Table 2 Guidance texts and information sources for early benefit assessment in Germany (G-BA/IQWIG) and single technology appraisal in England (NICE) – a comparison
From: Requirements for benefit assessment in Germany and England – overview and comparison
Methodological element | Benefit assessment in Germany (G-BA/IQWIG) | Single technology appraisal in England (NICE) |
|---|---|---|
Guidance on methodology | Comprehensive, very detailed, and available publicly and partly in English. | Comprehensive, detailed, and publicly available. |
Information sources used | ||
Dossier from manufacturer | > 300 pages, plus usually > 10,000 additional pages in confidential Module 5. | < 100 pages (no additional appendix); section on “decision problem” to be submitted in advance. |
Providers of other evidence and/or input | Written and oral comments from medical experts, patient organisations, pharmaceutical companies, industry organisations, pharmacists’ associations, and umbrella organisations of medical professionals on IQWiG’s assessment. | Evidence and input from assessment groups, manufacturers, patients, carers, and health care professionals throughout the appraisal. |
Studies | All (licensing and other) studies. | All (licensing and other) studies. |
Publications | Literature search. | Literature search (& independent search). |
Data | Published and confidential. | Published, unpublished, and confidential. |
Others | HTA reports (rarely) and web-based study registries. | HTA reports, public assessment reports, and clinical guidelines. |