HTA Services
Health technology assessments, the early benefit assessment and also the assessment in the context of fixed prices are largely based on the fundamentals of evidence-based medicine. We provide writing of medical-scientific texts, systematic literature searches and systematic searches in study registers. In addition, we support you in statistical analyses and evaluations.
Systematic Literature Searches
Systematic literature searches are an important component in the preparation of benefit dossiers and for the determination of the appropriate comparator therapy. We conduct systematic literature searches on your behalf based on your specific research question.
Systematic Search in Study Registries
The systematic search in study registries complements the systematic literature search in order to obtain an overview of studies that have been conducted and are ongoing in an indication or for an active ingredient. We conduct systematic searches in study registries or as part of the AMNOG dossiers for you.
Meta-Analysis
Meta-analyses based on randomised controlled trials represent the highest level and the gold standard in evidence-based medicine. During the benefit assessment there are often situations in which the results of several studies can be pooled. Talk to our experts if you need support in the preparation, study selection and calculation of meta-analyses.
Indirect Comparisons
Indirect comparisons are always necessary in the early benefit assessment, if no direct comparative studies of a new active ingredient are available against the appropriate comparator therapy determined by the G-BA. In the beginning, a comprehensive systematic search for studies and publications is required for the calculation of indirect comparisons, in order to describe the available evidence. The actual indirect comparison can then be carried out on this basis.
We will be happy to help you with any questions you may have about indirect comparisons in the context of the benefit assessment.
Medical Writing
Benefit assessments always include the medical presentation of the benefit and additional benefit of innovations and the corresponding comparators or the appropriate comparator therapy; be it in preparation for the G-BA consultation, in the preparation of the AMNOG dossier or in written comment procedures. Presenting medical content in a comprehensible way is an important part of presenting your own product. We offer you high-quality medical-scientific texts as a prerequisite for communication with health insurance funds and institutions for reimbursement.
Budget Impact Analyses
The AMVSG (German Act to Strengthen the Provision of Medicines) strengthened the possibility of price-volume agreements for new medicinal products in § 130b SGB V. In the contract negotiations on the reimbursement amount, volumes are regularly agreed in addition to the reimbursement amount. Budget impact analyses are therefore an important basis for negotiations with payers. We prepare budget impact analyses for you, in order to optimise pricing and reimbursement of your products.
Epidemiology
The basis of the benefit assessment also includes data on incidence and prevalence. This data is based on the results of systematic searches and analyses of registries, health insurance data and observational studies. Prevalence data must also be translated into supply shares. We carry out targeted research for you on the epidemiology of diseases and indications, enabling you to estimate market shares and volumes.