The impact of additive or substitutive clinical study design on the negotiated reimbursement for oncology pharmaceuticals after early benefit assessment in Germany [PDF]
Health Economics Review, 2020 Background We analysed the impact of clinical study design for oncological pharmaceuticals on the subsequent price negotiations after early benefit assessment between pharmaceutical companies and the German National Association of Statutory Health ...
C. M. Dintsios, I. Beinhauer
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Patient-reported data informing early benefit assessment of rare diseases in Germany: A systematic review [PDF]
Health Economics Review, 2019 Background Since the implementation of the Regulation on Patient Integration (2003), the Act on the Reorganization of the Pharmaceutical Market (2011), and the Patient Rights Law (2013), the inclusion of patient perspectives has been further anchored in ...
Ana Babac +2 more
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Patient relevant endpoints in oncology: current issues in the context of early benefit assessment in Germany. [PDF]
Health Econ Rev, 2014 Abstract The German AMNOG healthcare reform includes a mandatory early-benefit-assessment (EBA) at launch. As per German social code, EBA is based on registration trials and includes evaluation of the patient-relevant effect of the new medicines compared to an appropriate comparator as defined by the Federal Joint Committee (G-BA).
Dabisch I +9 more
europepmc +5 more sources
Alzheimer’s Research & Therapy, 2022 Background The need for preventive therapies that interrupt the progression of Alzheimer’s disease (AD) before the onset of symptoms or when symptoms are emerging is urgent and has spurred the ongoing development of disease-modifying therapies (DMTs) in ...
Sheila Seleri Assunção +7 more
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Assessment of the Cost–Benefit Literature on Early Childhood Education for Vulnerable Children
SAGE Open, 2015 Given international interest in evidence-informed early education policy, we sought to interpret what is often a confusing literature on the performance of early childhood education programs.
Kim M. Dalziel +2 more
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Methodological approach to determine minor, considerable, and major treatment effects in the early benefit assessment of new drugs [PDF]
Biometrical Journal, 2016 Beate Wieseler +2 more
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Early respiratory diagnosis: benefits of enhanced lung function assessment [PDF]
BMJ Open Respiratory Research, 2021 Introduction The National Health Service for England Long Term Plan identifies respiratory disease as one of its priority workstreams. To assist with earlier and more accurate diagnosis of lung disease they recommend improvement in delivery of quality-assured spirometry.
Sylvester, Karl P +4 more
openaire +4 more sources
Expanding the Role of Early Health Economic Modelling in Evaluation of Health Technologies; Comment on “Problems and Promises of Health Technologies: The Role of Early Health Economic Modeling” [PDF]
International Journal of Health Policy and Management, 2021 In this commentary, we discuss early stage assessments of innovative medical technologies both in terms of methods applied as well as their use in healthcare decision-making.
Carlo Federici, Aleksandra Torbica
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Early Assessment of Benefits [PDF]
Deutsches Ärzteblatt international, 2012 In their review article the authors present the results from the licensing studies for two recently approved hepatitis C virus (HCV) protease inhibitors (boceprevir, telaprevir). Both substances were evaluated by Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), which was commissioned by the Federal Joint Committee Gemeinsamer ...
Thomas, Kaiser +3 more
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Impact of the Early Benefit Assessment on A Pharmaceutical's Real Consumption in Germany [PDF]
Value in Health, 2014 The Act on the Reform of the Market for Medicinal Products (“AMNOG”) introduced an early benefit assessment (EBA) of pharmaceuticals in Germany in 2011. According to this law, all pharmaceuticals with a new active agent made available on the market for the first time have to go through a benefit assessment process.
Kotowa, W. +3 more
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