Training @ Staburo: AMNOG and HTA

Training @ Staburo: AMNOG and HTA

Training @ Staburo: AMNOG and HTA

How beneficial are new drugs? This question gained more and more importance, after the German authorities introduced the AMNOG law in 2011, to restructure the market and the reimbursement system. Since then, it is obligatory that every new introduced medication runs through the process of an early benefit assessment, where at the end a decision is made, if there is a beneficial need for the new introduced drug. Based on this benefit, the market price of the product is negotiated.

The training was structured in two major parts. In the beginning, the whole process was shown with the major players in the process (like the G-BA and IQWiG) and the process of the early benefit assessment itself. Here, the relevant statistics topics where highlighted. Furthermore, the whole process was presented.

The second part was about the statistics workflow needed for analyses in module 4 of the dossier. Here, the mandatory endpoints, like survival and quality of life, where shown in combination with the analysis to perform to proof the benefit of the new drug. In addition to the analysis of the mandatory and supportive analysis, a short overview of the work package in statistics was presented, beginning with the planning of the confirmatory trial and the tasks during the whole process, until the decision about the benefit is made.

In the end of the presentation, recent decisions of the G-BA and the IQWiG were shown, also to highlight potential problems, which can occur during the process.

Data analysis, clinical biostatistics and more.

Staburo at the G-BA in Berlin

Staburo at the G-BA in Berlin

Staburo at the G-BA in Berlin

Josef Höfler from Staburo participated as statistical expert in an advisory meeting at the institution of “Gemeinsamer Bundesausschuss” in Berlin, in the context of health technology assessment.

The Federal Joint Committee (G-BA) is the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany.

It issues directives for the benefit catalogue of the statutory health insurance funds (GKV) for more than 73 million insured persons and thus specifies which services in medical care are reimbursed by the GKV.

Data analysis, clinical biostatistics and more.

Staburo wishes you a Merry Christmas and a Happy New Year!

Staburo wishes you a Merry Christmas and a Happy New Year!

Staburo wishes you a Merry Christmas and a Happy New Year!

We thank our employees and clients, who helped us, to make 2019 very successful for our company!

We wish all partners and future partners, our employees, and their families a wonderful Christmas and a great start in 2020.

Staburo will continue to support you with experienced biostatisticians and statistical programmers next year and in the years to come! Thank you!

Data analysis, clinical biostatistics and more.

Staburo Wiesn-Workshop 2019

Staburo Wiesn-Workshop 2019

Staburo Wiesn-Workshop 2019

It is a very nice custom to have our Staburo statistics training session on the first Monday of the two-week Oktoberfest period. This year, the Staburo team had the chance to learn about our new R shiny App in the first presentation “OTTO – Demonstration and Methodology”. OTTO stands for Optimal Tool for Tracking of Outliers. Afterwards we heard a talk about “Sample Size Calculation in Time-to-Event Trials with Non-Proportional Hazards Using GESTATE”, presented by our new colleague Jasmin.

After lunch, there where two more Talks, one about “Optimal Plate Layout for Relative Potency Estimation – A Simulation Study” and the last one from our new employee Armin about “Subgroup identification by generalized Patient Rule Induction Method (PRIM)”.

As always, this was a great opportunity to share knowledge with the whole Staburo team, get the chance to get to know the team better and to exchange ideas afterwards.

The second important custom is to pay the Oktoberfest (or also called “Wiesn”) a visit, after the workshop. Once again, we had a wonderful time with our growing team and some long-time Staburo clients.

Everyone got home safely – with additional knowledge from the workshop and positive vibes from the Oktoberfest. We are already looking forward to the Staburo “Wiesn” Workshop 2020 and thank all participants for making this a great team event!

Data analysis, clinical biostatistics and more.

Staburo supported successful biosimilar development program

Staburo supported successful biosimilar development program

Staburo supported biosimilar development 

Together with Cinfa Biotech GmbH (now Mundipharma Biologics) and the University of Lucerne, Staburo recently published the first part of the results for a biosimilar which is used for preventing neutropenia, induced by chemotherapy (click here to read the whole article DOI: 10.1002/prp2.503). As part of the collaboration, Staburo Principal Statistician and Managing Director Josef Höfler supported the interdisciplinary team with biostatistics expertise, especially in PK/PD.

The team planned, conducted and analysed a single dose, randomized, double-blind, two-way crossover study and demonstrated the comparability for the two PK endpoints examined (area under the concentration curve from time zero to last measurable concentration and the maximum concentration). The PD comparability (area under the effect curve for absolute neutrophil count [ANC]) was demonstrated, as well. The team could show that there are clinically no differences between biosimilar and the originator with regard to immunogenicity and safety. The investigated drug was approved as biosimilar in Europe.

Data analysis, clinical biostatistics and more.

Staburo supported PD-L1 assay comparability study

Staburo supported PD-L1 assay comparability study

PD-L1 assay comparability study published

Staburo supported the evaluation of the first multicentric analytical comparability study of PD-L1 expression in urothelial bladder cancer using four clinically developed immunohistochemistry assays. Statistical analyses included the investigation of inter-assay differences using ANOVA and intra-class correlations and the concordance for clinically relevant cut-offs based on Fleiss‘ kappa.

The results suggest that all four currently clinically relevant assays are analytically similar for the evaluation of PD-L1-stained immune cells and three (SP263, 22C3, and 28-8) for PD-L1-stained tumor cells.

The paper, which was recently published in Virchows Archiv, can be downloaded here (Staburo’s Statistics contribution is mentioned in the Acknowledgments): https://rd.springer.com/article/10.1007%2Fs00428-019-02610-z

Data analysis, clinical biostatistics and more.