Confirmatory versus explorative endpoint analysis: Decision-making on the basis of evidence available from market authorization and early benefit assessment for oncology drugs

The efficacy, safety and quality of a new drug are considered to have been proven upon market authorization. According to the ‘Act to Reorganize the Pharmaceuticals Market in the SHI System’ (AMNOG), which came into effect on 1 January 2011, an additional benefit of new drugs based on patient-relevant outcomes has to be demonstrated for time-shifted reimbursement negotiations by means of an early benefit assessment.
Source: Health Policy - Category: Health Management Authors: Source Type: research