Posted by Michael Wonder on 10 Jul 2019
Biomarker-based cancer diagnostics: German pricing regulator sets high validation and reimbursement standards for novel diagnostic methods
10 July 2019 - On 20 June 2019, for the first time, the German Federal Joint Committee (G-BA), made the resolution that a specific biomarker-based test to support the treatment decision for or against adjuvant chemotherapy, i. e. after primary surgery, in certain breast cancer patients may be reimbursed by the statutory health insurance funds.
The present resolution is of general importance. The G-BA, inter alia, has further specified the validation standards for novel diagnostic methods.
The reimbursement of various biomarker-based diagnostics for the use in breast cancer treatment is currently under assessment also in other European jurisdictions, partly with a patchwork of different standards and outcomes.
