[Benefit Assessment and Price Negotiation Under AMNOG: Calculable Process or Unfair Poker Game?]

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Regulatory Science

Background:

• The German Market Restructuring Act introduced controversial drug evaluation and price negotiation processes.
• Pharmaceutical companies criticize the Federal Joint Committee's dual role in benefit assessment and price negotiation.

Purpose of the Study:

• To empirically investigate the transparency and evidence-based criteria of drug benefit assessments and price negotiations.
• To model and analyze the relationship between benefit assessment and price negotiation processes under the Act on the Improvement of the Benefit Assessment of Medicinal Products (AMNOG).

Main Methods:

• Modeling of the benefit assessment and price negotiation processes under AMNOG.
• Statistical analysis to determine the influence of various factors on benefit determination and price negotiations.

Main Results:

• The number of patients and annual costs of comparator therapies negatively influence the determination of added therapeutic benefit.
• The added value of a new therapy positively affects the mark-up for comparator therapies, while new therapy costs positively influence this.
• Conversely, added value negatively impacts price discounts, and comparator therapy costs negatively influence this.

Conclusions:

• While factors like patient population and therapy costs influence drug pricing, the study found no significant evidence for interdependence between added value decisions and subsequent price negotiations.
• The findings provide empirical insights into the complex dynamics of drug pricing and reimbursement in Germany.