Flyer Substitution Exclusion List

8 Costs and times for the preparation of the SEL application The effort and the associated costs for the conception of an SEL application depend on diffe- rent variables. On the one hand, the number of publications found through a literature search and their evaluation is relevant. On the other hand, it depends on the complexity of the argumentation, because basically a scientific expert opinion is prepared for the presentation of evidence, which proves why the substance/product under discussion should no longer be exchanged in the future. Often, when preparing the expert opinion, one finds that the available data do not really sufficiently support the application. Then either available supply research data must be sub- jected to a secondary analysis or a corresponding survey must still be carried out in order to improve the data situation accordingly. All these parameters can hardly be estimated correctly before the start of the application preparation, which results in an activity - based fee or one agrees on a fixed price with the cli- ent. If additional analysis and / or generation of specific supply data is required, these costs are also to be borne by the commissioning company. According to previous experience, the time required for a SEL application is between 3 and 6 months. If a detailed and extensive analysis of health care data and / or a generation of own health care research data is required, the period can be extended up to 9 months. Times and deadlines for the SEL application and evaluation by the G - BA Since the SEL application and the subsequent evaluation procedure by the G - BA is not an official and structured application procedure with associated applications, forms or specific rules of procedure, the corresponding application can then be submitted to the G - BA. It remains unclear when the G - BA will start processing the application. However, according to current experience, this will happen within the next 4 to 8 weeks. Processing is carried out by the Subcommittee on Medicinal Products in the G - BA, which takes an initial position on the submitted application and also prepares a corresponding statement. The G - BA then obtains further external opinions from external institutions or experts in the indication, if necessary. The application is then placed on the agenda of the G - BA's next hearing on the expansion of the SEL, and the applicant company is invited to the corresponding hearing and may also bring an external expert to the hearing. After the hearing, further internal consultations on the application take place in the G - BA. Once these have been completed, the result of the SEL application is published on the G - BA's website.