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Reflecting on the latest decision by the German pricing regulator on the reimbursement of novel biomarker-based cancer diagnostics

Breast cancer is the most common cancer in women. Surgery is the main treatment for early stage breast cancer. To treat a possible but undetectable metastasis and, thus, prevent recurrence, most doctors will recommend adjuvant systemic therapy, normally in the form of chemotherapy, following surgical resection. However, for some of these women, adjuvant chemotherapy is unnecessary. For these women, the risks of  chemotherapy-related harms can be higher than the actual cancer-related harms. 

With the evolution of genomic research enabling the genetic and molecular profiling of cancers, in recent years, an increasing number of biomarker-based tests which claim to identify those breast cancer patients who will benefit from adjuvant chemotherapy have entered the healthcare markets. The actual benefit and the reimbursement of such biomarker-based diagnostics for the use in breast cancer treatment is currently under assessment in several European jurisdictions. 

In Germany, the standards for the validation and reimbursement of novel diagnostics are very high, particularly, in case such diagnostics may potentially lead to the complete omission of a necessary standard treatment of a life threatening disease. Unlike companion diagnostics in the traditional sense, which aim to provide essential information for the safe and effective use of a certain corresponding drug, the concerned biomarker-based diagnostics are not related to a particular chemotherapy drug or method. They rather aim to support the treatment decision for or against adjuvant chemotherapy of a certain group of breast cancer patients in general. For a positive benefit assessment of such diagnostics,, the German pricing regulator basically demands data from prospective randomized trials. The standards are different elsewhere in Europe.

On 20 June 2019, for the first time, the German Federal Joint Committee (FJC − Gemeinsamer Bundesausschuss / G-BA), the highest decision-making body of the joint self-government of physicians, dentists, hospitals and statutory health insurance funds (SHI − gesetzliche Krankenversicherung / GKV) in Germany, 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 SHIs. The present resolution is of general importance. The FJC, 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.

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