Flyer Substitution Exclusion List

5 SEL products of the "second tranche In the final deliberations and fueled by the accompanying expert hearings for the 2nd tran- che of products for the substitution exclusion list, no uniform evaluation of the candidates under discussion emerged. For 4 substances/products: Buphrenorhine, Oxycodone, Phenobarbital and Phenprocoumon there is a clear vote of the G - BA for inclusion in the list. In contrast, there is a dissonant situ- ation within the G - BA for the three substances/products primidone, carbamezipine, and val- proic acid. The results of the G - BA were not published until the end of April 2016, as the deliberations were both controversial and unusually extensive. The following substances were newly in- cluded in the SEL: The next tranche is expected to be negotiated in the second half of 2021.  The opioids buprenorphine (patches), oxycodone (sustained - release tablets), hydro- morphone (sustained - release tablets) used for the treatment of pain, insofar as they have a different maximum duration or frequency of application,  the active ingredients phenobarbital (tablets), primidone (tablets), car - bamazepine (sustained - release tablets) and valproic acid (sustained - release tablets) used to treat epilepsy, and  the active ingredient phenprocoumon (tablets), which is used to inhibit blood clotting. Involvement of the relevant professional societies and stakeholders The chances of a successful application formulation increase considerably if it is possible to involve the relevant professional societies. For almost all applications, the German Pharmaceutical Society, which represents the phar- macists' point of view, should be considered. This professional society also publishes the guideline - good substitution practice, which is updated periodically. Furthermore, it is advisable to involve the relevant medical society in the conception of the application. This will also identify the COLs that may be required for the hearing at the G - BA. In addition, if there is one, the most important patient association should be involved, be- cause these are the people who are really affected. Patient organizations are also often very happy to support the acquisition of health services research data, such as a survey, which may be required. German Pharmaceutical Society Medical societies Patient associations KOLs