Lilly Responds to the Cost-Effectiveness Analysis of the CATIE Schizophrenia Trial
November 30 2006 - 11:01PM
PR Newswire (US)
Among the atypicals, Zyprexa found to be most cost-effective
INDIANAPOLIS, Dec. 1 /PRNewswire-FirstCall/ -- Eli Lilly and
Company commented today on findings from the cost-effectiveness
analysis (CEA) of the Clinical Antipsychotic Trial of Intervention
Effectiveness (CATIE). The data was published in the December 1
issue of The American Journal of Psychiatry. The objective of the
CATIE CEA was to determine whether the first drug to which patients
were randomized in phase 1 of CATIE resulted in differences in
cost-effectiveness over the entire study. The primary outcomes used
to measure cost-effectiveness in the 18-month analysis were total
healthcare costs (medication cost plus health services use, such as
hospital stays and outpatient services) and Quality Adjusted Life
Years (QALYs). According to the CATIE CEA, perphenazine, a
first-generation typical, was found to be the most cost-effective
treatment when used in modest doses in the treatment of patients
without pre-existing Tardive Dyskinesia (TD), followed closely by
Zyprexa(R) (olanzapine). Among the atypicals studied Zyprexa was
found to be the most cost-effective. These results are a secondary
analysis to the initial findings of CATIE, which showed that
Zyprexa was one of the most effective antipsychotic medications
studied, with Zyprexa-treated patients staying on their medication
longer and requiring fewer hospitalizations as reported in phase 1.
Cherri Miner, MD, Lilly U.S. Medical Director for Zyprexa said,
"Lilly supports studies such as CATIE that add to the body of
knowledge for enhancing the treatment of schizophrenia. However, as
in every study or analysis, there are limitations that need to be
recognized and understood. For example, the data was limited by a
high drop-out rate and an inability to capture longer-term effects,
and there was a need to statistically adjust for prior
hospitalization because patients with prior hospitalizations are
more likely to be hospitalized in the future. Most importantly, the
CATIE Cost Effectiveness Analysis findings with respect to
perphenazine are specific to a unique patient group -- that is,
schizophrenia patients treated with perphenazine at modest doses
without pre-existing tardive dyskinesia. Therefore, the relevance
of these findings to other typical antipsychotics is unknown as is
the relevance to patients with pre-existing tardive dyskinesia,
since they were not given perphenazine. It also is difficult to
determine the clinical relevance of the perphenazine findings given
how infrequently it is currently prescribed in the United States.
"In addition, we agree with the study's authors that
cost-effectiveness analyses can inform policy discussions, but they
should not necessarily translate into recommendations for clinical
care or healthcare policy. While cost may be one of the
considerations, it is not necessarily the only priority. Choosing a
medication that will quickly and effectively reduce a patient's
symptoms is of utmost importance. It is important for doctors and
patients to have access to the entire spectrum of treatment options
to find the medication that works best for each patient." Other
CATIE CEA findings included: * Among the atypicals studied
(Zyprexa, quetiapine, risperidone, and ziprasidone), Zyprexa had
the lowest total healthcare costs. Zyprexa was less costly by about
$2,700 per year than quetiapine, $1,212 per year less than
risperidone, and $3,564 per year less than ziprasidone. * Despite
being -- prior to enrollment in the study -- the costliest patient
group, with the highest rate of prior inpatient hospitalizations,
the Zyprexa group showed the largest decrease in total average
monthly healthcare cost during the study. CATIE Background CATIE
was designed to evaluate the overall clinical effectiveness of
antipsychotics in the treatment of schizophrenia, as measured by
any-cause medication discontinuation, a measure that integrates
both the patients' and the doctors' judgment of how well a
medication works, its safety and how well the patient tolerates the
treatment. In both CATIE 1 and 2, the dose range for Zyprexa was
7.5-30mg/day, which is outside of the current FDA approved labeling
of 5-20mg/day. CATIE found that for Zyprexa the average time to
discontinuation was 9.2 months as compared with 4.6 months for
quetiapine, 4.8 months for risperidone, 3.5 months for ziprasidone
and 5.6 months for perphenazine. The differences were statistically
significant for olanzapine compared with risperidone and
quetiapine, but not for perphenazine or ziprasidone. Patients
taking Zyprexa also experienced fewer hospitalizations for
schizophrenia than patients taking other medications. Total PANSS
scores improved over time in all groups, and patients taking
Zyprexa had greater initial improvement. The authors of CATIE phase
1 also noted that patients taking Zyprexa experienced greater
weight gain and increases in measures of glucose and lipid
metabolism versus patients using other antipsychotics that were
studied. Information about adverse events related to increases in
blood glucose levels, lipid metabolism and weight gain is included
in the Zyprexa product label. For patients who discontinued
treatment due to adverse events, more patients taking Zyprexa
discontinued because of weight gain and metabolic events. Zyprexa
Background Zyprexa is indicated in the United States for the short-
and long-term treatment of schizophrenia, acute mixed and manic
episodes of bipolar I disorder, and maintenance treatment of
bipolar disorder. Since Zyprexa was introduced in 1996, it has been
prescribed to approximately 20 million people worldwide. Zyprexa is
not approved for the treatment of patients with dementia- related
psychosis. Elderly patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at an increased risk of death
compared with those patients taking a placebo. In addition,
compared to elderly patients with dementia-related psychosis taking
a placebo, there was a significantly higher incidence of
cerebrovascular adverse events in elderly patients with
dementia-related psychosis treated with Zyprexa. Hyperglycemia, in
some cases extreme and associated with ketoacidosis or hyperosmolar
coma or death, has been reported in patients treated with atypical
antipsychotics, including Zyprexa. 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
Zyprexa 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. Full prescribing information, including a boxed warning, is
available at http://www.zyprexa.com/. 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/.
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http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO DATASOURCE:
Eli Lilly and Company CONTACT: Carole Puls, +1-317-277-1421, cell:
+1-317-612-4859; or Jaime Geiger, GCI Group, +1-212-537-8276, cell:
+1-646-319-6459
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