Market Access
Market Access is an additional hurdle which the pharmaceutical company has to pass after the regulatory ones (efficacy, safety, quality, safety) have been approved by the authorities. The objective is to prove the additional therapeutic benefit vs. a local standard therapy and to align the reimbursed price of a pharmaceutical with this additional benefit. Therefore, it is crucial for the pharmaceutical company to include the needs of payor authorities into their clinical development program. The scientific process is based on criteria of Evidence-Based-Medicine, medical outcome parameters or data calculated from surrogate ones. There is no international standard, however, all the various national procedures are linked somewhat.
The new process in Germany is a modified Health-Technology Assessment (performed by the Institute for Quality and Efficiency in Healthcare - IQWiG) followed by an appraisal of the Federal Taskforce of Physicians, Sick Funds, and Hospitals (G-BA). The latter Authority defines the critical terms “additional therapeutic benefit” and “appropriate standard therapy” for each pharmaceutical individually. The company has to provide a Value Dossier at the time of market launch. Appraisal is published six months later. Additionally, it serves as a platform for negotiations on a discount of ex-factory price between the pharmaceutical company and the Federal Association of Sick Funds. If an agreement cannot be negotiated in six months’ time, however, a judgment will be issued by the Federal Board of Arbitration, i.e. a mandatory discount on ex-factory price will be issued and published 12 months after launch. Almost 100% of German population is covered by that price. Additionally, the price in Germany is reference for about 25 other international markets, particularly, in Europe.
The described process is also applied on marketed drugs which still have document protection. If G-BA calls for a review the pharmaceutical company has three months’ time to compile and submit the Value Dossier.
We support you with:
- Review of market situation at time of launch re. “additional therapeutic benefit” and “appropriate standard therapy”
- Best clinical study plan for the given scenario
- Input of medical, regulatory, payor stakeholders
- Planning of Scientific Advice Meetings with G-BA and / or BfArM, Federal Association of Sick Funds, Federal Board of Arbitration
- Planning and compilation of a Value Dossier