Sentence examples for for early benefit from inspiring English sources

Figure 3 Structure of the dossier for early benefit assessment in Germany.

For rapid assessments, which are usually performed soon after marketing authorisation, a timeframe is often pre-specified, e.g. 6 months for early benefit assessments in Germany and approx. 39 weeks for rapid health technology appraisal (HTA) in England.

Table 4 Statistical analysis and categorisation of outcome for early benefit assessment in Germany (G-BA/IQWIG) and single technology appraisal in England NICEE) – a comparison Methodological element Benefit assessment in Germany (G-BA/IQWIG) Single Technology Appraisal in England NICEE) Systematic reviews & meta-analyses Assessment of review quality; assessment of heterogeneity.

Table 2 Guidance texts and information sources for early benefit assessment in Germany (G-BA/IQWIG) and single technology appraisal in England NICEE) – a comparison Methodological element Benefit assessment in Germany (G-BA/IQWIG) Single technology appraisal in England NICEE) Guidance on methodology Comprehensive, very detailed, and available publicly and partly in English.

While it is accepted by IQWiG that surrogate endpoints are especially important for early benefit assessment, it is also emphasized that there is no validation standard, i.e. no ideal evaluation method or criterion which would generally be accepted to support validity of surrogate endpoints (Section 3.1.2. IQWiG GM 4.0).

Table 3 Clinical study design and methodology for early benefit assessment in Germany (G-BA/IQWIG) and single technology appraisal in England (NICE) – a comparison Methodological element Benefit assessment in Germany (G-BA/IQWIG) Single Technology Appraisal in England (NICE) Study design features     Description According to international standards.

The Federal Joint Committee (Gemeinsamer Bundesausschuss), the main decision making body within the German statutory health insurance system, is responsible for the procedure of early benefit assessment, and ultimately decides on the added benefit.

For an early benefit assessment according to § 35a SGB V, the main source is a dossier that is provided by the drug manufacturer.

Therefore, in our sample even the new template did not result in full availability of the information required for our early benefit assessment.

Secondly, we excluded those dossiers that provided no suitable studies for a full early benefit assessment.

Data sources All dossier assessments conducted by IQWiG between 1 January 2011 and 28 February 2013 in which the dossiers contained suitable studies allowing for a full early benefit assessment.