Flyer Check, Phase-III Portfolio

6 1. Transparency in the indication Extent of the degree of standardization in diagnostics and therapy. The availability of meta - analyses, HTA reports or systematic reviews shows the extent to which diagnosis, therapy and other clinical modalities (pathways, etc.) are already standardized. High transparency leaves little room for poor clinical evidence. With high scientific transparency, the requirements for clinical evaluation are signi- ficantly higher. 2. Availability of guidelines The availability of guidelines indicates what payers will and will not reimburse. At the same time, gui- delines define accepted therapeutic standards and relevant comparative therapies. In addition, the timely inclusion of the new product in current guidelines should be worked towards at an early sta- ge. 3. Extent of the Unmet Medical Need The most important parameter for the level of therapeutic standard in the target indication. If this is high, a much greater additional benefit is required than if it is rather low. Therefore, those who inno- vate in indications with a high therapeutic standard should be sure that they will also be able to ge- nerate a corresponding additional benefit - despite the already high level of therapy. The situation is completely different for rare diseases with a correspondingly low standard of therapy (best supporti- ve care). 4. Economic pressure in the target indication This is where the economic pressure from payers and the awareness of regulators in the target indi- cation are tapped. Existing reference prices only allow higher prices in the event of a therapeutic bre- akthrough. Bid & tender indicate a very price - sensitive and correspondingly responsive market. The level of the DDD correlates predominantly inversely to the therapeutic standard in the target in- dication. Low DDDs are typical for indications with a high therapeutic standard, such as diabetes, asthma/COPD or hypertension. Conversely, indications with an unsatisfactory standard of care often have high to very high DDDs, such as rheumatoid arthritis or cancer. The DDD level is important for the negotiating leeway in price negotiations with the SpiBu. For rare and especially very rare dise- ases, the DDDs are often very high. 5. Study situation, outcomes and additional benefits The quality and level of evidence of available clinical evaluations are assessed. At the same time, the availability of HEOR studies* is queried. The quantification of the study base is the aim and purpose of this question. The depth and breadth of the clinical evaluation will be assessed. But also the number of patients treated with the innovative substance as well as the duration of treatment experience in patient - years. The choice of the compa- rator recommended by IQWiG/G - BA in the clinical studies is absolutely recommended. Any other, i.e. deviating, choice of comparator leads to a devaluation by IQWiG and/or the G - BA in the form of a missing proof of added benefit. Assessment concerning the quality and homogeneity of the clinical outcomes achieved. How strong and robust are the observed effects really. 6. Achievable refund price This question concerns the core of the objective of the assessment. Do the previously ticked benefit expectations correlate with the price expectations? If discrepancies arise here, it is advisable to follow up. Basically, the goal is to capture the stakeholders' sense of reality. Management of expecta- tions is the goal here.