scholarly journals EARLY BENEFIT ASSESSMENT OF ORPHAN DRUGS IN GERMANY: METHODOLOGICAL CHALLENGES AND IMPLICATIONS ON REIMBURSEMENT PRICE

2016 ◽  
Vol 19 (3) ◽  
pp. A281
Author(s):  
D. Schneider ◽  
D. Bot ◽  
T. Ecker
Keyword(s):  
Orphan Drugs ◽  
Benefit Assessment ◽  
Reimbursement Price ◽  
Early Benefit Assessment ◽  
Methodological Challenges ◽  
Early Benefit

scholarly journals PCN243 Price Changes after Indication Extension in the German EARLY Benefit Assessment

2020 ◽  
Vol 23 ◽  
pp. S466
Author(s):  
M. Freiberg ◽  
M. Karimi ◽  
D. Böckmann ◽  
P. Wagner
Keyword(s):  
Benefit Assessment ◽  
Price Changes ◽  
Early Benefit Assessment ◽  
Early Benefit

scholarly journals Impact of the Early Benefit Assessment on A Pharmaceutical's Real Consumption in Germany

2014 ◽  
Vol 17 (7) ◽  
pp. A416
Author(s):  
W. Kotowa ◽  
B. Häussler ◽  
S. Reindl ◽  
A. Höer
Keyword(s):  
Benefit Assessment ◽  
Early Benefit Assessment ◽  
Early Benefit

OP135 Confirmatory Versus Explorative Endpoints In Drug Approval Versus Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 63-64
Author(s):  
Ines Niehaus ◽  
Charalabos-Markos Dintsios
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Approval ◽  
Health Technology ◽  
Benefit Assessment ◽  
Benefit Ratio ◽  
Early Benefit Assessment ◽  
The Impact ◽  
Early Benefit

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

Frühe Nutzenbewertung neu zugelassener Arzneimittel – Methodische Anforderungen an die Daten zur Lebensqualität

2017 ◽  
Vol 22 (03) ◽  
pp. 125-125
Author(s):  
Helena Thiem
Keyword(s):  
Quality Of Life ◽  
Qualitative Study ◽  
New Drugs ◽  
Benefit Assessment ◽  
Health Econ ◽  
Life Data ◽  
Early Benefit Assessment ◽  
Frühe Nutzenbewertung ◽  
Early Benefit

Blome C et al. Four years of early benefit assessment of new drugs in Germany: a qualitative study on methodological requirements for quality of life data. Eur J Health Econ 2017; 18: 181–193 Der Gemeinsame Bundesausschuss (G-BA) führt für alle neu zugelassenen Arzneimittel eine frühe (Zusatz-)Nutzenbewertung durch. In die Entscheidung mit einbezogen wird die Auswirkung auf unterschiedliche Endpunkte, u. a. auch auf die Lebensqualität (QoL). Die Autoren haben für die zwischen den Jahren 2011–2014 veröffentlichten Nutzenbewertungen analysiert, inwieweit die Daten zur Lebensqualität bei der abschließenden Bewertung zum Tragen kommen.

scholarly journals Conditional Resolutions in the Amnog Early Benefit Assessment

2014 ◽  
Vol 17 (7) ◽  
pp. A442 ◽  
Author(s):  
G. Assmann ◽  
U. Schmidt ◽  
M. Drechsler ◽  
M. Pfannkuche
Keyword(s):  
Benefit Assessment ◽  
Early Benefit Assessment ◽  
Early Benefit
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