Mental Health

1. Medicare Drug Benefits and
Antipsychotic Use Among Medicare
Advantage Beneficiaries with
Schizophrenia
Vicki Fung, Ph.D.
Mid-Atlantic Permanente Research Institute
HMORN
May 1, 2012

2. Study Team
Vicki Fung, PhD1 Rita Hui, PharmD, MS6
Mary Price, MA2 Andy Nierenberg, MD7
Alisa B. Busch, MD, MS3,4 Richard Frank, PhD3
Mary Beth Landrum, PhD3 Joseph Newhouse, PhD3
Bruce Fireman, MA2 John Hsu, MD MBA MSCE3,7
William Dow, PhD5
1 Mid-Atlantic Permanente Research Institute, Mid-Atlantic Permanente Medical Group
2 Divisionof Research, Kaiser Permanente Northern California
3 Harvard University
4 McLean Hospital
5 University of California, Berkeley
6 Pharmacy Outcomes Research Group, Kaiser Permanente
7 Massachusetts General Hospital
Funding Support: National Institute of Mental Health (5R01MH090284) and the Alfred P.
Sloan Foundation
No other relevant financial relationships to disclose

3. Background
 Spending on antipsychotic drugs is growing rapidly
 Medicare Part D introduction was major shift in the financing of
antipsychotics
 Antipsychotics receive formulary protection under Part D, but subject
to cost-sharing
 ACA phases out coverage gap by 2020; however, ACA future
remains uncertain, and substantial cost-sharing remains
 Impact of Part D program on access, quality, and costs for
beneficiaries with serious mental illness is unknown

4. Objectives
Among Medicare Advantage beneficiaries with
schizophrenia, to examine the effects of Part D cost-
sharing on:
 Total antipsychotic drug spending
 Out-of-pocket antipsychotic drug spending
 Adherence to antipsychotic drug therapy

5. Methods
 Historical cohort study:
 Community-dwelling beneficiaries enrolled in Medicare Advantage (MA)
Prescription Drug plans offered by two plan sponsors: Integrated (IDS)
and Non-IDS
 Any antipsychotic dispensed in 2006
 1+ inpatient or 2+ outpatient diagnoses of schizophrenia 2006-2007
 Study period: 2007
 Comparison groups:
 Low income subsidy (LIS) beneficiaries: No coverage gap
 Unsubsidized (Non-LIS) beneficiaries: Coverage gap starting at $2,400
in total drug spending

6. Cost-sharing Levels
Initial Coverage Period Coverage Gap Catastrophic
Coverage
2007 Up to $2,400 in TDC $2,400 TDC to Above $3,850 OOP
$3,850 OOP
Full Low Income ≤$2.15/$5.35 ≤$2.15/$5.35 $0
Subsidy (LIS)
Non-LIS 3 or 4-tier copay 100% 5%
(Non-Integrated MA) (eg, $10 /$20/$45/25%)
Non-LIS 2 tier copay 100% $3/$10
(Integrated MA) $11/$40
TDC=Total drug costs; OOP=Out-of-Pocket drug costs
The study plans did not include a deductible ($265 in standard benefit)

7. Analyses
 Monthly drug use outcomes:
 Total drug costs (acquisition cost + dispensing fees)
 Out-of-pocket drug costs
 Adherence: proportion of days covered (PDC)
 Difference-in-difference estimation
 Linear fixed effects (within-person) models
 Accounted for “transition period” of 30 days and focused on 30+ days
after reaching gap threshold ($2,400 in total drug spending)
 Censored subjects in month they reached catastrophic coverage
 Fixed effects robust to unmeasured, time-stable confounders

8. Study Population
Non-Integrated MA Integrated MA
Non-LI S Non-LIS
(Gap) LIS (Gap) LIS
Total N 1,672 2,234 321 547
Age: <65 68% 85% 56% 86%
65-74 21% 11% 27% 9%
75+ 11% 4% 18% 6%
Gender: Female 52% 50% 65% 52%
Any of the chronic conditions below (2006-2007)* 50% 54% 36% 32%
Coronary artery disease 9% 10% 6% 6%
Chronic obstructive pulmonary disorder 21% 25% 11% 11%
Diabetes 34% 36% 25% 22%
Heart Failure 11% 10% 6% 4%
Mean Comorbidity (RxHCC) score (SD) 1.54 1.78 1.46 1.73

9. Antipsychotic Drug Use in 2007
Non-Integrated MA Integrated MA
Non-LIS Non-LIS
(Gap) LIS (Gap) LIS
Total N 1,672 2,234 321 547
Drug spending
Reached coverage gap threshold 47% 75% 44% 69%
Reached catastrophic coverage threshold 11% 40% 15% 41%
Adherence
Mean antipsychotic PDC 64.8 79.1 74.3 81.0
Adherent: PDC>80% 46% 66% 61% 73%
Antipsychotic drug use
Atypical antipsychotic use 62% 82% 54% 76%
Conventional antipsychotic use 43% 31% 50% 35%
Use of both 15% 17% 12% 16%
No Use 10% 4% 8% 6%

10. Percent Reaching the Gap Threshold
Non-Integrated MA
Integrated MA

11. Changes in Antipsychotic Use Before
and After Reaching the Gap Threshold
Diff-in-diff:
Non-LIS (Gap) LIS Non-LIS (Gap) – LIS
Non-Integrated MA Diff 95% CI Diff 95% CI Diff 95% CI
Total drug spending ($) -$97 (-110, -83) $37 (28, 46) -$133 (-149, -117)
Out-of-pocket spending ($) $93 (88, 98) -$1 (-4, 3) $94 (88, 99)
PDC (percentage points) -18. 4 (-19.7, -17.1) 1.8 (0.9, 2.7) -20.2 (-21.8, -18.6)
Integrated MA Diff 95% CI Diff 95% CI Diff 95% CI
Total drug spending ($) $78 (-32, 189) $226 (136, 316) -$147 (-238, -57)
Out-of-pocket spending ($) $155 (131, 179) $13 (-3, 32) $142 (122, 161)
PDC (percentage points) -0.2 (-4.3, 3.9) 5.7 (2.4, 9.1) -5.9 (-9.3, -2.5)

12. Monthly Changes in Adherence (PDC)
Non-Integrated MA
Subjects with a Schizophrenia Diagnosis
10.0
(PDC - PDC 1-month Pre-Gap)
5.0
0.0
Change in PDC
-5.0
-10.0 Basic
LIS
-15.0
-20.0
-25.0
-30.0
-5 -4 -3 -2 -1 0 1 2 3 4 5
Month from Gap-Month (=0)
Integrated MA
10.0
(PDC - PDC 1-month Pre-Gap)
5.0
0.0
Change in PDC
-5.0
Basic
-10.0
-15.0 LIS
-20.0
-25.0
-30.0
-5 -4 -3 -2 -1 0 1 2 3 4 5
Month from Gap-Month (=0)

13. Limitations
 Non-random allocation of drug benefits; unobserved differences
between groups
 Focus on patients with documented diagnoses and drug use
 Fixed effects estimation robust to time constant unobserved differences
 Measures of drug adherence based on dispensing data
 Conducted within MA drug plans offered by two Part D plan
sponsors; generalizability could be limited
 Preliminary work – next steps: impact of these drug use changes on
clinical outcomes and net medical spending

14. Conclusions
 Substantial differences between LIS and Non-LIS beneficiaries
 The LIS appears to be protective against cost-related non-
adherence in both settings
 The gap is associated with large increases in out-of-pocket costs for
antipsychotics
 However, changes in therapy adherence varied by setting  Large
declines in adherence in non-integrated setting

15. Implications
 Work is needed to determine the clinical and economic impact of
these drug use changes and potential delivery structure
mechanisms that mitigate adverse cost-sharing effects
 Need to identify benefit designs and care delivery models that
increase the value of drug coverage for vulnerable populations and
minimize unintended effects