PHILADELPHIA--A Massachusetts study suggests that legislation requiring insurers and HMOs to cover high-dose chemotherapy/autologous bone marrow or stem cell transplantation for metastatic breast cancer does not lead to significant increases in the number of procedures performed.
John K. Erban, MD, and his colleagues at the New England Medical Center and the Massachusetts Department of Public Health, surveyed the 10 institutions in Massachusetts that had performed such transplants between 1990 and 1995, to determine whether the state law, implemented in April 1994, influenced the number of procedures performed in the state and the number of procedures performed on protocol.
The legislation provided for an advisory committee to establish criteria for the procedure, Dr. Erban explained in his presentation at the American Society of Clinical Oncology meeting. This committee decided that any patient who had the equivalent risk of 10 or more positive lymph nodes or stage III or IV disease would be covered, and that patients would not be required to enroll in a clinical trial.
The committee also set up an appeals process. Denials would be reviewed first by an internal board and then, if the internal appeals were not satisfactory, by an independent review board.
Dr. Erban noted that 1993 was the last year for which there was no required insurance coverage. From 1990 to 1994, the number of protocol procedures increased in a linear fashion, but plateaued and did not increase in 1995 (see table ).
The study showed a a very slight, almost linear increase in the number of nonprotocol procedures performed. "Early in the 1990s, 100% of patients were reported as being treated on protocol (many in the context of NCI-sponsored randomized phase III trials), and none were reported as being treated in nonprotocol settings," Dr. Erban said. "That has decreased to about 85% and 15% at the current time."
These figures contrast with what has been reported to the Autologous Bone Marrow Transplant Registry (ABMTR). In 1995, only 10% of patients in the registry were reported as being treated in a randomized phase III clinical trial.