Assessment of off-label use for oncology drugs: A fair option for all?

e17601 Background: Therapeutic benefits of off-label use are often unclear. Swiss Government regulates insurance coverage. Prerequisite for reimbursement is a substantial clinical benefit (CB) for patients with no alternative. The costs are covered proportionally to the expected benefit. Medical officers of Helsana Group, the largest Swiss health insurer, evaluate the benefits of off- label drugs before starting therapy. Methods: The examiners use MediScore (MS). This model was developed 2011 by Helsana in cooperation with swiss pharma groups and integrates evidence based medicine. It scores within the frame of ”Clinically Meaningful Outcomes” (L. Ellis, ASCO 2013). MS allows high expected individual benefit also with inferior evidence/outcome data, therefore respecting ethical principles. The assessment shows the expected patient benefit with four categories (cat). A and B for good CB; C for doubtful CB in studies, but possible CB in individual case and D shows no proven CB. The requests are rated with M...