Breast Cancer and Bone Marrow Transplantation

American Cancer Society
Thursday, 15 April 1999

Background:

Bone marrow transplantation has become an established form of treatment for a number of neoplastic conditions, such as leukemia and lymphoma. Increasingly, autologous bone marrow transplantation (BMT) is being used as a treatment for breast cancer. In this procedure, bone marrow or stem cells from the blood are taken from the patient and reinfused after high doses of chemotherapy have been administered. The treatment is most commonly used in women with advanced breast cancer, but there is a growing trend for its use in patients with earlier stages of breast cancer. Proponents say the procedure provides breast cancer patients with access to a promising, potentially life-saving treatment, while opponents cite its cost and potentially harmful side effects.

Many insurers, including some of the nation's largest, routinely cover Bone Marrow Transplantation for breast cancer, although some still deny coverage for the treatment because it is considered experimental. Ten states currently require insurance coverage of Bone Marrow Transplantation or a mandated offering of the coverage option. Medicaid covers Bone Marrow Transplantation in some states, and coverage is provided to all beneficiaries of the Federal Employees Health Benefits Program. Medicare excludes Bone Marrow Transplantation coverage for breast cancer because the Health Care Financing Administration, which administers the Medicare program, considers the treatment experimental.

Bone Marrow Transplantation is widely considered an experimental therapy, and most experts have called for more research, particularly more randomized clinical trials, before definitive conclusions can be reached about the effectiveness of the treatment as compared with traditional treatment. The National Cancer Institute supported two randomized clinical trials of Bone Marrow Transplantation in the U.S., and in addition two randomized international trials were conducted. Originally NCI planned to conduct three clinical trials, but reduced the number to two as a result of difficulties in recruiting participants, due in part to problems with insurance company reimbursement of patient costs for participation in the trials. A total of 1427 women participated in the two NCI trials. The results, released on April 15, 1999, suggest that Bone Marrow Transplantation therapy is not necessarily an improvement over traditional treatment. The American Society of Clinical Oncology has examined this latest data and concludes that they are preliminary, the initial results are conflicting, and the study designs have specific differences; all of which make it not yet possible to draw definitive conclusions about the role of this therapy in breast cancer. Two large NCI-sponsored, randomized, clinical trials of Bone Marrow Transplantation are currently underway.

ACS Position:

The American Cancer Society strongly supports reimbursement for bone marrow transplantation by insurance carriers for the treatment of appropriate hematologic malignancies. We believe that there is currently insufficient evidence to determine the efficacy of Bone Marrow Transplantation for breast cancer, and support further analysis of clinical data obtained from carefully controlled peer-reviewed clinical trials. We call upon insurance companies to cover patient costs for participation in high quality clinical trials of Bone Marrow Transplantation, which are an important therapeutic option for patients as well as a critical means of advancing medical knowledge of the issue. The difficulty experienced by investigators in recruiting patients for clinical trials highlights the urgent need for policies ensuring that public and privately funded health insurance plans cover all patient care costs associated with participating in high quality peer-reviewed clinical trials.

The American Cancer Society urges insurance companies to continue to offer coverage of the costs of Bone Marrow Transplantation therapy for those patients who, in consultation with their physician, elect to undergo the treatment, preferably as part of a clinical trial. In view of the inconclusive nature of the current evidence, and the need for further studies, it would be premature to drop coverage of Bone Marrow Transplantation therapy. Until such time as the studies are conclusive, physicians and patients should not be impeded by limitations of health plan reimbursement and be free to determine on an individual basis what course of treatment is medically necessary and appropriate.

For more information, or to contact American Cancer Society, see their website at: www.cancer.org