Fixed Reimbursement Amounts for Medicinal Products in Germany

Legal Basis and Purpose

Fixed reimbursement amounts (Festbeträge) are established under the German Social Code Book V (SGB V) and the Framework Agreement on Medicinal Products. The system aims to promote economical prescribing within statutory health insurance by setting a maximum reimbursable price for groups of interchangeable medicines, encouraging the use of cost-effective alternatives without compromising therapeutic efficacy. BfArM is responsible for determining these fixed amounts based on expert assessments. Festbeträge - BfArM

Formation of Festbetrag Groups

Medicines are grouped if they are:

• Therapeutically equivalent (same active ingredient, strength, dosage form, and indication)
• Bioequivalent or pharmaceutically equivalent
• Interchangeable according to therapeutic and pharmacological criteria

Groups are defined at ATC level 5 (chemical substance) or higher when appropriate. BfArM publishes group decisions after consultation with expert committees.

Calculation of Fixed Reimbursement Amounts

• Methodology: Festbeträge are set at the level of the cheapest third of products in the group (often the lowest-priced generics or biosimilars).
• Factors Considered: Price comparisons, package sizes, daily therapy costs, and market availability.
• Adjustment: Amounts are reviewed and adjusted periodically based on market developments, new entrants, or price changes.
• Publication: Fixed amounts and group details are published in the official Festbetrag list on the BfArM website and in the G-BA decisions.

Implications for Patients and Prescribers

• If a prescribed medicine exceeds the Festbetrag, the patient pays the difference (unless exempted).
• Prescribers are encouraged to select products at or below the fixed amount to avoid additional patient co-payments.
• Pharmacies substitute with cheaper equivalents within the group when possible (aut idem substitution).

Exceptions and Special Cases

Certain products may be excluded from Festbetrag groups (e.g., innovative medicines with added therapeutic benefit, orphan drugs, or those with unique formulations). BfArM also handles applications for exemptions or adjustments.

The Festbetrag system supports sustainable financing of the German healthcare system by promoting competition among generics while safeguarding access to necessary treatments. Festbeträge - BfArM