Dissertation/Thesis Abstract

Vergleich der Frühen Nutzenbewertung nach §35a SGB V und des Single Technology Appraisals des NICE als Health Technology Assessments für neu zugelassene Arzneimittel
by Lämmel, Julia Helma Martha, Ph.D., Universitaet Bayreuth (Germany), 2016, 245; 27600499
Abstract (Summary)

Background: With the undertaking of the Early Benefit Assessment the German Federal Joint Committee acknowledges the probability and extent of an additional benefit of a newly authorized pharmaceutical. The Early Benefit Assessment, a so-called Health Technology Assessment, influences availability and prices of pharmaceuticals on the German market. Other countries undertake health technology assessments as well. Amongst them a special role is acknowledged for the long established Single Technology Appraisal of the British National Institute of Health and Care Excellence (NICE). Scientific Questions: On the basis of the available scientific literature at the time, the questions about the comparability of assessment results and their influence on prescribing could not have been answered. Therefore the thesis focuses on the following questions: Do the Early Benefit Assessment and the Single Technology Appraisal as Health Technology Assessments differ from each other? If so, does it influence the assessment of specific newly authorized pharmaceuticals? What influence has the assessment process on the availability of the drug within the specific health care setting? Is the assessment result reflected in the prescribing patterns seen? Material and Methods: The general methods of the Early Benefit Assessment and the Single Technology Appraisal are compared on the basis of the published method papers and their legal settings. The health technology assessments of the first five pharmaceuticals which had an Early Benefit Assessment and a Single Technology Appraisal have been assessed in detail. For the availability of pharmaceuticals and their prescribing density prescription data from the statutory health insurance AOK Plus for Germany and from the Welsh analytical prescribing support unit for the United Kingdom for the years 2010-2013 have been used. Results: The Early Benefit Assessment is undertaken for all newly authorized pharmaceuticals. For the Single Technology Assessment a prioritisation process is done for selection beforehand. In both assessments the process is two-staged, with a separation of the assessment process itself and the subsequent appraisal/ decision-making steps. In Germany the comparator for the pharmaceutical has to be licensed whereas in the UK the comparator needs to be used for this indication within the National Health System. The health-related quality of life is of higher importance for the British assessment, whereas the German Early Benefit differentiates patients in subgroups more often. The differences in the methodology, of the two Health Technology Assessments, are reflected in differing results for specific newly authorized pharmaceuticals. The results are influencing the availability of pharmaceuticals on the specific health care market. The prescribing patterns analysed do not show a correlation between the assessment results, the anticipated prescribing pattern and the prescribing patterns seen in reality. Discussion: Health Technology Assessments within Europe should rely on certain common propositions, e.g. the license status of the comparator and the feasibility of indirect comparisons. This is an important requirement to avoid contrarian assessment results which undermine the overall credibility of the assessment process. The assessment should play a more important role for the daily prescribing routine.

Indexing (document details)
School: Universitaet Bayreuth (Germany)
School Location: Germany
Source: DAI-C 81/4(E), Dissertation Abstracts International
Subjects: Health care management, Pharmaceutical sciences
Keywords: Prescription drug benefits
Publication Number: 27600499
ISBN: 9781687902276
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