ABSTRACT
The pharmaceutical industry has changed dramatically over the past few years after decades of steady growth. The economic crisis hit government nances and health care budgets hard and brought medical expenditures, especially those of pharmaceutical companies, and measures to save money under the spotlight. Budgetary decits have caused health care payers around the world to introduce new cost-containment measures and changes in how drugs are being assessed in order to be reimbursed (the most signicant being the change in Germany brought by AMNOG and the benet assessments by IQWIG linked to pharmaceutical pricing). A strong push towards generics and the introduction of biosimilars are also high on the current health policy agenda. High unmet need areas such as cancer experience numerous drug entrants (e.g. for melanoma) that compete for funding and reimbursement, and HTA agencies are becoming much stricter on the type of data (overall survival, head-to-head studies) required for reimbursement. At the same time the gradual shift to “outcomes-based” and/or “risk-sharing” agreements (e.g. Italy, the UK, regions in Spain, Germany) is further complicating the cost-benet relation of R&D investments. As this trend will increase, pharmaceutical company risk will increase as it will make it much more difcult to exactly forecast the expected revenues generated from the drug portfolio under development and will create signicant transactional cost via administration onto the manufacturer and health authorities, yet at the same time presenting an opportunity to overcome access (cost) related hurdles.
