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Executive Summary

Blue Cross/Blue Shield is changing its policy toward reimbursing off-label uses of approved drugs and will no longer consider such uses to be "investigational" and therefore ineligible for coverage. "Off-label indications should be eligible for coverage based on evaluation of efficacy," Blue Cross/Blue Shield Medical Necessity Program Director David Tennenbaum told an Oct. 25 meeting of the National Committee to Review Current Procedures for Approval of New Drugs For Cancer and AIDS. The committee is informally known as the Lasagna committee. Off-label drug uses will be evaluated to "determine whether health outcome is improved," Tennenbaum said. "Evidence for improved health outcome is from studies accepted for publication in peer-reviewed journals and, possibly, from the major drug compendia." Tennenbaum emphasized that the coverage recommendation "is advisory to our plans." The plans make independent reimbursement decisions but are advised by the national association. The change in policy is based on a "growing recognition that certain off-label drug uses are effective, well-documented in the medical literature and widely used," Blue Cross/Blue Shield said in a press release issued Oct. 25. * Blue Cross/Blue Shield is holding to its policy against routinely reimbursing Treatment IND drugs and cancer treatments designated by the National Cancer Institute as Group "C" drugs, Tennenbaum told the committee. The private insurer's position on those drugs is at odds with recommendations made recently by the committee to the Health Care Financing Administration (HCFA). "Treatment INDs and NCI Group C drugs are considered to be investigational because their efficacy has not been demonstrated sufficiently to warrant full FDA approval to market," Tennenbaum said. "Coverage of Treatment INDs and Group C drugs would be inconsistent with our principle of coverage for effective treatment." Reimbursement for "investigational" treatments is excluded in contracts between Blue Cross/Blue Shield and its individual insurance carriers. Tennenbaum noted the increasing pressure on FDA to facilitate the public availability of AIDS treatments and said that Blue Cross/Blue Shield is "especially concerned that parameters for the Treatment IND are shifting and seem to be a moving target." FDA regs "describe Treatment INDs as a bridge between the completion of Phase II studies and the point of marketing approval," Tennenbaum commented. However, he pointed out, "DDI [dideoxyinosine, Bristol-Myers' Videx] was recently given Treatment IND status on the basis of small Phase I studies." Despite the organization's unwillingness to establish a broad policy for reimbursement of the investigational agents, Tennenbaum noted that individual Blue Cross/Blue Shield insurance plans have developed mechanisms "consistent with their contractual responsibilities that provide access to promising investigational treatments." For example, he said, plans have covered Burroughs Wellcome's Retrovir (AZT) and Lyphomed's Nebupent (aerosolized pentamidine) through closely monitored "case management" programs while the drugs were still distributed only under Treatment INDs. * In a separate presentation, the Health Insurance Association of America stated that Treatment IND, Group C drugs and other investigational drugs for life-threatening conditions in FDA-sanctioned clinical trials "should not be considered ineligible for coverage on the grounds that they are experimental." Rather, "each agent should be evaluated to determine its demonstrated benefit." The association's position was presented by David Plocher, VP-medical services for the Prudential Insurance Company. Several members of the panel expressed frustration with the position taken by Blue Cross/Blue Shield. NCI Director Samuel Broder took "vigorous exception" to the statement that evidence of efficacy for Group C drugs is insufficient. Panel Chairman Louis Lasagna, dean of the Sackler School of Graduate Biomedical Sciences, Tufts University, emphasized that the "Blues" hesitancy with regard to the investigational drugs runs counter to conclusions reached by NCI and FDA "in their collective wisdom." Washington, D.C. attorney Peter Hutt (Covington and Burling) pointed out that the insurer "is taking the position that the most effective treatments available" are not reimbursable. In a Sept. 25 statement, the committee urged HCFA to require Medicare coverage of Treatment IND, Group C and other investigational drugs when "safety and efficacy have been demonstrated to a sufficient extent to achieve such treatment use while still in investigational status." The committee also had recommended that "Medicare coverage of drugs prescribed for unlabeled indications should rely primarily on the status of such indications in authoritative medical compendia such as the three intended for use under the 1988 Catastrophic Coverage Act." The three compendia listed in the act are: the U.S. Pharmacopoeia Dispensing Information Volume I; the American Medical Association's Drug Evaluations; and the American Hospital Formulary Service Drug Information.

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