Belgif Linked Data Fragments server

Matches in Data.gov.be for { <http://data.gov.be/.well-known/genid/97c111a523604f4dac6684a233a43a172-b960> ?p ?o ?g. }

• 97c111a523604f4dac6684a233a43a172-b960 accessRights PUBLIC @default.
• 97c111a523604f4dac6684a233a43a172-b960 accrualPeriodicity CONT @default.
• 97c111a523604f4dac6684a233a43a172-b960 description "Kalydeco est un médicament destiné au traitement des patients atteints de mucoviscidose. Ce médicament est réservé aux patients atteints de mucoviscidose présentant une mutation génétique spécifique sur le gène CFTR: G551D, G1244E, G1349R G178R, G551S, S1251N, S1255P, S549N ou S549R. Le 26/11/2015, le fabricant de Kalydeco, Vertex Pharmaceuticals et le NIHDI ont signé un accord pour le remboursement temporaire de Kalydeco. Dans le cadre de ce remboursement temporaire, des données supplémentaires doivent être collectées pour tous les patients traités par Kalydeco. Avec ces données, Vertex Pharmaceuticals doit préparer des rapports qui sont destinés au NIHDI et qui doivent permettre d'évaluer l'efficacité du médicament sur la base des questions suivantes: a) Quel est l'effet (à long terme) sur la progression de la maladie, sur l'utilisation de thérapies standard, sur la nécessité d'une transplantation pulmonaire et sur la mortalité? b) Quelle est la réduction réelle de l'utilisation d'antibiotiques et des hospitalisations? c) Quel est l'effet sur l'amélioration de la survie?. Sur la base de ces rapports, le NIHDI décidera si le remboursement peut être poursuivi." @default.
• 97c111a523604f4dac6684a233a43a172-b960 description "Kalydeco is a medicine for the treatment of cystic fibrosis (CF) patients. This medicine is only for CF patients with a specific genetic mutation on the CFTR gene: G551D, G1244E, G1349R G178R, G551S, S1251N, S1255P, S549N or S549R. On 26/11/2015, the manufacturer of Kalydeco, Vertex Pharmaceuticals, and the NIHDI signed an agreement for the temporary reimbursement of Kalydeco. As part of this temporary reimbursement, additional data should be collected for all patients treated with Kalydeco. With this data, Vertex Pharmaceuticals must prepare reports that are intended for the NIHDI and that must allow to evaluate the effectiveness of the medicine based on the following questions: a) What is the (long-term) effect on disease progression, on the use of standard therapies, on the need for lung transplantation and on mortality?; b) What is the actual reduction in antibiotic use and hospitalizations?; c) What is the effect on improving survival?. Based on these reports, the NIHDI will decide whether the reimbursement can be continued." @default.
• 97c111a523604f4dac6684a233a43a172-b960 description "Kalydeco is een geneesmiddel voor de behandeling van patiënten met cystische fibrose (CF). Dit geneesmiddel is alleen bedoeld voor CF-patiënten met een specifieke genetische mutatie in het CFTR-gen: G551D, G1244E, G1349R G178R, G551S, S1251N, S1255P, S549N of S549R. Op 26/11/2015 ondertekenden de fabrikant van Kalydeco, Vertex Pharmaceuticals en het NIHDI een overeenkomst voor de tijdelijke terugbetaling van Kalydeco. In het kader van deze tijdelijke vergoeding moeten aanvullende gegevens worden verzameld voor alle patiënten die met Kalydeco worden behandeld. Met deze gegevens moet Vertex Pharmaceuticals rapporten opstellen die bedoeld zijn voor het NIHDI en die het mogelijk moeten maken om de effectiviteit van het geneesmiddel te evalueren op basis van de volgende vragen: a) Wat is het (langdurige) effect op ziekteprogressie, op het gebruik van standaardtherapieën, op de noodzaak van longtransplantatie en op sterfte?; b) Wat is de werkelijke vermindering van antibioticagebruik en ziekenhuisopnames?; c) Wat is het effect op het verbeteren van de overleving?. Op basis van deze rapporten zal het NIHDI beslissen of de terugbetaling kan worden voortgezet." @default.
• 97c111a523604f4dac6684a233a43a172-b960 description "Kalydeco ist ein Arzneimittel zur Behandlung von Patienten mit Mukoviszidose (CF). Dieses Medikament ist nur für CF-Patienten mit einer spezifischen genetischen Mutation auf dem CFTR-Gen: G551D, G1244E, G1349R G178R, G551S, S1251N, S1255P, S549N oder S549R. Am 26.11.2015 unterzeichneten der Hersteller von Kalydeco, Vertex Pharmaceuticals und die NIHDI eine Vereinbarung über die vorübergehende Erstattung von Kalydeco. Im Rahmen dieser vorübergehenden Erstattung sollten zusätzliche Daten für alle mit Kalydeco behandelten Patienten erhoben werden. Mit diesen Daten muss Vertex Pharmaceuticals Berichte erstellen, die für die NIHDI bestimmt sind und die es ermöglichen müssen, die Wirksamkeit des Arzneimittels anhand der folgenden Fragen zu bewerten: a) Was sind die (langfristigen) Auswirkungen auf das Fortschreiten der Erkrankung, auf die Anwendung von Standardtherapien, auf die Notwendigkeit einer Lungentransplantation und auf die Mortalität? b) Was ist die tatsächliche Verringerung des Antibiotikaeinsatzes und der Krankenhausaufenthalte?; c) Welche Auswirkungen hat dies auf die Verbesserung des Überlebens?. Auf der Grundlage dieser Berichte wird das NIHDI entscheiden, ob die Erstattung fortgesetzt werden kann." @default.
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• 97c111a523604f4dac6684a233a43a172-b960 language ENG @default.
• 97c111a523604f4dac6684a233a43a172-b960 modified "2021-04-02T00:00:00" @default.
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• 97c111a523604f4dac6684a233a43a172-b960 spatial 2802361 @default.
• 97c111a523604f4dac6684a233a43a172-b960 title "Bewertung des neuen Medikaments Kalydeco zur Behandlung von Mukoviszidose" @default.
• 97c111a523604f4dac6684a233a43a172-b960 title "Evaluatie van het nieuwe medicijn Kalydeco voor de behandeling van cystische fibrose" @default.
• 97c111a523604f4dac6684a233a43a172-b960 title "Evaluation of the new medication Kalydeco to treat cystic fibrosis" @default.
• 97c111a523604f4dac6684a233a43a172-b960 title "Évaluation du nouveau médicament Kalydeco pour traiter la mucoviscidose" @default.
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• 97c111a523604f4dac6684a233a43a172-b960 keyword "KEGG D09916" @default.
• 97c111a523604f4dac6684a233a43a172-b960 keyword "Kalydeco" @default.
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• 97c111a523604f4dac6684a233a43a172-b960 keyword "cystic fibrosis" @default.
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