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ASCP’s CLOZARIL PHARMACY-BASED MONITORING PROPOSAL

Executive Summary

ASCP's CLOZARIL PHARMACY-BASED MONITORING PROPOSAL will be discussed by top executives of the American Society of Consultant Pharmacists and Sandoz in a meeting tentatively scheduled for the week of June 11. More informal discussions already have been held by staff of the two organizations. The pharmacy group describes its plan as an alternative to the "no choice" Clozaril (clozapine) patient monitoring system provided by CareMark and Roche through an exclusive arrangement with Sandoz. Under the proposal, pharmacies would take a blood sample once a week from a patient using Clozaril and would send it to Roche or another participating pharmacy that agrees to specified protocols. Patient data and lab results would be entered into a national computerized database, such as those operated by PCS or RxNet. Pharmacies would then check the database to confirm that the patient's blood results are within recommended limits before dispensing the next week's supply of Clozaril. The plan closely follows the procedures of the present monitoring program, but allows a pharmacy, rather than Caremark, to take blood samples and dispense the drug, and also uses a database other than Caremark's. ASCP pointed out that many community pharmacies already are on national databases like PCS or RxNet and also take finger sticks for screening, such as glucose or cholesterol testing. ASCP proposes use of special blood draw kits that include a mailer to Roche or other participating labs. The blood monitoring is aimed at reducing the risk of agranulocytosis associated with Clozaril, which is approved for severely schizophrenic patients who do not respond to standard antipsychotic therapies. Pharmacists wishing to participate in the alternative monitoring system would go through a "comprehensive educational program" addressing clinical issues as well as patient counseling, ASCP said. Sandoz' closed-loop monitoring system for Clozaril is drawing scrutiny from state attorneys general, including those in Michigan and Massachusetts. It also apparently helped to prompt a provision in Sen. Pryor's (D-Ark.) Medicaid drug bill that would allow FDA to contract with an alternative manufacturer when a single-source drug's marketer establishes a restrictive distribution system ("The Pink Sheet" May 21, p. 12). Sandoz VP-Scientific & External Affairs David Winter, MD, commented June 6 that the "major source" of criticism of the Clozaril distribution system is "coming from states, who ultimately will have to pay for the drug." Addressing the Drug Information Association's annual meeting in San Francisco, Winter remarked that "states do not want to pay [for Clozaril]. They're willing to pay $50,000 a patient for dialysis; they're not willing to pay $9,000 for schizophrenic patients who are indigent." Some states appear concerned not solely about price but about lack of information about drug costs versus patient monitoring costs. For example, Tennessee Medicaid officials said they are willing to pay the roughly $170 per week for Clozaril therapy, but not until they get a breakdown of expenses within that total payment. The package cost of Clozaril could break the state's already strapped Medicaid drug budget, one official said, estimating that about 200 Tennessee Medicaid recipients could be eligible for the drug. The state would like to allot expenses related to patient monitoring into the budgets for medical care services. Noting also that the dosage needed could vary among patients, the official said Sandoz' refusal so far to give a price breakdown "makes us suspicious about the profit factor" in setting a package price.

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