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- Kanai, M, et al.
(författare)
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- 2023
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swepub:Mat__t
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| 3. |
- Moorkens, E, et al.
(författare)
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The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures
- 2021
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Ingår i: Frontiers in pharmacology. - : Frontiers Media SA. - 1663-9812. ; 11, s. 591134-
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Tidskriftsartikel (refereegranskat)abstract
- Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry.Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures.Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab.Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80–90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 – €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures.Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.
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| 5. |
- Soust-Verdaguer, B., et al.
(författare)
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Implications of using systematic decomposition structures to organize building LCA information: A comparative analysis of national standards and guidelines- IEA EBC ANNEX 72
- 2020
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Ingår i: IOP Conference Series: Earth and Environmental Science. - : IOP Publishing. - 1755-1307 .- 1755-1315. ; 588:2
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Konferensbidrag (refereegranskat)abstract
- Introduction: The application of the Life Cycle Assessment (LCA) technique to a building requires the collection and organization of a large amount of data over its life cycle. The systematic decomposition method can be used to classify building components, elements and materials, overcome specific difficulties that are encountered when attempting to complete the life cycle inventory and increase the reliability and transparency of results. In this paper, which was developed in the context of the research project IEA EBC Annex 72, we demonstrate the implications of taking such approach and describe the results of a comparison among different national standards/guidelines that are used to conduct LCA for building decomposition. Methods: We initially identified the main characteristics of the standards/guidelines used by Annex participant countries. The “be2226” reference office building was used as a reference to apply the different national standards/guidelines related to building decomposition. It served as a basis of comparison, allowing us to identify the implications of using different systems/standards in the LCA practice, in terms of how these differences affect the LCI structures, LCA databases and the methods used to communicate results. We also analyzed the implications of integrating these standards/guidelines into Building Information Modelling (BIM) to support LCA. Results: Twelve national classification systems/ standards/guidelines for the building decomposition were compared. Differences were identified among the levels of decomposition and grouping principles, as well as the consequences of these differences that were related to the LCI organization. In addition, differences were observed among the LCA databases and the structures of the results. Conclusions: The findings of this study summarize and provide an overview of the most relevant aspects of using a standardized building decomposition structure to conduct LCA. Recommendations are formulated on the basis of these findings.
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| 8. |
- Frischknecht, R., et al.
(författare)
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Comparison of the greenhouse gas emissions of a high-rise residential building assessed with different national LCA approaches - IEA EBC Annex 72
- 2020
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Ingår i: IOP Conference Series. - : IOP Publishing. ; , s. 022029-
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Konferensbidrag (refereegranskat)abstract
- Introduction: The international research project IEA EBC Annex 72 investigates the life cycle related environmental impacts caused by buildings. The project aims inter alia to harmonise LCA approaches on buildings. Methods: To identify major commonalities and discrepancies among national LCA approaches, reference buildings were defined to present and compare the national approaches. A residential high-rise building located in Tianjin, China, was selected as one of the reference buildings. The main construction elements are reinforced concrete shear walls, beams and floor slabs. The building has an energy reference area of 4566 m2 and an operational heating energy demand of 250 MJ/m2a. An expert team provided information on the quantities of building materials and elements required for the construction, established a BIM model and quantified the operational energy demand. Results: The greenhouse gas emissions and environmental impacts of the building were quantified using 17 country-specific national assessment methods and LCA databases. Comparisons of the results are shown on the level of building elements as well as the complete life cycle of the building. Conclusions: The results of these assessments show that the main differences lie in the LCA background data used, the scope of the assessment and the reference study period applied. Despite the variability in the greenhouse gas emissions determined with the 17 national methods, the individual results are relevant in the respective national context of the method, data, tool and benchmark used. It is important that environmental benchmarks correspond to the particular LCA approach and database of a country in which the benchmark is applied. Furthermore, the results imply to include building technologies as their contribution to the overall environmental impacts is not negligible. Grant support: The authors thank the IEA for its organizational support and the funding organizations in the participating countries for their financial support.
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| 9. |
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| 10. |
- Habert, Guillaume, et al.
(författare)
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Carbon budgets for buildings: harmonising temporal, spatial and sectoral dimensions
- 2020
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Ingår i: Buildings and Cities. - : Ubiquity Press, Ltd.. - 2632-6655. ; 1:1, s. 429-452
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Tidskriftsartikel (refereegranskat)abstract
- Target values for creating carbon budgets for buildings are important for developing climate-neutral building stocks. A lack of clarity currently exists for defining carbon budgets for buildings and what constitutes a unit of assessment—particularly the distinction between production-and consumption-based accounting. These different perspectives on the system and the function that is assessed hinder a clear and commonly agreed definition of ‘carbon budgets’ for building construction and operation. This paper explores the processes for establishing a carbon budget for residential and non-residential buildings. A detailed review of current approaches to budget allocation is presented. The temporal and spatial scales of evaluation are considered as well as the distribution rules for sharing the budget between parties or activities. This analysis highlights the crucial need to define the temporal scale, the roles of buildings as physical artefacts and their economic activities. A framework is proposed to accommodate these different perspectives and spatio-temporal scales towards harmonised and comparable cross-sectoral budget definitions. Policy relevance The potential to develop, implement and monitor greenhouse gas-related policies and strategies for buildings will depend on the provision of clear targets. Based on global limits, a carbon budget can establish system boundaries and scalable targets. An operational framework is presented that clarifies greenhouse gas targets for buildings in the different parts of the world that is adaptable to the context and circumstances of a particular place. A carbon budget can enable national regulators to set feasible and legally binding requirements. This will assist the many different stakeholders responsible for decisions on buildings to coordinate and incorporate their specific responsibility at one specific level or scale of activity to ensure overall compliance. Therefore, determining a task specific carbon budget requires an appropriate management of the global carbon budget to ensure that specific budgets overlap, but that the sum of them is equal to the available global budget without double-counting.
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| 11. |
- Hoxha, A., et al.
(författare)
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Identification of discrete epitopes of Ro52p200 and association with fetal cardiac conduction system manifestations in a rodent model
- 2016
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Ingår i: Clinical and Experimental Immunology. - : Wiley-Blackwell. - 0009-9104 .- 1365-2249. ; 186:3, s. 284-291
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Tidskriftsartikel (refereegranskat)abstract
- Congenital heart block (CHB) is a potentially lethal condition characterized by a third-degree atrioventricular block (AVB). Despite anti-Ro52 antibodies being detected in nearly 90% of mothers of affected children, CHB occurs in only 1-2% of anti-Ro/Sjogrens-syndrome-related antigen A (SSA) autoantibody-positive pregnancies. Maternal antibodies have been suggested to bind molecules crucial to fetal cardiac function; however, it remains unknown whether a single antibody profile associates with CHB or whether several specificities and cross-reactive targets exist. Here, we aimed to define further the reactivity profile of CHB-associated antibodies towards Ro52p200 (amino acid 200-239). We first analysed reactivity of a monoclonal anti-Ro52 antibody shown to induce AVB in rats (7.8C7) and of sera from anti-Ro52p200 antibody-positive mothers of children with CHB towards a panel of modified Ro52p200 peptides, and subsequently evaluated their potential to induce AVB in rats upon transfer during gestation. We observed that CHB maternal sera displayed a homogeneous reactivity profile targeting preferentially the C-terminal part of Ro52p200, in contrast to 7.8C7 that specifically bound the p200 N-terminal end. In particular, amino acid D233 appeared crucial to maternal antibody reactivity towards p200. Despite low to absent reactivity towards rat p200 and different binding profiles towards mutated rat peptides indicating recognition of different epitopes within Ro52p200, immunoglobulin (Ig)G purified from two mothers of children with CHB could induce AVB in rats. Our findings support the hypothesis that several fine antibody specificities and cross-targets may exist and contribute to CHB development in anti-Ro52 antibody-positive pregnancies.
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| 12. |
- Kronbichler, A, et al.
(författare)
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Rituximab treatment for relapsing minimal change disease and focal segmental glomerulosclerosis: a systematic review
- 2014
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Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 39:4, s. 322-330
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Tidskriftsartikel (refereegranskat)abstract
- <b><i>Background:</i></b> Minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS) remain a therapeutic challenge, since steroids and other immunosuppressive agents exhibit an unfavorable adverse event spectrum. The aim of this review was to systematically summarize and analyze data from preexisting studies reporting the outcome of rituximab (RTX) treatment in these patients. <b><i>Methods:</i></b> Study data on adult patients with either steroid-dependent or frequently relapsing MCD/FSGS were identified by a PubMed and Embase search. The number of relapses was calculated and the use of immunosuppressive co-medication prior to and after RTX treatment was quantified. <b><i>Results:</i></b> We identified<b> </b>14 studies<b> </b>including 86 patients with frequently relapsing and steroid-dependent MCD or FSGS. Treatment with RTX reduced the number of relapses per year from 1.3 (0-9) relapses prior to treatment compared to 0 (0-2) after therapy (p < 0.001). Proteinuria decreased from 2.43 (0-15) g/day to 0 (0-4.89) g/day (p < 0.001), while serum albumin increased from 2.9 (1.2-4.6) at baseline to 4.0 (1.8-5.09) g/l after RTX (p = 0.001). The use of immunosuppression used at the time of RTX administration was also reduced after RTX therapy (p < 0.001). Baseline serum albumin was lower (p = 0.018), whereas the number of immunosuppressants prior to RTX was higher (p = 0.018) in patients with relapse after RTX. <b><i>Conclusions:</i></b> The published data suggest that RTX is effective in reducing the number of relapses and sparing immunosuppression in frequently relapsing and steroid-dependent nephrotic syndrome due to MCD and FSGS. These promising findings have to be confirmed in controlled and prospective studies.
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