Certain Genomic Tests May Soon Be Reimbursable for Breast Cancer Patients in Germany

Certain Genomic Tests May Soon Be Reimbursable for Breast Cancer Patients in Germany

Techniker Krankenkasse, one of the largest healthcare insurers in Germany, will begin reimbursing their breast cancer patients for genomic tests, announced Agendia, a diagnostics company that offers a test called MammaPrint.

The insurance company has joined the selective contract — a reimbursement instrument of Germany’s healthcare system — of the German Pathologists Organization for the reimbursement of genomic testing costs to breast cancer patients.

This contract includes only diagnostic tests with CE marking, meaning that they comply with the European Union’s health, safety, and environmental protection requirements, MammaPrint being one of them.

“This sends a good message; it helps our patients and supports our work,” Burkhard Otremba, MD, from Onkologische Praxis in Oldenburg, Germany, said in a press release.

MammaPrint looks at the activity of the 70 most important genes associated with breast cancer recurrence to classify early-stage breast cancer patients according to their risk of having their cancer return or spread to other parts of the body (metastasis) within the first 10 years after diagnosis.

The test was validated in the MINDACT Phase 3 clinical trial (NCT00433589), which included 6,693 women with early-stage breast cancer (more than 800 in Germany), recruited across 112 institutions in nine European countries.

The trial evaluated MammaPrint’s clinical utility as an additional approach to the standard criteria for assessing patients’ risk of cancer recurrence and selecting them for adjuvant chemotherapy.

The test was used to determine the women’s genomic risk, with their clinical risk assessed by a modified version of Adjuvant! Online — the standard method to estimate the risk of cancer recurrence based on clinical data (patient’s age, tumor size, etc.).

Results showed that 46% of women who were considered candidates for chemotherapy based on their high clinical risk were classified as having low genomic risk, according to MammaPrint, suggesting that they would not benefit from chemotherapy.

In the trial, chemotherapy had no significant impact in these women, as the five-year survival rate of patients who did not receive chemotherapy was 1.5% lower than those who did, which was not statistically significant. Also, none of these women developed metastasis, regardless of whether they underwent chemotherapy.

These findings suggested that nearly half of early-stage breast cancer patients usually indicated for chemotherapy may not need it. Therefore, the MammaPrint test may help clinicians decide which patients are more likely to benefit from chemotherapy, and reduce the number of patients exposed to its toxic effects.

Further data from this trial also highlighted that nearly one in four women with small tumors — a feature considered by standard methods as low-risk — had a high genomic risk, based on MammaPrint, and benefited from chemotherapy.

While reimbursement for genomic tests to all breast cancer patients is still pending in Germany, Agendia noted that healthcare insurers have already started giving patients access to MammaPrint, based on the belief that it will significantly improve patient care.

A re-evaluation of all genomic tests, including MammaPrint, is being conducted by Germany’s Institute for Quality and Efficiency in Health Care, which is expected to provide an update at the beginning of this year, according to Agendia.

Besides Europe, MammaPrint is also approved in the U.S. as a risk assessment test for women of all ages with early-stage breast cancer. The test is covered by a number of public health systems in the world, including several European countries, and by most health plans in the U.S.

Agendia’s additional genomic test, BluePrint, analyzes the activity of 80 genes to allow tumor subtype classification and further enhance treatment planning.

The combined results of these tests can help clinicians assess the risk for recurrence and metastasis, and predict the outcome of early-stage breast cancer. This may allow clinicians to discriminate which patients are more sensitive to different types of therapies, and which may be treated instead with other less toxic and costly methods.