Statistics for Market Access
The statistical requirements for a successful market access are very complex, but nevertheless essential. Depending on the national HTA process, clinical study data have to be evaluated and presented in a different way. The Ecker + Ecker statisticians take on all statistical tasks and questions related to market access for pharmaceutical companies for both internal and external purposes.
Statistical Analyses for Early Benefit Assessment and EU HTA
The best-possible market access strategy generally requires a re-evaluation of clinical study data, on the one hand to meet the methodological requirements of early benefit assessment and EU HTA, and on the other hand to support the value story and prepare the price negotiation. Ecker + Ecker supports with long-term expertise:
- Analyses according to the international standards of evidence-based medicine based on individual patient data (IPD) or aggregated data
- Statistical programming in R and SAS
- Identification of the HTA analyses needed
- Re-evaluation of studies according to the HTA requirements (e. g. analyses for AMNOG, EU HTA, and NICE)
- Calculation of meta-analyses, indirect comparisons, matching-adjusted indirect comparisons (MAIC), network meta-analyses
- Output of results in requested file formats
- Preparation of all results for HTA submission
Statistical Advice and Other Statistical Services
The Ecker + Ecker statisticians are available to provide strategic advice in statistical questions on both HTA and beyond. The main areas include:
- Recommendations on methodology for study evaluations
- Target-group-specific communication of statistical requirements and analyses
- Explorative analyses for purposes other than HTA
- Synthesis of evidence and interpretation of results
- Analyses for publications from clinical studies
- Review and pre-specification of analyses for early benefit assessment and EU HTA
- Assessment of new methods (e. g. methods discussed for EU HTA)
- Preparation and review of study protocols and statistical analyses plans
- Participation in HTA submission, dossier preparation, and oral hearing
- Planning of sample size for clinical studies
- Identification of confounders
Routine Practice Data Collection ("Anwendungsbegleitende Datenerhebung")
If there is no sufficient evidence available for early benefit assessment at the time of the market launch of a medicinal product, in some cases the Federal Joint Committee (G-BA) may initiate a routine practice data collection. The services of Ecker + Ecker comprise:
- Risk analyses and mitigation strategies
- Cost-benefit assessment of the routine practice data collection
- Strategic advice on the concept for routine practice data collection
- Preparation of study protocol and statistical analysis plan
- Participation in expert consultation
- Analysis of registry protocol and support in adjustment of registry
- Statistical analyses of the collected data and preparation of status reports
- Participation in the subsequent benefit assessment and price negotiation
Statistics Trainings
Ecker + Ecker offers tailor-made expert trainings that can optionally be held either locally, in Hamburg, or online. Target groups are statisticians, programmers or colleagues from market access. Possible training topics are:
- Basic statistics of marketing authorization and HTA
- Statistical programming in in R
- Statistical requirements of early benefit assessment and EU HTA
- Special topics: indirect comparisons, meta-analyses, surrogate validation, and more
Please contact
Dr. Florentin Köhnemann
Phone +49 (40) 41 33 081-48