Flyer Substitution Exclusion List

4 SEL products of the "first tranche The birth of the substitution exclusion list was a difficult one, because the self - governing bo- dies in charge of it (ABDA and SpiBu) could not agree on what this list should look like. In the end, the responsible Ministry of Health got fed up and ordered a " substitute implementa- tion " by transferring the responsibility for the SEL to the G - BA. The implementation of the legal mandate is based on Section 129 (1a) SGB V. The non - substitutable products are to be listed in Section M of the AM - RL . Part A of the list is to con- tain references to the substitutability of dosage forms, and Part B is to contain the products excluded from substitution by a drug with the same active ingredient. Since the advent of generics, there has also been debate about whether the original drug and the (usually multiple) generics are truly therapeutically equivalent, i.e., whether efficacy and tolerability remain the same when switching from one generic to another. In fact, different products, even if they are the same in terms of the type and quantity of acti- ve ingredients, can differ in terms of their galenics, i.e., their excipients and dosage form, and lead to differences in the absorption of the active ingredients and thus the mode of ac- tion. And regardless of whether such pharmacokinetic differences occur, external diffe- rences in the drugs (e.g., in shape, size, and color) can lead to compliance problems, which can also result in changes in efficacy. Listings of the first tranche After completion of the first tranche, the following substances will be included in the list: The entire process is documented on the G - BA's website, including the supporting rationale, and all comments can be viewed here. The decisions of the G - BA on the first tranche were controversial by stakeholders and medi- cal science, but were basically considered to be consensual.  Betaacetyldigoxin, tablets  Ciclosporin, oral solution  Ciclosporin, soft capsules  Digitoxin, tablets  Digoxin, tablets  Levothyroxine - Na, tablets  Levothyroxine - Na + potassium iodide (fixed combinati- on), tablets  Phenytoin, tablets