OBJECTIVES: To assess the effort it takes for manufacturers to develop HTA submissions in Germany and the UK and to compare it to the estimates proposed by the legislator. METHODS: A review on available sources was conducted to assess the proposed as well as the actual effort it takes to develop and submit a dossier to the HTA agencies in Germany (G-BA/ IQWiG) and UK (NICE). Evidence from the review was supplemented by interviews with experts from pharmaceutical and consulting industry. RESULTS: The time proposed for HTA submission was particular low in Germany were the legislator estimated that a submission to the G-BA/ IQWiG could be done within 2.5 days. However, according to the review and expert judgment actual effort of HTA submission in Germany required a minimum of one year for multidisciplinary teams collaborating on generation of evidence following the exact guidance that details the methods, contents, and format of submissions to the German HTA body. Effort in UK is seen as lower due to the more collaborative and interactive nature of the process avoiding unnecessary effort and allowing for a clear focus on the critical questions. However, since the process in Germany is still fairly new, it could be assumed that due to learning curve effort will be lower in subsequent submission as the process gets more rationalized. CONCLUSIONS: The actual burden exceeds the burden that was estimated particularly in Germany by magnitudes. This study shows that the burden also depends on the organization of the consulting process during dossier development. Whereas the early and structured interaction in UK was seen as favorable to avoid spending time on aspects that are not relevant for the decision of the HTA body the highly formalized German process where such an action is much less intense requires a more mechanistic approach.