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Executive Summary

SANDOZ CLOZARIL MANDATORY BLOOD MONITORING PROGRAM is being pilot tested as a means of reducing the risk of agranulocytosis among the drug's target population of treatment-resistant schizophrenics. Under the test program, which was described May 8 at the annual meeting of the American Psychiatrist Association in Montreal, all patients receiving the drug will be required to have blood drawn at least once a week prior to receiving an additional seven-day supply of Clozaril (clozapine). The unique patient monitoring requirement proposed for the anti-psychotic agent is in response to concerns about agranulocytosis, a potentially fatal side effect which occurs in roughly 1% - 2% of patients taking Clozaril. The program grew out of Sandoz' experience with patients enrolled in its clinical trials and "compassionate use" IND for the drug, Sandoz senior associate director of clinical research Gilbert Honigfeld, PhD, told "The Pink Sheet." It is also used in the European marketing of the anti-psychotic agent. "Our experience has been that physicians become somewhat lax after they get experienced using the drug" in keeping track of patients' white blood cell counts (WBC), Honigfeld commented. For those few individuals at risk for agranulocytosis, the condition can be reversed if caught at the initial signs of WBC suppression, he added. Pilot testing is beginning at about five clinical centers around the country. The program will be expanded in the coming months. It could be implemented nationally if Clozaril gains FDA approval, expected late this year or in early 1989. If the restricted distribution format proves feasible it will be a "major departure from other new drug introductions," Honigfield maintained. It will enable Sandoz to provide "100% coverage" in its subsequent post-approval reporting to FDA, he said. The monitoring will be administered for Sandoz by a national home health care organization in conjunction with a national clinic laboratory company, Honigfeld explained. "Case administrators" from the home health agency will handle enrollment procedures for patients referred by physicians. The case worker will also arrange for time and locations for the blood sampling. Any indication of WBC suppression will be reported to the doctor. Distribution of the drug will also be handled through the home health agency, Honigfeld explained. Costs for mandatory monitoring are expected to be incorporated in Clozaril's pricing structure. To provide additional justification for the predicated premium price, Sandoz commissioned a study on the "Economic Costs of Treatment-resistant Schizophrenia." Bryan Luce, with the Battelle Institute, presented the cost estimates at the APA meeting. Based on a literature review, he found that "drug trial data suggest 10%-20% [of the] schizophrenic population" does not respond to current anti-psychotic agents. That works out to between 240,000 and 480,000 patients, he added. Direct costs for treating refractor patients range from $ 16,263 to $ 58,418 per year, Luce reported. Lost earnings cost the economy another $ 16,991 annually per patient, another study suggested. Estimates on the overall costs for refractory schizophrenics in the U.S. range from $ 14 billion to over $ 28 billion a year, he said.

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