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The cost-effectiveness assessment will use a decision-tree framework to quantitatively assess the costs and effects for the randomized groups.
This fact is also reflected in the current AMNOG regulations for pharmaceuticals that request only a short term budget impact analysis but no (long-term) cost-effectiveness assessment.
The cost-effectiveness assessment revealed a significant advantage to the use of intraprocedural CEUS (4,639 vs 6,592) (Fig. 2).
The area of cost-effectiveness assessment, however, was not subject of this study as it does not form part of the initial, early benefit assessment in Germany.
The primary source of effectiveness data used in the models was clinical expert opinion, which was obtained through Delphi panel research conducted in a number of European countries as part of the cost-effectiveness assessment of BUCCOLAM.
Irrespective of the discussions around the WTP threshold it needs to be considered that a reimbursement decision of AVDs, especially in the German setting, will not be limited to the outcomes of a cost-effectiveness assessment.
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The assessment of clinical effects followed a non-inferiority design, while patient satisfaction and cost-effectiveness assessments followed a superiority design.
The 3% discount rate recommended by WHO for cost-effectiveness assessments in developing countries [ 22] was included in the range assessed in sensitivity analysis.
For instance, the British National Institute for Health and Care Excellence (NICE), besides evaluating the "clinical effectiveness" of a new technology, also performs cost-effectiveness assessments.
Cost-effectiveness assessments, from a healthcare payer perspective, will capture the added value in terms of savings in drug administration costs.
However, looking at the outcomes of ARMD cost-effectiveness assessments the efficiency frontier approach might justify a WTP of around €80,000 per QALY gained (please refer to the 'Interpretation of Results' section).
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