STATISTICAL TREND ANALYSIS OF GERMAN BENEFIT RATINGS AND THEIR CORRELATION WITH NEGOTIATED REBATES FOCUSING ON ORPHAN ONCOLOGICS

Author(s)

Dehnen J, Jonas F, Wenzel R
Charles River Associates, München, Germany

OBJECTIVES: We evaluated the development of the Early Benefit Assessments (benefit rating) of the German Federal Joint Committee (G-BA) and their influence on the outcome of the later net price negotiations across all therapeutic areas and for orphan and oncology drugs in particular.

METHODS: We collected and analyzed the outcome of all 230+ G-BA resolutions until June 2017. We evaluated them by therapeutic area and by orphan status over 2 year time bins and tested their relation with linked rebate levels of 100+ marketed pharmaceuticals (pPU, Lauer-Taxe) with Pearson correlation coefficient.

RESULTS: The share of quantifiable positive benefit ratings, e.g. minor, considerable or mayor benefit, for orphan drugs (42%) is similar to that of non-orphan drugs (44%) across all therapeutic areasOncology therapies represent the major share of submissions to the G-BA (~34%, non-orphan and orphan). Comparing different therapeutic areas, we find that therapies in oncology achieve more positive ratings (59%) than therapies in any other therapeutic areas (13%-42%), but the share of positive benefit ratings in oncology decreased from ~65% to ~50% in the past 2 years. The number of orphan oncology assessments increased from 4 in the first two years to more than 10 in the past two years with the share of non-quantifiable

CONCLUSIONS: German benefit ratings of orphan oncology therapies worsened over time but are not correlated to the negotiated rebate. This trend may have contributed to the worsened perception of orphan drugs.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PSY140

Topic

Health Policy & Regulatory, Health Technology Assessment, Organizational Practices

Topic Subcategory

Academic & Educational, Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

Multiple Diseases, Oncology, Rare and Orphan Diseases

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