Question

CASES FOR ANALYSIS the treat- 1. Clozapine (Clozaril) is a drug manufactured by Sandoz for t ent of severe chronic schizophrenics who are unresponsive to regular treatments. One study indicates that after a year of treatment 68 percent o the treatment-resistant patients were improved. In another study, 55 percent of those improved were able to work or go to school, and readmissions to the mental hospital were reduced by 88 percent (Meltze et al., 1990, p. 892). A third study (Eichelman and Hartwig, 1990) in a state mental hospital showed that over two years the new treatment saved the state s2o,000 a year per patient. In addition, clozapine has a low incidence of side effects, such as tardive dyskinesia, associated with other drugs for schizophrenics. It can, however, produce seizures and tachycardia, which can cause indi- viduals to refuse further treatment. Unfortunately, unless constantly monitored, the drug often produces damage to the bone marrow, reducing immunity and exposing patients to all sorts of infection and even death. The proper use of the drug demands weekly blood tests of peripheral white cell counts. As a result, in the United States the combination of drug and tests costs s$8,944 per person per year for the remainder of the patient 's life. One study estimates that it would cost s1.2 billion a year to treat the 133,000 patients defined as eligible for the drug (Terkelsen and Grosser 1990, p. 866) If the use of the drug is extended to groups other than the eligible group Terkelsen and Grosser (199o, p. 867) estimate that 186,000 patients could benefit. Under these assumptions, the treatment could cost s1.7 billion a year The fact that most eligible patients are indigent makes these figures all the more significant. Part of the cost seems to be explained by the fact that the manufacturers have insisted that the drug and tests be bought as a package, with the tests be ing administered by a for-profit home health company, Caremark, Inc. Many professionals feel that the price of the package or system is excessive and that

Answer 1

*Clozapine is a drug coming under the classification known as "atypical antipsychotic agents".Like other classification of antipsychotic agents, it will not exhibit the typical extrapyramidal side effects such as tremor, rigidity, acute dystonia, tremor, and akathisia.

*2% of all patients taking clozapine had been associated with an elevated rate of agranulocytosis and making the patient more susceptible to potentially fatal infections.

*The use of clozapine was restricted to :

#Patients who cannot tolerate the extrapyramidal symptoms of conventional antipsychotics

#Treatment resistant patients with schizophrenia

#Patients with evident tardive dyskinesia that is not suppressed.

*Approximately 2.4 million Americans are afflicted with schizophrenia, and out of that 250,000 of these patients receive little or no benefit from conventional antipsychotics.

*But the fact is that approximately 60-80,000 would respond to clozapine therapy of Sandoz

*The major market barrier to the success of clozapine in the U.S was prohibitively high cost.

*The FDA's novel regulatory requirement of a patient monitoring system the prohibitively high cost of clozapine treatment which severely impeded sales despite high clinical demand.

*The issues related to the high cost of clozapine can be only resolved through legal action involving the Food and Drug Administration, the Federal Trade Commission, the Centers for Medicare and Medicaid Services and the providers such as the Department of Veterans Affairs and as well as the hospitals who are demanding a lower cost of clozapine distribution.

*The cost of approximately 1990 dollars per patient per year making clozapine therapy 8 to 15 times more expensive than therapy with traditional antipsychotics.

*Clozapine was sold primarily to the state mental health hospitals, the VA hospitals, and the state Medicaid programs.

*But instance Sandoz was criticized for charging so much for a drug that was desperately needed for a relatively small group of patients whose treatment was funded mostly by the Medicaid.

*Clozapine served as the first model of an antipsychotic agent without extrapyramidal side effects but having the side effects that is the increased risk for agranulocytosis.

*But although newer classes of an atypical anti-psychotics have entered the market today with the same clinical efficacy as clozapine without the side effects such as eg: risperidone although needed more clinical research.

Because of the restrictive cost of clozapine, the poor distribution of a needed drug and provider lawsuits prompted the federal government, through legal and regulatory activity, to force Sandoz to separate the drug from the patient management system.

Be aware that the drug may cause confusion and blurred vision