HTA Statistics and Market Access for Pharmaceuticals

Statistical Analyses for HTA and Benefit Assessment

co.value and Cytel combine HTA statistics with Market Access and AMNOG strategy. We support statistical planning and analysis of clinical evidence, AMNOG-specific additional analyses, as well as indirect comparisons and network meta-analyses. Results are directly aligned with G-BA and IQWiG requirements and integrated into the AMNOG dossier.

AMNOG-Specific Statistical Analyses

Statistical analyses for AMNOG need to address the specific German assessment question. Together with your Market Access team, we assess relevant populations, endpoints, subgroups and the appropriate comparator therapy (ACT) and derive the required analyses.

Changes in populations, the ACT or data cuts may require additional analyses. Statistical planning and dossier strategy should therefore be aligned at an early stage.

New Data Cuts and JCA-to-AMNOG

New data cuts can change the evidence base for the German benefit assessment. We assess which analyses from global studies or the Joint Clinical Assessment (JCA) can be used for AMNOG and where additional Germany-specific analyses are required.

This allows new data, relevant subpopulations and changing assessment questions to be incorporated into the AMNOG strategy and dossier.

Indirect Comparisons and Network Meta-Analyses

If no direct comparison with the relevant comparator is available, we support the planning and conduct of indirect comparisons. This includes adjusted indirect comparisons using a common comparator, network meta-analyses and other evidence synthesis methods.

The appropriate method depends on the available evidence and the specific HTA question.

Automated AMNOG Analyses and G-BA Tables

co.value and Cytel combine statistical analyses, statistical programming and dossier development in an integrated workflow. German and English tables can be generated from the same analytical basis and reproducibly updated when new data cuts become available or populations change.

This reduces manual transfer steps and facilitates the consistent integration of extensive analysis packages into the AMNOG dossier.

Our HTA Statistics and Market Access Services

  • AMNOG-specific statistical analysis planning and execution
  • Analysis of relevant populations, endpoints and subgroups
  • Analysis of new data cuts
  • Indirect comparisons and network meta-analyses
  • Statistical programming and quality control
  • Automated AMNOG and G-BA tables
  • Integration of statistical results into the AMNOG dossier
 

Frequently Asked Questions About HTA Statistics and Market Access

Which statistical analyses does co.value support for AMNOG and HTA?

co.value and Cytel support AMNOG-specific additional analyses, subgroup and population analyses, indirect comparisons, network meta-analyses and the statistical analysis of new data cuts.

Can new data cuts be analyzed for AMNOG?

Yes. New relevant data cuts may require additional analyses for the German benefit assessment. We assess the analytical requirements and integrate the results into the AMNOG evidence strategy and dossier.

Does co.value support indirect comparisons and network meta-analyses?

Yes. Together with Cytel, we plan and conduct indirect comparisons, network meta-analyses and other evidence synthesis analyses for HTA and Market Access.

Can AMNOG analyses be automated?

Yes. Statistical analyses and German and English AMNOG tables can be generated in a reproducible workflow and systematically updated when requirements change.