[Analysis of Late AMNOG Benefit Assessments]

Area of Science:

• Health Economics
• Pharmaceutical Policy
• Drug Regulation

Background:

• Germany's AMNOG regulation mandates early benefit assessments (EBA) for new drugs, influencing price negotiations.
• Initial EBAs may rely on limited evidence due to the drug's recent market entry.
• Later benefit assessments (LBA) are selectively performed when initial evidence was insufficient.

Purpose of the Study:

• To analyze the impact of later benefit assessments (LBA) on drug evaluations and prices within the AMNOG framework.
• To determine if a broader implementation of LBAs is warranted.

Main Methods:

• Analysis of all completed LBAs between 2011 and 2016.
• Comparison of initial EBAs with subsequent LBAs for drugs assessed multiple times for the same indication.

Main Results:

• Oncology and diabetes were prominent in LBAs, more so than in EBAs.
• 15 drugs initially approved with time-limited evidence showed varied outcomes in LBA (4 improved, 5 worsened).
• Negotiated drug prices significantly correlated with changes in benefit assessment outcomes.

Conclusions:

• LBAs, even with more extensive data, did not significantly alter overall drug benefit conclusions.
• A universal LBA is not deemed necessary due to limited impact and administrative costs.
• Selective LBAs are sufficient for drugs with initially weak evidence bases.