Explosive AOK position paper facing 10 years AMNOG

On the 18th of November, the AOK Federal Association, Germany’s most influential payer organization, published a position paper on the tenth anniversary of the Medicines Market Reorganisation Act (AMNOG), containing some critical points for discussion. In this paper, there is next to a call for greater supply security in the generics market, a strong request for a reform of the pricing scheme for innovative drugs (1, 2).

Fri, 2020 / 11 / 20
This demand is substantiated by the high expenditure on patent-protected drugs, which reached a new record level of 21 billion euros in 2019. According to the AOK, precisely these innovative, high prized drugs, would account for a total share of 47.8% of the overall drug costs, but have only a supply share of vanishing small 6.5% (1). According to Dr. Sabine Richard, managing director of the supply division of AOK Germany (1), the "cardinal error" of the AMNOG is the first year in which the manufacturer is free to determine the price of his drug.

As a possible solution to this imbalance, the AOK Federal Association, representing around 26,5 million persons covered by statutory health insurance (3), proposed so called "interim prices" . These were to be calculated by the umbrella organization of the statutory health insurances, (Gesetzliche Krankenversicherung Spitzenverband - GKV-SV), based on the comparative therapy defined by the Federal Joint Committee (Gemeinsamer Bundesausschuss - G-BA). According to the AOK , once the price negotiations had been concluded, the reimbursement amount negotiated was to be retroactively reimbursed. This would have a considerable effect on the pricing strategy of the pharmaceutical industry.

This new pricing scheme would be accompanied by a reduction of the immediate post-launch (former free) pricing period from twelve to nine months and the possibility of restricting the reimbursement of these medicines to specialized treatment centers if the authorization of the respective pharmaceutical could only be supported by weak evidence.

The complex of issues surrounding rising costs in the health care system, particularly in the area of innovative medicines, is repeatedly on the negative agenda of the statutory health insurances (4). Further pressure on the pharmaceutical industry and the market access of innovative medicines can therefore be expected. We at SKC are closely following this renewed advance by the SHI system and are evaluating the implications that will arise for our clients.

German Sources:

 

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Ihr Ansprechpartner Prof. Matthias P. Schönermark, M.D., Ph.D.
Prof. Matthias P. Schönermark, M.D., Ph.D.
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