Flyer Substitution Exclusion List

3 Introduction to the topic Discount agreements pursuant to Section 130a (8) of the German Social Code, Book V (SGB V) are a major threat to pharmaceutical manufacturers following the patent expiration of an original drug, as they often lead to a spiral of price reductions. Discount contracts are put out to tender by the GKV funds and are subject to a public bidding process with clearly defi- ned rules. Rebate contracts are the greatest threat to formerly patent - protected products, along with generic competition per se and constantly moving downward fixed prices. Only two instruments remain to escape the rebate contract trap. On the one hand, physici- ans can be motivated to put the " autidem " cross on the prescription, which rules out substi- tution by the pharmacist. The autidem cross is set - over all indications with a frequency of 12.5% by the physicians, because the physicians know very well that not all products are in- terchangeable. In particular, physicians have increasing concerns about indications such as epilepsy, Parkinson's disease, multiple sclerosis, or pain therapy with transdermal patch sys- tems. On the other hand, the active ingredient of the product must first be added to the list of non - substitutable substances/products (SEL), which must be achieved via an application to the G - BA. The third option, non - substitution due to pharmaceutical concerns by the pharmacist dis- pensing the drug, plays only a marginal role, as this happens in less than 1% of cases. In principle, the payers have no interest in including many products in the SEL, because this would counteract the effectiveness of the rebate contracts in accordance with § 130a Para. 8 SGB V. Preparations that have been included on this list may not be exchanged by the phar- macist within the framework of rebate contracts, even if a rebate contract has been con- cluded. Criteria for inclusion on the SEL There are a number of criteria for inclusion on the list:  Extent of aut idem exclusion by physicians when prescribing.  How often do pharmacists report pharmaceutical concerns, thereby preventing inter- change?  Poor solubility in water.  A narrow therapeutic range, according to the Critical Dose Drug (CDD) criteria.  Also open to the list are drugs for which drug monitoring is required according to their marketing authorization and information in the SmPC when switching to another drug with the same active ingredient.  Wide variation in plasma levels.  Variable bioavailability.  Critical dosage forms: Extended - release capsules, gastric juice - resistant capsules. These are empirical criteria that still require confirmation by practice.