Flyer Substitution Exclusion List

7 Support from health services research data In simple terms, the Subcommittee on Medicinal Products of the G - BA formulates a draft de- cision for inclusion in the substitution exclusion list for the substances in question and for- wards it to the groups of stakeholders - affected by the topic - with the request to comment on it. The comments can be made both in writing and verbally at a hearing. They are subse- quently evaluated by the G - BA and then assessed as to whether and how they are taken into account in the decision on inclusion in the substitution list. This evaluation is final. After the conclusion of the commenting procedure and the resulting evaluation assessment, if any, a final hearing will be scheduled at the G - BA, to which the participants will be invited in writing. Only 2 participants per applicant are admitted. In the course of the hearing, the corresponding application is called up and final, concluding findings or statements can be presented. After the hearing, the final evaluation results are published on the G - BA website at intervals of a few months. Opinion procedure and expert hearing at the G - BA Collection of utility data and/or secondary analysis of existing utility data. Often, it is already apparent from the first data review that the scientific evidence is not real- ly sufficient to justify a substitution exclusion. In addition, the product information often contains statements that do not support a substitution exclusion, or only to a limited extent, because it was written with a different intention. In this situation, it should be considered whether it is not possible to generate correspon- ding evidence from existing secondary data or, alternatively, to collect such evidence prima- rily in the sense of a survey among affected patients or physicians. We offer the analysis of secondary data as well as the collection of primary data and related evidence via the institute TakeCare GmbH, which cooperates with us. Often it is the evidence on PROs (patient relevant outcomes) that is the key to the success of the SEL application. Relevant modules from application to opposition Checking the chances of success Proposal - Argumentation Formulation of the application Involvement of companies Monitoring of the evaluation Coaching f.d. Hearing Stakeholder Involvement Argumentation Opposition Formulation