Reimbursement

The MammaPrint service is classified into CMS reimbursement category B6 as a new, but proven, technology meeting a clinical need and reimbursement is recommended to be given by Medicare. Based on the FDA approval and the CMS B6 category assignment, the reimbursement situation for MammaPrint in the US is favorable. FDA clearance in February 2007 has acted as a positive catalyst for reimbursement not only in the US, but also in Europe, Oceania, South Africa and Latin America.

Effective healthcare

A service such as MammaPrint that can distinguish whether the individual patient is at a high or low risk of cancer recurrence can play a significant role in reducing costs at the same time as improving the quality of life for the patient.

Age when first detected, type of cancer (ER-positive tumors are the most common), nodal status, hormonal treatment with tamoxifen alone or in combination with polychemotherapy and whether or not the ovaries are removed, are all factors which may play a significant role in cancer recurrence and survival. Regular reviews of data from randomized trials in early breast cancer therefore play an important role in assessing the effects of various adjuvant therapies on breast cancer recurrence and survival. Evidence suggests that some of the widely used adjuvant drug treatments that were being tested in the 1980s, which substantially reduced 5-year recurrence rates (but had somewhat less effect on 5-year mortality rates), also substantially reduce 15-year mortality rates (1).

However, the costs of unnecessary therapy and dealing with frequent side effects are serious economic considerations. For example, it has been estimated that approximately 60-80% of patients with node-negative breast cancer will be alive 10 years after initial treatment without adjuvant therapy (2). Even so, up to 58% of patients with node-negative breast cancer may develop recurrent disease and reduction of cancer recurrence in patients has been documented as a result of adjuvant chemotherapy or tamoxifen. In this situation, it becomes crucial to identify patients with node-negative breast cancer at highest risk for recurrence so that they may receive appropriate adjuvant therapy, while patients at lower risk can be spared the toxic effects and unnecessary expenditure can be avoided.

1 Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials; Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), Lancet 2005; 365: 1687–1717

2 Adjuvant therapy of node-negative breast cancer, PD Hall, BA Lesher, and RK Hall, The Annals of Pharmacotherapy: Vol. 29, No. 3, pp. 289-298, 1995, Harvey Whitney Books Company.