New Study Showed No Difference in Total Treatment Costs When Comparing Those Starting Treatment with Older Conventional Antipsyc
21 December 2005 - 12:00AM
PR Newswire (US)
Data also showed Zyprexa was significantly more effective than
conventional antipsychotics on clinical and social measures
INDIANAPOLIS, Dec. 20 /PRNewswire-FirstCall/ -- Requiring people
with schizophrenia to first fail on an older, inexpensive generic
antipsychotic before allowing them to switch to the newer
antipsychotic Zyprexa(R) (olanzapine) may not result in cost
savings overall, according to a new study published in this month's
issue of Value in Health. The data showed that despite higher
medication costs of Zyprexa, the difference in one-year direct
total costs between Zyprexa, as initial (first-line) treatment, and
conventional antipsychotics as first line treatment, was small and
not statistically significant. Findings indicate that any savings
on medication costs were offset by the increased costs of other
services associated with treatment with conventional antipsychotics
including hospitalizations, crisis interventions and emergency room
visits. Researchers in this study also compared the
cost-effectiveness of Zyprexa (mean modal dose 13.49 mg/day) and
Risperdal(R) (risperidone) (mean modal dose 4.95 mg/day) as
first-line treatment for schizophrenia and found the total costs
associated with the two medications to be similar and not
significantly different from each other. This cost-effectiveness
study was designed specifically to compare the clinical and social
effectiveness and total direct costs of treatment with different
antipsychotics, to help inform private and public payer systems'
practices and policies regarding first-line antipsychotic options
for treating schizophrenia. "These data showed that regardless of
whether a person was initiated on a conventional or atypical
antipsychotic, the overall direct costs of treating a person with
schizophrenia for one year were essentially the same," said Ralph
Aquila, M.D., one of twenty-one study investigators who is the
director of residential community services at St. Luke's/Roosevelt
Hospital Center. "This study suggests that cost cutting efforts
that require patients with schizophrenia to first fail on older,
conventional antipsychotics before providing access to newer
medications like Zyprexa, do not necessarily result in overall cost
savings and may unnecessarily restrict access to the most optimal
treatment for patients." Attempts to contain high costs of
treatment for severe mental illnesses have led to cost cutting
efforts that include restricting access to more expensive
antipsychotics, such as preferred drug lists, prior authorization
requirements and "fail-first" treatment algorithms (where failure
on a less expensive medication is required before a more expensive
medication is covered). However, questions have been raised by
state and federal government officials as to whether these measures
actually result in overall cost savings or if any savings in
medication costs may be offset by increased costs of other
services. "Finding the most effective treatment for each patient is
critical, because the consequences of relapse for patients with
serious mental illnesses and their families can be devastating.
They have a more difficult time recovering and regaining the life
that they had before," said Dr. Aquila. "The ideal approach for
treating schizophrenia is to start with the most effective
treatment for each individual patient. This may help them remain on
that treatment longer which can lead to better functional
outcomes." Key Findings In this one-year, multi-center, randomized,
open-label study, more than 660 patients with schizophrenia were
assigned to one of three treatment regimens between May 1998 and
September 2001: a) Zyprexa as a first-line treatment (n=229), b)
first-line treatment with conventional antipsychotics such as
perphenazine, loxapine, haloperidol, thiothixene, fluphenazine
(maximum of two consecutive agents before a possible switch to
Zyprexa, n=214), and c) risperidone as a first-line treatment
(n=221). Choice of particular conventional agent was made by the
treating physician. Barring any clinically significant adverse
events, all patients were to remain on their randomized treatment
regimen for at least eight weeks, but could continue on their
initial treatment regimen for as long as clinically indicated
during the one-year trial. Results were analyzed from the
perspective of the public payer health care system and included
total direct treatment costs and the treatment effectiveness for
patients with schizophrenia, measured in both clinical and social
terms. Total direct costs reflected resources considered to be
"mental health" or "psychiatric" (e.g., antipsychotic/psychotropic
medications, psychiatric hospitalizations, outpatient visits to
psychiatrists, etc.), as well as resources considered to be
"non-psychiatric" (e.g., non-psychotropic medications,
hospitalizations for physical illnesses, primary care physician
visits, etc.). Clinical effectiveness was measured using the Brief
Psychiatric Rating Scale (BPRS) and social effectiveness was
measured using the Lehman Quality of Life Scale (LQLI) social
relations scores. Results showed: * Total one-year mean direct
costs were $20,891 for Zyprexa, $21,283 for conventional
antipsychotics, and $21,347 for Risperdal. The differences were not
statistically significant. * Approximately half of patients who
began the study on conventional antipsychotics switched to an
atypical antipsychotic, and rates of switching from the initial
antipsychotic were significantly lower for Zyprexa than for the
conventional antipsychotics (14% vs. 53%, p <
0.001) or Risperdal (14% vs. 31%, p < 0.001). * For patients
who required a switch from their initial antipsychotic to another,
there was a modest savings of $195 in yearly medication costs.
However, this was offset by an additional $3,741 needed for other
services. -- More than 70% of these additional costs were for acute
inpatient/outpatient services such as hospitalizations, partial
hospitalizations, crisis interventions and emergency room visits. *
When taking switching of antipsychotics into consideration, in
treating schizophrenia, Zyprexa was significantly more effective
than conventional antipsychotics on both clinical symptoms (BPRS)
(p=0.025) and social relations (LQLI) (p=0.043), and compared to
Risperdal on social relations (p=0.002). About Schizophrenia
Schizophrenia is a severe and debilitating illness often
characterized by acute psychotic episodes including delusions
(false beliefs that cannot be corrected by reason), hallucinations
(usually in the form of non-existent voices or visions) and
long-term impairments such as diminished emotion, lack of interest
and depressive symptoms, such as hopelessness and suicidal
thoughts. In addition to these symptoms, patients with
schizophrenia are at greater risk for medical comorbidities than
the general population. About Zyprexa Olanzapine is indicated for
the treatment of schizophrenia, for acute manic and mixed episodes
of bipolar disorder, and for maintenance treatment in bipolar
disorder. Increased Mortality in Elderly Patients with
Dementia-Related Psychosis Elderly patients with dementia-related
psychosis treated with atypical antipsychotic drugs are at an
increased risk of death compared to placebo. Analyses of seventeen
placebo-controlled trials (modal duration of 10 weeks) in these
patients revealed a risk of death in the drug-treated patients of
between 1.6 to 1.7 times that seen in placebo-treated patients.
Over the course of a typical 10 week controlled trial, the rate of
death in drug- treated patients was about 4.5%, compared to a rate
of about 2.6% in the placebo group. Although the causes of death
were varied, most of the deaths appeared to be either
cardiovascular (e.g., heart failure, sudden death) or infections
(e.g., pneumonia) in nature. Olanzapine is not approved for the
treatment of patients with dementia-related psychosis. Safety
experience in elderly patients with dementia-related psychosis - In
placebo-controlled clinical trials of elderly patients with
dementia-related psychosis, the incidence of death in
olanzapine-treated patients was significantly greater than
placebo-treated patients (3.5% vs. 1.5%, respectively). Olanzapine
is not approved for the treatment of patients with dementia-related
psychosis. Cerebrovascular adverse events (CVAE), including stroke,
in elderly patients with dementia - Cerebrovascular adverse events
(e.g., stroke, transient ischemic attack), including fatalities,
were reported in patients in trials of olanzapine in elderly
patients with dementia-related psychosis. In placebo-controlled
trials, there was a significantly higher incidence of CVAE in
patients treated with olanzapine compared to patients treated with
placebo. Olanzapine is not approved for the treatment of patients
with dementia-related psychosis. Hyperglycemia and diabetes
mellitus - Hyperglycemia, in some cases associated with
ketoacidosis, coma, or death, has been reported in patients treated
with atypical antipsychotics including olanzapine. Assessment of
the relationship between atypical antipsychotic use and glucose
abnormalities is complicated by the possibility of an increased
background risk of diabetes mellitus in patients with schizophrenia
and the increasing incidence of diabetes mellitus in the general
population. All patients taking atypicals should be monitored for
symptoms of hyperglycemia. Persons with diabetes who are started on
atypicals should be monitored regularly for worsening of glucose
control; those with risk factors for diabetes should undergo
baseline and periodic fasting blood glucose testing. Patients who
develop symptoms of hyperglycemia during treatment should undergo
fasting blood glucose testing. Prescribing should be consistent
with the need to minimize the risk of neuroleptic malignant
syndrome, tardive dyskinesia, seizures, and orthostatic
hypotension. The most common treatment-emergent adverse event
associated with olanzapine in placebo-controlled, short-term
schizophrenia and bipolar mania trials was somnolence. Other common
events were dizziness, weight gain, personality disorder (COSTART
term for nonaggressive objectionable behavior), constipation,
akathisia, postural hypotension, dry mouth, asthenia, dyspepsia,
increased appetite, and tremor. About Eli Lilly and Company Lilly,
a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about
Lilly is available at http://www.lilly.com/. P-LLY For full
prescribing information please see http://www.zyprexa.com/ To read
the manuscript please see:
http://www.blackwell-synergy.com/doi/full/10.1111/j.1524-4733.2006.00083.x
This press release contains forward-looking statements about the
potential of olanzapine for the treatment of schizophrenia and
reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that the product will continue to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements. (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Carole Copeland of Eli Lilly and
Company, +1-317-277-3661; or Kerry Dixon of GCI Group,
+1-720-216-0011
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