Abstracts by keywords: GSAV
In addition to other topics relevant to the pharmaceutical market, the law for greater security in the supply of pharmaceuticals (GSAV) in 2019 also stipulated regulations that affect the biosimilar market in the GKV. With the GSAV, certain new regulations have already been created and implemented, but additional changes are also promised after a period of three years. The latter relate not least to the planned interchangeability of biosimilars in pharmacies from 2022. Against this background, the authors of this article have published a scientific report, which is available as a full publication online under the “eFirst” section of the “Monitor Healthcare Research” (https: //www.monitor-sorgesforschung.de/efirst/Versorgung_Bios_2022/view), considerations were given as to which regulatory framework would do justice to the special market situation of biosimilars, particularly with regard to pricing (Bauer et al. 2021). The model developed in this context, which is intended as an alternative or counter-proposal to (partial/exclusive) discount contract tenders - which will be the logical consequence of the GSAV regulations - is presented below. This reimbursement and pricing model is intended to do justice to the market conditions analyzed in detail in the full publication in the sense of a sustainable competition concept in the biosimilar market and to be introduced into the health policy discussion.
01.02.2021
With the Act for More Safety in the Supply of Medicines (GSAV), the legislature has, among other things, provided for the automatic substitution of biologics in pharmacies from 2022. In fact, the new regulation on automatic substitution in the GSAV paves the way for the introduction of exclusive discount agreements in the biologicals market. The current contractual practice in the biologics market is determined by health insurance companies' tenders for non-exclusive open-house contracts in accordance with Section 130a Paragraph 8 SGB V. Both manufacturers of the biological reference products and the respective biosimilars, including any imports, can agree to these contracts at the rates specified by the respective health insurance company join the specified conditions. Although interchangeability can also come into play in the context of other types of competition models, it seems obvious that the GKV side in particular is aiming for such exclusive tenders based on the model of the generics market. Against this background, published calculations by the AOK Scientific Institute (WIdO) show that a savings volume of 141 million euros was achieved through the use of biosimilars in the period from July 2017 to June 2018.
28.07.2020
The following concept is intended to contribute to the methodological discussion about the use of application-related data in benefit assessment. Based on an overview of the current handling of non-randomized data by relevant health technology assessment (HTA) organizations as well as an overview of possible methodological evaluation procedures, recommendations are formulated on evidence generation, evidence assessment and necessary G-BA specifications that must be taken into account of the data for the quantifiability of an additional benefit.