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ORTHO BIOTECH’s PROCRIT APPROVED FOR CHEMOTHERAPY-INDUCED ANEMIA

Executive Summary

ORTHO BIOTECH's PROCRIT APPROVED FOR CHEMOTHERAPY-INDUCED ANEMIA in patients with non-myeloid malignancies, a supplemental indication, on April 1. Procrit (epoetin alfa) was approved in late December 1990 for predialysis chronic renal failure (CRF) and AZT-induced anemia in AIDS patients. Amgen markets the glycoprotein for CRF with dialysis, or end-stage renal disease, under the brand name Epogen. "Procrit is indicated to decrease the need for transfusions in patients who will be receiving concomitantly administered chemotherapy for a minimum of two months," newly approved labeling states. Procrit is "not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding," labeling adds. The recommended starting dose of Procrit is 150 units/kg, or about 10,000 units for a 145-pound patient, three times a week. The cost of 10,000 units of the drug ranges from $64.60 on the federal supply schedule to an AWP of $95. The approval of the supplemental indication legitimizes significant off-label usage of the drug in conjunction with chemotherapy and will make reimbursement for that use more readily available. In December 1991, Pharmacy Deputy Division Head Stephen Huber said the MD Anderson Cancer Center was using about 460,000 worth of Procrit per month off-label and was getting reimbursed for about half that amount. Huber estimates that use of the drug may have decreased slightly since then because of the disinscentive provided by the rate of reimbursement. Kaiser Northwest told the American Society of Hospital Pharmacists in December that it also has a procedure in place for the use of Procrit in cancer patients. Procrit sales more than doubled in the fourth quarter of 1992. Ortho estimates that about 20% of cancer patients receive blood transfusions for chemotherapy-induced anemia. The firm has established reimbursement programs for the new indication: a financial assistance program supplies Procrit free of charge, usually to patients with annual incomes under $30,000 who cannot obtain reimbursement from third-party payors. Another program limits annual drug costs to $8,500 for patients who use the drug in large doses or for an extended period of time. Ortho also will provide Procrit free of charge to the physician for administration while a patient is waiting for an insurance firm to evaluate whether it will cover the cost of the drug. The supplemental approval was based on placebo-controlled clinical trials in a total of 131 anemic cancer patients, 59 receiving cisplatin-containing chemotherapy and 72 receiving non- cisplatin chemotherapy. Patients received 150 units/kg of Procrit of placebo three times a week for 12 weeks. Of cisplatin-treated patients, those receiving Procrit experienced a mean hematocrit rise of 6.9%, compared to .6% in the placebo group. In other chemotherapy patients, the Procrit group registered a 7.6% increase, compared to a 1.3% increase in the placebo group. Both differences were statistically significant. In addition, in month two and three of the trial, both the mean number of transfused units of blood in placebo versus Procrit patients (.71 versus 1.84) and the proportion of patients transfused (22% versus 43%) showed statistically significant differences. Ortho has agreed to perform a controlled Phase IV study of erythropoietin "to evaluate the possible stimulatory effects of Epoetin alfa treatment on solid tumor growth," FDA's approval letter observes. The 300-patient Phase IV study is expected to begin this month. The randomized, double-blind trial will evaluate Procrit's effect on tumors in patients with newly diagnosed small- cell lung cancer. The warning section of Procrit's expanded labeling explains: "Procrit is a growth factor that primarily stimulates red cell production. However, the possibility that Procrit can act as a growth factor for any tumor type, particularly myeloid malignancies, cannot be excluded." A similar concern was brought up during FDA's Biological Response Modifiers Advisory Committee review of Amgen's growth factor G-CSF (Neupogen) in December 1990. "The overall safety profile of Procrit appeared to be consistent with the disease process of advanced cancer," the adverse reaction section of labeling states. Both diarrhea and edema occurred with significantly greater frequency in Procrit- treated patients. Nausea and trunk pain were significantly less frequent.
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