Three presentations at the PSI conference 2016 in Berlin

Presentations give an overview of Benefit-Risk methodology in the HTA setting with special focus on the German environment – Presentations by the EFSPI SIG on benefit-risk in collaboration with the HTA SIG

The session in Berlin on Tuesday morning will be introduced by Friedhelm Leverkus. He will give an overview of the processes of determining a price under the new law (Arzneimittelmarktneuord- nungsgesetz, AMNOG) on the regulation of medicinal products that applies to all pharmaceutical products with active ingredients that are launched beginning January 1, 2011. There are two steps – the determination of the added benefit vs an appropriate comparator and the price negotiations itself. Friedhelm will discuss choice of the comparator, patient relevant endpoints, subgroup analyses, extent of benefit, determination of net benefit, primary and secondary endpoints, and uncertainty of the additional benefit in this environment and what impact this has on the final summary of additional benefits and risks.

Welcome to the benefit-risk BLOG of the EFSPI benefit-risk SIG

This is the first BLOG entry in hopefully a long journey of helpful information around benefit-risk.

The benefit-risk special-interest-group is a cross-pharma and academia group of statisticians working together on statistical topics related to benefit-risk. The group is chaired by Alexander Schacht (Lilly) and co-chaired by Ian Hirsch (AstraZeneca). Further members represent many other companies. The group is still growing and please contact Alexander Schacht ( if you’re interested.

The main aims of the Benefit-Risk Special Interest Group are split into 5 key areas