More Insurers Covering ABMT, Despite Lack of Efficacy Data

WASHINGTON--A General Accounting Office (GAO) report has foundthat more insurers are now covering autologous bone marrow transplants(ABMT) for patients with breast cancer even though the treatmentis expensive and the benefits are not proven.

The procedure costs from $80,000 to $150,000, compared with $15,000to $40,000 for more conventional therapy, the report said.

[Editors' note: William P. Peters, MD, PhD, formerly of Duke Universityand now chief and CEO of the Karmanos Cancer Institute, Detroit,said at ASCO that costs for ABMT in the outpatient setting areapproximately $65,000, and that his patients have been quite successfulin obtaining coverage for such transplants. In his breast cancertransplant study reported at ASCO, only four of 105 eligible patientswere not randomized due to insurance company refusal to pay.]

The GAO's survey of 12 major insurers found that companies arebasing their decisions to pay for transplants on preliminary clinicalresearch rather than waiting for completion of ongoing randomizedtrials. Nonmedical factors, such as fear of litigation and adversepublic relations, also play a role, the insurers reported.

In some cases, the companies may not have a choice, since at leastseven states have mandated that insurance companies, under certainconditions, must provide such coverage and seven others stateshave similar legislation pending (see table). Moreover, the NationalAssociation of Insurance Commissioners is considering a modelact for states that would set minimum standards of coverage.

The GAO report raises questions about the growing popularity ofABMT, noting that "the public is not well-served by the proliferationof an unproven treatment that is costly and possibly harmful."

Scientists at the National Cancer Institute said that the reportunderscores the urgent need to complete transplant studies. "Thepreliminary evidence on bone marrow transplants is based on small,mostly nonrandomized trials that do not define the role of transplantsin the treatment of breast cancer," said Jeffrey Abrams,MD, senior investigator at the NCI. "The GAO report clearlysupports the need for large, carefully controlled, randomizedtrials."

The NCI has three such clinical trials now under way and a fourthhas just been launched. However, patient enrollment in the trialshas been slower than expected.

"We worry that women are not enrolling because they mistakenlyassume that the procedure is already a proven treatment and becausethey can receive it outside of studies," Dr. Abrams said.At the current rate of enrollment, answers about the treatmentwill not be available for at least 2 more years.

In the three NCI trials under way, breast cancer patients areassigned to receive either high-dose chemotherapy with ABMT and/orperipheral blood stem cell transplantation or a standard, state-of-the-artchemotherapy regimen. Patients in the fourth trial will receiveeither transplant or another form of high-dose chemotherapy.

Patients in Trials

To complicate matters further, increasingly insurers are payingfor ABMT outside of studies, while refusing to reimburse patientswho take part in clinical trials. "We believe that the insuranceand managed care industries should reimburse beneficiaries whoparticipate in the NCI-sponsored randomized clinical trials,"Dr. Abrams said. "The only way to reach definitive conclusionsabout this treatment is to complete the trials."

The report, Health Insurance: Coverage of Autologous Bone MarrowTransplantation for Breast Cancer (GAO/HEHS-96-83), may beordered from the GAO by calling 202-512-6000, and is also availableon the GAO's Internet home page at www.gao.gov.

Status of State Legislation Requiring Coverage of ABMT forBreast Cancer

States that have enacted pending legislation

Florida

Georgia

Massachusetts

Minnesota

New Hampshire

Rhode Island

Virginia

States with pending legislation

California

Connecticut

Louisiana

Missouri

New Jersey

New York

Ohio