Author: Dr. Florian Stieglitz, Market Access Consultant Germany’s statutory health insurers (GKV) face mounting deficits, now compounded by surging expenditures […]
Client Challenge Six years after initial approval, the German branch of the pharmaceutical company was surprised by an indication expansion
Client Challenge The company’s German organisation, inexperienced with AMNOG and understaffed for the process, had great difficulty explaining the importance
Client Challenge The pharmaceutical company engaged us to develop a negotiation strategy for a product that has been on the
Client Challenge When innovative drugs are used in hospital treatment after their approval, the question often arises as to how drug
Client Challenge Innovative gene therapies can offer patients with serious illnesses an alternative treatment option. Unfortunately, they also pose risks
Client Challenge The client submitted a dossier in the early benefit assessment based on a study whose comparator did not
Client Challenge For drugs used to treat rare diseases, presenting directly comparative data for the benefit assessment is a significant challenge. Due
Client Challenge The devices were intended to become part of an integrated care solution : operated on in a specialised clinic,
Authors: Sam Bryant, Regulatory Affairs Manager and Wim Neckebroeck, Director Regulatory Affairs At the World Orphan Drug Congress (WODC) USA
