Background: This study examined the relationship between pretreatment hospi
tal use and the cost-effectiveness of clozapine in the treatment of refract
ory schizophrenia.
Methods: Data from a 15-site randomized clinical trial were used to compare
clozapine with haloperidol in hospitalized Veterans Affairs patients with
refractory schizophrenia (n = 423). Outcomes were compared among those with
many days in the hospital use (hereafter, high hospital-users) (n = 141; m
ean = 215 psychiatric hospital days in the year prior to study entry) and t
hose with few days in the hospital use (hereafter, low hospital users) (n =
282; mean = 58 hospital days). Analyses were conducted with the full inten
tion-to-treat sample (n = 423) and with crossovers excluded (n = 291).
Results: Clozapine treatment resulted in greater reduction in hospital use
among high hospital users (35 days less than controls, P = .02) than among
low users (21 days less than controls, P = .05). Patients taking clozapine
also had lower health care costs; after including the costs of both medicat
ions and other health services, costs were $7134 less than for controls amo
ng high hospital users (P = .14) but only $759 less than for controls among
low hospital users (P = .82). Clinical improvement in the domains of sympt
oms, quality of life, extrapyramidal symptoms, and a synthetic measure of m
ultiple outcomes favored clozapine in both high and low hospital user group
s.
Conclusions: Substantial 1-year cost savings with clozapine are observed on
ly among patients with very high hospital use prior to initiation of treatm
ent while clinical benefits are more similar across groups. Cost-effectiven
ess evaluations, and particularly studies of expensive treatments, cannot b
e generalized across type of use groups.