Numerus has provided statistical support for AMNOG submissions since the government Act on the Reform of the Market for Medicinal Products (Arzneimittelmarktneuordnungsgesetz - AMNOG) came into force in Germany in 2011. Since then we have helped sponsors in Europe and the USA develop statistically robust additional benefit narratives, opening the way to reimbursement in Europe's largest healthcare market.
Interpreting what the G-BA guidelines require you to submit in your dossier can be challenging. The temptation can be to include every possible analysis just to ensure nothing is "missing", vastly increasing the work required as well as the associated costs and timeline. Numerus focuses on what the G-BA wants to see and employs the appropriate statistical methodology to ensure your dossier is complete. After a thorough assessment of your value strategy we identify which analyses to present to the G-BA, perform a GAP analysis and report what's missing and discuss with you what the G-BA are likely to demand.
Data rarely comes in a ready to analyse form. Often multiple phase II, III studies with different designs, treatment periods and data formats need to be pooled into one cohesive database. This can be a challenging and time-consuming process.
Numerus is uniquely placed to help. Our statisticians are not only experienced in HTA but have solid experience working with data from randomised controlled trials. They are experts in SAS, arguably the only appropriate software tool to perform this kind of work, and knowledgeable in CDISC, medical coding (MedDRA, WHODrug), and the plethora of other necessary know-how required to ensure data are aggregated and transformed correctly.
Working extensively with individual patient data (IPD), Numerus employs robust data security measures, comprehensive standard operating procedures and high quality standards.
Numerus has developed the training course "AMNOG-Related statistics". This two day course can be tailored to meet your individual needs and is currently delivered online. We also provide training and guidance based on IQWiG guidelines, in preparation for meetings with the G-BA.
The benefit assessment for a new drug often requires reviewing hundreds if not thousands of analyses. The obligatory interaction and subgroup analyses required by IQWiG and the G-BA significantly inflate the number of statistical analyses to be performed, increasing the chance of postulating an effect that does not exist in reality. Numerus has addressed this challenge by developing the Interaction Explorer Board, an interactive online tool that allows the user to visually explore risks and opportunities among subgroup interaction analyses.
The AMNOG process requires adherence to tight timelines. We fully understand the pressure this creates and our client's subsequent need for analyses to be delivered quickly and accurately. To ensure we can support our clients in this regard, Numerus has built an extensive library of standard programming that significantly impacts timelines and provides opportunities for cost efficiencies. Just as importantly, we are happy to "go the extra mile" to keep projects moving on time when the unforeseen happens.
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