PubMed · 7695950
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G Linazasoro. 1995. [Clozapine].. https://pubmed.ncbi.nlm.nih.gov/7695950/
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The European Clozapine Task Force is a group of psychiatrists and pharmacologists practicing in 18 countries under European Medicines Agency (EMA) regulation, who are deeply concerned about the underuse of clozapine in European countries. Although clozapine is the most effective antipsychotic for people with treatment-resistant schizophrenia, a large proportion of them do not have access to this treatment. Concerns about clozapine-induced agranulocytosis and stringent blood monitoring rules are major barriers to clozapine prescribing and use. There is a growing body of evidence that the incidence of clozapine-induced agranulocytosis is very low after the first year of treatment. Maintaining lifelong monthly blood monitoring after this period contributes to unjustified discontinuation of clozapine. We leverage recent and replicated evidence on the long-term safety of clozapine to call for the revision and updating of the EMA's blood monitoring rules, thus aiming to overcome this major barrier to clozapine prescribing and use. We believe the time has come for relaxing the rules without increasing the risks for people using clozapine in Europe.
Cost-effectiveness analyses determine whether a new therapy will find a place in clinical practice, based on the cost of its use and the health outcomes it produces, compared with other available therapies. Clozapine, indicated for treatment-resistant schizophrenia, has been evaluated in uncontrolled, mirror-image studies; clinical decision analysis models; and prospective, randomized clinical trials. Results from randomized trials demonstrate that clozapine controls symptoms of psychopathology and improves quality of life slightly more effectively than traditional neuroleptic medications. It has a lower incidence of extrapyramidal side effects than traditional medications, resulting in a lower drop-out rate. Beginning in the second year of treatment, clozapine may produce cost savings for the health care system, when its higher acquisition cost begins to be offset by reduced hospitalization. Mirror-image studies and clinical decision analysis models provide further support for these findings.
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