AMNOG insights: Added benefit of the early benefit assessment of orphan drugs does not correlate with negotiated rebates

Tue, 2019 / 06 / 25
Until 2011, prices for innovative medicines in Germany were unregulated. Pharmaceutical companies were able to demand monopoly prices for their medicines within the patent term. This led to above-average rising costs in the health care system and in January 2011, consequently to a paradigm shift through the introduction of the AMNOG as regulatory measure.

The AMNOG consists of two process steps, the additional benefit assessment and the following price negotiation. Based on the available study data, the added benefit compared to an appropriate comparative therapy is assessed by the Joint Federal Committee (G-BA). Depending on the extent of the added benefit and other price anchors, the pharmaceutical company negotiates the reimbursement amount valid from the 13th month after launch with the umbrella association of statutory health insurances (GKV-SV). In the field of orphan drugs, challenging negotiations often result due to the rarity of the disease, the limited study data, the often high annual therapy costs and the lack of price anchors.

SKC analysed the rebates from over 60 orphan drug processes and examined the relationship between added benefit and negotiated rebates.

In the case of orphan drugs, the added benefit is already proven by law and all investigated procedures achieved at least a non-quantifiable added benefit. The negotiated rebates (§§ 130 a and 130 b, net) were in a heterogeneous range of about 10% to 70% with a median of 26%. No correlation between the added benefit and the negotiated rebates could be recognized in the analysis. This may be justified by other influencing factors in the price negotiation process, such as 

  • the launch price, 
  • the European average price, 
  • the costs of comparable drugs and 
  • the budget impact.

As a specialist for orphan drugs and with many years of expertise, SKC consulting works intensively on the interrelationships and challenges of market access for innovative medicines, in particular for orphan drugs.

BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Bianca Prelle, B. A. Health Management

Source: SKC analysis based on the G-BA benefit assessment and the Lauer-Fischer-Taxe

About the author

Ihr Ansprechpartner Prof. Matthias P. Schönermark, M.D., Ph.D.
Prof. Matthias P. Schönermark, M.D., Ph.D.
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
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