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IMMUNOSUPPRESSIVE DRUG MULTI-CENTER CLINICAL TRIALS

Executive Summary

IMMUNOSUPPRESSIVE DRUG MULTI-CENTER CLINICAL TRIALS should be conducted to assess the safety, effectiveness and costs of different treatment protocols, HHS' Task Force on Organ Transplantation recommended in a report released last month. The report notes that most research on treatment protocols is done in lone centers, each with its own case-mix and methodology. The result is that findings among the various centers "cannot always be compared, making it difficult to reach conclusions about preferred treatment regimens," the report says. In establishing multi-center trials and research/demonstration projects to evaluate immunosuppressive therapies, the task force urged that the following issues be addressed: "The optimal treatment period for cyclosporine (or cyclosporine plus prednisone or azathioprine) use. Is cyclosporine required in perpetuity or can a patient be converted from cyclosporine to some other drug (e.g., Immuran) at some point? Also, what are the optimal dosages for cyclosporine?" "The merits of 'triple drug therapy' (cyclosporine, azathioprine, prednisone) relative to other drug protocols." "The benefits from cyclosporine for special transplant population subgroups such as diabetics, blacks, retransplanted patients and the aged. There is strong evidence that these groups benefit from cyclosporine to a greater extent than the transplant population as a whole. If confirmed, cyclosporine use for these groups could be more uniformly applied so that they would derive the greatest possible benefit from their immunosuppressive treatment." The report was required under the National Organ Transplant Act, which passed the Congress in 1984 following a series of oversight hearings on the shortage of donor organs in the U.S. and problems involving patient access to transplantation procedures and post-transplant care. It was forwarded to Congress on Oct. 25. After analyzing the costs of cyclosporine and other immunosuppressive drugs, the kidney transplantation procedure and dialysis, the HHS task force concluded that use of cyclosporine "appears" to be "an example of a medical technology which confers substantial benefits without adding to costs." The task force found that use of cyclosporine in renal transplantation patients has lowered per patient Medicare charges by $1,600 for the transplant procedure and first six months of post-transplant care, excluding outpatient drug costs. However, if the costs for outpatient use of cyclosporine are added to the calculation, "its use in the first six months of a transplant is still approximately cost neutral," the panel maintained. It estimated that one-year maintenance costs of using cyclosporine are about $5,000 per patient. The transplant procedure and initial six months of aftercare cost more than $40,000. The cost of maintaining a patient on dialysis ranges from $15,000 to $25,000, depending upon the mode of treatment and setting. Under a one-year cyclosporine treatment regimen, total costs would be $87.4 mil., while a six-month program would cost $77.2 mil. Immunosuppressant costs would reach $67.1 mil. in 1987, excluding cyclosporine, the task force projected. "Assuming that outcomes comparable to those obtained at the centers already experienced with cyclosporine can be achieved generally when all centers use the drug for cadaver donor kidney transplants," the report observes, "indefinite use of cyclosporine will result in high overall ]end-stage renal disease[ program costs for maintenance of all patients, whether by dialysis or transplantation, compared to those which would be expected if cyclosporine were not used and if the transplant success rates achieved without use of the drug continued into the future." However, the task force said, if "use of the drug can safely be discontinued after three years, the charges for treatment of the end-stage renal disease population will be the same as they would have been if cyclosporine had not been used at all, and if the drug can be discontinued six months post-transplant, progressively larger savings will result. Current evidence suggests that this should be possible in a large proportion of patients perhaps as early as after six months."
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