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
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.