Abstracts by keywords: biosimilars
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
Based on the statements on the GSAV, it can be seen that, among other actors, the medical profession in particular has expressed considerable criticism of the planned regulation on the interchangeability of biosimilars. The National Association of Statutory Health Insurance Physicians (KBV) points out that biosimilars cannot “automatically be substituted by the pharmacist without close monitoring by the doctor” [2]. The Federal Council also expressed clear reservations about the change in the law and stated that there is currently a “lack of valid data to assess the effects of substitution on adherence and therapy results”. At the same time, the Federal Council warns of “a significant risk to the success of a therapy and patient safety” that can be associated with an aut-idem substitution of biosimilars [3]. The National Association of Statutory Health Insurance Funds, on the other hand, expressly welcomes the proposed regulation and regrets the delayed entry into force, which the association finds “also incomprehensible in terms of content” [4]. The present report is intended to contribute to the health policy discussion about the requirements for the underlying evidence for the possible interchangeability of biosimilars.
04.04.2020
Biopharmaceuticals are medicines whose active ingredients are obtained as part of a genetic engineering manufacturing process using DNA recombination methods. This manufacturing process is fundamentally different from the synthesis of the active ingredients of chemical drugs. While a chemical synthesis route can be copied identically, the production of drugs from genetically modified organisms is much more complex and results in the active ingredient remaining unique and can only be imitated by another manufacturer, but not reproduced identically. For this reason, copycat biopharmaceuticals are referred to as biosimilars and not as generics, as is the case with chemical medications. In the next few years, a number of biopharmaceuticals will lose their exclusivity, so new biosimilars are likely to complement the biosimilar market, which is currently limited to three drug groups. Even if this can result in cost savings for the payers, it is not possible to validly forecast market developments.
24.01.2013
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.