Predictors of German Amnog Decisions and GKV Rebate Negotiations: A Database Analysis.

In Germany, with the introduction of the new Arzneimittelmarktneuordnungsgesetz (AMNOG) in 2011, the pricing regulations for newly authorized pharmaceuticals and their reimbursement by statutory health insurance providers has changed. Now, there are three main stakeholders: the Joint Federal Committee (G-BA1), the Institute for Quality and Efficiency in Health Care (IQWiG2) and the National Association of Statutory Health Insurance Funds (GKV-SV3). G-BA is a committee of the joint self-government of physicians, hospitals and health insurance funds. It evaluates the benefits of pharmaceuticals using a standardized procedure that follows the criteria of evidence-based medicine. IQWiG helps G-BA to fulfil its legal responsibilities by issuing scientific recommendations.*1 The list price of a product is set by the manufacturer upon launch. After negotiations with the GKV-SV, a commonly undisclosed price rebate or reference price for the statutory health insurance providers is agreed on the grounds of the AMNOG assessment.*2 The manufacturer has the option to unilaterally end the price rebate negotiation procedure within four weeks of the publication of the G-BA resolution, a so-called “opt-out”, thereby choosing not to launch the product in Germany. As previous publications4 have not systematically addressed predictors on the G-BA assessment and its impact on rebate, the aim of this poster is to generate hypotheses on the following topics: 1. Identification of possible predictors for GB-A decisions 2. Determination of the association between added benefit and rebate