Abstracts by keywords: Europe
In order to determine the so-called EU reference price, the pharmaceutical company must “report the amount of the actual selling price in other European countries (see Appendix 2, RV) (…) to the extent that the drug in question is offered there” (framework agreement according to Section 130b Paragraph 9 SGB, §3 paragraph (2) SGB V). According to Annex 4 to the RV, in order to “determine the actual sales price weighted according to purchasing power and sales, the company’s actual country-specific sales price must be corrected according to purchasing power and weighted with the sales share of this country in the total sales of the countries to be taken into account. The prices weighted in this way are added together for the comparison countries (framework agreement according to §130b SBG V, Annex 4) and result in the European reference price. However, the arbitration award on the RV of June 21, 2016 (§6 (3) RV) expressly included a regulation in the RV according to which, in justified cases, the turnover weighting can be deviated from and the turnover weighting can instead be carried out approximately using the number of inhabitants. Furthermore, a regulation was included in the RV according to which the contractual partners can deviate from the requirements of Annex 4 No. 2 and No. 3 of the RV, provided that both contractual partners agree or the special features of the specific reimbursement amount agreement or special problems in obtaining data give rise to this. Which methodology appears suitable in which cases and what limitations there are, particularly when it comes to sales weighting, will be discussed below.
04.04.2019
In recent years, the use of biotechnologically produced drugs has increased significantly. These active ingredients, which are usually produced through the use of bacteria or cell cultures, are used in a variety of indication areas. Biotechnologically produced active ingredients are used particularly in the treatment of serious diseases such as anemia in kidney disease, rheumatoid arthritis and other systemic diseases as well as various cancers (Roger 2006). One way to save costs in the area of biologicals is to increase the use of so-called “biosimilars”, which can be developed by other manufacturers and brought onto the market after the patent protection of the biological has expired. As part of a model calculation, it was examined how high these expected savings could be by substituting the reference biologicals with biosimilars using the example of selected European countries between 2007 and 2020.