gms | German Medical Science

Background: Total expenditures for pharmaceuticals in Germany in 2012 added up to approx. 43 billion euros [1] with a considerably increasing share of patented drugs during the last 20 years [2]. Since 2011 an early benefit assessment in accordance with the AMNOG legislation is required for all newly authorised, patented pharmaceuticals. Subsequently, a reimbursement price is being negotiated between the pharmaceutical company and the National Association of Statutory Health Insurance Funds [3]. The principle of AMNOG states that the reimbursement price should be based on the benefit assessment [4]. Yet initially, pharmaceutical companies can freely determine a price that is valid until the negotiations are completed. In order to estimate the importance of the early benefit assessment as a regulatory instrument it is worth knowing in how far these initial prices are already related to the additional benefit of new pharmaceuticals [5]. In this context we investigated whether there is a relationship between the additional annual treatment costs (AATC) and the later results of the early benefit assessment as published by the Federal Joint Committee (G-BA).

Materials and Methods: 63 new pharmaceuticals were assessed by the G-BA in accordance with § 35a SGB V until the cut-off day of 1 April 2014. They can be further distinguished into 101 subgroups, corresponding to different target populations [6], which were looked at separately in the following calculations. The costs of the new pharmaceuticals and the appropriate comparators were identified according to data of the G-BA (www.g-ba.de). As a basic principle, annual treatment costs were used for calculation, with the exception of a few cases where the costs per intervention were used. In numerous cases the G-BA declares a span for the costs of the new pharmaceutical or the appropriate comparator. This happens for several reasons, e.g. various possible combinations of substances or doses or different possible durations of therapy. As a general rule, the arithmetic mean was used as the basis for calculation in these cases. Some exceptions were made for medical reasons, e.g. where clinical standard is defined by a fixed duration of therapy. In these cases, the minimum, the maximum or a specifically calculated value was used. Finally, the AATC was calculated by subtracting the annual treatment cost for standard/comparative therapy from the annual treatment cost for the new drug.

Results: The median of the absolute AATC of those new pharmaceuticals (or their subgroups), which later received the rating "no additional benefit proven", was € 1,025 (n = 52; arithmetic mean € 10,978). AATC came to € 38,580 (n = 20; arithmetic mean: € 58,239) for those drugs with the rating "marginal additional benefit" and to € 55,952 (n = 13; arithmetic mean: € 70,526) for those with the rating "significant additional benefit". AATC was € 54,581 (n = 12; arithmetic mean: € 57,832) for pharmaceuticals with an "unquantifiable additional benefit". The maximum AATC for pharmaceuticals (or subgroups) with "no additional benefit proven" came to € 118,811, € 289,060 for those with a "marginal" or "significant additional benefit" and € 102,811 for those with an "unquantifiable additional benefit".

Conclusion: The additional costs of new pharmaceuticals compared to their appropriate comparators are related to the category of additional benefit as rated by the G-BA later on. This is especially true for the pharmaceuticals (or subgroups) with "no additional benefit proven", as their additional annual treatment costs are considerably lower than for the pharmaceuticals of other categories. There is a much smaller difference between the pharmaceuticals with a "marginal" compared to those with a "significant additional benefit". There are noticeably wide ranges regarding the cost differences within each category, and some cases with additional costs of over € 100,000 per year. This is also true for two cases with "no additional benefit proven", but these are subgroups of pharmaceuticals that were assessed as having a marginal or significant additional benefit for a different target population. Overall, the data presented underline the relevance of an early benefit assessment with subsequent price negotiations.