OBJECTIVES

: In future, biosimilars will be increasingly used in the form of oncological preparations produced by specialist pharmacies. In Germany, purchase- and pricing regulations on these markets differ from markets of pharmaceuticals directly sold in pharmacies. From 2017, there is a new regulation for markets of pharmaceutical preparations. The aim of this study is the critical assessment of the regulation on these markets especially with regard to market access of biosimilars.

METHODS

: Based on a literature search in electronic databases and a hand search on websites of relevant national regulation authorities, complemented by stakeholder interviews, we compared past and present regulations concerning markets for pharmaceutical preparations and the resulting incentives concerning the use of biosimilars.

RESULTS

: General regulations for preparation markets lead to a key role of specialist pharmacies or their purchasing organizations in pricing, as they buy the ingredients independently from pricing regulations on the general pharmaceutical markets. Their market power in biological markets is only reduced by the non-substituability of biologicals and biosimilars by pharmacists.

The new parallel regulation of the pricing process by collective contracting of pharmaceutical ingredient prices by regional health funds and fixed price discounts on the preparation prices may generally prove inconsistent. The new regulations concerning the price discount, the so-called “Hilfstaxe”, a treaty on the corporative level of the German health system, officially installs market disadvantages for some biosimilars.

CONCLUSIONS

: As there is a general trend towards substitutability of biologicals and biosimilars, which would lead to a stronger influence of specialist pharmacies on the use of biologicals, the “Hilfstaxe” has to be assessed urgently if substitution rights should be given to pharmacies. Independent from this, it has to be discussed whether the general regulations on German pharmaceutical markets concerning pricing should be expanded to pharmaceutical preparation markets.