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.
PHILADELPHIA--A Massachusetts study suggests that legislationrequiring insurers and HMOs to cover high-dose chemotherapy/autologousbone marrow or stem cell transplantation for metastatic breastcancer does not lead to significant increases in the number ofprocedures performed.
John K. Erban, MD, and his colleagues at the New England MedicalCenter and the Massachusetts Department of Public Health, surveyedthe 10 institutions in Massachusetts that had performed such transplantsbetween 1990 and 1995, to determine whether the state law, implementedin April 1994, influenced the number of procedures performed inthe state and the number of procedures performed on protocol.
The legislation provided for an advisory committee to establishcriteria for the procedure, Dr. Erban explained in his presentationat the American Society of Clinical Oncology meeting. This committeedecided that any patient who had the equivalent risk of 10 ormore positive lymph nodes or stage III or IV disease would becovered, and that patients would not be required to enroll ina clinical trial.
The committee also set up an appeals process. Denials would bereviewed first by an internal board and then, if the internalappeals were not satisfactory, by an independent review board.
Dr. Erban noted that 1993 was the last year for which there wasno required insurance coverage. From 1990 to 1994, the numberof protocol procedures increased in a linear fashion, but plateauedand did not increase in 1995 (see table ).
The study showed a a very slight, almost linear increase in thenumber of nonprotocol procedures performed. "Early in the1990s, 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 AutologousBone Marrow Transplant Registry (ABMTR). In 1995, only 10% ofpatients in the registry were reported as being treated in a randomizedphase III clinical trial.
Internal data from the registry suggest that the number of proceduresbeing performed nationally is increasing dramatically: 16% ofall procedures reported in 1990 were breast cancer related, risingto 40% in 1995. "It is likely, therefore, that the numbernationally is increasing at a rate as least as high as, if nothigher than, the rate in Massachusetts," Dr. Erban said.
He concluded that there has been no apparent acceleration in therate of increase in ABMT performed since the legislation was introduced."The percentage of nonprotocol patients is increasing, butit is significantly lower than the national average," hesaid. The increase may be due to the slow increase in the numberof Massachusetts centers doing transplants.
The study authors believe that factors other than insurance restrictionare limiting whether transplants are being performed in Massachusetts."I think the essence of the paper is to try to define whethera committee procedure, such as that required by the legislation,would be a useful prospective method of defining who and who shouldnot be transplanted," Dr. Erban said.
The discussant for the study, Sam Turner, of Fox, Bennett &Turner, who serves as counsel to ASCO in Washington, disagreedsomewhat with Dr. Erban's conclusions. "The numbers for 1994seem to represent an almost 40% increase over those for 1993 whenthe legislative debate over this provision was presumably alreadyhaving an anticipatory effect," he commented. "Peoplemay have been pushing harder to have the procedure covered bytheir insurers, and some insures may have anticipated that thelegislation was going to be passed."
He further noted that comparing the 1994 numbers with those of1992, before the legislative debate commenced, reveals more thana 100% increase, "so I'm not so sure that the evidence isclear."
Although far fewer Massachusetts patients received treatment outsideof a protocol than in the rest of the country, it was still increasing,Mr. Turner said.
"I think it will be interesting to see, in light of the factthat the legislation does not require enrollment in a trial, whetherthe number of patients receiving treatment outside a protocolmay increase further," he said. "That would obviouslynot be a positive development."
As an alternative to mandated coverage for a specific procedure,Mr. Turner suggests that insurers be required to cover any treatmentthat is given in the context of a qualified NCI-supported clinicaltrial. "This approach will encourage patients to participatein clinical trials," he commented.