PATIENT INDIVIDUAL THERAPY AS APPROPRIATE COMPARATOR IN AMNOG-DOSSIERS IN THE FIELD OF ONCOLOGY- STATUS QUO AND STRATEGIC IMPLICATIONS FOR PHARMACEUTICAL COMPANIES
Author(s)
Templin C, Italia N, Damen D, Kulp W
Xcenda GmbH, Hannover, Germany
Presentation Documents
OBJECTIVES: For the assessment of an added value in the AMNOG process in Germany, the Federal Joint Committee (FJC) 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. METHODS: 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. RESULTS: In 2 out of 4 dossiers with added benefit direct evidence to patient individual therapy was presented. In contrast, in 4 out of 7 indications with no added value the comparator in the relevant study deviated from patient individual therapy. CONCLUSIONS: 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.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCN242
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Approval & Labeling, Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy
Disease
Oncology