Long-acting risperidone increases medication costs and does not improve outcomes in unstable schizophrenia
Question: What is the effect of long-acting injectable (LAI) risperidone on healthcare costs and outcomes in people with unstable schizophrenia or schizoaffective disorder?
Patients: In total, 369 adult patients who had Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder and were at risk of psychiatric hospitalisation (those hospitalised in the previous 2 years and those whose use of mental health services to prevent relapse had been increasing).
Setting: Nineteen Veterans Affairs medical centres, USA; 2006–2008.
Intervention: LAI risperidone 25–50 mg every 2 weeks or psychiatrist's choice of oral antipsychotic medication (control).
Outcomes: Utilisation of health services and medication (acute medical/surgical hospital stays, acute psychiatry hospital stays, residential and other inpatient hospitalisation and outpatient visits); healthcare cost (inpatient stays, outpatient visits and outpatient medications; analysed from the perspective of the US Medicaid healthcare sponsor); symptoms of schizophrenia using Positive and Negative Syndrome Scale and health-related quality of life using Quality of Well-Being (QWB) Scale.
Patient follow-up: Not reported.
Design: Randomised controlled trial.
Allocation: Not reported.
Blinding: Single blind (assessors blinded).
Follow-up period: Maximum 24 months (mean 16.2 months).
There were no significant differences between the groups in the number of inpatient stay days of or in the number of outpatient visits. The exception was that participants in the LAI risperidone (LAIR) group had a significantly higher number of days of stay for hospitalisation already underway at the time of randomisation than those in the control group (mean 1.0 with LAIR vs 0.3 days with control; p=0.021). Although the overall healthcare cost was higher for the participants allocated to LAI risperidone ($14 916 per quarter) than the controls ($13 980 per quarter), this difference was not statistically significant (p=0.732). However, the breakdown of costs showed that significantly higher costs with LAI risperidone compared with the controls in terms of the cost of atypical antipsychotic (both oral and long acting) medications (mean per quarter: $1919 with LAIR vs $1157 with control; p=0.017) and total outpatient medication (mean per quarter: $3028 with LAIR vs $1913 with control; p<0.003). There were no significant differences between the groups in the trend in total healthcare costs over time. No significant differences were observed between the groups in schizophrenia symptoms or health-related quality of life.
LAI risperidone increased medication costs, and did not reduce hospital or total healthcare cost and did not result in better health outcomes in people with unstable schizophrenia or schizoaffective disorder. It does not appear to be a cost-effective treatment option in this population.
Results of the RCT had been reported in a previous publication. At baseline, more participants in the long-acting risperidone group were in an inpatient stay at an acute psychiatry hospital than in the control group.
Sources of funding: The Veterans Affairs Cooperative Studies Program. An unrestricted grant and the study drug (long acting risperidone) were provided by Ortho-McNeil Janssen Scientific Affairs, LLC.
▸ Additional data are published online only. To view this file please visit the journal online (http://dx.doi.org/10.1136/eb-2012-101076).
The authors of this study report a cost analysis of a trial of 369 people with schizophrenia randomised to either long-acting injectable risperidone, or oral antipsychotic medication. The results of this same study had previously been reported as showing no additional benefit for long-acting injections over oral medication.1 This paper adds an economic analysis. As one might expect, if there is no clinical benefit from the use of the long-acting injectable medication there will also be no economic benefit.
The methodology is well described. The problem with the paper is not with what was reported, but with what was omitted. Long-acting injectable antipsychotic medications are not only an alternative medication, they also change a private act into a public act. A clinician can find out who is taking medication consistently, and can either respond or not. Clinicians can respond with a traditional approach to missed injections by trying to convince the patient to take medication, or can alternatively focus on the consumer's personal goals and how medication might help. Phone calls about missed injections can come from an impersonal clerk, or from a clinician who has an ongoing relationship.
Study participants received 19.7 injections over 2 years, less than 1/3 of consistent use. The mean number of phone calls was 2.4. Repeated attempts to re-engage someone after a missed appointment was clearly not common.
What this study actually demonstrates is that a long-acting injection will not be effective if it is not used with some consistency, and that consistent use requires more than just administering a medication. This study, like many of the other long-term studies of people with schizophrenia, describes the medications used but not the services that surround these medications. It provides statistics on Positive and Negative Syndrome Scale scores and rehospitalisations, but is not concerned with whether people are more likely to stay on medication if it is given with a large dose of hope and respect, administered by a clinician whom they know and focused on the consumer's own life goals rather than just symptom measures. This is an excellent study about medication, but not a very good study about treatment.
Competing interests RD is an editorial consultant for a consumer-focused newsletter that is sponsored by Janssen Pharmaceuticals.