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Applying HEDIS® Measures and New Data to Optimize Outcomes in Major
Depressive Disorder
Jointly sponsored by North American Center for Continuing Medical Education, LLC,An HMP Communications Holdings Company, and NCQA
Supported by educational grants from Takeda Pharmaceuticals International, Inc. and Lundbeck
Faculty
Jeffrey D. Dunn, PharmD, MBASenior Vice President
VRxSalt Lake City, Utah
Rakesh Jain, MD, MPHDirector of Psychiatric Drug Research
R/D Clinical Research CenterLake Jackson, Texas
Associate Clinical ProfessorDepartment of Psychiatry and Behavioral Sciences
University of Texas Medical School at HoustonHouston, Texas
Junqing Liu, PhD, MSWResearch Scientist
National Committee for Quality AssuranceWashington, DC
Vladimir Maletic, MD, MSClinical Professor of Neuropsychiatry and Behavioral Science
University of South Carolina School of MedicineColumbia, South Carolina
Consulting AssociateDivision of Child and Adolescent Psychiatry
Department of PsychiatryDuke University
Durham, North Carolina
Learning Objectives
• Discuss the heterogeneous nature of major depressive disorder (MDD) symptoms and its impact on diagnosis and therapy
• Evaluate the clinical and economic downstream consequences of MDD treatment failure
• Outline the benefits, limitations, and comparative effectiveness of antidepressant medication classes and the factors involved in treatment selection
• Summarize current evidence and understanding of receptor pharmacology for efficacy and tolerability of emerging treatment options in MDD
• Apply concepts in study design and outcomes measurement/decision support tools to the evaluation of emerging clinical evidence for MDD pharmacotherapy
• Institute depression-related Healthcare Effectiveness Data and Information Set (HEDIS) measures to improve health plan performance and patient adherence
MDD: Introduction
• MDD is a product of an interaction between early and late life adversity, and complex epistatic and epigenetic factors
• MDD appears to be a clinically and biologically heterogeneous condition
• Current descriptive nomenclature does not allow us to deduce specific treatment strategies that could be more effective for MDD subtypes
• Mood disorders are associated with changes in endocrine, immune, and autonomic function
• Remission and functional recovery are the optimal outcomes in the treatment of MDD
Hamer D. Science. 2002;298(5591):71-72. Harald B, et al. J Affect Disord. 2012;139(2):126-40.Maletic V, et al. Int J Clin Pract. 2007;61(12):2030-2040. Maletic V, et al. Front Biosci. 2009;14:5291-5338. Keller MB, et al. Arch Gen Psychiatry. 1992;49(10):809-816. American Psychiatric Association. Am J Psychiatry. 2000;157(4 suppl):1-45.
Question 1
According to the American Psychiatric Association, which of the following is an example of an emotional symptom of MDD?
A. Irritability
B. Brooding
C. Lack of interest
D. Anxiety or phobias
Multidimensional Aspects of Depression
Anxiety orPhobias
Tearfulness
Brooding
ObsessiveRumination
Irritability
Change in Appetite Excessive
Worry Over Physical Health
Depression
Feelings of Guilt
Lack of Interest
Change in Sleep
Lack of Energy
Physical symptomsEmotional symptomsAssociated symptoms
Decreased Concentration
Aches andPains
Change in Psychomotor Skills
Suicidal
Sadness
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th Ed, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association; 2000:352.
STAR*D: Unresolved Symptoms Following Antidepressant Treatment*
*N = 2876.STAR*D = Sequenced Treatment Alternatives to Relieve Depression; QIDS-SR = quick inventory of depressive symptomatology-self-report. Trivedi MH, et al. Am J Psychiatry. 2006;163(1):28-40.
Per
cen
t
67%
Mild symptoms
~28%
Moderate symptoms
~23%
Severe symptoms
~12%
Very severe symptoms
~4%
Depressive symptoms (QIDS-SR score) After Up to 12 Weeks of Antidepressant Treatment
Remission~33%
0
1
2
3
4
5
6
7
8
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27
Core symptoms: depressed mood/diminished interest1.00
0.80
0.60
0.40
0.20
0.00
Lack of energy Sleeping problems
Death ideations
Mea
n P
rop
ort
ion
of
Tim
e D
SM
-IV
S
ymp
tom
Clu
ster
Is P
rese
nt
Weeks of Follow-Up
The presence of DSM-IV depressive symptom clusters during the 3-year follow-up of 267 initially depressed primary care patients
Cognitive problems
Psychomotor problems
Eating problemsWorthlessness/guilt
1 145
Not All Symptoms of MDD Respond Equally Well to Treatment
DSM-IV = Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.Conradi HJ, et al. Psychol Med. 2011;41(6):1165-1174.
Neurobiology of Mood Disorders
ELA = early-life adversity.Maletic V, et al. Front Biosci. 2009;14:5291-5338.
Neuropsychiatric Symptoms
Emotional Cognitive Behavioral Physical
Systemic Manifestations
“Network” Level: Dysregulation of Neural Circuitry
Functional Changes Structural Changes
“Network” Level: Dysregulation of Neural Circuitry
Functional Changes Structural Changes
Neuroendocrine, Autonomic, and Immune Dysregulation
Neuroendocrine, Autonomic, and Immune Dysregulation
Cellular and Subcellular Level Impact on
Intracellular Signaling Gene Transcription Neurotrophic Support
Cellular and Subcellular Level Impact on
Intracellular Signaling Gene Transcription Neurotrophic Support
Epigenome
Epigenetic Modulation
Genetic Epistasis
ELA
Stress
Etiology Pathophysiology Clinical Presentation
D E V E L O P M E N T
A Psychosocial stress,social isolation, personality
factors
IL-1, TNF-, IL-6IL-6
EuthymiaStress resilience
Major depression sickness behavior
G
Immunoregulation
t
HP
A A
xis
IL-10, TGF-
NE /-AR
IL-1, TNF-, IL-6
NF-B
ACh TLR
7nAChr
GR
Infection, tissue trauma, neoplasm Macrophage GCs
IL-10, TGF-
Stress and Inflammation in MDD
IL = interleukin; TNF = tumor necrosis factor; TGF = transforming growth factor; HPA = hypothalamic-pituitary-adrenal axis; NE = norepinephrine; ACh = acetylcholine; GCs = glucocorticoid; TLR = toll-like receptor; /-AR = α- or β-adrenoreceptor.Raison CL, et al. Arch Gen Psychiatry. 2010;67(12):1211-1224.
Antidepressant Strategies
Antidepressants: Guidelines
APA = American Psychiatric Association; CANMAT = Canadian Network for Mood and Anxiety Treatments; SNRIs = serotonin-norepinephrine reuptake inhibitors; SSRIs = selective-serotonin reuptake inhibitors; TCA = tricyclic antidepressant; NA = not applicable; MAOI = monoamine axidase inhibitor; DNRI = dopamine norepinephrine reuptake inhibitor. Gelenberg, et al. Practice Guideline for the Treatment of Patients with Major Depressive Disorder. Third Edition. http://www.psych.org/guidelines/mdd2010. Accessed September 5, 2013. Lam RW, et al. J Affect Disord. 2009;117(Suppl 1):S26-S43.
AgentCANMAT (first-line recommendations)
APA (Level 1 = recommended with substantial clinical confidence)
SNRIsDesvenlafaxine, duloxetine, venlafaxine
Desvenlafaxine, duloxetine, venlafaxine
SSRIsCitalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
Citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline
TCAs NAAmitriptyline, doxepin, imipramine, nortriptyline, protriptyline, maprotilinetrimipramine
Serotonin modulators NA Nefadozone, trazodone
Norepinephrine-serotonin modulator
Mirtazapine Mirtazapine
MAOIs MoclobemideIsocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine
DNRI Bupropion Bupropion
Depressed moodloss of happiness (joy)
loss of interest/pleasureloss of energy/enthusiasm
decreased alertnessdecreased self-confidence
Reduced positive affect
++
++ +
Targeting More than One Mechanism: Does That Offer Any Further Help?
Normalmood
Depressed moodguilt/disgustfear/anxiety
hostilityirritabilityloneliness
Increased negative affect
-- - -
-
DA = dopamine; 5HT = serotonin.Stahl SM. Stahl’s Essential Psychopharmacology. Neuroscientific Basis and Practical Applications. 3rd Ed. NY, NY: Cambridge Univ Press; 2008.
Functional Interactions Between the Monoamine Systems: 5HT, NE, and DA
GABA = gamma-aminobutryic acid; GLU = glutamate.Kennedy SH, et al. J Affect Disord. 2011;132(Suppl 1):S21-S23; Trivedi MH, et al. J ClinPsychiatry. 2008;69(2):246-258.
++-
--
PostsynapticNeuron
Interneuron5-HT2A for NE neurons5-HT2C for DA neurons
GLU
GABA
GABA
5HT Neurotransmission
G-protein coupling
NegativeFeedback /gK+ GPCR
5-HT1A/1B 5-HT1-2
Gi/o 5-HT4-7PDE
Synthesis AC Transduction
Cascades PLC Gs PLA2
Gq TPH-2 5-HT [Ca2+]i
Kinases Tryptophan
Arrestin
5-HIAA CREB gCa2+ Precursor availability
BDNF MAO
5-HT3 Ion Flow Effector
Transcription /Gene expression
Genes Catabolism Ion
Transporter Channel
PDE
MAO = monoamine oxidase; TPH = tryptophan hydroxylase; GPCR = G-protein-coupled receptor; PLC = phospholipase C; PLA2 = phospholipase A2; AC = adenylyl cylase; CREB = cAMP-responsive binding element; BDNF =brain-derived neurotrophic factor; PDE = phosphodiesterase; 5-HIAA = 5-hydroxyindole-amino acid; [Ca2+]I = intracellular concentration of calcium. Millan MJ. Pharmacol Ther. 2006;110(2):135-370.
Obstacles to Better Treatment Outcomes
Sexual Dysfunction with Antidepressant Treatment
*Based on Changes in Sexual Function Questionnaire, the Rush Sexual Inventory, the Arizona Sexual Experience Scale, and the PRESexDQ prospective outcomes.Serretti A, et al. Clin Pharmacol Ther. 2011;89(1):142-147.
Total Sexual Dysfunction*
0.22
60
40
90
80
20
10
0
Per
cen
tag
e o
f P
atie
nts
wit
h S
exu
al D
ysfu
nct
ion
50
30
70M
ocl
ob
emid
e(n
= 2
6)
Ag
om
elat
ine
(n =
228
)
Am
ine
pti
ne
(n =
29)
Nef
azo
do
ne
(n =
50)
Bu
pro
pio
n(n
= 6
45)
Pla
ce
bo
(n =
605
)
Mir
taza
pin
e(n
= 4
9)
Flu
voxa
min
e(n
= 2
44)
Du
loxe
tin
e(n
= 2
74)
Ph
enel
zin
e(n
= 2
4)
Imip
ram
ine
(n =
54)
Flu
oxe
tin
e(n
= 1
718)
Pa
rox
eti
ne
(n =
126
1)
Cit
alo
pra
m(n
= 6
54)
Ve
nla
fax
ine
(n =
610
)
Ser
tral
ine
(n =
970
)
Es
cit
alo
pra
m(n
= 3
05)
15.59 16.86
20.27 24.82 27.43
3.27
3.444.36 6.43
7.24
0.46 0.46 0.75
2.32
0.25
Weight Change During Antidepressant Treatment
CI = confidence interval.Serretti A, et al. J Clin Psychiatry. 2010;71(10):1259-1272.
Filled Squares Indicate a Significant Effect
0
3
4
2
1
-1
-2We
igh
t C
han
ge
du
rin
gA
cu
te T
reat
men
t
Mean Weight Change (95% CI), kg
Mean Weight Change (95% CI), kg
0
4
6
2
-2
-4We
igh
t C
han
ge
du
rin
gM
ain
ten
ance
Tre
atm
ent
How Do We Select the Optimal Treatment?
The More Treatments Required to Achieve Remission, the Greater the Relapse
Number at Risk:
Step 1
Step 2
x2(3) = 23P < .0001
0
0.25
0.50
0.75
1.00
Cu
mu
lati
ve P
rob
abili
tyo
f N
ot
Rel
apsi
ng
0 3 6 9 12
Follow-up (months)
Step 3
1085
383
35
628
199
16
84
20
2
431
133
11
290
79
8
Step 4 15 8 25 5
Total 1518 851 108580 382
Step 1
Step 2
Step 3
Step 4
Rush AJ, et al. CNS Drugs. 2009;23(8):627-647.
Evidence Supporting Augmenting Antidepressants with Psychotherapy
*P < .001.CBT = cognitive behavioral therapy.Wiles N, et al. Lancet. 2013;381(9864):375-384. Thase ME, et al. Am J Psychiatry. 2007;164(5):739-752.
64 142
0.75
1.00
0.50
0.25
0
0
Cu
mu
lati
veP
rob
abili
ty o
f R
emis
sio
n
Weeks in Treatment
12
Cognitive Therapy Augmentation
Medication Augmentation
9
Cognitive
Medication
Total
65
117
182
58
100
158
52
83
135
45
65
110
26
37
63
40
47
87
10
7
17
40
30
50
20
10
0
6 MonthResponse
Per
cen
t (%
)
Antidepressant + Usual Care
Antidepressant + CBT
6 MonthRemission
Number:
Log-rank = 5.2124, P = .0224
*
*
Question 2
According to the GSRD study, which of the following was determined to be the most successful course of action after initial treatment failure?
A. Increase the dosage of the current treatment
B. Begin treatment within a different class of antidepressant
C. Switch to a treatment within the initial antidepressant class
D. None of the above
GSRD = Group for Study of Resistant Depression.
Switching within vs across Class vsContinuing Original Antidepressant
STAR*DRemission after Switching
to 2nd Antidepressant30
20
10
0Bupropion-SR
(n=239)Sertraline(n=238)
Venlafaxine XR(n=250)
Pa
tie
nts
Ac
hie
vin
gH
AM
-D R
em
iss
ion
(%
)
30
20
10
0Week 4 Week 5 Week 6 Week 8
HA
M-D
To
tal
Sc
ore
Week 7
25
15
5
GSRDSwitching by Class and
Compared with Continuation50
40
20
0Response Remission
Pe
rce
nt
30
10
Switched
Nonswitched
* * **
Same Antidepressant Class
Different Antidepressant Class
*P < .001.HAM-D = Hamilton Depression Rating Scale.Rush AJ, et al. N Engl J Med. 2006;354(12):1231-1242. Schosser A, et al. Eur Neuropsychopharmacol. 2012;22(7):453-468.
*
*
†
Presence of Sleepiness and Fatigue Might Influence Our Treatment Choice
*P < .05 vs placebo. †P < .01 vs SSRIs and placebo. ITT = intention to treat.Papakostas GI, et al. Biol Psychiatry. 2006;60:1350-1355.
Improvement in Fatigue(ITT)
-0.4
-0.6
0
-0.2
-0.8
-1.0
-1.2
Baseline
Ch
ang
e in
HA
M-D
Fat
igu
e S
core
2 Weeks 4 Weeks 6 WeeksEnd Point
(ITT)
Improvement in Sleepiness(ITT)
End Point(ITT)
-0.4
-0.6
0
-0.2
-0.8
-1.0
-1.2
Baseline
Ch
ang
e in
HA
M-D
Sle
epin
ess
Sco
re
2 Weeks 4 Weeks 6 Weeks
Bupropion
SSRI
Placebo
Bupropion
SSRI
Placebo
†
*
†
†
*
†
†
†
*
SNRIs May Provide a Greater Relief for Psychomotor Retardation than SSRIs in MDD
100 Escitalopram (n=57)
Venlafaxine (n=41) 50
0
-50
-100
-150
F = 4.76, d.f. = 2, P < .013
8 1 4
HA
M-D
ite
m 8
(p
sych
om
oto
r re
tard
atio
n)
Time (weeks)
Percent change from baseline in psychomotor retardation (item 8 17-item HAM-D) for participants completing 8
weeks of treatment (n=98) with venlafaxine (n=41) or escitalopram (n=57) adjusted for baseline HAM-D score
Singh AB, et al. Int Clin Psychopharmacol. 2013;28(3):121-126.
-200
SSRI vs SNRI: The Largest Meta-Analysis to Date
59.3 63.6
0
10
20
30
40
50
60
70
80
90
100
SSRI SNRI
RR = 1.05, favoring SNRIs over SSRIs
Total: 93 trials, n = 17,036
*
P = .003.Papakostas GI, et al. Biol Psychiatry. 2007;62(11):1217-1227.
The Relevance of 5-HT1a Receptor for Speed of Antidepressant Response
60
50
40
30
20
10
07 14 21 28 35 42
Time Points of Trial (days)
Cu
mu
lati
ve S
ust
ain
ed
Rem
issi
on
(%
)Pindolol
Placebo
Portella MJ, et al. J Clin Psychiatry. 2011;72(7):962-969.
Vilazodone: A Novel 5-HT1A Partial Agonist and Serotonin Uptake Inhibitor
1 3 5
0
-2
-4
-6
-8
-10
-14
-12
Baseline 2 4 6 7 8
MA
DR
S S
core
(m
ean
ch
ang
e)
Week of Treatment
1 3 5
0
-2
-4
-6
-8
-10
-14
-12
Baseline 2 4 6 7 8
HA
M-D
-17
Sco
re (
mea
n c
han
ge)
Week of Treatment
P = .013
P<.001
P<.001
P<.001
P = .001
P = .001
P = .007
P = .023
P = .001P = .022
Vilazodone (n=198)Placebo (n=199)
MADRS = Montgomery-Åsberg Depression Rating Scale.Rickels K, et al. J Clin Psychiatry. 2009;70(3):326-333.
Safety and Tolerability of Vilazodone
Short-term tolerability of oral vilazodone in adult patients with MDDIncidence of treatment-emergent adverse events occurring in ≥5% of vilazodone 40 mg once-
daily recipients in two 8-week, double-blind, placebo-controlled studies (pooled results)
20
15
30
25
10
5
0
Inci
den
ce (
% o
f p
atie
nts
)
Placebo (n=433)
Vilazodone (n=436)
Frampton JE. CNS Drugs. 2011;25(7):615-627.
Vortioxetine: A Multiple SerotoninReceptor Modulator and Uptake Inhibitor
†
‡
‡
‡
†
-5
0
-10
-15
-20
-25
Mea
n C
han
ge
fro
m B
asel
ine
(MA
DR
S)
-30
0 2 4 6 LOCF
Treatment (Weeks)
-4
0
-2
-6
-8
-10
-12
-14
Mea
n C
han
ge
fro
m B
asel
ine
(HA
MA
)
-16
0 2 4 6 LOCF
Treatment (Weeks)
‡** *
†
††
† †
‡
‡
‡‡
‡‡
‡‡
‡ ‡
‡
‡‡
‡
‡‡
‡
‡
Venlafaxine (n=112)
Placebo (n=105)
Vortioxetine 5 mg (n=108)
Vortioxetine 10 mg (n=100)
Placebo (n=101)
Venlafaxine (n=105)
Vortioxetine 10 mg (n=94)
Vortioxetine 5 mg (n=101)
§Vortioxetine (1-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]-piperazine) is a novel compound under development as an antidepressant with affinity for the human 5-HT1A, 5-HT1B, 5-
HT3, and 5-HT7 receptors and the 5-HT transporter
*P < .05. †P < .01. ‡P < .001.§Vortioxetine is not yet approved for treatment of MDD. HAMA = Hamilton Anxiety Scale; LOCF = last observation carried forward.Alvarez E, et al. Int J Neuropsychopharmacol. 2012;15(5):589-600.
Adverse Events Noted in a Vortioxetine Study
*P < .05. †P < .01. ‡P < .001 vs placebo.APTS = all-patients-treated set.Alvarez E, et al. Int J Neuropsychopharmacol. 2012;15(5):589-600.
Placebo (n=105)
Vortioxetine5 mg (n=108)
Vortioxetine10 mg (n=100)
Venlafaxine 225 mg (n=113) Preferred Term
Patients with Adverse Events 64 (61.0%) 73 (67.6%) 74 (74.0%)85 (75.2%)Nausea 10 (9.5%) 32 (29.6%)‡ 38 (38.0%)‡ 38 (33.6%)‡
Headache 26 (24.8%) 23 (21.3%) 25 (25.0%)32 (28.3%)Hyperhidrosis 2 (1.9%) 3 (2.8%) 10 (10.0%)* 17 (15.0%)‡
Vomiting 1 (1.0%) 2 (1.9%) 9 (9.0%)† 4 (3.5%)
Dry mouth 7 (6.7%) 8 (7.4%) 8 (8.0%) 19 (16.8%)*Diarrhoea 5 (4.8%) 9 (8.3%) 7 (7.0%) 5 (4.4%)Dizziness 8 (7.6%) 7 (6.5%) 7 (7.0%) 14 (12.4%)Nasopharyngitis 9 (8.6%) 8 (7.4%) 7 (7.0%) 4 (3.5%)
Fatigue 6 (5.7%) 4 (3.7%) 6 (6.0%) 11 (9.7%)Insomnia 5 (4.8%) 7 (6.5%) 6 (6.0%) 14 (12.4%)Constipation 1 (1.0%) 1 (0.9%) 3 (3.0%) 11 (9.7%)†
Vision blurred 2 (1.9%) 2 (1.9%) 1 (1.0%) 6 (5.3%)Anorgasmia 0 0 0 7 (6.2%)*Ejaculation delayed (men)a 0 0 0 4 (7.8%)Erectile dysfunction (men)a 0 0 0 4 (7.8%)Tremor 3 (2.9%) 5 (4.6%) 0 6 (5.3%)
Addressing the Unmet Needs of Depression
• Challenges still exist in identifying optimal treatments for MDD
• The rationale for multitarget strategies in improving the treatment of depression is vital when considering new individualized approaches to care
• Having an understanding of the most current agents in our psycho-armamentarium (including efficacy and safety signals) will procure the best benefit to patients we treat
• A continued need to implement strategies in improving treatment adherence is necessary, and can be obtained via monitoring for adverse effects and modifying treatment accordingly to mitigate these effects and improve outcomes for patients with MDD
HEDIS® Antidepressant Medication Management Measure
Junqing Liu, PhD, MSWResearch Scientist
National Committee for Quality AssuranceWashington, DC
Milesh Patel, MSSenior Health Care Analyst
Importance of Performance Measurement
• Affecting 6.7% of the US adult population, major depression is the most common type of mental illness
• Medication has been shown to bring depressive moods under control and prevent relapse once a patient’s mood has been stabilized
• APA, ICSI, and VA/DOD guidelines recommend that people with mild to major depression should adhere to appropriate pharmacotherapy
• HEDIS performance rates indicate there is room for improvement
ICSI = Institute for Clinical Systems Improvement; VA/DOD = Department of Veterans Affairs/Department of Defense. Kessler RC, et al. Arch Gen Psychiatry. 2005;62(6):617-627.
Considerations for Quality Measures
• Measure Intent and Importance
– Does the measure effectively target a gap in care?
• Feasibility
– Are data sources available? Can data be extracted without extreme burden?
• Progress
– Are we seeing improvement in performance? Are these measures still valuable?
Antidepressant Medication Management (AMM)
• Measure description
– Percentage of members 18 years of age and older with a diagnosis of major depression and were treated with antidepressant medication, and who remained on an antidepressant medication for the acute (12 weeks) and continuation phase (6 months)
• Features
– Product lines: Commercial, Medicaid, Medicare
– Required benefits: Medical and pharmacy
– Continuous enrollment: 105 days prior to the index prescription start date through 231 days after
– Negative medication history
AMM Performance 2011–2013: Commercial
AMM Performance 2011–2013: Medicare
AMM Performance 2011–2013: Medicaid
2014 Measure Refinements
• Intent
– Continue the new focus of the measure on new treatment episodes versus new depression episodes
• Refinement
– Changed the denominator steps to first look for an index prescribing event, and then look for diagnosis of major depression with 60 days of the index prescribing date
– Extended continuous enrollment period from 90 days to 105 days
Conclusion
• Medication adherence important
• Performance on depression-related HEDIS® measure not optimum and can be improved
• Improvements in care can help reduce the burden of major depression relapse and recurrence
Ben Druss, MD, MPHEmory University
Bruce Bobbitt, PhD, LPUnited Behavioral Solutions
Bruce L. Rollman, MD, MPH University of Pittsburgh School of Medicine
Charlotte Mullican, BSW, MPHAHRQ
Connie Horgan, ScDBrandeis University
Wayne Lindstrom , PhDMental Health America
Frank A. Ghinassi, PhDWestern Psychiatric Institute and Clinic and UPMC Behavioral Health Network
Harold Pincus, MDColumbia UniversityNew York-Presbyterian HospitalRAND
Michael Schoenbaum, PhDNational Institute of Mental Health
Michael Quirk, PhD (Chair)Group Health Cooperative
Nancy JaeckelsInstitute for Clinical Systems Improvement
Neil Korsen, MD, MSMaine Medical Center
Peter Delany, PhD, LCSW-CSAMHSA
Rick Hermann, MDTufts Medical Center and UpToDate, Inc.
Behavioral Health Measurement Advisory Panel
Applying HEDIS® Measures and New Data to Optimize Outcomes in MDD:
The Managed Care Perspective
Jeffrey D. Dunn, PharmD, MBA
Senior Vice President
VRx
Salt Lake City, Utah
The Clinical and Economic Downstream Consequences of MDD
Treatment Failure
Depression Epidemiology
• Using a structured diagnostic interview, point prevalence estimated to be 7%, with
– 30% having a severity of “serious”
– 50% having a severity of “moderate”
– 20% having a severity of “mild”
• Using a longitudinal survey tool, lifetime prevalence of 8.7% to 11.5% in females and 3.6% to 5.9% in males
• Studies have shown that prevalence has more than doubled from 1990s to 2000s
• Peak onset in 4th decade of life, but first episodes may occur from childhood to old age
• Most episodes resolve with or without treatment, but up to 10% to 30% may have residual symptoms
• Major depression recurrent in up to 85% of patients
Kessler RC, et al. Arch Gen Psychiatry. 2005;62:617. Murphy JM, et al. Arch Gen Psychiatry.2000;57:209. Compton WM, et al. Am J Psychiatry. 2006;163:2141.
Outcomes of Depression
• Significant societal and economic consequences of depression include:
– Reduced quality of life
– Decreased work productivity
– Increased absenteeism
– Increased utilization of health care resources
– Increased morbidity
– High rates of complicating comorbidities
Nemeroff CB. J Psychiatr Res. 2007;41(3-4):189-206.
Highest Determinants of Disability Worldwide
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2
3
4
5
6
7
8
9
10
Per
cen
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COPD = chronic obstructive pulmonary disease.Andrews G, et al. Lancet. 2007;370(9590):808-809.
Proportion of Total Years Lived with Disability
Medical Comorbidity
• Depression is much more common among those with chronic medical conditions, as compared with general population
• Depression is recognized as a cause of increased morbidity and mortality in patients with chronic medical illness
• Evidence suggests that biological mechanisms underlie a bidirectional link between mood disorders and many medical illnesses
– Mood disorders may adversely affect the course of medical illness
Benton T, et al. Ann Clin Psychiatry. 2007;19(4):289-303. Evans DW, et al. Biol Psychiatry. 2005;58:175-189.
Lave JR, et al. Arch Gen Psychiatry. 1998;55(7):645-651. Donohue JM, et al. Pharmacoeconomics.2007;25(1):7-24. Simon GE, et al. Med Care. 2002;40(10):941-950.
Cost of Depression Management
• Evidence of medical-cost offsets is mixed
• Use of standardized treatments or guidelines improves outcomes but also leads to increased costs
– Mental health costs were lower in the intervention group, but total costs increased
• Cost per quality-adjusted life-year associated with improved depression care ranges from $2519 to $49,500
– Cost for patients at high risk of relapse was higher than costs for patients entered into programs from the beginning of depression care
• Patients at high risk of relapse had improved costs over patients in usual care
MCOs = managed care organizations. Kee C, et al. J Contin Educ Health Prof. 2007;27(Suppl 1):S26-S32.
Aspects of Managed Care Potentially Affecting Depression Care
• Access to care
– Presence of health insurance does not necessarily guarantee access to high-quality care
• Patient issues and satisfaction
– Patients’ attitudes toward and compliance with physician recommendations may impact outcomes of depression care
• Physician issues and behaviors
– Lack of collaboration between medical specialties, negative perceptions of managed care by psychiatrists, and resistance by psychiatrists to reimbursement through MCOs may all impact depression care
• Inadequate treatment
– Undertreatment of depression for all individuals is common and certainly affects care
System Issues for MDD
Factors InfluencingMDD Care
• Individual feedback to providers
• Cost-sharing
• MBHO
• Depression disease management
• Access to antidepressant medications
MDD Management Issuesin Managed Care
• Utilization management
• Quality improvement
• Mental health integration
• Cost implications
Question 3
According to a study by Nutting et al, __________ is the most significant burden to initiating antidepressant therapy.
A. Patient resistance
B. Patient noncompliance with visits
C. Healthcare system problems
D. Patient psychosocial burden
Patient resistance 30.6%
Patient noncompliance with visits 24.2%
Physician judgment overruled guideline-concordant treatment 19.3%
Patient psychosocial burden 12.9%
Healthcare system problems 12.9%
Nutting PA, et al. J Gen Intern Med. 2002;17:103-111. Brown C, et al. J Community Psychol. 2010;38(3):350-368.
Social stigmas about mental illnessmay also be a barrier to effective diagnosis and treatment
Barriers to Effective Treatment of Depression
• Cluster analysis of 239 patients having 5 or more symptoms of depression seen by 12 physicians in 6 primary care practices
• Most significant burdens to initiating antidepressant therapy were
Thompson D, et al. Am J Manag Care. 1996;2:1239-1246. Sheehan DV, et al. J Clin Psychopharmacol.2004;24:544-548. Eaddy M, et al. Presented at: American Psychiatric Association (APA) 157th Annual Meeting; May 1-6, 2004; New York, NY.
Cost of Nonadherence
• Nonadherence expenditures
– Cost savings result from failure to purchase prescribed medication
– Cost increases occur from untreated depression, which begets more frequent hospitalizations due to other medical conditions
• Adherence reduces total cost
– Retrospective analysis of large national managed care database
– 30-day increments of continued antidepressant therapy each reduced likelihood of hospitalization for anxiety by 22%, depression-related hospitalization by 19%, and any type of hospitalization by 14%
Emerging Clinical Evidence for MDD Pharmacotherapy
CER
• Defined as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose treat, and monitor health conditions in “real-world” settings
• Decision makers need comparative information to support informed treatment choices
• CER produces information that decision-makers can use to make informed treatment and coverage decisions
• Value of CER
– Generates data comparing the effectiveness of competing therapies
– Provides insights on use of therapies in “real-world” patients
– Support selection of the most effective and safe drug
– Results can be applied to an individual patient
CER = comparative effectiveness research.Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and the Congress. US Department of Health and Human Services; June 30, 2009. National Pharmaceutical Council. http://www.npcnow.org/App_Themes/Public/pdf/Issues/pub_cer/experimental_nonexperimental_study_final.pdf. Accessed September 5, 2013. Oderda GM, et al. J Manag Care Pharm. 2011;17:S19-S24.
Application of CER Results to Support Decision Making
• Guideline concordant care
– Reduces variability in outcomes
– Reduces variability in costs
– Invests in patients’ health and improves health outcomes
– Reduces wasteful spending by using evidence to optimize efficacy and minimize toxicity
57
CER in Formulary and Benefit Design: Current Reality
• Impact of drug formulary or benefit design decisions on health outcomes is generally not measured
– Most likely reflects a lack of real-world CER data at a product’s launch
• Patients are not currently part of the formulary decision-making chain
– Increasing availability of PCOR will allow more patient-centered decision making in the future
• Reassessments of drugs for inclusion, exclusion, or change in position in the drug formulary are currently rarely performed
– Real-world CER can only effectively add value if reassessments of formulary decisions are conducted throughout the life cycle of a product
• Evaluation of the real-world ability of drugs to improve outcomes requires technology that effectively integrates all stakeholders
Biskupiak JE, et al. J Manag Care Pharm. 2012;18(5):S19-S28.
2008 Healthcare Reform Driving a Move Away From Volume and Toward Value
• Payment/delivery paradigm emphasis is on rewarding value instead of volume
– Value-based purchasing, shared savings, gain-sharing, bundled payments, capitation, etc
• Incentives such as the CMS 5-Star Rating System are being implemented to coordinate care among/across providers
– As of January 2012, plans with ≥4 stars receive bonuses along with higher rebates and plans with ≤3 stars will be flagged as “low-quality” on the Medicare website
• New structures are promoting actual and virtual integration
– ACOs, medical homes, home-based chronic care management, community health teams, healthcare innovation zones
• HEDIS® vs STARS
CMS = Centers for Medicare & Medicaid Services; ACO = accountable care organization.Biskupiak JE, et al. J Manag Care Pharm. 2012;18(5):S19-S28.
Consistent Themes: New Models
• ACOs may use various models and tactics including
– Organizational structure that supports health promotion, patient-centered care, and clinical integration
• Patient-centered medical homes (advanced primary care)
– Payment mechanisms focused on “fee for value” rather than “fee for volume”
• Quality incentives for improved processes and outcomes
• Likely to take it in steps: fee-for-service – per case/“at-risk” quality payments – bundled – capitation
Environment
Present
• Perverse incentives—volume over value
• Unsustainable healthcare cost trajectory
• Medicare and Medicaid will cut payment rates
• Will reach a point where we can no longer cost-shift to commercial payers to make up for declining government payment levels
• Efficiency gains will not be enough for success
Future
• Consequences of care outcomes will be shared between payers and providers
• Primary care will be pivotal in managing health and utilization
• Proactively managing the health of individuals will be rewarded
• Proactively managing of the health of our communities will be rewarded
• If we can perform better than others, we have more to gain financially in a capitation environment
HEDIS® 2013 Measures:Measuring 2012 Data
Question 4
The HEDIS® AMM Measure measures eligible patients on an antidepressant medication treatment for _____ days in the acute phase.
A. 24
B. 48
C. 76
D. 84
AMM
• Care, screening, or test needed (ages 18 years or older)
• Adults newly diagnosed with depression and treated with an antidepressant who received the following
– Effective acute phase: filled sufficient number of prescriptions to allow for 84 days of continuous therapy
– Effective continuation phase: filled sufficient number of prescriptions to allow for 180 days of continuous therapy
• To qualify as a new diagnosis, 2 criteria must be met
– A 120-day (4 month) negative diagnosis history on or before the start date
– A 90-day (3 month) negative medication history on or before the start date
2013 HEDIS Measures. http://www.fchp.org/providers/resources/hedis-measures.aspx. Accessed August 26, 2013.
AMM (continued)
63.77%
46.34%
63.47%
47.39%
66.83%
49.79%
66.60%
49.18%
63.39%
46.81%
64.09%
48.03%
72.22%
55.63%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Effective Acute Phase Treatment Effective Continuation Phase Treatment
2008 2009 2010 2011 2010 Mountain Average 2010 National Average 2010 National 90 %ile
Ass
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n 2011 Goal 68.83% 2011 Goal 51.79%
AMM (continued)
• What we measure
1. Acute phase: percentage of members who remained on their antidepressant for at least 84 days during the first 3 months
2. Continuation phase: The percentage of members who remained on their antidepressant medication for at least 180 days during the first 6 months
AMM (continued)
Action Plan
• Send a letter to the member when they first start on an antidepressant
– Encourage them to adhere to their medication as prescribed by their provider
– Lists websites where they can find information about depression
• Web MD and the Intermountain Healthcare website
• Track the member for 6 months after starting their medication
– If they do not refill medication within 3 days past refill due date
• Send the member a refill reminder
– If they do not refill medication within 10 days past refill due date
• Fax a notice to their prescriber stating that the patient has not filled their antidepressant medication
AMM (continued)
Action Plan
• Primary care pay-for-performance
• Case management referral
• Integration of data
– ACO/SAO, patient-centered medical home projects
• Medication therapy management
• Increased provider and patient education
– Care Process Model
• Data tracking and evaluation
Managed Care Approaches to Improving Outcomes
Piette JD, et al. Arch Intern Med. 2005;165(15):1749-1755. Butterworth SW. J Manag Care Pharm.2008;14(6 Suppl B):S21-S25. Roter D. J Pharmacoepidemiol. 1995;3:37-48. Fleming WK. J Manag Care Pharm. 2008;14(6 Suppl B):S16-S20. Hoffman L, et al. Am J Manag Care. 2002;9(1):70-80. Tutty S, et al. Eff Clin Pract. 2000;3(4):170-178. Gilbody S, et al. Arch Intern Med. 2006;(21)166:2314-2321. Azocar F, et al. J Behav Health Serv. 33;(3) 2006;33(3):347-353. Hoffman L, et al. Am J Manag Care. 2002;9:70-80. Bambauer KZ, et al. Arch Intern Med. 2006;166(5):498-504.
Strategies to Improve Compliance and Improve Outcomes
• Pay-for-performance
• Strengthening patient–provider relationships
• Patient empowerment
• Integrated communication channels
• Medication therapy management
• Telephonic counseling
• Medication reminders
• Collaborative care/mental health integration
• Increased patient education
• Improved access to care
• Formulary management
• Value-based benefit design
VCM
• Integrated care
– Nurse case management
– Mental health management
– Utilization management
– Medication therapy management
– Disease management
• Coordinated care
– Complex acute illness
– Chronically ill
– Longitudinal—beyond episodic care that is related to hospitalization
• Quarterly follow-up
VCM = Veridicus Care Management.
Benefits of VCM
• Multiple licensed professionals under one roof
– Eliminate the “silo” effect of fragmented care management
– Coordinated care for better outcomes
• Improved health
– Members are able to navigate through the appropriate health system better
• Lower cost
– Less emergency room visits
– Less readmission to the hospital
• Less resource utilization
– Work is not duplicated by multiple professionals BUT collaboratively reviewed
• Communication with the physician
– Consultations are documented and sent to the physician
– Standard case management does not communicate with the physician
– Facilitates an educated discussion between the physician and patient
• Encourages patient to be more involved in their own healthcare
Conclusions
• The burden of depression in chronic medical illness is substantial• Tools exist that can assist the practitioner in recognizing and managing
depression• Safe and effective treatment for comorbid medical illness is presently
available and has the potential to improve outcomes in a variety of disease states
• Issues influencing depression care can be addressed through the implementation of managed care programs designed to maximize clinical and economic outcomes
• Why do we “care?”– Most of the medications used to treat depression are generic, or will be
generic soon, but…patients with depression demonstrate• Increased utilization of healthcare resources
• Increased morbidity
• High rates of complicating comorbidities
– Have a HEDIS® measure, so plans that desire NCQA accreditation need to work on the measures
– These members still need to be managed
Question & Answer Session
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