PCN242 - Patient Individual Therapy as Appropriate Comparator in Amnog-Dossiers in The Field of Oncology: Status Quo and Strategic Implications For Pharmaceutical Companies

Abstract

For the assessment of an added value in the AMNOG process in Germany G-BA defines appropriate comparators. These can be categorized into four classes: (1) one specific drug; (2) a list of drugs; (3) best supportive care (BSC); and (4) patient individual therapy. The latter category implies several methodological challenges for having an added benefit granted. Therefore our analysis focused on dossiers with patient individual therapy as appropriate comparator. Information was retrieved from the G-BA website. All non-orphan AMNOG-dossiers in oncology published until the end of 2015 were screened. Data on indication, size of target population, line of therapy, the comparator utilized in the company’s dossier, and outcome (added benefit) were obtained. 41 relevant dossiers with 71 indications were identified. The appropriate comparators were distributed as follows: 26 (36.6%) specific drug, 15 (21.1%) list of drugs, 19 (26.8%) BSC and 11 (15.5%) patient individual therapy. In the last years, the latter was increasingly defined as appropriate comparator (2011-2013: 3.0% of all comparators; 2014-2015: 26.3% of all comparators). For clinical trials not containing patient individual therapy as comparator, the chance of getting an added value recognized was low (substantial added value: 4, no added value proven: 7). In 3 out of 4 dossiers with added benefit direct evidence to patient individual therapy was presented. In contrast, in 5 out of 7 indications with no added value the comparator in the relevant study deviated from patient individual therapy. Patient individual care is rarely used in clinical trials. Despite this, it seems that the relevance of comparative evidence against patient individual therapy is increasing. Pharmaceutical companies should take this development into account, in order to maximize the likelihood of getting an added benefit granted.