According to the Mar-2019 draft, the G-BA would be able to commit manufacturers to carry out data collection, if not enough evidence is available to assess the benefit at the time of the dossier submission. If no added benefit is demonstrated or no additional data is collected, then this can impact the to be agreed reimbursement price1. The research aimed to evaluate the rationale behind the benefit assessment ratings of orphan drugs and to explore payer’s opinions on the impact of this new law. All completed orphan drugs G-BA assessments between Jan-2011 to May-2019 were reviewed. Drugs receiving a non-quantifiable additional benefit were further studied to identify reasons behind their rating, using the G-BA justification of the resolution documentation. Furthermore, via the IPSOS Dimensions software, 38 payers in Germany were asked about their opinion on the new law, regarding orphan drugs. 115 orphan drug patient-populations were evaluated by the G-BA. 65 drugs were granted a non-quantifiable added benefit. The primary reasons observed were related to the study design, mainly the lack of a direct comparator(n=51) but also the short length of trials, small target population and lack of blinding. Moreover, the new law is expected to worsen the conditions for new orphan drug evaluations. The lack of a direct comparator was the main reason for unquantifiable additional benefit score in orphan indicated. The new law, which addresses the benefit assessment for orphan drugs, will likely add hurdles to manufacture’s developing orphan drugs, according to payers.

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Orthogonal Turning Simulations for Casted Steel Alloy Using Mesh Free Methods

Automobile components have to fulfil comprehensive requirements in terms of functional performance, reliability and production cost which are at the leading edge of technology. For that, they often undergo machining operations. Robust, high-precision machining processes are critical to the reduction of scrap rates which severely affect the cost per part. Owing to this reason, computational modelling of machining by means of the Finite Element Method (FEM) has gained increased emphasis in recent years in order to enhance process design and optimization. A major drawback of FEM in modelling of machining, however, is the handling of mesh distortions which are inherent to cutting processes. In contrast, mesh-free methods such as Smooth Particle Hydrodynamics (SPH) or Smooth Particle Galerkin (SPG) methods eliminate this drawback. Hence, this paper focuses on the mesh-free simulation of orthogonal turning of a recent cast steel alloy using the SPH and SPG methods. Simulations of variable particle diameters do indicate low do to be favorable for both methods. Forces and chips from mesh-free simulations were compared against FEM simulation and experimental results. Simulations in LS-DYNA and experiments both using Design of Experiments (DoE) were carried out in order to investigate the effects of cutting velocity, feed and rake angle on force components, which demonstrate good agreement of results from mesh-free simulations and tests. With the mesh-free methods the effort to model the machining process was significantly decreased compared to the FEM, however at the expense of higher computation time. In future, mesh-free methods, especially SPG, can significantly improve the efficiency of the machining process layout reducing today’s mostly experimental expense, which arises in particular for recent materials, thereby contributing to the production at the leading edge of technology.

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Collaborative services provision for solar power plants

PurposeThe purpose of this paper is to support effective business services provision along the life cycle of complex service-enhanced products, such as the case of solar power plants, and to explore collaborative approaches for multi-stakeholder business services.Design/methodology/approachDesign and implementation of adequate collaboration strategies and cloud-based support mechanisms to facilitate creation and management of collaborative networks in this sector. For this purpose, a conceptual framework, a cloud-based platform and a set of collaboration support tools are proposed. Validation is based on a pilot implementation and interactions with a large group of end users.FindingsValidation results confirmed the suitability of the collaborative networks approach in this sector, which often involves multiple small and medium size enterprises.Originality/valueThe interplay between long-term strategic networks and goal-oriented collaborative networks and their interaction with the various phases of the product-services life cycle correspond to a novel approach in this sector, traditionally focused on a sub-contracting model. This opens new opportunities for enhancing the value of complex products through collaborative value-added services. Of particular relevance is also the adoption of collaborative approaches for service co-creation.

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