Use of conventional antipsychotics and the cost of treating schizophrenia.

This study documents the drug therapy patterns and 1-year treatment costs for 18,833 Medicaid patients with schizophrenia treated with conventional antipsychotic medications in Michigan, Kentucky, Alabama, and Georgia. One in four patients used no antipsychotic, but had total costs that were less than for treated patients (-$2,576, p < .0001); 18 percent of treated patients delayed therapy for at least 1 month and had significantly higher total costs of $3,994 (p < .0001); 41 percent of treated patients changed therapy with similar results (+$4,067, p < .0001). Only 20 percent of patients were compliant with drug therapy but this had no significant impact on total treatment costs.

Antipsychotic drug use patterns and the cost of treating schizophrenia.

This study investigated the relationships between antipsychotic drug use patterns and direct costs for 3,321 Medi-Cal patients with schizophrenia. Ordinary least-squares regression models were used to estimate the impact on costs of receiving antipsychotic drug treatment, delays in treatment, changes in therapy, and continuous therapy. Average costs were $25,940 per year per patient. Having used an antipsychotic drug was correlated with lower psychiatric hospital costs ($2,846 less) but higher nursing home costs. Completing one year of uninterrupted drug therapy was correlated with higher nursing home costs. Delayed drug treatment and changes in therapy increased the cost by $9,418 and $9,719, respectively.

Olanzapine versus risperidone. A prospective comparison of clinical and economic outcomes in schizophrenia.

OBJECTIVE: To compare the clinical and economic outcomes associated with olanzapine and risperidone treatment for schizophrenia. DESIGN AND SETTING: An international, multicentre, double-blind, prospective study. To facilitate economic comparisons, our sample was restricted to patients enrolled in US sites. 150 patients with a Diagnostic and Statistical Manual of mental disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder were randomised to therapy with either olanzapine 10 to 20 mg/day (n = 75) or risperidone 4 to 12 mg/day (n = 75) for a maximum of 28 weeks. In addition to tolerability and efficacy assessments, use of health services was assessed at baseline and prospectively, at 8-week intervals and at study completion. Clinically important response, defined as a 40% improvement in the Positive and Negative Syndrome Scale total score, maintenance of response and rates of treatment-emergent extrapyramidal symptoms were compared between groups. Direct medical costs were estimated by assigning standardised prices to resource units. Median total, inpatient/outpatient service and medication acquisition costs were compared between treatment groups. MAIN OUTCOME MEASURES AND RESULTS: The mean modal dosages for the olanzapine and risperidone treatment groups were 17.7 +/- 3.4 mg/day and 7.9 +/- 3.2 mg/day, respectively. Olanzapine-treated patients were more likely to maintain response compared with risperidone-treated patients (p = 0.048). In addition, a smaller proportion of olanzapine-treated patients required anticholinergic therapy compared with risperidone-treated patients (25.3 vs 45.3%; p = 0.016). Total per patient medical costs over the study interval were $US2843 (1997 values) [36%] lower in the olanzapine treatment group than in the risperidone treatment group (p = 0.342). Medication costs were significantly higher for olanzapine-treated patients ($US2513 vs $US1581; p < 0.001), but this difference was offset by a reduction of $US3774 (52%) in inpatient/outpatient service costs for olanzapine-treated patients in comparison with risperidone-treated patients ($US3516 vs $US7291, p = 0.083). Median cost findings were consistent with results observed using other robust measures of central tendency and provide conservative estimates of potential savings that may be obtained from olanzapine therapy. CONCLUSIONS: In this study, olanzapine-treated patients experienced clinical improvements that translated into savings in costs of care for both inpatient and outpatient services. These savings offset the difference in medication acquisition cost between olanzapine and risperidone.

Designing naturalistic prospective studies of economic and effectiveness outcomes associated with novel antipsychotic therapies.

The cornerstone of recent pharmacoeconomic work in schizophrenia is the hypothesis that the improved efficacy of novel antipsychotic medications will lead to a reduction in medical services utilization, thereby reducing direct medical costs associated with treatment. Creating the most valid design to prospectively examine the effectiveness and costs of competing pharmacotherapies requires a dialectic of opposing research paradigms. The final protocol must represent a series of decisions that strike a careful balance between being scientifically sound (internal validity) and generalizable to the real world of clinical treatment (external validity). The results must be useful to decision-makers in determining to what extent reductions in healthcare expenditures can offset higher drug acquisition costs within their type of treatment environment. This article is a review of several methodological challenges in the design of medical effectiveness trials, including whether to blind the study, definition of the patient population, degree of physician discretion in treatment, and how to collect and analyze data for patients who discontinue their originally assigned medication. The article also provides a discussion of how clinical practices can inform decisions made to meet these challenges. The issues are illustrated through a prospective study designed to evaluate the cost-effectiveness of the newer antipsychotics in general and olanzapine in particular. Cost-effectiveness studies of novel antipsychotic medications, particularly those with naturalistic designs, will increase in importance as the use of these second-generation agents continues to expand.

The use of conventional antipsychotic medications for patients with schizophrenia in a medicaid population: therapeutic and cost outcomes over 2 years.

OBJECTIVE: To evaluate the association between drug therapy patterns achieved with conventional antipsychotics and direct healthcare costs over 2 years. METHODS: Paid claims data from the California Medicaid (Medi-Cal) program were used to identify 2476 patients with schizophrenia for whom 2 years of data were available. Ordinary least squares (OLS) regression models were used to estimate the association between lack of antipsychotic drug therapy, delayed therapy, changes in medications, and continuous therapy on healthcare costs over a 2-year period. RESULTS: Nearly 99% of Medi-Cal patients with schizophrenia were treated with conventional antipsychotics. Patients with schizophrenia consumed nearly $48,000 in direct costs over 2 years. Over 16% of patients did not use any antipsychotic medication for 2 years. Untreated patients used more healthcare resources than treated patients did ($10,833, P = .0422), especially psychiatric hospital care ($8,027, P = .0004). However, treated patients frequently experienced suboptimal drug use patterns. Nearly 33% of treated patients delayed antipsychotic therapy for up to 2 years. Delayed therapy was associated with increased costs of $12,285 (P = .070). Over 56% of patients experienced changes in therapy that were associated with higher total direct costs ($17,644, P < .0001). Finally, only 3.2% of treated patients used an antipsychotic medication consistently for 2 years. However, continuous drug therapy was not associated with lower costs. CONCLUSION: Suboptimal drug use patterns are common and costly in Medi-Cal patients with schizophrenia who initiated therapy with conventional antipsychotics.

Changes in perceived health and functioning as a cost-effectiveness measure for olanzapine versus haloperidol treatment of schizophrenia.

We utilize data from a large, double-blind, randomized clinical trial of treatment for schizophrenia to compare the effect of therapy with the second generation antipsychotic olanzapine versus therapy with the conventional agent haloperidol on the perceived functioning and well-being of patients over 1 year as measured by the Medical Outcome Study Short Form (SF-36). We also compare the total cost of care between the treatment groups over 1 year and combine cost and functional outcomes information to estimate the incremental cost-effectiveness of both therapies in this sample. Over 1 year of therapy, patients receiving olanzapine experienced a mean of 5.75 units greater improvement than did haloperidol-treated patients on the physical health and functioning factor of the SF-36 and 1.66 units greater improvement on the mental health and functioning factor. The mean annual total cost of care, including the cost of medication therapies, was $9386.87 less for olanzapine-treated patients than for haloperidol-treated patients. The incremental cost-effectiveness ratio for olanzapine versus haloperidol treatment indicated a savings of $1632.50 per unit of improvement in the SF-36 physical health and functioning score and a savings of $5654.74 per unit of improvement in the mental health and functioning composite. Improvements in perceived health and functioning were also associated with reduction in hospital costs in the full sample. These findings suggest that patient-centered measures of functioning such as the SF-36 are an important component of the evaluation of the cost-effectiveness of novel treatments for schizophrenia.

Reliability, validity, and application of the medical outcomes study 36-item short-form health survey (SF-36) in schizophrenic patients treated with olanzapine versus haloperidol.

UNLABELLED: Schizophrenia leads to impairments in mental, social, and physical functioning, which should be included in evaluations of treatment. OBJECTIVES: This study was designed to determine the reliability and validity of the Medical Outcomes Study Short Form Health Survey (SF-36) for schizophrenic patients, to characterize perceived functioning and well being and to compare short-term change in SF-36 scores for patients treated with olanzapine or haloperidol. RESEARCH DESIGN: Data were obtained from a randomized, double-blind trial comparing these agents for safety, efficacy, and cost effectiveness. A 6-week acute treatment portion preceded a 46-week "responder extension" phase. SUBJECTS: A subsample (n = 1,155) completing a pre-treatment SF-36 provided data for this study. MEASURES: Psychometric analyses were conducted, and perceived level of functioning was compared with that for the US adult population. Change from baseline to 6 weeks was examined by treatment group. RESULTS: Clear evidence was obtained for the instrument's reliability and validity for these patients. There were marked deficits in General health, Vitality, Mental health, Social functioning, and in Role limitations resulting from both physical and emotional problems. Olanzapine-treated patients improved in 5 of 8 domains to a significantly greater degree than did haloperidol patients. CONCLUSIONS: The SF-36 can be a reliable and valid measure of perceived functioning and well being for schizophrenic patients. The perceptions of functioning can be valuable indices of disease burden and can help to demonstrate the effectiveness of newer antipsychotic medications such as olanzapine.

Information needs for medication coverage decisions in a state Medicaid program.

BACKGROUND: Health plans commonly face the conflicting demands of trying to provide access to novel technologies, including new classes of medications, while trying to contain costs. These demands are particularly acute for California's Medicaid program, known as Medi-Cal, which is responsible for delivery of medical care to an unusually large population of mentally ill individuals in the context of a culturally diverse environment. To meet the challenge, Medi-Cal has instituted a formal process for technology assessment of new and existing pharmaceutical products known as the Therapeutic Class Review (TCR). OBJECTIVE: The purpose of this paper is to describe the information produced for Medi-Cal in the TCR process for antidepressant medications and the individual petition review of antipsychotic medications, and to synthesize our experience in a series of policy recommendations designed to improve the quality of coverage decisions. OUTCOME: A collaborative process between Medi-Cal and Lilly resulted in a substantive body of new evidence regarding the needs of Medi-Cal recipients, the quality of current treatment, and prospects regarding the cost-effectiveness of introducing newer treatments. CONCLUSION: Medi-Cal has a formal process for evaluating new medicines. This process allows researchers to understand the needs of those who make coverage decisions. We recommend increasing routine epidemiologic surveillance, including service use, and clinical trials that include aspects of usual medical care early in the drug development process.

Evaluation of antipsychotic and concomitant medication use patterns in patients with schizophrenia.

OBJECTIVE: To describe antipsychotic medication use patterns in an inner-city, outpatient population of indigent patients with schizophrenia. METHODS: This retrospective cohort study used the Regenstrief Medical Record System to identify schizophrenic patients receiving antipsychotic medication(s). Patients were included and identified as initiating a new treatment episode if they did not receive any antipsychotic prescription for 90 days before their first antipsychotic prescription in 1995. Each patient was followed for 1 year. RESULTS: Three hundred and sixteen patients met study criteria. Typical and atypical (clozapine and risperidone) antipsychotic agents were selected as initial therapy in 88% and 12% patients, respectively. The majority of patients (71.5%) were exposed to only one antipsychotic agent during their treatment year. Approximately 25% of all patients switched from one antipsychotic to a different antipsychotic during 12 months of therapy. Nearly 90% of patients augmented their prescribed antipsychotic with a concomitant medication during the 12-month study period. Approximately 30% of the cohort received treatment with an antipsychotic for 12 continuous months and were, thus, classified as having stable antipsychotic therapy. The majority of patients (67.1%) had periods of interrupted therapy (range, 1-11 months) during the 12 month study period. CONCLUSION: As of 1995 an overwhelming majority of schizophrenic patients in this indigent, inner-city population initiated therapy with a typical antipsychotic. Patients frequently switched antipsychotics and discontinued their therapy during the 1 year study period. Reasons for switching or discontinuing may include the following: ineffective therapy; patient intolerance; change in symptoms; and improved assessment and understanding of the diagnosis or physician preference.

Pharmacoeconomic evaluation of antipsychotic therapy for schizophrenia.

Medications comprise a minor portion of the costs of schizophrenia, but may have a major impact on the likelihood of successful outcome of care. Novel antipsychotic medications which demonstrate superior symptom control, an improved safety profile, and benefits to quality-of-life may also reduce patients' need for medical services and the associated costs of these treatments. This report first considers key experimental design elements involved in integrating pharmacoeconomic and clinical objectives in studies of new drug therapies for schizophrenia. We briefly discuss the choice of therapies for comparison, randomization and blinding, sample size and composition, data collection, selection of the time frame for economic evaluation, and the importance of an intent-to-treat perspective. Second, as an example we present the design and selected results from a new economic clinical trial of the novel antipsychotic olanzapine. This trial utilized a randomized, double-blind design to compare the use of medical services and the cost of treatment for 817 schizophrenic patients from the United States treated with olanzapine or haloperidol. In comprehensive health care cost comparisons that incorporated the expenditures for study medications, the total cost of health care for olanzapine-treated patients was reduced by an average of $431 per month in comparison with haloperidol-treated patients during the initial 6 weeks of treatment. Among treatment responders receiving double-blind therapy for a maximum of 1 year, the total cost of care among olanzapine responders was reduced by an average of $345 per month in comparison with haloperidol responders. The results of this economic evaluation suggest that olanzapine's superior treatment profile may lead to reductions in the overall costs of medical care for patients with schizophrenia.