Market access: Early benefit assessment and guidance related to legal performance standards of new drugs

Innovations in the field of pharmaceuticals are crucial for the continued improvement of healthcare and ultimately for addressing major medical challenges of our time such as cancer, infectious and immune diseases, or Alzheimer’s.

In addition to proof of efficacy and safety of a drug, nowadays demonstrating benefits is a mandatory part of market launch. In Germany, a number of very specific regulations apply. Early benefit assessments provide important clues to the importance of a new drug for healthcare and help ensure quality.

  • AMNOG dossiers

  • Early benefit assessment

  • Early Federal Joint Committee (GBA) guidance

  • Systematic literature review and quality assessment of studies

  • Strategic study planning

  • Market research

  • Market overviews and position papers

  • Pharmaceutical expenditure control

  • Employee training

  • Presentations and workshops