scholarly journals Health technology assessment of diagnostic strategies for Alzheimer’s disease

2014 ◽  
Author(s):  
R.L.H. Handels
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Diagnostic Strategies

scholarly journals Regulatory and Health Technology Assessment Considerations for Disease-Modifying Drugs in Alzheimer’s Disease

CNS Drugs ◽  
2018 ◽  
Vol 32 (12) ◽  
pp. 1085-1090 ◽  
Author(s):  
Jacoline C. Bouvy ◽  
Pall Jonsson ◽  
Diana O’Rourke ◽  
Antonella Santuccione Chadha ◽  
Niklas Hedberg ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Disease Modifying Drugs ◽  
Disease Modifying

OP170 Regulatory And Health Technology Assessment Considerations In Alzheimer's Disease

2018 ◽  
Vol 34 (S1) ◽  
pp. 61-62
Author(s):  
Jacoline Bouvy ◽  
Pall Jonsson
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Real World ◽  
Data Access ◽  
Health Technology ◽  
Advisory Group ◽  
Real World Evidence ◽  
Disease Modifying

Introduction:There has been a move towards the development of disease-modifying agents in Alzheimer's disease (AD) and it is likely that early disease-modifying treatments will initially be offered to people who have positive AD markers and mild cognitive impairment (MCI). Consequently, disease-modifying drugs will have distinctive features as compared to currently licensed symptomatic treatments, which makes the implications of these new agents for regulatory and health technology assessment (HTA) processes unclear.Methods:The ROADMAP (Real-world Outcomes across the AD spectrum for better care: Multi-modal data Access Platform) project provides the foundation for a European data platform for real-world evidence in AD, and established an expert advisory group (EXAG) consisting of regulatory and HTA experts. This presentation will summarize the key lessons from the first year of ROADMAP's EXAG and identifies the next steps that are required to prepare Europe's healthcare systems for a disease-modifying drug.Results:The EXAG identified a need for: (i) establishing the rationale for the selection of priority outcomes in pre-clinical AD and MCI; (ii) establishing accepted outcomes for defining prevention of AD or delayed AD onset; (iii) exploring modern technology that could assist in testing cognition that could easily be used in clinical practice; and (iv) establishing caregiver-relevant outcomes (e.g. quality of life, loss of income, carer time) that are important to capture; and found that not all evidence to support modelling assumptions can be generated through RCTs, making the case for using real-world evidence.Conclusions:Many of the challenges that the EXAG identified can be solved by generating better real-world data in AD. There is a clear need to agree on the outcomes that will facilitate and inform regulatory and HTA decision-making. Once the gaps in the availability of outcomes in AD will be closed, we will be one step closer towards being ready for a disease-modifying drug.

scholarly journals Valuing Alzheimer's disease drugs: a health technology assessment perspective on outcomes

2020 ◽  
Vol 36 (4) ◽  
pp. 297-303
Author(s):  
Annette Bauer ◽  
Raphael Wittenberg ◽  
Amanda Ly ◽  
Anders Gustavsson ◽  
Christin Bexelius ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Health Technology Assessment ◽  
Outcome Measures ◽  
Technology Assessment ◽  
Health Technology ◽  
Clinical Scales ◽  
Price Negotiations ◽  
Early Discussion ◽  
Made In

ObjectivesDue to the nature of Alzheimer's disease (AD), health technology assessment (HTA) agencies might face considerable challenges in choosing appropriate outcomes and outcome measures for drugs that treat the condition. This study sought to understand which outcomes informed previous HTAs, to explore possible reasons for prioritizations, and derive potential implications for future assessments of AD drugs.MethodWe conducted a literature review of studies that analyzed decisions made in HTAs (across disease areas) in three European countries: England, Germany, and The Netherlands. We then conducted case studies of technology assessments conducted for AD drugs in these countries.ResultsOverall, outcomes measured using clinical scales dominated decisions or recommendations about whether to fund AD drugs, or price negotiations. HTA processes did not always allow the inclusion of outcomes relevant to people with AD, their carers, and families. Processes did not include early discussion and agreement on what would constitute appropriate outcome measures and cut-off points for effects.ConclusionsWe conclude that in order to ensure that future AD drugs are valued appropriately and timely, early agreement with various stakeholders about outcomes, outcome measures, and cut-offs is important.

Versorgungsforschung in der Klinischen Neuropsychologie – eine Standortbestimmung

2008 ◽  
Vol 19 (4) ◽  
pp. 253-269 ◽  
Author(s):  
Sabine Heel ◽  
Sonja Fischer ◽  
Stefan Fischer ◽  
Tobias Grässer ◽  
Ellen Hämmerling ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Empirische Forschung

Zunächst führt dieser Artikel in die wesentlichen Begrifflichkeiten und Zielstellungen der Versorgungsforschung ein. Er befasst sich dann mit der Frage, wie die einzelnen Teildisziplinen der Versorgungsforschung, (1) die Bedarfsforschung, (2) die Inanspruchnahmeforschung, (3) die Organisationsforschung, (4) das Health Technology Assessment, (5) die Versorgungsökonomie, (6) die Qualitätsforschung und zuletzt (7) die Versorgungsepidemiologie konzeptionell zu fassen sind, und wie sie für neuropsychologische Anliegen ausformuliert werden müssen. In diesem Zusammenhang werden die in den einzelnen Bereichen jeweils vorliegenden versorgungsrelevanten Studienergebnisse referiert. Soweit es zulässig ist, werden Bedarfe für die Versorgungsforschung und Versorgungspraxis in der Neurorehabilitation daraus abgeleitet und Anregungen für die weitere empirische Forschung formuliert. Der Artikel bezieht sich – entsprechend seines Anliegens – ausschließlich auf Studien, die sich mit der Situation der deutschen Neurorehabilitation befassen.

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