AMNOG

AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) is a German law that was enacted to regulate the pricing and reimbursement of new pharmaceutical products. The law came into effect on January 1, 2011, and aims to ensure that new drugs provide added value compared to existing treatments before they can be reimbursed by the statutory health insurance system.

Background

The AMNOG was introduced as part of a broader effort to control rising healthcare costs in Germany. Prior to the implementation of AMNOG, pharmaceutical companies had the freedom to set prices for new drugs without any mandatory assessment of their therapeutic benefits. This often led to high prices for new medications, which placed a significant financial burden on the healthcare system.

Key Provisions

The AMNOG process involves several key steps:

Early Benefit Assessment

When a new drug is launched, the manufacturer must submit a dossier to the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) within three months. This dossier should provide evidence of the drug's added benefit compared to existing standard treatments. The G-BA then commissions the Institute for Quality and Efficiency in Health Care (IQWiG) to conduct an early benefit assessment.

Negotiation of Reimbursement Price

If the early benefit assessment concludes that the new drug offers an added benefit, the manufacturer and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) enter into price negotiations. These negotiations must be completed within six months. If no agreement is reached, an arbitration board sets the price.

Re-Evaluation

The added benefit of the drug is re-evaluated after one year based on real-world data. This ensures that the initial assessment remains valid and that the drug continues to provide the claimed benefits.

Impact

The implementation of AMNOG has had a significant impact on the pharmaceutical market in Germany. It has led to more rigorous assessments of new drugs and has helped to control costs by ensuring that only drugs with proven added benefits are reimbursed at higher prices. This has also encouraged pharmaceutical companies to focus on developing truly innovative treatments.

Criticism

Despite its benefits, AMNOG has faced criticism from various stakeholders. Some argue that the process is too complex and time-consuming, potentially delaying patient access to new treatments. Others believe that the stringent requirements for demonstrating added benefit may discourage innovation.

See Also

• Federal Joint Committee
• Institute for Quality and Efficiency in Health Care
• Statutory health insurance
• Pharmaceutical industry in Germany
• Healthcare in Germany