James Signorovitch, Ph.D.
1
Ben-Hamadi, M.Sc.
1
; Howard Birnbaum, Ph.D.
1 ; Rym
Lawson, M.A.
2
; Andrew P. Yu, Ph.D.
; Daniel Ball, DrPH 2
1 ; Yohanne Kidolezi,
B.A.
1 ; David Kelley, B.A.
1 ; Glenn Phillips, Ph.D.
2 ; Anthony
1. Analysis Group, Inc., Boston, MA, USA
2. Eli Lilly and Company, Indianapolis, IN, USA
Study funding provided by Eli Lilly and Company
AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Atypical antipsychotics (AAs) are frequent targets of cost containment measures
 AAs account for over 13% of Medicaid prescription drug spending
 About 40% of state Medicaid programs require prior authorization (PA) for AAs 1
Formulary policies limiting access to AAs have been associated with 2,3,4 :
 Reduced treatment compliance
 Increased use of medical services
 Increased use of other medications
2 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

On July 11th, 2005, Florida Medicaid re-classified olanzapine as non-preferred
 Existing olanzapine users were not “grandfathered” – physicians had 60 days to transition olanzapine patients to a different antipsychotic
 The policy change was communicated via a public awareness campaign to physicians, patients, and pharmacists
 The policy change was rescinded just prior to the end of the
60-day transition period and was thus never fully implemented
3 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Assess the impact of the Florida Medicaid policy change among olanzapine-treated patients diagnosed with schizophrenia or bipolar disorder in terms of:
 Continuity of olanzapine therapy
 Health care resource use
 Health care reimbursements
4 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

De-identified Medicaid claims data from 01/2004-01/2006 in two states:
 Florida (FL):
 3.9 million lives
 Policy change affecting atypical antipsychotics on 7/11/2005
 New Jersey (NJ):
 2.7 million lives
 No policy change affecting atypical antipsychotics during the study period
5 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

The data from both FL and NJ includes
 complete medical and pharmaceutical claims from both feefor-service and managed care organizations
 dates of services
 dates of prescription fills
 prescription days of supply
 Medicaid reimbursed amounts
All reimbursements were inflated to 2005 U.S. dollars using the medical component of the Consumer Price Index
6 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Disruption of olanzapine: prescription gap
≥15 days
 Switching: filling 2 or more prescriptions for another antipsychotic before or during the first olanzapine disruption
 Discontinuation: patients with disrupted olanzapine treatment who were not classified as switchers (i.e., those who did not establish use of other antipsychotics during the follow-up period after the olanzapine gap)
Use of other antipsychotics
7 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Health care resource use:
 Hospitalization
 Emergency room (ER) visits
Health care reimbursements:
 Medical services
 Prescription drugs
 Total (medical services + drugs)
8 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Policy change index date
(7/11/2005)
6-month baseline period
 Continuous Medicaid eligibility
 ≥ 2 continuous prescriptions for olanzapine with the last one covering the index date
 ≥ 2 outpatient or ≥ 1 inpatient diagnosis for schizophrenia and / or bipolar disorder
 Aged 18-64 years on the index date
9 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago
6-month outcome period
 Continuous Medicaid eligibility

FL
2005
Policy change
(7/11/2005)
2004
7/11/2004
10 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

FL
2005
Policy change
(7/11/2005)
2004
7/11/2004
11 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago
NJ
7/11/2005
7/11/2004

FL
2005
NJ
1:1 matching 1:1 matching
2004

Patients were matched in terms of their propensity to be in the 2005 vs. 2004 cohorts
 The propensity score was developed from baseline characteristics including demographics, comorbidities, prescription drug use, and health care service use
12 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

FL NJ
2005
1:1 matching
Comparison of outcomes
1:1 matching
Comparison of outcomes
2004
 Outcomes were compared between matched pairs within states using Wilcoxon signed rank tests for continuous variables and
McNemar’s test for dichotomous variables
13 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

FL
2005
NJ
1:1 matching
Comparison of outcomes
1:1 matching
Comparison of outcomes
2004
 Within-state changes in olanzapine disruption and health care resource use 2004-2005 were compared in FL vs. NJ
14 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Baseline
Characteristics
Age (years), mean ± s.d.
Before Matching
2004 2005
(N=7,257)
49.47 ± 13.72
(N=5,164)
49.91 ± 13.77
After Matching
2004
(N=4,255)
49.45 ± 13.50
Male, % (N)
Schizophrenic disorders, % (N)
Charlson
Comorbidity Index
(CCI), mean ± s.d.
53.6%
(3,890)
59.7%
(4,332)
0.63 ± 1.33
*P<0.05; **P<0.01; ***P<0.001
56.1%
(2,896)*
57.3%
(2,957)*
0.49 ± 1.16***
54.9%
(2,338)
57.3%
(2,436)
0.41 ± 0.94
2005
(N=4,255)
49.87 ± 13.50
55% (2,341)
57.6%
(2,452)
0.43 ± 1.01
15 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Baseline Characteristics
Before Matching
2004 2005
After Matching
2004 2005
Medication Use, % (N)
Typical antipsychotics 11.5% (835)
Atypical antipsychotics 27% (1,959)
Anticholergenics 19.1% (1,384)
11.4% (586)
25.6% (1,322)
19.4% (1,000)
Benzodiazepines/ anxiolytics
58.1% (4,216) 51% (2,634)***
11% (469)
25% (1,065)
19% (807)
52.9% (2,250)
11.2% (477)
26.2% (1,114)
19.3% (820)
51.4% (2,187)
Antidepressants
Mood stabilizers
61.4% (4,452) 58.3% (3,010) 59.7% (2,540) 59.6% (2,534)
35.1% (2,548) 36.2% (1,869) 33.7% (1,433) 33.9% (1,443)
Medical Resource Use, % (N)
Hospitalization 16.5% (1,194) 13.9% (717)***
Emergency visits 21.2% (1,540) 18.2% (940)***
*P<0.05; **P<0.01; ***P<0.001
10.5% (447)
15.8% (672)
10.3% (437)
15.2% (648)
16 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

2004 2005
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Cumulative Disruption Rates
Florida p < 0.001
0 1 2 3 4 5 6
Months Following Index Date
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Cumulative Disruption Rates
New Jersey p = 0.23
0 1 2 3 4 5 6
Months Following Index Date
17 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

2004 2005
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
Cumulative Switching Rates
Florida p < 0.001
0 1 2 3 4 5 6
Months Following Index Date
45%
40%
35%
30%
25%
20%
15%
10%
5%
0%
Cumulative Switching Rates
New Jersey p = 0.14
0 1 2 3 4 5 6
Months Following Index Date
18 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Other Medication Use
Patients with Outcome, % (N)
2004 2005
Florida Medicaid (N=4,255)
Typical antipsychotics
Atypical antipsychotics 1
10.6% (450) 13.7% (581)
33.6% (1,428) 67.7% (2,882)
Change from
2004 to 2005
29.1%
101.8%
p-value
<.0001
<.0001
New Jersey Medicaid (N=2,680)
Typical antipsychotics 13.4% (358)
Atypical antipsychotics 1 27.9% (748)
14.0% (374)
26.4% (708)
4.5%
-5.3%
1.
aripripazole, clozapine, quetiapine, risperidone, ziprasidone (excludes olanzapine)
0.5143
0.2140
19 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Hospitalizations ER Visits
40%
40%
P = 0.95
30%
30%
P <0.001
20%
20%
P = 0.78
P < 0.001
10%
10%
0%
0%
2004 2005
Matched FL Cohorts
2004 2005
Matched NJ Cohorts
 Hospitalization and ER visits increased by 20% following the policy change in FL Medicaid
 No significant changes in these outcomes in NJ Medicaid during the same time periods
20 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Per-Patient Reimbursements
Medical services 2
Hospitalization
Emergency visits
Prescription drugs
Olanzapine
Other atypicals
Total
U.S. Dollars (2005), Mean ± SD
2004
(N=4,255)
4190 ± 7747
709 ± 3634
33 ± 128
4554 ± 2616
2210 ± 1379
494 ± 958
8744 ± 8213
2005
(N=4,255)
4471 ± 9206
966 ± 5499
40 ± 133
4255 ± 2727
1316 ± 1304
1046 ± 1203
8726 ± 9673
Change from
2004 to 2005 P-value 1
281
256
6
-299
-895
552
-18
0.1026
0.0468
0.0926
<.0001
<.0001
<.0001
0.1374
1. Dichotomous outcomes were compared using McNemar's test; continuous outcomes were compared using the Wilcoxon signed rank test.
2. Includes reimbursements associated with all Medicaid claims including home and community health services.
21 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

For olanzapine-treated patients diagnosed with schizophrenia or bipolar disorder, removal of olanzapine from Florida Medicaid’s preferred drug list without “grandfathering” existing users was associated with:
 Increased disruption of olanzapine treatment
 Increased use of other atypical antipsychotics
 Increased rates of hospitalization and ER visits
 Decreased reimbursements for prescription drugs largely offset by increased reimbursements for hospitalization
 No significant change in total medical costs
22 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Findings support recommendations of the National Association of State Mental Health Program Directors 5
 “Patients should not be forced to switch medications due to changes in formulary policy”
 “‘Grandfathering’ is the recommended practice for individuals stabilized on a nonformulary antipsychotic medication to minimize risk of relapse and support continuity of care”
23 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

Thank You
| AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago

1.
Polinski, J. M., P. S. Wang, et al. (2007). "Medicaid's Prior Authorization
Program and Access to Atypical Antipsychotic Medications." Health Affairs
26(3): 750-760.
2.
K.T. Mueser and S.R. McGurk, "Schizophrenia," Lancet 363, no. 9426
(2004): 2063–2072
3.
Zeber, J., K. L. Grazier, et al. (2007). "The Effect of a Medication
Copayment Increase in Veterans with Schizophrenia." The American
Journal of Managed Care 13(6 (Part 2)): 335-346
4.
Soumerai, S. B., T. J. McLaughlin, et al. (1994). "Effects of limiting Medicaid drug-reimbursement benefits on the use of psychotropic agents and acute mental health services by patients with schizophrenia." New England
Journal of Medicine 331(10): 650-5.
5.
Parks, J., A. Radke, et al. (2008). "Principles of Antipsychotic Prescribing for Policy Makers, Circa 2008. Translating Knowledge to Promote
Individualized Treatment." Schizophr Bull: sbn019.
25 | AcademyHealth Annual Research Meeting, June 30 th , 2009, Chicago