Download Abstracts from Professional Poster Presentations at AMCP`s 2011

ABSTR AC T S
Abstracts from Professional Poster Presentations
at AMCP’s 2011 Educational Conference
T
he following poster presentations have been prepared for the
Academy of Managed Care Pharmacy’s 2011 Educational
Conference, October 19-21, 2011, in Atlanta, Georgia. Poster
presentations are selected by the Program Planning and Development
Committee from proposals that are submitted to AMCP. Authors of
posters are responsible for the accuracy and completeness of the data
presented in the posters and in the abstracts published here. For more
information about the studies described below, please contact the corresponding authors, indicated by an asterisk (*), whose addresses are
listed in full. The names of the individuals who are scheduled to present
at the meeting are shown in bold.
■■  Assessment of Health Care Resource Utilization by
Level of Flare Severity in Patients with Systemic Lupus
Erythematosus (SLE) in the Managed Care Setting
Garris CP, Oglesby AK,* Dennis G. GlaxoSmithKline, 5 Moore Dr.,
Mail Stop-B.3202.3C, Research Triangle Park, NC 27709;
[email protected], 919.483.7827
Background: Systemic lupus erythematosus (SLE), a chronic autoimmune disorder affecting multiple organ systems, is characterized by
disease flares alternating with periods of remission. Recent research has
described the incidence of SLE flares by level of severity, but the impact
on health care resource use (HRU) has not been fully described.
Objective: To assess hospital and emergency room (ER) use by flare
severity among commercially insured patients with SLE.
Methods: Patients aged 18-64 years with diagnosed SLE and at least 3
years of continuous coverage were identified from a large administrative
claims database between the years January 2004 and December 2008.
A diagnosis of SLE required at least 2 claims for rheumatologist visits
on separate dates accompanied by a diagnostic code for SLE (ICD-9-CM
code 710.0x) and, in some cases, an additional requirement for at least
1 claim for a typical SLE medication. Severe and nonsevere SLE flares
were identified using an algorithm based on the Lupus Foundation’s 2nd
International Lupus Flare Conference definition and outpatient visits,
inpatient hospitalizations and ER visits supported by a qualifying SLE
diagnosis or SLE-related condition. The 1-year period following the initial SLE claim served as the index period, and patients were followed for
an additional 2 years to ascertain flare-associated inpatient admissions
and ER visits. All medical and pharmacy services utilized for 30 days
from the start of a flare event were included.
Results: There were 2,990 SLE patients included in the analysis,
and nearly all experienced at least 1 flare (95.7%) during the 2-year
follow-up. There were 30,701 distinct flare events for an average annual
flare rate of 5.1 per SLE patient. Severe flares accounted for 5.6% of
the total number of flares. Approximately 1/3 of severe flares required
ER services (37.3%) compared to 6.6% of nonsevere flares (P < 0.001).
More than half of the severe flares (59.7%) required inpatient stays with
an average cost of $22,898 per inpatient event compared to 1.1% and
$12,926 for nonsevere flares (P < 0.001).
Conclusions: SLE patients average multiple flares per year. Severe
flares contribute disproportionately to the use of inpatient and ER services. Avoiding flares, particularly severe flares, may be associated with
significant cost savings.
SPONSORSHIP: This research was funded by GlaxoSmithKline,
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Research Triangle Park, NC, and Human Genome Sciences, Inc.,
Gaithersburg, MD.
■■  Association Between Osteoporosis Treatment
Change and Total Direct Health Care Costs in Medicare
Advantage Prescription Drug (MA-PD) Plan
Ward M,* Viswanathan HH, Xu Y, Adams J, Stolshek B, Kallich J, Saag K.
Competitive Health Analytics Inc., 325 W. Main St., WFP 6W, Louisville,
KY 40202; [email protected], 502.580.2508
Background: Several therapies are available for the treatment of
osteoporosis, allowing patients to switch between treatments. Treatment
change is often anticipated to improve outcomes, including total health
care costs. However, little is known about the association between osteoporosis treatment change and health care costs.
Objective: To examine the association between osteoporosis treatment change and total direct health care costs among MA-PD members
in a large U.S. health plan.
Methods: This was a retrospective cohort study of MA-PD members
aged 50 years or older, newly initiated on an osteoporosis medication
(i.e., no medication claim 1 year prior to the index date or date of the first
osteoporosis medication) between January 1, 2006, and December 31,
2008. Members with Paget’s disease or neoplasm, multiple osteoporosis
medications, those who reinitiated the index therapy post-switching or
discontinued the index therapy without switching to another osteoporosis therapy were excluded. Treatment change was defined as a change
in therapy or schedule within 12 months post-index. Unadjusted direct
health care costs at 12 and 24 months post-index were examined for the
2 cohorts. A pre-/post-treatment change difference-in-difference (DID)
generalized linear model (golimumab) model controlling for covariates was used to assess the association between treatment change and
health care costs. A “change date” was randomly assigned to no-change
cohort members based on length of enrollment to conduct the pre-/posttreatment change DID cost analysis.
Results: A total of 19,574 MA-PD members were identified; 2,814
(14.4%) changed therapy within 12 months. The majority of members
(75%) changed treatment between bisphosphonates. The change cohort
had higher mean unadjusted costs ($9,647) at 12 months compared to
the no-change cohort ($8,533, P < 0.01). At 24 months, no differences
were found in unadjusted costs between the cohorts (P = 0.357). No
statistically significant association between treatment change and health
care costs was found in the DID golimumab model after controlling
for covariates including age, gender, ethnicity, lower income subsidy
status, comorbidity score, prevalent fracture, and total medication count
(P = 0.40).
Conclusions: Osteoporosis treatment change was not significantly
associated with total direct health care costs after controlling for
covariates. Improved economic outcomes in terms of reduced direct
health care costs as a result of osteoporosis treatment change, primarily
between bisphosphonates, were not found.
SPONSORSHIP: This research was funded by Amgen Inc., Thousand
Oaks, CA.
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
■■  Budgetary Impact of Adopting Abiraterone Acetate Plus
Prednisone for the Treatment of Patients with Metastatic
Castration-Resistant Prostate Cancer to a U.S. Health Plan
Senbetta M,* Sorensen S, Ellis L, Hutchins V, Wu Y, Linnehan J.
Janssen Biotech, Inc., 800 Ridgeview Rd., Horsham, PA 19044;
[email protected], 215.325.2403
Background: Abiraterone acetate (ABI), an androgen biosynthesis
inhibitor, recently received FDA approval for metastatic castrationresistant prostate cancer (mCRPC) patients who have received prior
chemotherapy containing docetaxel.
Objective: To estimate the projected budget impact of adopting ABI
for mCRPC patients from a U.S. health plan’s perspective.
Methods: A decision analytic model compared mCRPC treatment
cost before and 1-3 years after ABI adoption, based on a hypothetical
1 million-member plan. Plan mCRPC prevalence was derived from
prostate cancer incidence reported in U.S. epidemiology statistics
and disease progression data from published trials. Market shares for
alternative mCRPC treatments (prednisone (P) alone; cabazitaxel + P;
mitoxantrone + P; docetaxel + P) and ABI + P uptake (8% - year 1 to
55% - year 3) were derived from market research data. Treatment costs
were computed using prescribing information, treatment duration from
phase III trials, and drug costs considering common U.S. cost listing and
reimbursement schemes. Prevalence and costs of managing treatmentrelated toxicities were estimated from literature, treatment guidelines
and expert clinical opinion. Sensitivity analyses were conducted to
assess changing input values.
Results: In each modeled year, 58 new patients received treatment for
mCRPC. The annual budgets, averaged over 3 years were estimated to be
$2,455,268 without ABI and $2,454,662 with ABI. Over 3 years, medication cost increased an average of $53,225, and toxicity management cost
decreased an average of $53,831. The resulting net budget impact was
$606. The average incremental per member per month (PMPM) cost
impact was -$0.0001. When costs of treating toxicities were removed
from the model, the average incremental cost was estimated at $0.0044
PMPM after ABI introduction. When testing key sensitivity scenarios,
the model indicated ABI treatment duration (average incremental cost
PMPM increased to $0.0105), and cabazitaxel market share (average
incremental cost PMPM increased to $0.0158) were the main drivers
of cost.
Conclusion: The model results indicate that reimbursement for ABI
may have a neutral impact on a U.S. health plan’s budget given the relatively small size of the eligible population.
SPONSORSHIP: This research was conducted by Janssen Biotech Inc.,
Horsham, PA, without external funding.
■■  Characteristics of Gout Patients Initiating
Febuxostat in a Large U.S. Managed Care Population
Results: The study sample included 452 patients taking FBX and
5,870 patients taking ALLO. The ALLO cohort was slightly older (mean
age 57 vs. 55; P < 0.01) with a greater percentage of patients older than 75
years (9.8% vs. 4.7%; P < 0.01); 41% of FBX patients had prior ALLO use.
At baseline, FBX patients were more likely than ALLO patients to suffer
from kidney failure (defined from medical claims: 4% vs. 2%, P < 0.01),
heart failure (8% vs. 5%, P < 0.01), peripheral artery disease (2% vs. 1%,
P = 0.04), osteoarthritis (23% vs. 17%, P < 0.01), hypertension (70% vs.
63%, P < 0.01), hyperlipidemia (62% vs. 56%, P = 0.01); and presence of
tophi (2% vs. 1%, P = 0.06). FBX patients had a higher Quan-Charlson
Index score (1.4 vs. 1.0, P < 0.01) and a higher percentage of patients with
3 + comorbidities (20% vs. 13%, P < 0.01) compared with ALLO patients.
FBX patients had higher mean baseline sUA values (8.53 vs. 7.82 mg per
dL, P < 0.01). A higher percentage of FBX patients had an ER visit (23%
vs. 17%, P < 0.01) and an office visit (99% vs. 94%, P < 0.01) during the
baseline period. Patients taking FBX had higher per member per month
total health care costs during the baseline period compared to ALLO
patients ($1,293 vs. $817, P = 0.02).
Conclusions: Gout patients receiving ALLO were slightly older; however, those receiving FBX had more comorbidities, higher sUA levels,
and higher baseline resource utilization and health care costs compared
with ALLO patients.
SPONSORSHIP: This research was funded by Takeda Pharmaceuticals
North America, Inc., Oak Park, IL.
■■  Characteristics of Patients Taking Oxycodone
Controlled-Release and Related Medical Resource Use
Howe A, Anastassopoulos KP,* Chow W, Tapia CI, Baik RL, Biondi D,
Kim M. Covance Market Access Services Inc., 9801 Washingtonian Blvd.,
9th Fl., Gaithersburg, MD 20878; [email protected],
240.632.3304
Background: While oxycodone controlled-release (oxycodone CR) is
one of the most widely used oral long-acting opioids for pain, it is often
associated with bothersome side effects (SEs), resulting in additional
medical resource use (MRU) and productivity loss.
Objective: To characterize patients with noncancer pain who take
oxycodone CR and their experiences with it, focusing on SEs and their
impact on MRU, including out-of-pocket (OOP) costs and productivity.
Pinsky B,* Pandya BJ, Gomez RG, Singh J. OptumInsight, 1329 Avondale
Spring Dr., O’Fallon, MO 63368; [email protected], 636.272.4149
Background: Allopurinol (ALLO) has been commonly used for treatment of hyperuricemia for the past 40 years. Febuxostat (FBX) is a new
urate-lowering medication recently approved for the treatment of hyperuricemia in patients with gout.
Objective: To identify the characteristics of patients receiving FBX for
the treatment of gout in real world managed care settings in the United
States.
Methods: This retrospective study used 2009-2010 medical and
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pharmacy claims from adult patients with gout enrolled in a large U.S.
commercial health plan. All study patients had at least 1 medical claim
for gout and at least 1 pharmacy claim for either ALLO or FBX. Patients
were assigned to the FBX cohort if they had a pharmacy claim for FBX,
regardless of prior ALLO use; the ALLO cohort consisted of patients
with no evidence of FBX use. The date of first fill for cohort medication
was identified as the index date. Patients were also required to have at
least 1 serum uric acid measurement at least 14 days post-index date.
Patients were required to have 6 months of continuous enrollment prior
to index date (baseline period) and were followed for ≥ 90 days after
initiation of treatment.
Methods: A nationwide convenience sample of adults taking oxycodone CR (n = 438) for noncancer pain completed an online survey.
Respondents reported on SEs, level of SE bother (not bothered, bothered, very bothered), prescription and over-the-counter (OTC) medication use, physician visits, at-work productivity loss, and OOP costs,
along with other measures not reported here.
Results: The average age of the respondents was 41.7 years (range
18-86). Most (88.6%) were Caucasian, and more than half (63.9%) were
female. Low back pain was most frequently reported (41.2%), followed
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
by osteoarthritis/rheumatoid arthritis (20.1%), neuropathic pain (10.5%),
fibromyalgia (8.9%), neck pain (6.8%), recent surgery (4.3%), and other
(8.2%). The mean daily dose was 74.8 mg (median: 40.0 mg), taken in 2
doses (range 1-4 doses), on average. Most respondents (82.2%) reported
experiencing at least 1 SE, with 36.5% and 40.9% being bothered and
very bothered by at least 1 SE, respectively. The most frequently reported
SEs ( > 25%) were drowsiness (41.6%), constipation (36.8%), fatigue
or daytime sleepiness (36.5%), and dizziness (27.2%). Respondents
reported taking prescription (16.9%) and OTC (26.5%) medications to
manage SEs. As the level of SE bother increased, respondents reported,
on average, increased use of prescription (P < 0.001) and OTC (P < 0.001)
medications for SEs, increased monthly physician visits (P < 0.001), and
a $153 increase in monthly OOP costs (P = 0.014). Average at-work productivity loss over the past 2 weeks increased by $42 (P = 0.020).
any therapy change 6 months after having rejected aliskiren claims due
to utilization management tools, indicating potential clinical inertia in
hypertension management. Patients with restrictive formulary were
least likely to have therapy change. Clinical inertia could be a concern
in designing utilization management tools. More aggressive follow-up
with patients with a rejected claim may be warranted to reduce treatment gaps.
Conclusions: The majority of the respondents experienced SEs, with
most being bothered or very bothered by those SEs. As the level of SE
bother increased, other medication use, physician visits, patient OOP
costs, and employer costs increased. Further analyses of this survey data
will assess the impact on patient-reported outcomes, including, among
other measures, pain relief and functionality.
Trivedi D,* Rosenblatt L, Hebden T. Bristol-Myers Squibb, 777 Scudders
Mill Rd., Plainsboro, NJ 08536; [email protected], 609.897.3183
SPONSORSHIP: This research was funded by Novartis Pharmaceuticals
Inc., East Hanover, NJ.
■■  Comparative Cost-Efficacy of Biologic Agents
Used to Treat Patients with Rheumatoid Arthritis
and an Inadequate Response to Methotrexate
SPONSORSHIP: This research was funded by Janssen Scientific Affairs,
LLC, Raritan, NJ.
Background: Since 1998, a number of biologic agents have been
approved in the United States to treat adult patients with rheumatoid
arthritis (RA) who had an inadequate response to methotrexate (MTX).
While numerous cost analyses for these biologics have been performed,
no study has compared the cost-efficacy of both the long-standing and
more recently approved biologics for this population.
■■  Clinical Inertia Associated with Rejected Aliskiren Claims
Objective: To evaluate the cost per ACR 20, 50, and 70 response of
biologic + MTX relative to MTX alone in the treatment of RA at 1 year.
Zeng F,* Park J, Plauschinat C, Patel BV. MedImpact Healthcare Systems,
Inc., 10680 Treena St., Stop 5, San Diego, CA 92131; [email protected],
858.790.7124
Background: Clinical inertia, defined as delay in therapy intensification, is a serious problem in the treatment of hypertension. There
is concern that utilization management tools may be associated with
preventing or delaying needed therapy changes and, thus, resulting in
clinical inertia.
Objective: To investigate whether clinical inertia is associated with
rejected aliskiren claims due to utilization management, such as prior
authorization, step therapy, and restrictive formulary.
Methods: A retrospective study was conducted using MedImpact
Healthcare Systems, Inc., pharmacy claims data. Patients with a rejected
aliskiren claim due to utilization management and naïve to aliskiren
prior to having rejected aliskiren claim were included. Patients were
followed for 6 months after the initial rejected aliskiren claim to see
whether there was therapy change. Therapy change was defined as
titration of old regimens, fulfillment of aliskiren or fulfillment of a new
antihypertensive medication not used previously.
Results: A total of 1,955 patients were identified. The average age was
64.5 and 54.4% patients were female. Commercial HMOs, Medicaid and
Part D accounted for 53.9%, 10.3% and 35.9% respectively. Six months
after having rejected aliskiren claims, 36.8% overcame the utilization
management and filled aliskiren, 45.1% filled a new antihypertensive
medication not used previously and 11.0% patients titrated old antihypertensive medications. More than a quarter of patients (28.3%) did not
have therapy change in antihypertensive treatment. Logistic regression
analysis shows that patients rejected due to prior authorization (odds
ratio [OR] = 4.00, 95% confidence internal [CI] = 1.89-8.44) or step
therapy (OR = 2.59, 95% CI = 1.26-5.32) were more likely to have therapy
change compared to patients rejected due to a restrictive formulary.
Other variables, such as age, gender, and geographical location, were
not significant.
Conclusions: A significant number of patients (28.4%) did not have
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Methods: The annual therapy costs of abatacept, infliximab, etanercept, adalimumab, certolizumab, and golimumab were computed based
on the wholesale acquisition cost (WAC) per unit dose multiplied by
frequency of administration as per label. For biologics with an IV route
of administration, infusion administration costs were also included.
Efficacy data were derived from the clinical trials of biologics in patients
who had an inadequate response to MTX. ACR response rates at 1 year
were adjusted to a comparable scale using the formula proposed by Choi
et al.: Marginal ResponseActive B = (ResponseActive B - ResponseMTX
B) / (1 - ResponseMTX B); adjusted to MTX Response in Trial
A = ResponseMTX A + Marginal ResponseActive B* (1 - ResponseMTX A).
Results: The cost per response ratio was comparable across all biologics except for infliximab 10 mg per kg every 4 weeks (see table).
TABLE
Cost Per Response Ratio for
Biologics Plus Methotrexate
Biologic + Methotrexate (MTX)
Abatacept - 10 mg per kg
every 4 weeks + MTX
Certolizumab - 400 mg
every 4 weeks + MTX
Adalimumab - 40 mg
every 2 weeks + MTX
Infliximab - 3 mg per kg
every 8 weeks + MTX
Etanercept - 25 mg twice
a week + MTX
Golimumab - 50 mg every
month + MTX
Infliximab - 10 mg per kg
every 4 weeks + MTX
Cost Per
ACR20
Response
$69,051
Cost Per
ACR50
Response
$76,116
Cost Per
ACR70
Response
$101,600
$74,824
$77,580
$124,754
$78,505
$74,774
$119,850
$86,640
$145,528
$182,481
$94,411
$64,221
$85,381
$99,932
$119,944
$203,402
$242,785
$283,491
$454,801
ACR = American College of Rheumatology.
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
Conclusions: In adult RA patients with an inadequate response to
MTX, treatment with the indicated dose of a biologic was associated
with similar cost efficacy with the exception of infliximab at the highest
maintenance dose. These results suggest that factors other than cost per
response should be considered in deciding which biologic to prescribe
in this patient population.
SPONSORSHIP: This research was funded by Bristol-Myers Squibb,
Plainsboro, NJ.
■■  Comparative Effectiveness of Allopurinol and
Febuxostat in Lowering Serum Uric Acid in a Large
U.S. Commercially Insured Population
Gleason PP,* Starner CI, Slavik K. Prime Therapeutics LLC, 1305
Corporate Center Dr., Eagan, MN 55121; [email protected],
612.777.5190
Background: Dabigatran is a direct thrombin inhibitor indicated
to reduce the risk of stroke and systemic embolism in patients with
nonvalvular atrial fibrillation. The landmark RE-LY trial (N Engl J
Med. 2009;361:1139-51) demonstrated fewer dabigatran-treated (150
mg orally twice daily) individuals experienced the negative composite
outcome, and the number needed to treat (NNT) to obtain 1 net benefit
compared with warfarin was 137.
Objective: To report dabigatran cost-effectiveness compared with
warfarin using real-world data of total medical and pharmacy costs and
the NNT of 137 from the RE-LY trial.
Singh J,* Pandya BJ, Gomez RG, Pinsky B. University of Alabama
at Birmingham, 510 S. 20th St., EOT 805B, Birmingham, AL 35294;
[email protected], 205.504.9559
Background: Gout affects an estimated 8.3 million Americans.
Recent studies have shown that attaining target serum uric acid (sUA)
levels is an effective way to manage gout.
Objective: To assess the comparative effectiveness of allopurinol
(ALLO) and febuxostat (FBX) in lowering sUA in a real world managed
care setting in the United States.
Methods: This retrospective study utilized 2009-2010 medical and
pharmacy claims along with laboratory data from adults with gout
enrolled in a large U.S. commercial health plan. Study patients had at
least 1 medical claim with a diagnosis of gout and 1 fill for ALLO or
FBX. Regardless of ALLO use, any patient initiated on FBX was placed
in the FBX cohort. All other study participants were placed in the ALLO
cohort. The date of first cohort medication fill was identified as the index
date. Patients were also required to have at least 1 sUA measurement
a minimum of 14 days post-index date. Patients had a minimum of 6
months of continuous enrollment prior to their index date (baseline
period) and were followed for a minimum of 90 days after start of treatment. Effectiveness of lowering sUA was examined as both change in
sUA from baseline period to first available sUA in the follow-up period,
and the percentage of patients achieving sUA goal ( ≤ 6 mg per dL).
Results: The study sample included 452 patients taking FBX and
5,870 patients taking ALLO. At baseline, FBX patients had a higher
Quan-Charlson comorbidity Index score (1.4 vs. 1.0, P < 0.01), and a
higher mean sUA level (8.53 vs. 7.82 mg per dL, P < 0.01) compared to
ALLO patients. FBX-treated patients had an average decrease in sUA
of 2.1 mg per dL versus 1.2 (P < 0.01) for ALLO-treated patients. After
controlling for baseline patient demographic, uric acid and baseline
comorbidities characteristics, FBX was associated with a 0.52-mg per
dL greater drop in sUA versus ALLO (P < 0.01). After controlling for
comorbidities (hypertension, peripheral artery disease, heart failure,
rheumatoid arthritis, osteoarthritis, hyperlipidemia, kidney failure [kidney failure was defined from the medical claims], and presence of tophi),
geographic region, gender, age, and insurance type, FBX-treated patients
had 72% higher odds of attaining sUA goal at ≤ 6 mg per dL (OR = 1.72,
95% CI = 1.40-2.11, P < 0.01) and 2x higher odds of attaining sUA of ≤ 5
mg per dL (OR = 2.09, 95% CI = 1.68-2.60, P < 0.01).
Conclusions: FBX lowered sUA in gout patients significantly more
than ALLO as demonstrated by both the absolute value of the change in
sUA as well as the likelihood that a patient would achieve sUA goals.
SPONSORSHIP: This research was funded by Takeda Pharmaceuticals
North America, Inc., Oak Park, IL.
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■■  Cost-Effectiveness of Warfarin Compared with Dabigatran
Methods: Medical data from a 2 million-member commercial insurer
were queried to identify continuously enrolled members in 2009 with:
(a) warfarin claim in January 2009, (b) cumulative warfarin supply in
2009 of at least 270 days, and (c) at least 1 medical claim indicating warfarin management/monitoring. Current procedural terminology codes
were used to identify claims specific to warfarin management (see table).
Using allowed amounts from the claims, the average per patient per year
(PPPY) cost for each category (office visits, laboratory [INR], and blood
draws) was identified. Pharmacy costs are reported as wholesale acquisition cost (WAC), and patients were deemed 100% compliant for 1 year.
Results: Among 1,642,464 continuously enrolled members, 13,337
(0.8%) had a warfarin claim during 2009; 3,343 (25.1%) had a warfarin
claim in January 2009 with cumulative warfarin supply of at least 270
days; 2,975 (89.0%) patients met warfarin monitoring criteria and the
PPPY total warfarin management costs were $712 ($498 medical plus
$214 pharmacy). Total dabigatran costs were $2,582 ($118 medical
[estimate 2 office visits] plus $2,464 pharmacy). Per patient dabigatran
management costs were $1,870 higher than warfarin. Treating 137
patients with dabigatran instead of warfarin would result in an additional medical-pharmacy cost of $256,190 with a clinical benefit avoidance of 1 stroke at a cost of $26,407 (Medicare DRG 65) for a net cost of
$256,190-$26,407 = $229,783 per event avoided.
Conclusion: Health insurers and payers should consider performing warfarin management cost analyses to determine their warfarin
compared with dabigatran cost-effectiveness in order to make more
informed formulary placement decisions.
SPONSORSHIP: This research was conducted by Prime Therapeutics
LLC, Eagan, MN, without external funding.
TABLE
Warfarin Management Annual Medical
Utilization and Costs (n = 2,975 patients)
Total
Paid ($)
620,279
Average
Total
[SD]
Average
Medical Claims
Cost
Claims
PPPY
PPPY ($)
10,529 3.5[5.9]
209
Office visits (CPT codes
99211-99215, 99201-99205)
INR (CPT codes 85610)
617,829
42,675 14.3[11.0]
208
Blood draw (CPT codes
207,616
19,344 6.5[7.4]
70
36415-36416)
Home INR (CPT codes G0248,
31,281
281 0.1[0.9]
11
G0249, G0250, 99363-99364)
CPT = current procedural terminology; INR = international normalized ratio;
PPPY = per patient per year; SD = standard deviation.
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
■■  Cost-Effectiveness Analysis of Roflumilast/Tiotropium
Combination Therapy Versus Tiotropium Monotherapy in
Patients with Severe to Very Severe COPD
Yu AP, Sun SX,* Marynchenko M, Banerjee R, Mocarski M, Yin D, Wu EQ.
Forest Research Institute, Harborside Financial Center, Plaza V, Jersey City,
NJ 07311; [email protected], 201.427.8316
Background: Roflumilast, a once-daily oral selective phosphodiesterase-4 inhibitor recently approved by the FDA, reduces the risk
of chronic obstructive pulmonary disease (COPD) exacerbations in
patients with severe COPD associated with chronic bronchitis and a
history of exacerbations. Tiotropium is a commonly used long-acting
bronchodilator for the maintenance treatment of COPD.
Objective: To conduct a cost-effectiveness analysis comparing the
combination therapy of roflumilast and tiotropium versus tiotropium
monotherapy in patients with severe to very severe COPD.
Methods: The economic evaluation applied a disease-based Markov
cohort model with 5 health states: (1) severe COPD, (2) severe COPD
with a history of severe exacerbation, (3) very severe COPD, (4) very
severe COPD with a history of severe exacerbation, and (5) death.
Within a given health state, a patient may have a mild/moderate or
severe exacerbation or die. The probability of each event depends on the
severity of COPD. Evidence from roflumilast clinical trials was used to
estimate the relative risk of having an exacerbation and the change in
lung function in patients treated with roflumilast. Data from published
literature were used to populate other model parameters. The model
calculated health outcomes and costs for roflumilast/tiotropium combination therapy versus tiotropium monotherapy over a 5-year horizon.
Incremental cost and benefits were then calculated, and expressed as
cost-effectiveness ratios, including cost per exacerbation avoided and
cost per quality adjusted life year ($ per QALY).
Results: Over a 5-year horizon, the estimated incremental costs per
exacerbation avoided and per severe exacerbation avoided with the addition of roflumilast to tiotropium are $589 and $5,869, respectively, and
the incremental cost per QALY is $15,815. One-way sensitivity analyses
varying key parameters produced an incremental cost per QALY ranging from $1,963 to $32,773. The cost-effectiveness ratio was sensitive to
the relative risk reduction of exacerbations from adding roflumilast to
tiotropium.
Conclusion: The addition of roflumilast to tiotropium may be costeffective for the treatment of severe to very severe COPD patients.
SPONSORSHIP: This research was conducted by Forest Laboratories,
Inc., New York, NY, without external funding.
■■  Costs, Absences, Prevalence, and Impact of Bipolar
Disorder, Other Mental Disorders, Chronic Constipation,
Functional Dyspepsia, GERD, Gout, and Insomnia
Brook RA,* Kleinman N, Smeeding JE. The JeSTARx Group, 18 Hirth Dr.,
Newfoundland, NJ 07435; [email protected], 973.208.8621
Background: Health conditions impact employers’ costs across a
number of benefit types. Publications with objective data comparing
conditions are limited. To assess the impact of different conditions, it is
advisable to compare the impact of different conditions using objective
data and similar methodologies.
Objective: To compare the costs, absences, and prevalence for employees with bipolar disorder (BPD), other mental disorders (OMD), chronic
constipation (CC), functional dyspepsia (FD), gastroesophageal reflux
disease (GERD), gout, and insomnia.
556 Journal of Managed Care Pharmacy
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Methods: A 2001-2010 U.S. employee database was used to identify
subjects with the study conditions and controls (employees without disease). All studies used 2-part regression models to control for differences
between subjects with and without each condition. Direct costs included
medical and prescription drug claims paid. Absence costs (due to Sick
Leave, Short- and Long-term Disability, and Workers’ Compensation)
were based on payments to the employee. Absences were based on
reported hours or days of missed work. Incremental costs and absences
were calculated as regression-adjusted differences between the cohorts
and were considered significant at P < 0.05. All costs were adjusted to
2010 U.S. dollars. Cost and prevalence data were combined to project
the impact across a population of employees.
Results: Numbers of employees for each disease/control cohort were:
BPD (761/229,145), OMD (26,776/185,802), CC (2,095/295,911), FD
(1,669/274,206), GERD (11,653/255,616), gout (1,171/274,867), and
insomnia (17,230/281,958). The highest prevalence was for OMD
(12.6%), followed by insomnia (5.76%), GERD (4.36%), CC (0.70%),
FD (0.61%), gout (0.47%) and BPD (0.33%). BPD was associated with
the most incremental absence days (11.5) but only $1,343 in absence
costs. Gout had the highest incremental absence costs ($1,818), but
only 4.6 incremental absence days. From highest to lowest, the total
incremental direct and absence costs per employee were BPD ($9,085),
FD ($5,075), OMD ($5,034), GERD ($4,481), CC ($4,236), gout ($4,107),
and insomnia ($2,226). Projected costs for a cohort of 1,000 employees were: OMD = $634,284; GERD = $195,372; insomnia = $128,218;
FD = $30,958; BPD = $29,981; CC = $29,652; and gout = $19,303.
Conclusions: This research highlights the need to report not just the
costs for those with a condition, but also the costs for controls, and the
prevalence of the condition. Examining the projected budget impact
enables organizations to make better coverage decisions.
SPONSORSHIP: This research was conducted by The JeSTARx Group,
Newfoundland, NJ, and HCMS Group, Cheyenne, WY, without external
funding.
■■  Development of a Conceptual Model of
Adherence to Oral Anticoagulants to Prevent Stroke
in Patients with Nonvalvular Atrial Fibrillation
Siu K,* Walker DR, Mordin M, Sander S, Pladevall-Vila M, Brown M.
Boehringer-Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., Ridgefield,
CT 06877; [email protected], 203.778.7815
Background: Oral anticoagulant (OA) medication is the recommended therapy in preventing thromboembolic complications of atrial
fibrillation (AF). A conceptual model can depict a process of specific
relationships between different factors that ultimately affects patient outcomes. A conceptual model of adherence would help focus and inform
efforts in improving adherence by identifying these influencing factors.
Objective: To develop a conceptual model of adherence to OA medication to improve adherence and potentially prevent strokes among
patients with AF.
Methods: PubMed search was conducted for English-language articles,
published 2005-2010, relating to factors affecting OA medication adherence, excluding mechanical heart valve-replacement articles. Four focus
groups with 38 participants were also conducted in 2011, including
patients aged 60 years of older, diagnosed with nonvalvular AF, and
currently taking OA medication. Participants were asked about motivators and barriers related to taking OA medication. Factors identified in
the literature review and focus groups were evaluated for inclusion in
the model.
Vol. 17, No. 7
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
FIGURE
Conceptual Model of Adherence to Oral Anticoagulants
to Prevent Stroke in Patients with Atrial Fibrillation
Predisposing, moderating,
and contexual factors
Knowledge
base and
reinforcement
Short-term and
long-term
motivation
Personalized system,
habit formation, and
system adaptation
Results: 181 publications were identified, and 30 were selected for
full-text review. The focus group participants had a mean age of 70
years. One-half or more reported a diagnosis of hypertension or high
cholesterol, and half had been taking an OA medication for less than
5 years. The resulting conceptual model from the literature review and
focus groups identified 4 influencing components: (a) knowledge base of
the disease and continued reinforcement (i.e., health care provider reinforcement); (b) short-term and long-term motivation (e.g., avoidance of
negative health consequences); (c) personalized system, habit formation,
and system adaptation (e.g., developing a routine or external reminders);
and (d) self-efficacy loop (i.e., the personalized system and its adaptability is reinforced as patients become more consistent, confident, and
adherent). Exogenous factors, such as age, sex, education also may affect
patient adherence.
Conclusions: Adherence in patients with AF is complex and multifactorial. This model identifies opportunities for effective interventions
to improve patient adherence with OA medications.
SPONSORSHIP: This research was conducted by Boehringer-Ingelheim
Pharmaceuticals, Inc., Ridgefield, CT, without external funding.
■■  Effects of a Desvenlafaxine Prior Authorization on Health Care
Resource Utilization and Costs in Commercially Insured Patients
Whiteley J,* Landsman-Blumberg PB, Cao Z, Alvir J, Harnett J. Pfizer
Inc., 235 E. 42nd St., New York, NY 10017; [email protected],
212.733.1258
Background: Health plans and pharmacy benefit managers often use
prior authorization (PA) to encourage less costly prescription drug utilization. Evidence of PA effectiveness however is mixed especially with
respect to pharmacologic treatment of depression.
Objective: To compare changes in health care resource use and costs
for management of patients with major depressive disorder (MDD) in
commercial health plans requiring a PA for desvenlafaxine use and plans
with no known desvenlafaxine restrictions.
Methods: Retrospective claims data (May 2007-October 2009) for
patients diagnosed with MDD from 7 health plans with and 8 health
plans without a PA for desvenlafaxine were selected. Patients aged
18-64 years with at least 1 inpatient or 2 outpatient claims for MDD in
the baseline period and continuously enrolled for the full study period
were identified. To capture all MDD-related health care resource use and
costs, mental health and substance abuse claims for selected patients
www.amcp.org
Self-efficacy loop
OA
medication
adherence
had to be available in the database. Differences in MDD-related health
care resource use and costs were compared using a pre-post, parallel
group design with 1-year baseline and follow-up periods bounding a
6-month desvenlafaxine launch period. Difference-in-difference analyses comparing the cohorts year-over-year were conducted using both
t-tests and generalized linear models adjusting for differences in patient
demographic and clinical characteristics.
Results: There were 41,878 patients in PA plans and 21,910 patients
in non-PA plans. Compared with non-PA plans, the probability of desvenlafaxine use in the PA plans relatively decreased by 0.65 percentage
points (P < 0.001). The PA was associated with a relative increase of 0.77
percentage points in the probability of using any other MDD-related
medications (P = 0.018). The PA was also associated with a 0.28 percentage point relative increase in the rate of MDD-related hospitalizations
(P = 0.001) and a 1.18 percentage point relative increase in the rate of
MDD-related nonpsychotherapy office visits (P < 0.001). There were no
statistically significant differences in MDD-related total, inpatient, outpatient or pharmacy costs.
Conclusions: Although the PA policy was associated with controlled
access to desvenlafaxine, the overall effect was a shift to the use of other
MDD-related medications and increased utilization of MDD-related
medical services. There was no statistically significant effect on MDDrelated health care resource utilization or expenditures.
SPONSORSHIP: This research was conducted by Pfizer Inc, New York,
NY, without external funding.
■■  Effects of a High-Cost Generic Program on Drug Expenditures
Zeng F,* Leung K. MedImpact Healthcare Systems, Inc., 10680 Treena St.,
Stop 5, San Diego, CA 92131; [email protected], 858.790.7124
Background: High-cost generics (HCGs) have increasingly become
a concern in the management of medication costs. In 2010, MedImpact
Healthcare Systems, Inc assisted a commercial MCO plan to develop a
new benefit design for HCGs. HCGs are defined as drugs whose average
ingredient cost per prescription exceeded $50 and lower cost alternative drugs were available. Exceptions to these criteria were made where
drugs used for the standard of care exceeded $50 per prescription.
Medications in the HCG tier were raised from 10% to 30%, the same
coinsurance as formulary brand tier. This program was implemented in
October 2010.
Vol. 17, No. 7
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Journal of Managed Care Pharmacy 557
Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
Objective: To investigate the impact of HCG benefit design on health
plan’s expenditure.
Methods: This research is a retrospective data analysis. Patients in the
plan with HCG program were traced 6 months prior and 6 month after
the program. Another health plan within the same state was used as the
control group. An interrupted time series model was used to analyze per
member per month (PMPM) cost before and after the implementation of
the HCG program.
Results: The list of HCGs included 193 medications. These 193
medications accounted for roughly 20% of the total spending in generic
medications. After the new design for HCGs, the number of HCG claims
in the health plan in 6 months dropped from 21,161 to 19,395 while
membership is constant. The average health plan payment per HCG
claim decreased from $122.0 (standard deviation [SD] = $137.0) to $97.8
(SD = $124.2). The average copayment increased from $9.8 (SD = $16.1)
to $25.3 (SD = $24.1). An interrupted time series model showed that
PMPM cost for HCGs decreased by $1.35 (P < 0.001) after the implementation of the HCG program. The implementation of a HCG program did
not lead to increased spending for other non-HCG medications.
Conclusion: A health plan can have substantial saving by implementing a HCG program.
SPONSORSHIP: This research was conducted by MedImpact Healthcare
Systems, Inc., San Diego, CA, without external funding.
■■  Evaluating the Impact of Varenicline
Adherence on Quit Rates in the Geisinger Clinic
Liberman JN,* Shah NR, Stewart W, Lichtenfeld M, Kirchner L, Mastey
V, Harnett J, Galaznik A. Geisinger Center for Health Research, 100 N.
Academy Ave., MC 44-00, Danville, PA 17822; [email protected],
570.214.9627
Background: Use of smoking cessation pharmacotherapies can
significantly aid the success of quitting smoking. Treatment success,
however, is higher in patients who adhere to medications.
Objective: To estimate the association between adherence to varenicline therapy and 3-, 6-, and 12-month smoking cessation rates.
Methods: A retrospective cohort study was conducted among adult
subjects aged 18 years and older who were assigned to Geisinger primary
care physicians and had pharmacy insurance provided by Geisinger
Health Plan. Eligible subjects (n = 1,477) had a varenicline prescription
TABLE
Adjusted Hazard Ratio (95% Confidence
Interval) for the Association Between
Adherence and Smoking Cessation
Adjusted Hazard Ratio (95% CI)
Adherence
Full versus Zero
3 Months
6 Months
12 Months
1.30 (0.96-1.75) 2.08 (1.65-2.63) 1.93 (1.59-2.33)
P = 0.087
P < 0.001
P < 0.001
Full versus Partial
1.17 (0.78-1.77)
2.26 (1.64-3.12) 2.18 (1.68-2.84)
P = 0.450
P < 0.001
P < 0.001
Partial versus Zero
1.11 (0.74-1.63)
0.92 (0.67-1.26)
0.88 (0.69-1.13)
P = 0.619
P = 0.599
P = 0.325
a Adjusted for age, systolic blood pressure, marital status, and prior lung cancer
diagnosis.
Full = at least 90 days supply, with grace periods between fills but at least 80% proportion of days covered (e.g., 90 days supply in a 113-day period); Partial = at least
one 30-day fill after initial prescription; Zero = no varenicline claims.
558 Journal of Managed Care Pharmacy
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September 2011
ordered between January 1, 2006, and December 31, 2009, and a followup clinic visit within the subsequent 12 months. Adherence metrics
were calculated by linking the electronic health record (EHR) with adjudicated pharmacy claims. Nonadherence (n = 823) was defined as having failed to initiate on the prescribed varenicline therapy. Adherence
(n = 359) required claims covering at least 90 days of therapy over the
following 113-day period (resulting in a minimum of 80% of days with
medication available). Partial adherence (n = 295) was defined as having
initiated therapy but not completing the full 3-month course of therapy.
Quit rates were based on self-reported smoking status collected during
clinic visits in the 12-month follow-up period. Proportional hazards
regression modeling was used to evaluate the association between varenicline adherence and quit rates.
Results: No statistical difference was found in quit rates at 12 months
between those partially or completely nonadherent to a 12-week varenicline regimen (adjusted HR = 0.88, 95% CI = 0.69-1.13). Conversely,
patients fully adherent to the varenicline regimen were over twice
as successful in quitting smoking compared with completely nonadherent patients at 6 months (HR = 2.08, 95% CI = 1.65-2.63) and
12 months (HR = 1.93, 95% CI = 1.59-2.33). Similarly, fully adherent
patients were also more successful than partially adherent patients at 6
months (HR = 2.26, 95% CI = 1.64-3.12) and 12 months (HR = 2.18, 95%
CI = 1.68-2.84) (see table).
Conclusions: Smoking cessation occurred more often among individuals fully adherent to varenicline therapy; however, medication
nonadherence was common. After prescribing varenicline, physicians
may consider active patient follow-up to ensure adherence and optimize
treatment outcomes.
SPONSORSHIP: This research was funded by Pfizer Inc., New York, NY.
■■  Evaluation of an Interactive Voice
Response (IVR) Statin Adherence Program
Mitchell M,* Dunn J. SelectHealth, 5381 Green St., Murray, UT 84123;
[email protected], 801.442.7817
Background: Several retrospective analyses have demonstrated poor
adherence for medications used to treat chronic conditions including
hyperlipidemia.
Objective: To evaluate the impact of an Interactive Voice Response
(IVR) program on adherence and persistence among health plan members starting statin therapy.
Methods: This analysis is based upon 3,453 members who had an
“index” statin date between October 13, 2008, and March 1, 2010 (no
pharmacy claims evidence of a lipid-lowering therapy during the previous 6-month period). Ten percent of these members were not contacted
and placed in the control group. Approximately 55% of the eligible
members were unsuccessfully contacted via an automated phone call
due to a discontinued phone number, inability to reach after 6 attempts,
refusal to participate, or hang-ups (no contact group). The remaining
35% of members (intervention group) completed an interactive voice
response phone call. Sociodemographic characteristics by study group
were evaluated. Medication possession ratio (MPR) and persistence were
evaluated and compared for members receiving an IVR intervention,
members identified to receive the intervention but not reached by IVR,
and the control group. Subanalyses of adherence and persistence were
also evaluated based on comorbid conditions and out-of-pocket costs
for members. Laboratory values were also used to determine the impact
on low-density lipoprotein (LDL) reduction as related to intervention as
well as MPR rates.
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
Results: The majority of members in the analysis were males, 57.4%
compared with females 42.6%. The mean age of all groups was 50.2
years old. Six-month persistency for all groups combined was 76.0%.
Persistency for the intervention group (80.7%) was significantly higher
(P < 0.01 for both groups) than the control group (67.8%) and the no contact group (74.9%). Contrary to expectation, the lowest persistency rate
was detected among members with a $0 copayment. The highest level
of persistency was observed among members with mid-level payments
of $1-$19, and members with copayments > $20 demonstrated a level
persistency between the other groups. MPR for the intervention group
(0.68) was significantly higher (P < 0.01 for both groups) than the control
group (0.56) and the no contact group (0.61). Among members with
pre- and post-index laboratory values available, a greater percentage of
members in the intervention group reached their LDL goal compared
with the no contact group and control groups.
Conclusion: Within a therapeutic class of medications with known
poor adherence, higher MPR and persistence scores were achieved
through IVR compared with nonintervention and control groups.
SPONSORSHIP: This research was funded by AstraZeneca, Wilmington,
DE.
■■  Evaluation of Factors Associated with
Adherence to Phosphodiesterase Type 5 Inhibitors
for the Treatment of Pulmonary Arterial Hypertension
Waxman A, Chen S, Boulanger L, Tuggle F,* Golden G. United
Therapeutics Corporation, 47 Waterman Hill Rd., Norwich, VT 05055;
[email protected], 802.649.2330
Background: Pulmonary arterial hypertension (PAH) is an orphan
disease that requires chronic pharmacologic therapy and published
adherence data are limited on use of phosphodiesterase type 5 inhibitors (PDE5Is) in clinical practice. Economic burden could be substantial
from patient and payer perspectives, especially if patients are nonadherent.
Objective: To assess factors associated with adherence to PDE5Is in
the management of PAH.
Methods: We analyzed pharmacy claims from Medco between
January 2008 and December 2010. Patients were selected if they had
at least 1 claim for sildenafil or tadalafil (PAH-indicated brands only)
between May 2009 and May 2010. Patients naïve to PDE5Is during
12 months prior to the index date (date of first prescription) were
included. Patients were considered adherent if their proportion of days
covered (PDC) was ≥ 80% over a 6-month period. Logistic regressions were estimated to assess the factors associated with adherence.
Analyses were performed stratified by use of a specialty pharmacy (SP)
or retail pharmacy (RP).
Results: A total of 2,143 patients (mean age: 65 years; 65.1% female)
were included in the study, of which 1,817 were sildenafil (approved
dose 20 mg thrice-daily) and 326 were tadalafil (approved dose 40 mg
once-daily) users, respectively. Overall, 46.8% of patients were adherent
to PDE5Is, and adherence was higher among 930 SP users (65.6%) than
1,213 RP users (32.3%, P < 0.001). Adherence was higher among tadalafil
(60.7%) than sildenafil users (44.3%, P < 0.001). The mean [SD] copayment for a 30-day prescription of index PDE5I was $108 [$235]. Among
RP users, adherence was higher in patients using tadalafil (odds ratio
[OR] = 2.62; 95% = CI = 1.61-4.24) and patients with index prescription
by a pulmonologist (OR = 1.68, 95% CI = 1.14-2.47) while patients with
higher copayment ($51-$250: OR = 0.62, 95% CI = 0.42-0.91; $251 + :
OR = 0.58, 95% CI = 0.40-0.84) were less adherent. Among SP users, only
high copayment ($251 + : OR = 0.55, 95% CI = 0.34-0.88) was found to be
www.amcp.org
a significant factor for nonadherence.
Conclusions: Adherence to PDE5Is for PAH is suboptimal. Our findings suggest adherence to PDE5Is in patients with PAH is associated
with use of SP, simpler dosing frequency, lower financial barrier, and
index prescription from a pulmonologist.
SPONSORSHIP: This research was funded by United Therapeutics
Corporation, Research Triangle Park, NC.
■■  Frequent Nausea in Episodic Migraine Is Associated with
Increased Health Care Utilization and Costs: Results from the
American Migraine Prevalence and Prevention (AMPP) Study
Lipton RB, Buse DC,* Fanning KM, Reed ML. Montefiore Medical Center/
Albert Einstein College of Medicine, 1575 Blondell Ave., Ste. 225, Bronx, NY
10461; [email protected], 718.405.8364
Background: After pain, nausea is one of the most debilitating symptoms of migraine.
Objective: To assess health care utilization as a function of nausea
frequency in persons with episodic migraine (EM).
Methods: The 2009 American Migraine Prevalence and Prevention
(AMPP) survey was mailed to a U.S. population sample of 16,983 preidentified headache sufferers. Validated criteria were used to identify
EM. Nausea frequency was self-reported as occurring None of the
Time, Rarely, Less Than Half the Time, or Half the Time or More
with headache. Imaging (CT scan and MRI), overnight hospital stays
and visits to health care providers were reported for the preceding 12
months. Conservative direct care cost estimates were obtained from
public sources (Medicare fees, Healthcare Cost and Utilization Project).
Logistic regression and golimumab (controlling for sociodemographics)
were used to assess nausea group differences. Odds ratios (OR) and 95%
confidence intervals (CI) were generated.
Results: Among 11,839 returned surveys (69.7% response), 6,448 EM
cases reported nausea symptoms with headache; 21.4% with no/rare
nausea, 29.1% with some nausea (Less Than Half the Time) and 49.7%
with frequent nausea (Half the Time or More). Those with frequent
nausea versus no/rare nausea were more likely (P < 0.001) to report
a CT (OR = 1.40, 95% CI = 1.23-1.59), MRI (OR = 1.33, 95% CI = 1.171.50) or overnight hospital stay (OR = 2.21, 95% CI = 1.21-4.04), 1 or
more visits to primary care provider (OR = 2.30, 95% CI = 1.91-2.80),
neurologist/headache specialist (OR = 1.80, 95% CI = 1.30-2.30), pain
specialist (OR = 2.00, 95% CI = 1.00-3.70) or emergency room/urgent
care (OR = 3.53, 95% CI = 2.42-5.15), but not visits with psychiatry/
mental health (OR = 1.40, 95% CI = 0.75-2.60, P = 0.290) or chiropractic/
alternative care providers (OR = 1.31, 95% CI = 0.97-1.77, P = 0.073).
Mean number of health care provider visits and overnight hospital
stays were higher (P < 0.001) for those with frequent nausea. Estimated
annual per person direct care costs for frequent versus no/rare nausea
were 4.7 times higher for emergency room/urgent care, 4.3 times higher
for overnight hospital stays and 2.1 times higher for neurology/headache
specialist visits.
Conclusions: In this population-based sample of persons with EM,
headache-related nausea was common and associated with more health
care utilization and higher costs. Better control of this symptom may
reduce disease burden and lower health care utilization frequency and
costs.
SPONSORSHIP: This research was funded by National Headache
Foundation from Ortho-McNeil Neurologics, Inc., Titusville, NJ, and
NuPathe Inc., Conshohocken, PA.
Vol. 17, No. 7
September 2011
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Journal of Managed Care Pharmacy 559
Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
■■  Health Care Costs Among Gout
Patients on Allopurinol and Febuxostat
costs remained unchanged for FBX patients and increased in ALLO
patients.
Pandya BJ,* Pinsky B, Gomez RG, Singh J. Takeda Pharmaceuticals
North America, Inc., One Takeda Pkwy., Deerfield, IL 60015;
[email protected], 224.554.3105
SPONSORSHIP: This research was funded by Takeda Pharmaceuticals
North America, Inc., Deerfield, IL.
Background: Gout affects about 8.3 million Americans. On average,
patients with gout have $3,000 higher annual health care costs compared to patients without gout.
Objective: To identify total health care costs for gout patients receiving
allopurinol (ALLO) or febuxostat (FBX).
Methods: This retrospective study in adult patients used 2009-2010
medical & pharmacy claims linked with laboratory data from a large
U.S. managed care population. All patients had at least 1 fill for ALLO
or FBX; any patient prescribed FBX was placed in the FBX cohort. The
ALLO cohort included only patients with no FBX use. The index date
was the date of first fill during the study period. No exclusion criteria
related to previous ALLO treatment. Patients were required to have at
least 1 serum uric acid (sUA) measurement at least 14 days post-index
date. Patients had 6 months of continuous enrollment prior to their
index date (baseline period) and were followed for at least 90 days post
treatment start (follow-up). Total health care costs were calculated as per
patient per month (PPPM) to adjust for variable follow-up. The change in
cost (baseline vs. follow-up) was examined.
Results: The study sample included 452 FBX patients and 5,870 ALLO
patients. Prior to starting therapy, FBX patients had a higher QuanCharlson score (1.4 vs. 1.0, P < 0.001). Baseline PPPM total health care
costs were higher for FBX patients versus ALLO patients (P = 0.022).
Following initiation of index medication, FBX patients had a decrease
of $97 (P = 0.677) in total PPPM health care costs from baseline, while
ALLO patients had an increase of $204 (P < 0.001). The change in
costs is mainly due to medical costs. Medical costs decreased 18% in
the FBX patients and increased 23% in ALLO patients. After controlling for comorbidities (hypertension, peripheral artery disease, heart
failure, rheumatoid arthritis, osteoarthritis, hyperlipidemia, kidney
failure, presence of tophi), geographic region, gender, age, and insurance
type, no differences in follow-up total health care costs were observed
between ALLO and FBX patients (P = 0.754).
Conclusions: At baseline, total health care costs for FBX patients
were higher compared to patient on ALLO; however, the follow-up total
health care costs between the 2 cohorts were similar. Total health care
TABLE
P
Follow-Up Follow-Up
P
Valuea
FBX
ALLO Valuea
0.022
1,196
1,022
0.136
0.045
857
818
0.713
0.054
339
204
< 0.001
0.160
381
385
0.956
0.323
28
19
0.073
0.046
379
356
0.520
aP
value determined by student’s t-test.
ALLO = allopurinol; ER = emergency room; FBX = febuxostat.
560 Journal of Managed Care Pharmacy
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September 2011
Meissner B,* Trivedi D, Rosenblatt L, You M, Hebden T.
Bristol-Myers Squibb, 2731 Carnoustie Way, Missoula, MT 59801;
[email protected], 406.531.4864
Background: Health care costs of patients with rheumatoid arthritis
(RA) who initiate therapy with a biologic disease modifying antirheumatic drug (bDMARD) and then switch 1 or more times to other
bDMARD therapies is poorly described.
Objective: To examine the health care costs of RA patients who switch
treatment over the first 12 months of bDMARD therapy.
Methods: This observational, retrospective analysis utilized administrative claims from a large database containing commercially insured
beneficiaries between January 1, 2004, and March 31, 2010. The study
population consisted of RA patients that were newly initiated on abatacept, etanercept, infliximab, or adalimumab and who had 12 months
of continuous follow-up. Switching was defined as a different bDMARD
claim within a 100% gap in days supply from the prior bDMARD claim.
The days supply for bDMARDs identified within the medical file was
imputed based on the dosing frequency stated in the product label.
Among those defined as switchers, the follow-up period was divided
into the post-initiation period defined as the time between the start of
the biologic and the switch, and the post-switch period defined as the
time following the switch. All costs in the follow-up period are monthly
and were calculated only for the time the patient was on a bDMARD.
Both bivariate and multivariate statistical analyses were conducted
examining the costs of bDMARD switchers versus nonswitchers.
Results: bDMARD switchers tended to be younger (53 vs. 55, P < 0.001),
have higher baseline hospitalization rates (9.5% vs. 7.2%, P = 0.015), and
higher baseline monthly costs ($1,025 vs. $796, P < 0.001). Furthermore,
during the post-initiation period, the monthly cost was $291 higher
than for nonswitchers ($2,634 vs. $2,343, P < 0.001) and $1,416 higher
($3,759 vs. $2,343, P < 0.001), following the switch. After controlling
for potential confounders (age, gender, Charlson Comorbidity Index,
and pre-index costs) post-switching costs increased by 51% (P < 0.001)
compared to the post-index costs of nonswitchers.
Conclusions: This study demonstrates that RA patients who subsequently switch their index bDMARD are significantly more costly at
baseline, and this difference in cost is exacerbated when switching to
another bDMARD occurs. A critical evaluation and understanding of
second-line bDMARD therapy selection is necessary both from a clinical
and economic perspective.
Unadjusted Health Care Costs in
the Baseline and Follow-Up Periods
Health Care
Costs Per
Patient Per
Baseline Baseline
Month ($)
FBX ALLO
Total costs
1,294
817
Medical costs
1,040
634
Pharmacy costs
255
182
Inpatient costs
482
241
ER costs
21
18
Office or out447
326
patient costs
■■  Health Care Costs Associated with Switching of
Biologic Disease Modifying Anti-Rheumatic Drugs
SPONSORSHIP: This research was conducted by Bristol-Myers Squibb,
Plainsboro, NJ, without external funding.
■■  Health Care Costs of Metastatic Prostate Cancer Patients
in the United States: Results from 2 Large Databases
Senbetta M,* Lafeuille M, McKenzie RS, Lefebvre P. Janssen Biotech
Inc., 800 Ridgeview Rd., Horsham, PA 19044; [email protected],
215.325.2403
Background: In metastatic prostate cancer (MPC) patients, treatment
options include secondary hormonal therapies, chemotherapy, and
radiotherapy.
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Objective: To quantify the health care cost of patients with MPC.
Methods: Health insurance claims from 40 self-insured companies
across the United States (Employer database: January 1999 to February
2009) and from the Medicare 5% (1999-2008) database were analyzed.
Patients < 65 years in Employer, ≥ 65 years in Medicare, with a metastasis diagnosis (ICD-9-CM codes 196-199) following 2 prostate cancer
diagnoses (ICD-9-CM codes 185, V10.46) within 365 days were identified. Patients with other malignant diagnoses at baseline, defined as
365 days prior to the metastasis diagnosis (index date), were excluded.
Patients were evaluated for baseline medical history and for total health
care costs during both the baseline and the study observation periods
(post-index date). Costs for the first and second year following the index
date were also reported.
Results: The study population comprised 9,229 patients (Employer
[E]: 731; Medicare [M]: 8,498). Mean age (SD) was 58.7 (5.1) in Employer
and 78.1 (7.7) in Medicare. Mean observation period (SD) was 1,030
(816) days for Employer and 9.2 (8.2) quarters for Medicare. Baseline
mean Charlson comorbidity index (SD) was 0.57 (1.03) for Employer
and 1.7 (1.9) for Medicare. Comorbidities included hypertension
(E = 40%; M = 66%), cardiovascular diseases (E = 24%; M = 57%), and
diabetes (E = 20%; M = 27%). Average (SD) baseline health care cost was
$15,903 ($20,908) for Employer and $11,625 ($14,434) for Medicare
patients. During the observation period, mean (SD) total health care
cost per patient per year (PPPY) was $24,056 ($1,401) for Employer and
$24,964 ($24,669) for Medicare patients. Mean (SD) PPPY costs for the
first year following the index date was $43,127 ($41,608) for Employer
and $38,117 ($40,661) for Medicare, whereas costs for the second
year were $17,773 ($27,416) for Employer and $22,621 ($29,008) for
Medicare. The main cost drivers were outpatient services (E = $15,171
PPPY; M = $11,252 PPPY), followed by inpatient services (E = $5,569
PPPY; M = $9,257 PPPY).
Conclusions: The current observational study described health care
costs in patients with metastatic prostate cancer during the baseline and
observation periods, and stratified by year following the index date.
Such evidence provides greater understanding of the economic burden
for this patient population.
SPONSORSHIP: This research was conducted by Janssen Biotech Inc.,
Horsham, PA, without external funding.
■■  Identifying Diabetes Behavioral Patient
Segments Using Medical/Pharmacy Claims
Davis PM,* McKinnon I, Cannon HE. Kantar Health, 11 Madison Ave.,
New York, NY 10010; [email protected], 610.544.2030
Background: One-size-fits-all educational interventions leave many
diabetic patients without optimal control. Programs customized for specific patient types are hypothesized to improve patient outcomes. Select
Health, a subsidiary of Intermountain Health, had an average HbA1C of
7.3% with nearly 22% of diabetics 8 +, and wanted to improve.
Objective: To (a) identify segments of patients with different clinical
attributes and attitudes via primary research, and (b) assign patients
not part of the original study to their behavioral segments utilizing only
medical and claims data. The results can be used to combine patient
behaviors and their clinical resource utilization to describe the patients
and tailor interventions for improved outcomes.
Methods: 403 Select Health members were surveyed. The research
made use of validated diabetes scales to help inform the design. Key
behavioral parameters, clinical characteristics, and attitudinal elements were evaluated, and 5 distinct segments were identified. The
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403 patients were then matched to their pharmacy and medical claims
data. An algorithm was developed to predict segment membership for
these patients using only the pharmacy and medical claims data. The
goal of the algorithm was to test whether Select Health’s entire diabetic
population could be classified utilizing only medical and pharmacy
claims, allowing inference of attitudes and behaviors, and thus the
types of interventions that would likely succeed with each segment. The
mined medical and pharmacy claims data was used to find patterns
linking such data to segment membership. Steps to finding patterns to
link patients to their respective segments included Computer-Assisted
Piecewise Linear Regressions, nonlinear approaches, neural nets, timelagged relationships, and other data mining and modeling procedures.
The algorithm was then tested for accuracy using n-fold cross validation.
Results: Using the algorithm, the surveyed patients were assigned
to 1 of the 5 previously identified segments using only their pharmacy
and medical claims data. Across the segments, 78% of the patients were
correctly classified in their segments, allowing a high level of confidence
in the method.
Conclusions: Patient segmentations can be developed to aggregate
patients in ways that can be used for enhanced patient interventions.
Medical claims can add more detail to the patients’ behaviors. An
algorithm can be developed from claims data to efficiently segment the
entire patient population. Across all segments, the classification utilizing
claims data is very robust.
SPONSORSHIP: This research was funded by Lilly USA, LLC
Indianapolis, IN.
■■  Impact of a Reference-Based Pricing
Program for Select Drug Classes
Lin J.* CVS Caremark, 2211 Sanders Rd., Northbrook, IL 60062;
[email protected], 847.559.3676
Background: Clients are exploring ways to manage plan costs by
decreasing the burden of expensive brand drugs while encouraging
the use of generics. Reference-Based Pricing (RBP) generates savings for
plans by shifting cost share of costly brand drugs to members. A “reference price” or fixed price is selected and paid by the plan. The reference
price is often established at the drug class level and is equivalent to the
average cost of the generics in that class. A penalty amount for selecting
a brand would be assessed to the member, which would equal the difference between the cost of the brand drug and the reference cost.
Objective: To (a) determine the effects of a price-driven approach
designed to shift cost share of brand drugs to members while promoting generic utilization; (b) measure increased generic dispensing ratio
(GDR) as well as the resulting cost savings for both plans and members;
and (c) compare RBP classes to non-RBP classes to determine the financial impact and increase in generic utilization attributed to this program.
Methods: In 2010, a large Midwest university implemented an aggressive approach that comprised dispense as written (DAW) penalties in
conjunction with RBP. Reference prices were determined by the cost per
pill of utilized generics in the classes across the previous 12 months. A
more aggressive reference price would be established for classes with the
most cost-effective generics. Members were required to pay the generic
copayment plus the difference between the brand and the reference
price established within that class. The introduction of this program was
proactively communicated to members though various formats including print and web. The implementation of this program is projected to
save the university over $4 million in the first year.
Results: Implementation of the program yielded an immediate increase
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in GDR in the targeted classes. Substantial increases in GDR for all 6
classes were sustained 12 months post-implementation. Average member cost share was 20% in RBP class in the pre-period. In the 12 months
after implementation of RBP, average member cost share increased to
38% in RBP classes. Average member cost share for non-RBP classes
decreased from 20% to 18%. RBP classes experienced a 75% decrease
in brand drug claims filled whereas non-RBP classes experienced a 13%
decrease in the same post-implementation period. Results in the classes
will be adjusted to account of the impact of generic launches.
Conclusions: GDR increases driven by RBP have been sustained
throughout the implementation year. Other classes which did not implement RBP did not experience the same significant increase in GDR.
SPONSORSHIP: This research was conducted by CVS Caremark,
Northbrook, IL, without external funding.
■■  Impact of No-Cost Diabetes Medications and Health
Education on Diabetes and Related Therapies Adherence
Weber K.* CVS Caremark, 2211 Sanders Rd., Northbrook, IL 60656;
[email protected], 847.559.5438
N
W
A
R
D
H
T
I
W
Background: Medication adherence is a known driver of successful diabetes management. A study of people with diabetes with < 80%
adherence to all diabetes and diabetes-related therapies showed higher
glycosylated hemoglobin, blood pressure, cholesterol, and all-cause
hospitalization and mortality. An evidence-based plan design (EBPD) is
a strategy utilizing copayment incentives to help remove cost as a barrier to adherence. CVS Caremark data have shown increased diabetes
medication adherence rates as a result of diabetes EBPD implementation. A comprehensive diabetes management pilot program was implemented by a client offering medications at no member cost for diabetes,
hypertension, hyperlipidemia, and depression as long as the member is
enrolled in a disease management program.
Objective: To evaluate the effect of no-cost medications for diabetes
and concurrent common comorbidities on adherence change for members enrolled in pilot program.
Methods: A retrospective observational study design using claims preand post-pilot implementation from an integrated database of administrative pharmacy claims. The analysis was performed on the pilot
membership of a 67,000-member employer pharmacy benefit client. The
pilot program was initiated January 1, 2009. Adherence was analyzed for
diabetes medications as well as concurrent cholesterol, hypertension and
depression therapies. The proposed metric for adherence is the medication possession ratio (MPR). Results was analyzed as a percent change in
(a) adherence and (b) shift between adherent (MPR 80% or greater) and
nonadherent groups (MPR less than 80%). Comparisons were evaluated
for pilot members pre- and post-implementation as well as for nonpilot
diabetic members during the same timeframe. T-test analyses will be
performed to determine the statistical significance of the results.
Results: Average MPR for pilot group increased 45% more than
nonpilot members from pre-implementation to post-implementation.
Results in the concurrent disease-states (hyperlipidemia, hypertension,
depression) for pilot members experienced MPR rates increases greater
than those seen within the diabetic population.
■■  Impact of Side Effects of Hydrocodone
or Oxycodone Immediate-Release: PatientReported Bother and Other Medication Use
Howe A, Anastassopoulos KP,* Chow W, Baik RL, Tapia CI, Moskovitz B,
Kim M. Covance Market Access Services Inc., 9801 Washingtonian Blvd.,
9th Fl., Gaithersburg, MD 20878; [email protected],
240.632.3304
Background: While hydrocodone and oxycodone immediate-release,
alone or in combination with acetaminophen, ibuprofen, or aspirin,
are widely used to treat pain, both medications are reported to cause
bothersome side effects (SEs). Treating those SEs often requires other
prescription or over-the-counter (OTC) medications, burdening patients
with additional out-of-pocket (OOP) costs.
Objective: To assess the frequency and bother of SEs and their impact
on the use of other medications and related OOP costs among patients
taking hydrocodone or oxycodone.
Methods: A nationwide convenience sample of adults taking hydrocodone (n = 630) or oxycodone (n = 601) for noncancer pain completed
an online survey. Respondents reported on SEs, level of bother, medication use, and OOP costs, along with other measures not reported here.
Results: Hydrocodone respondents were older with less employed
(mean: 50.1 vs. 45.2 years; 38.6% vs. 53.4% employed). Almost half
reported taking hydrocodone (46.8%) or oxycodone (45.6%) for back
or neck pain. The mean daily dose was 14.0 mg hydrocodone or 16.5
mg oxycodone. More hydrocodone respondents reported > 90 days of
use (81.4% vs. 33.1%). However, more oxycodone respondents were
bothered by at least 1 SE (84.0% vs. 67.3%) with more also very bothered (30.8% vs. 26.0%). Dizziness, headache, and drowsiness combined
were most frequently reported (42.2% hydrocodone, 68.2% oxycodone).
Similar rates were observed for nausea, vomiting, and constipation
combined (41.0% hydrocodone, 61.7% oxycodone). Slightly more
hydrocodone respondents reported prescription (12.4% vs. 11.0%) and
OTC (22.4% vs. 18.6%) medications for SEs. As the level of SE bother
increased, respondents reported increased use of prescription (hydrocodone: r =1.00; oxycodone: r = 0.99) and OTC (hydrocodone: r = 1.00;
oxycodone: r = 0.99) medications for SEs, with associated average
monthly OOP costs of $5.42 for hydrocodone respondents and $5.23 for
oxycodone respondents. Among those very bothered, these costs were
double ($11.12 hydrocodone, $11.47 oxycodone).
Conclusions: The majority of the respondents experienced SEs for
each of the medications. As the level of SE bother increased, use of other
medications increased, levying economic and potential clinical burdens
on the respondents. Further analyses of these data will assess the impact
on other medical resource use and patient-reported outcomes, including, among other measures, pain relief and functionality.
SPONSORSHIP: This research was funded by Janssen Scientific Affairs,
LLC, Raritan, NJ.
■■  Longitudinal Analysis of Golimumab Utilization: Evidence from
the Wolters Kluwer Source LX National Health Claims Database
Ellis L,* Ryan A, Haas S, Gunnarsson C, Tandon N. Janssen Biotech, Inc.,
800 Ridgeview Rd., Horsham, PA 19044; [email protected], 410.939.3680
Conclusions: The study outcomes will provide data on whether a
behavior shift in adherence is present within the diabetes treatment
class as well as the other targeted disease states.
Background: Golimumab is a once monthly subcutaneous fully
human anti-tumor necrosis factor treatment for rheumatoid arthritis
(RA), ankylosing spondylitis (AS), and psoriatic arthritis (PsA).
SPONSORSHIP: This research was conducted by CVS Caremark,
Northbrook, IL, without external funding.
Objective: To report golimumab utilization patterns in a large retrospective U.S. health care claims database.
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Methods: This study measured longitudinal golimumab dosing patterns in adult patients with golimumab claims between April 24, 2009
and December 31, 2010, at least 1 diagnosis of interest (RA, PsA or AS)
and continuous activity in the Source LX database ( ≥ 6 months pre; ≥ 6
months post golimumab initiation). Eligible patients had at least 6 golimumab fills recorded. The proportion of fills with a 28-31 day supply
of 50 mg or 100 mg golimumab was determined and confirmed by plan
paid cost fields. The golimumab dosing interval (days) was defined as
the difference between consecutive fill dates.
Results: A total of 794 patients were studied. The sample was predominantly female (76%); had rheumatoid arthritis (RA = 76%, n = 607) and
mean age of 52.5 years. Approximately 56% of patients had used biologics prior to golimumab initiation (bio-experienced) while 44% had no
history of biologic use before initiating golimumab (bio-naïve). A 50 mg
dose was observed in 97.7% of fills. Overall, median dosing interval was
30 days and mean was 33.9 days. Dosing intervals were similar among
bio-naïve patients and bio-experienced patients. The average plan paid
cost per golimumab fill was $1,601.88.
Conclusions: In this longitudinal study of golimumab utilization in
a U.S. health care claims database, 3 quarters of golimumab users had
a diagnosis of RA and more than half of golimumab users had prior
treatment with biologic therapies. The majority of golimumab fills were
50 mg with a median refill interval of every 30 days. Golimumab dosing patterns in bio-naïve and bio-experienced patients were similar.
Assuming an average plan-paid cost per fill of $1,601.88, average annual
golimumab therapy costs in this population would be $19,223.
SPONSORSHIP: This research was conducted by Janssen Biotech, Inc.,
Horsham, PA, without external funding.
■■  Lower Medication Utilization Is Associated with Higher
Health Care Costs in Parkinson’s Disease Patients
Durgin T, Makaroff L, Moran K,* Moorcroft E, Senior E, Richy F.
UCB Pharma Inc., 1950 Lake Park Dr., Smyrna, GA 30080;
[email protected], 770.970.8235
Background: Parkinson’s disease (PD) is a chronic, progressive,
neurodegenerative disorder due to diminished activity of dopaminergic
neurons with a median age of onset of 57 years. Decreased medication
compliance may lead to less effective treatment of symptoms.
Objective: To compare clinical characteristics and direct medical
costs in compliant versus noncompliant PD patients within the general
population.
Methods: This study used a data cut of the PharMetrics U.S. claims
database complete up to 2009. Patients were required to have at least
2 PD diagnoses, continuous enrolment for at least 12 months after the
second PD diagnosis and at least 1 PD-related pharmacy claim with the
12-month study period. Patients aged < 18 years were excluded from
the study. Noncompliance was defined as patients being without any
pharmacy claims for any PD-related medication for > 20% of the study
period.
Results: A total of 15,846 patients were included, of which 54% were
assessed as “compliant” and 46% as “noncompliant.” 33% of compliant
patients were treated for a depressive or dysthymic disorder (ICD-9-CM
codes 296.3x, 311.xx, 300.4x, 296.2x or 296.3x) compared with 37%
of noncompliant patients (P < 0.001). 62% of compliant patients had a
gastrointestinal dysfunction (ICD-9-CM codes 787.2x, 530.xx-538.xx,
560.xx, 564.xx, 568.xx or 569.xx) compared with 68% of noncompliant
patients (P < 0.001). Compliant patients were prescribed a mean of 3.5
daily PD pills, compared to 3.7 daily PD pills for noncompliant patients
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(P < 0.001). Noncompliant patients had an increase of U.S. $7,450 in
their annual health care costs, with a total of U.S. $84,949, compared to
compliant patients with totals of U.S. $77,499 (P < 0.001), driven mainly
by inpatient and outpatient hospitalizations.
Conclusions: Almost half of the patients within this study were
assessed as “noncompliant” to their PD drug regime. Noncompliant
patients had higher rates of depression and gastrointestinal disorders
and a higher pill burden, as well as 10% higher overall health care costs
than the compliant population. Taken together, these data suggest that
noncompliant PD patients may be a greater burden to the health care
system.
SPONSORSHIP: This research was conducted by UCB Pharma, Inc.,
Smyrna, GA, without external funding.
■■  Medicaid Pharmacy Benefit Carve-Outs and Their Impact
on Generic Dispensing Rates and Implied Program Costs
Miller S,* Hunter D. CVS Caremark, 2211 Sanders Rd., NBT 3,
Northbrook, IL 60062; [email protected], 847.559.3633
Background: Several states have carved-out the pharmacy benefit
usually provided by Medicaid managed care organizations (MCOs) to
take advantage of drug rebates provided by pharmaceutical manufacturers. Medicaid managed care members then use the Medicaid fee-forservice (FFS) program for their pharmacy benefit. However, a recent
study conducted by CVS Caremark on a midwestern state’s carve-out
program appears to back other research in showing that carve-out
programs are not as effective in utilization management as traditional
managed care pharmacy benefits. Preliminary research concludes that
a carve-out arrangement is not as effective in directing patients to lower
cost generic medications as a traditional pharmacy benefit program
managed by an MCO.
Objective: To investigate the changes in generic dispensing rates
and utilization rates that occur when a state chooses to carve out the
pharmacy benefit from a traditional Medicaid managed care organization and to estimate the potential financial impact that such a shift may
imply.
Methods: This observational pre- and post-intervention study uses
nonparametric statistical tests to measure the impact on lower cost
generic drug utilization and utilization when a state moves to a carve-out
program. Sample characteristics include pre- and post-period demographics on member composition. Additional emphasis is placed on
analyzing the cohorts of those who joined, left, or stayed in the plan, and
then comparing their respective generic dispensing rates and utilization
rates. Results are based on primary data gathered from an integrated
database of administrative pharmacy claims and findings from a key
Medicaid managed care organization operating in a midwestern state.
Results: Since the implementation of the carve-out program in this
midwestern state, there has been over a 6% decline in the generic dispensing rate over a 12-month period. Initial findings also imply that this
reduction in generic dispensing rate played a significant role in driving
up pharmacy costs to the state’s Medicaid program over the previous
year.
Conclusions: Carve-in approaches appear to be associated with positive utilization management and cost benefit. They allow for improved
care coordination since pharmacy and other medical benefits are managed under 1 entity. MCOs also have the capability to access in-house
pharmacy and medical claims data in real time, which may help in
better identifying prescribing patterns and in addressing opportunities
where higher cost drugs could be interchanged with lower cost alternatives.
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SPONSORSHIP: This research was conducted by CVS Caremark,
Northbrook, IL, without external funding.
■■  Multidisciplinary Approach to Management of
Atypical Antipsychotics in an Adolescent Population
Hogge JA,* Bishop SJ, Szczotka AD, Hancy NE, Dorsey J. HealthTrans,
8300 E. Maplewood Ave., Ste. 100, Greenwood Village, CO 80111;
[email protected], 720.528.6745
Background: Schizophrenia and bipolar disorder are listed among
the top 10 leading causes of years lost due to disability worldwide in the
World Health Organization’s (WHO) Global Burden of Disease Report.
Clinical studies suggest that the onset of schizophrenia before age 13
years is rare, and the onset rate increases during the teenage years and
peaks in ages ranging from 15 to 30 years. Antipsychotic medications
represent the fifth costliest therapeutic class of drugs, with over $16 billion spent on these agents in the United States during 2010.
Objective: To evaluate the impact of an active utilization management
approach to the atypical antipsychotic therapeutic drug class in an adolescent population on medication utilization, cost, and drug switching
behavior.
Methods: A multidisciplinary collaborative approach among the
physician practice group, commercial insurer and pharmacy benefits
manager was developed to manage the atypical antipsychotic drug category. Prescription drug claims were evaluated through a multiple phase
process using point-of-sale technology edits that were then screened
through an established protocol and reviewed by a psychiatrist for
appropriate use. Medication utilization, cost, adherence to drug therapy,
and alternative drug therapies were measured.
Results: There was an overall decrease in antipsychotic prescription
utilization in the adolescent population of over 41% and a corresponding decrease in insurer costs of the atypical antipsychotic medications of
greater than 52%. This trend was minimized through dose escalation of
defined first-line or second-line drug therapies.
Conclusions: A collaborative approach to utilization management
of a high-cost drug category demonstrated a decrease in utilization of
atypical antipsychotics of 41% and insurer savings of 52%. Additionally,
medication switch rates and adherence rates were consistent with the
pre-study period.
SPONSORSHIP: This research was conducted by HealthTrans,
Greenwood Village, CO, without external funding.
■■  Outcome Analysis Following Glucose Test Strip
Quantity Standardization in Type 2 Diabetes
Christopher M,* Tran J, Bounthavong M, Mendes M, Kazerooni R. VA San
Diego Healthcare System, 3350 La Jolla Village Dr., Mail Code 119-E, San
Diego, CA 92161; [email protected], 858.552.8585 ext. 2783
Background: Several studies have shown that while maintaining
access to home glucose testing, limiting quantities may provide a costeffective approach to management of diabetes for type 2 diabetics not
using insulin therapy. A previous retrospective study conducted within
the Veterans Affairs (VA) population showed that limiting test strip
quantity in type II diabetic patients on oral antidiabetic medications had
no significant effect on hemoglobin A1c and no changes in medication
therapy.
Objective: To evaluate the consequences following the implementation of a health care resource management initiative to reduce the
quantity of glucose test strips for patients using oral medications with
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type 2 diabetes.
Methods: This is a retrospective cohort study of pharmacy records and
laboratory results from VA data warehouse, an operational data mart
based on VistA developed for decision support and quality assurance
analysis. Patients identified for a prescription change in the quantity
of glucose test strips on August 1, 2009, were included in the study.
Primary endpoint was the mean change in A1c. Secondary outcomes
included emergency room visits, hospital admissions, and outpatient
visits for hypoglycemia and for diabetes. Paired t-tests and chi square
tests were used to compare pre- and post-index clinical and economic
outcomes.
Results: The analysis included 904 patients, 94.8% males with an
average age of 63.4 years, who were converted to a standardized quantity
of glucose test strips. Average (SD) Charlson Comorbidity Index score
was 1.66 (1.21), pre-index mean A1c was 7.27 (1.39), and the average
(SD) number of diabetic medications was 1.42 (0.89). Post-index mean
A1c was 7.04, with an average significant reduction of 0.23 (P < 0.001).
There was a significant increase in the average number of diabetes medications of 1.64 (P < 0.001). No significant changes were found in overall
and diabetes-specific admissions to ER and hospitalizations. There was
no significant change in the number of encounters for hypoglycemia.
Outpatient utilization of diabetes-specific encounters significantly
decreased an average of 0.22 encounters per patient (P < 0.001).
Conclusions: Standardizing the utilization of glucose test strips
in type 2 diabetes not using insulin had no adverse impact on A1c
control, ER visits, hospital admissions and outpatient encounters.
Minor improvements in these parameters were found in the post-index
period.
SPONSORSHIP: This research was conducted by VA San Diego
Healthcare System, San Diego, CA, without external funding.
■■  Palivizumab Treatment Course Fulfillment Via a Specialty
Pharmacy Compared with Nonspecialty Pharmacy
Starner CI, Hermes M, Ritter ST, Phillips J, Gleason PP.* Prime
Therapeutics LLC, 1305 Corporate Center Dr., Eagan, MN 55121;
[email protected], 612.777.5190
Background: Palivizumab is the only preventive therapy approved
for respiratory syncytial virus (RSV) and treatment course completion
has been shown to decrease costly RSV-related hospitalizations. The
American Academy of Pediatrics (AAP) maintains eligibility criteria for
RSV prevention in high-risk infants/children based on seasonality and
risk factors.
Objective: To evaluate palivizumab treatment course completion for
members filling all claims through a specialty pharmacy compared to
those using a nonspecialty pharmacy.
Methods: Using medical and pharmacy claims from 2,853,925
commercially insured members in the Midwest, we identified individuals with a palivizumab claim during the 2009-2010 RSV season.
These individuals were required to: (a) be continuously enrolled from
November 2009 through March 2010; (b) born between January 2008
and October 2009; and (c) utilize a specialty or nonspecialty pharmacy
solely for all palivizumab doses. The appropriate number of palivizumab
doses was based on the member’s date of birth and matched to the lowest AAP 2009 guidelines-recommended number. A member was defined
as meeting the treatment threshold if the number of doses received was
equal to or more than the AAP guidelines, and a 2-sided chi-square
test was used for statistical comparison. We were limited by unobtainable gestational age and unidentified chronic lung disease; therefore,
Vol. 17, No. 7
www.amcp.org
Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
we assigned all members 12 months of age or older a 5-dose treatment
completion threshold.
Results: 445 members (16 per 100,000) met our analytic criteria in
the 2009-2010 season, and 325 (73.0%) utilized a specialty pharmacy
for all doses. Based on AAP guidelines, 105 (23.6%) members’ treatment
course was 5 palivizumab doses and 202 (45.4%) should have received
1 or 2 doses. Infants/children who obtained their palivizumab from the
specialty pharmacy were significantly more likely to receive the recommended number of doses (83.4% specialty versus 65.8% nonspecialty,
P < 0.001). For every 6 (95% confidence interval 4 to 12) infants/children receiving palivizumab from a specialty pharmacy an additional 1
received the AAP-recommended number of doses compared with members receiving palivizumab via a nonspecialty pharmacy.
Conclusions: Using a specialty pharmacy to obtain palivizumab was
associated with a 17.6 percentage point, significantly higher likelihood
of receiving the AAP-recommended treatment doses compared with
receiving palivizumab from a nonspecialty pharmacy. Health insurers
should consider encouraging use of specialty pharmacies to improve
compliance and potentially reduce costs associated with treatment
course completion.
405 patients. SOC was categorized as rheumatologist in-office infusion
(rheum IOI), gastroenterologist in-office infusion (gastro IOI), hospital
outpatient department (HOPD), or infusion therapy provider (ITP).
Patient experience with attributes of infusion centers were rated on
7-point Likert scales (1 = Poor, 7 = Excellent).
Results: Of the 392 patients reporting SOC information, 154 (39.3%)
received infusions in rheum IOI, 102 (26.0%) in gastro IOI, 111 (28.3%)
in HOPD, and 25 (6.4%) in ITP. Rheum and gastro IOIs were more likely
to receive high ratings for interaction with staff compared with HOPD.
Gastro IOIs were the most likely to receive high ratings for waiting times
compared to rheum IOIs and HOPD, though waiting time was still more
highly rated in rheum IOIs than HOPD. HOPDs were least likely to
receive high ratings for ease of parking, waiting time, interaction with
staff, and expertise of staff. ITPs were most likely to receive high ratings
for convenient scheduling of infusions.
Conclusions: Patient experience with specific attributes of infusion
centers significantly differ by SOC. Therefore, patient perceptions and
experiences should be considered in choice of SOC.
SPONSORSHIP: This research was conducted by Janssen Biotech, Inc.,
Horsham, PA, without external funding.
SPONSORSHIP: This research was conducted by Prime Therapeutics
LLC, Eagan, MN, without external funding.
■■  Patient-Reported Psoriasis Disease Flaring and
Impact of Flare Frequency on Humanistic Outcomes
■■  Patient Perceptions and Experiences with Sites
of Care Among Patients with Immunology Conditions
Currently Using Intravenous Biologic Therapy
Carter C,* Martin S, DiBonaventura M, Annunziata K, Freedman D.
Janssen Biotech Inc., 800 Ridgeview Rd., Horsham, PA 19044;
[email protected], 302.376.4387
Ellis L, Bolge SC,* Vanderpoel J, Eldridge H, Mody S, Lofland J, Ingham M.
Janssen Biotech, Inc., 800 Ridgeview Rd., Horsham, PA 19044;
[email protected], 215.325.4859
Background: Intravenous infusion (IV) biologic therapy can be
administered in various sites of care (SOCs). Patient preference and satisfaction data informing quality of care perceptions are sparse.
Objective: To evaluate patient perceptions, satisfaction, and experiences by SOC, among patients with immunology conditions currently
treated with an IV biologic medication.
Methods: Semistructured telephone interviews were conducted with
TABLE
Patient Ratings (6 or 7 on 7-Point Scale)
of Attributes of Infusion Centers by SOC
(a)
(b)
SOC Attribute
Rheum IOI Gastro IOI
Convenient location
61.7%
60.8%
Easy to get there
64.3%
66.7%
Free parking
87.4%b,c
76.5%
75.5%
Ease of parking
83.4%c
Waiting time
77.9%c
89.2%a,c
c
Interaction with staff
93.5%
93.1%c
Handling insurance
90.9%c
88.2%
coverage and paperwork
Convenient scheduling
80.5%
82.4%
Expertise of staff
94.1%c
94.1%c
(c)
HOPD
59.5%
69.4%
67.0%
66.1%
54.1%
82.0%
83.8%
(d)
ITP
60.0%
64.0%
84.0%
88.0%c
76.0%c
88.0%
84.0%
87.4%
85.6%
96.0%a,b
96.0%c
abcd P < 0.05
when compared to group with listed column letter; P values determined
by independent z-tests.
Gastro = gastroenterologist; HOPD = hospital outpatient department; IOI = in-office
injection; ITP = infusion therapy provider; Rheum = rheumatologist; SOC = site of
care.
www.amcp.org
Background: Psoriasis may exhibit a flare and remission pattern.
Psoriasis patients may have increased outpatient health care resource
utilization during the times when they are experiencing disease flares.
Literature reports that health plans may reimburse up to $86.6 million
nationally on outpatient physician visits for approximately 1.4 million
Americans with psoriasis.
Objective: To assess psoriasis flaring and the impact of the frequency
of flares on psoriasis-related quality of life outcomes.
Methods: Cross-sectional data were collected via the Psoriasis Patient
Study Project conducted March 1, 2010, through April 30, 2010. Study
participants were recruited from an Internet panel, aged 18 years or
older, and self-identified as having psoriasis. Current treatment type
(biologics, prescription [Rx] oral, phototherapy, Rx topical, overthe-counter [OTC], and untreated) and self-reported disease severity
(mild, moderate, severe) were reported. Frequent flaring was defined
as occurring continuously or more than once per week, as reported by
the patient. Infrequent flaring was defined as occurring less frequent
than once per week. Outcomes were measured by the Dermatology Life
Quality Index (DLQI) and Skindex-16 instruments.
Results: A total of 1,017 respondents completed the survey (57%
female; mean age = 53 years; mean 17 years of diagnosed psoriasis).
When asked about disease severity, 60% reported mild disease, 35%
moderate, and 5% severe. Overall, 28% of all psoriasis patients reported
their disease as continuously flaring, with a significantly higher proportion of those with severe (60%) and moderate (36%) disease experiencing continuous flares compared with mild (20%; P < 0.05). Biologic use
was significantly greater in patients with severe (33%) and moderate
(17%) disease compared with those with mild disease (5%; P < 0.05).
Fewer moderate/severe biologic-treated patients (n = 79) reported continuous flares (25%) compared with moderate/severe Rx topical or moderate/severe untreated patients (47% for both; P < 0.05). Patient-reported
frequent flaring was statistically significantly associated with worsened
outcomes compared to infrequent flaring.
Vol. 17, No. 7
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JMCP
Journal of Managed Care Pharmacy 565
Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
Conclusions: Greater psoriasis disease severity may be associated
with frequent flaring and worsened outcomes. Once biologic-experienced, 1 out of 4 moderate-to-severe patients reported continuous flares.
There is still an unmet need for treatment options offering better flare
control.
SPONSORSHIP: This research was conducted by Janssen Biotech Inc.,
Horsham, PA, without external funding.
final height, change in insurance coverage is one of the most common
reasons for discontinuation of patients treated with Norditropin from
this registry. It is difficult to determine the impact this disruption in
therapy may have on height outcomes for these patients. Based on
LOCF, those discontinuing therapy for other reasons seem to have the
worst height outcomes. Future research should explore these 2 subpopulations further.
SPONSORSHIP: This research was funded by Novo Nordisk Inc.,
Princeton, NJ.
■■  Persistence with Growth Hormone Therapy by
Pediatric Patients: Results from the ANSWER Program
Miller BS,* Cohen P, Rotenstein D, Deeb LC, Germak JA, Wisniewski T.
University of Minnesota, Amplatz Children’s Hospital, 2450 Riverside Ave.,
MMC 8952D, East Bldg. Rm. MB671, Minneapolis, MN 55455;
[email protected], 612.624.5409
Background: Since 2002, the American Norditropin Studies: WebEnabled Research (ANSWER) program, a U.S.-based registry, has
collected long-term efficacy and safety information on patients treated
with Norditropin (somatropin rDNA origin, Novo Nordisk A/S) at the
discretion of participating physicians.
Objective: To identify persistency rates and height outcomes among
pediatric patients from the ANSWER Program who discontinued
therapy with Norditropin.
Methods: As of October 2010, data were collected from 826 treatmentnaive pediatric patients with isolated/idiopathic growth hormone (GH)
deficiency (n = 778) and multiple pituitary hormone deficiency (n = 48)
who discontinued ANSWER. Patients were categorized into 4 mutually exclusive groups based on reasons for discontinuation: final height
achieved (FHA), insurance reasons (IR), patient/caregiver decision
(PCD), and other. Among all groups, persistency rates over time were
estimated using a Cox proportional hazards model adjusted for baseline
age and sex. Height SD scores (HSDS) were also analyzed at baseline,
years 1, 2, 3, and last observation carried forward (LOCF).
Results: FHA patients (n = 288, 34.9%) had a mean baseline age of
12.9 ± 2.3 years and baseline HSDS of -2.1 ± 0.8. Mean baseline ages for
IR patients (n = 231, 27.9%), PCD patients (n = 134, 16.2%), and other
(n = 173, 20.9%) were 9.9 ± 3.8, 12.8 ± 2.9, and 11.7 ± 3.6 years, respectively, and mean treatment durations were 32 ± 20.8, 35 ± 15.1, and
31 ± 17.6 months, respectively. After adjusting for baseline age and sex,
IR patients were the least persistent on therapy (see figure). Among FHA
patients, treatment was received for a mean of 46 ± 20.6 months and
the HSDS at LOCF (adult height) was -0.6 ± 0.9. At year 2, the HSDS for
IR patients was -1.2 ± 0.8 vs. -1.0 ± 1.0 for the PCD group and -1.5 ± 0.9
for all other reasons. LOCF of HSDS for these groups was -1.2 ± 0.9,
-0.9 ± 1.2, and -1.3 ± 1.1, respectively.
■■  Plan Savings from Stepped-Generic Copayment Reduction
Brinkman A.* CVS Caremark, 2211 Sanders Rd., Northbrook, IL 60062;
[email protected], 847.559.3669
Background: City government plans need to reduce costs while keeping in mind the economic needs and improving the health outcomes of
lower-paid blue collar employees. Increasing generic utilization benefits
both the plan and all plan members. Implementing strong financial
incentives by way of significant copayment changes should instigate
brand-to-generic shifts.
Objective: To (a) measure brand-to-generic conversion rates and
resulting cost savings to plan and members during the different copayment steps implemented; and (b) compare plan’s increases in the generic
dispensing ratio (GDR) to standard pipeline-related increases to determine the conversion that is attributable to the copayment changes.
Methods: A city government located in the Southeast with existing
generic copayments of $10 at retail and $20 at mail implemented a
stepped copayment change program. In the first stage, which lasted 3
months, all generic drugs were charged a copayment of $0, while the
brand drug copayments remained the same. In the second stage, the
generic copayments were set at $7 at retail and $14 at mail, a decrease
from the original values. Also in this stage, the brand copayments were
increased significantly so that they were at least 5 times the generic
copayment. The GDR was measured through the 3 stages and subsequently on a quarterly basis. The GDR increases that were observed were
normalized based on the Caremark book-of-business GDR increase in
order to determine GDR increase attributable to the stepped copayment
change program.
Conclusions: These results show that, aside from achievement of
FIGURE
Generic Dispensing Ratio (GDR)
78%
76%
74%
72%
Survivor Function
Estimate
1.0
0.8
0.6
0.4
0.2
0.0
68%
66%
64%
62%
FHA
PCD
IR
All other reasons
0
69.7% 69.2%
70%
FIGURE
10
20
60%
58%
30
Month
566 Journal of Managed Care Pharmacy
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40
50
September 2011
60
Vol. 17, No. 7
63.8%
63.8%
65.2%
65.2% 65.7%
66.6%
70.8%
68.4%
71.9%
69.2%
73.0%
70.4%
75.2%
71.3%
2008 Jan-Jun Jul-Sep Oct-Dec Jan-Mar Apr-Jun Jul-Sep Oct-Dec
2009 2009 2009 2010 2010 2010 2010
Actual GDR
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Projected GDR w/o Program
Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
Results: The plan’s GDR showed an immediate increase of 3.6% over
the course of the initial 3-month $0 stage. The subsequent 5 quarters of
data with $7/$14 generics culminated in a 4.9% sustained GDR increase
for the plan. Overall, this plan design continues to save the plan about
4.5% of its annual gross cost and 5.8% of annual net cost.
outcomes was undertaken using descriptive statistics.
Results: A total of 36 citations, representing 24 unique studies,
met inclusion criteria. This included 9 studies reporting dyspeptic
(n = 14,181), 14 reporting gastroesophageal (n = 58,701), 5 reporting dyspeptic and/or gastroesophageal symptoms (n = 103,175), and 7 reporting
PUD prevalence (n = 269,299). The pooled prevalence of dyspeptic, gastroesophageal, and dyspeptic and/or gastroesophageal symptoms were
16.3% (95% CI = 9.1%-25.1%), 24.2% (95% CI = 18.2%-30.5%) and 35.2%
(95% CI = 14.9%-58.9%), respectively. The pooled prevalence for studies
asking for shorter term PUD recall was 3.3% (95% CI = 2.2%-4.6%), with
lifetime PUD prevalence estimated at 13.8% (95% CI = 10.7%-17.0%).
The influence of covariates evaluated as part of included studies’ multivariate analyses was often inconsistent both within and between the
different upper GI symptom outcomes.
Conclusions: Significant cost-share changes to brand and generic
prescriptions can drive dramatic GDR results. Piquing the interest
of members with free generic copayments can be an effective way to
jump-start a GDR increase. Increasing brand copayments to at least 5
times the generic copayment also can affect positive movement towards
generic products.
SPONSORSHIP: This research was conducted by CVS Caremark,
Northbrook, IL, without external funding.
Conclusions: While estimates of upper GI symptom prevalence are
variable, it appears that upper GI symptoms and disorders are common
to inhabitants of the United States. Further, this systematic review has
identified both patient- and study-level factors that should be considered
when assessing the upper GI symptom prevalence literature or when
conducting future research.
■■  Prevalence of Upper Gastrointestinal Symptoms
in the United States: A Systematic Literature Review
Coleman CI,* Sobieraj DM, Coleman SM, Sood NA. University of
Connecticut School of Pharmacy, 80 Seymour St., Hartford CT 06102;
[email protected], 860.545.2096
Background: Data suggests that prevalence of upper gastrointestinal
(GI) symptoms can vary markedly between countries. Despites this fact,
no previous systematic review focusing on U.S. prevalence rates of upper
GI symptoms has been undertaken.
SPONSORSHIP: This research was funded by Ortho-McNeil Janssen
Scientific Affairs, LLC, Raritan, NJ.
■■  Projected Lifetime Economic Burden of Hepatitis
C Virus in U.S. Birth Cohorts with High Prevalence
Objective: To conduct a systematic review to quantify the prevalence
of dyspeptic and gastroesophageal symptoms and peptic ulcer disease
(PUD) in the U.S. and to identify factors that affect upper GI symptom
prevalence.
Parekh H, McGarry L,* Pawar V, Deniz B, Weinstein M. OptumInsight,
10 Cabot Rd., Ste. 304, Medford, MA 02155; [email protected],
781.518.4025
Methods: A systematic literature search of MEDLINE and Web of
Science from the earliest possible date through November 2010 was conducted to identify studies enrolling only patients from the United States,
that evaluated a general adult sample selected without prior knowledge
or suspicion of the presence or absence of GI symptoms or disorders,
and that reported the prevalence of at least 1 upper GI outcome of
interest including dyspeptic symptoms, gastroesophageal symptoms,
dyspeptic and/or gastroesophageal symptom or PUD. The proportion
of individuals in each study reporting symptoms were combined using
a random-effects model to derive separate pooled prevalence estimates
(with 95% CIs) for each outcome. Qualitative synthesis of data depicting multivariate relationships between various covariates and upper GI
Overall Management Cost
(Billions U.S. $)
FIGURE
14
12
10
8
6
4
2
0
Background: Although the incidence of hepatitis C virus (HCV) has
declined over the last 2 decades, significant economic consequences of
HCV are likely to arise in the future due to the aging of birth cohorts
with high HCV prevalence.
Objective: To quantify the birth cohort-specific lifetime economic
burden of untreated HCV and the potential impact of treatment in the
United States.
Methods: A lifetime Markov model of the natural history of HCV
and subsequent complications was developed. Model health states
included chronic HCV states (fibrosis stages F0-F4) and advanced
liver disease (decompensated cirrhosis and hepatocellular carcinoma)
Economic Burden of HCV for 5-Year Age Cohorts
Economic Burden of HCV without Treatment
$10.9B
$13.0B
$12.1B
$7.5B
40-44
(218,800)
45-49
(320,800)
50-54
(380,300)
55-59
(362,000)
14
12
10
8
6
4
2
0
$9.6B
60-64
(303,800)
(Total N)
Economic Burden of HCV with Treatment
$10.8B
Liver Transplant
$12.5B
$10.3B
$7.2B
40-44
(218,800)
Age Cohorts (in 2010)
Treatment
$13.0B
45-49
(320,800)
50-54
(380,300)
55-59
(362,000)
60-64
(303,800)
Age Cohorts (in 2010)
Hepatocellular Carcinoma
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Decompensated Cirrhosis
Vol. 17, No. 7
September 2011
JMCP
Chronic HCV
Journal of Managed Care Pharmacy 567
Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
which may lead to liver transplant. The target population was HCVinfected individuals born from 1946 to 1970 (aged 40-64 in 2010). The
analysis compared 2 scenarios: (1) patients remain untreated and (2)
all patients are diagnosed and treated within the first model year with
currently-available treatments (pegylated-interferon+ribavirin). For the
treated group, fibrosis stage-specific treatment success rates ranged
from 33-60% for genotype 1 to 57-76% for genotypes 2 and 3. Model
inputs were derived from published literature and a large commercial
insurer database. Primary outcomes were HCV management and treatment costs, and costs associated with advanced liver disease. Costs were
discounted at 3% per year.
Results: Model-estimated total lifetime HCV-related costs were $53.2
billion ($33,548 per person) for an untreated cohort vs. $53.7 billion
($33,846 per person) with treatment. The additional cost associated with
treatment ($29.2 billion) was partially offset by reductions in advanced
liver disease-related costs ($22.1 billion). Among all health states, decompensated cirrhosis was associated with the highest cost ($24.4 billion
for untreated; $12.3 billion for treated). When 5-year age cohorts were
considered, treatment resulted in cost savings in the youngest cohorts
(born from 1961 to 1970), but increased costs in older cohorts.
Conclusions: Model results suggest that the future economic burden
of managing HCV among currently infected U.S. residents born 19461970 will be substantial. The potential cost of treating HCV patients is
offset by cost savings from avoiding advanced liver disease, resulting in
similar costs for treated and untreated patients.
SPONSORSHIP: This research was funded by Vertex Pharmaceuticals
Inc., Cambridge, MA.
■■  Promoting the ADA’s Diabetes Type 2 Treatment
Guidelines Through Pharmacy Step-Therapy Programs
Cotter ND.* BlueCross and BlueShield of Florida, 4800 Deerwood Campus
Pkwy., Jacksonville, FL 32246; [email protected], 904.905.5037
Background: In early 2010, BCBS of Florida conducted a retrospective
pharmacy claims analysis of member utilization of thiazolidinediones
(TZDs) and dipeptidyl peptidase-4 (DPP-4) enzyme inhibitors. This
analysis utilized all pharmacy claims from April 1, 2009, through March
31, 2010, and indicated that potentially up to 30% of new users of the
targeted medications had not utilized metformin or a sulfonylurea as
monotherapy prior to initiation of a TZD or DPP-4 enzyme inhibitor.
Objective: To increase the utilization of metformin as first-line pharmacotherapy according to the 2009 ADA’s diabetes type 2 treatment
guidelines as well as to decrease pharmacy costs associated with oral
diabetic therapies.
Methods: An oral diabetic step-therapy program was implemented
in 2010, across BCBS of Florida’s commercial book of business with
all fully-insured PPO and HMO pharmacy plans included that had
utilization management programs as part of their benefits. Self-insured
groups with pharmacy coverage had the option to exclude this program.
Appropriate pharmacy messaging at the point of service was also implemented for the dispensing pharmacist. The program also allowed the
prescribing physician to submit information for a member-specific prior
authorization (PA) review for coverage of the targeted medication in the
event metformin and a sulfonylurea were contraindicated.
Results: In early 2011, a retrospective analysis was completed to determine the impacts of the program to overall utilization of metformin as
well as to TZDs and DPP-4 inhibitors. The analysis period was October
1, 2009, through December 31, 2010. Utilization based on the total
number of paid claims per month was tracked as well as the market
568 Journal of Managed Care Pharmacy
JMCP
September 2011
share for metformin in the category of oral diabetic agents. The analysis
indicated an increase in metformin utilization post implementation.
Metformin market share at the time of implementation was 42.1%.
The market share of metformin increased to 54.1% by the end of 2010.
Additional metrics that were tracked quarterly included net plan savings and program return on investment (ROI). Significant savings have
occurred since implementation with net plan paid savings of $0.08 per
member per month (PMPM) in the last 3 calendar quarters of 2010, with
a program ROI of 20:1.
Conclusions: The initial results have been positive for BCBS of
Florida’s goal of promoting the ADA’s 2009 diabetes type 2 treatment
guidelines. Metformin utilization has steadily increased in the 12
months following implementation. The program also demonstrated consistent plan paid savings and a significant ROI of 20:1 over the second,
third and fourth quarters of 2010.
SPONSORSHIP: This research was conducted by BlueCross and
BlueShield of Florida, Jacksonville, FL, without external funding.
■■  Psoriasis and Psoriatic Arthritis Patient
Productivity Burden in the United States
Carter C,* Naim A, Martin S, Goren A, Annunziata K, Freedman D.
Janssen Biotech Inc., 800 Ridgeview Rd., Horsham, PA 19044;
[email protected], 302.376.4387
Background: Limited data exist describing the current productivity
burden for psoriasis (PsO) or psoriatic arthritis (PsA), relative to other
diseases, in the United States.
Objective: To describe the productivity burden of PsO or PsA for
patients residing in the United States, relative to other costly diseases.
Methods: Data were generated from the U.S. Work Productivity and
Activity Impairment (WPAI) Recontact Study, administered in FebruaryMarch 2009 and May-June 2010. Study participants were recruited from
an Internet panel, aged at least 18 years, employed currently or within
the past 2 years, and self-identified as having physician-diagnosed atrial
fibrillation (afib), neck/lower back pain (pain), PsO, PsA, or stroke.
Absenteeism (percent work time missed due to condition in past 7 days),
presenteeism (percent impairment while working due to condition),
work productivity loss (work and productivity loss [WPL] - percent of
overall work impairment due to condition), and activity impairment
(percent activity impairment due to condition) were measured with the
WPAI Scale. Higher scores indicated greater impact of the condition
on productivity/activity. Absenteeism, presenteeism, and overall work
impairment costs were calculated.
Results: A total of 1,934 patients employed in the United States
completed the survey (afib [n = 319], pain [n = 504], PsO [n = 498],
PsA [n = 347], and stroke [n = 266]). PsO patients had higher mean
presenteeism, WPL, and activity impairment scores compared to afib
patients. PsA patients had higher mean WPAI scores, across all domains,
compared to patients with afib or stroke. Mean PsO absenteeism costs
($2,350) were lower than afib ($3,358), pain ($6,755), or stroke ($3,652).
Mean PsA absenteeism costs ($5,748) were higher than afib or stroke.
Mean PsO presenteeism costs ($9,440) were higher than afib ($5,915) or
stroke ($9,004), but lower than pain ($13,181). Mean PsA presenteeism
costs ($11,665) were also higher than afib or stroke. Mean PsO overall
work impairment costs ($11,790) were higher than afib ($9,273) and
lower than pain ($19,935) or stroke ($12,656). Mean PsA overall work
impairment costs ($17,413) were higher than afib or stroke.
Conclusions: PsO patients reported more of an economic presenteeism burden relative to afib or stroke. PsA patients reported an increased
Vol. 17, No. 7
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Abstracts from Professional Poster Presentations at AMCP’s 2011 Educational Conference
economic productivity burden across absenteeism, presenteeism, and
overall work impairment relative to afib or stroke.
antidepressant medications may cause or worsen insomnia, further
complicating treatment decisions.
SPONSORSHIP: This research was conducted by Janssen Biotech, Inc.,
Horsham, PA, without external funding.
Objective: To estimate resource utilization and costs associated with
insomnia treatment among newly treated MDD patients.
■■  Real-World Data on Patient Adherence
to the Rivastigmine Transdermal System after
Switching from an Oral Cholinesterase Inhibitor
Abouzaid S,*Gabriel S, Tian H, Kim E, Kahler K. Novartis
Pharmaceuticals, USEH, 405-2097B, One Health Plaza, East Hanover,
NJ 07936; [email protected], 862.778.0493
Background: Cholinesterase inhibitors (ChEIs) are a core element of
Alzheimer’s disease (AD) management. Factors affecting adherence may
include inconvenience, pill burden, side effects, and memory loss. While
clinical trials have demonstrated the safety of switching from oral donepezil to rivastigmine patch, little is known about outcomes associated
with such switching in real world practice.
Objective: To examine patient adherence before and after switching
from an oral ChEI to rivastigmine patch using real-world data.
Methods: This retrospective cohort study used data from the
MarketScan Commercial and Medicare datasets (2004-2009). Patients
were included if they had a diagnosis of AD, were new users of oral
ChEI (12-month prior period with no ChEI use), and subsequently
switched from oral ChEI to rivastigmine patch. Paired t-tests were used
to compare the proportion of days covered (PDC) of an oral ChEI 1 year
after initiation compared to the PDC of rivastigmine patch 1 year after
switching from an oral ChEI. Multivariate logistic regression assessed
predictors of higher PDC of patch use compared to an oral ChEI, including the copayment costs, time to switch, baseline gastrointestinal complications, medication burden, comorbidities, and demographics.
Results: The study sample included 1,056 patients, with a mean age
of 77.6 (SD = 7.6): 57% were female; 4% had dysphagia; 24% had gastrointestinal complications; 35% had a Charlson comorbidity score greater
than 2; 45% had at least 10 medications; and the mean time of switching
from oral drug to patch was 562 (SD = 316) days. PDC for rivastigmine
patch was significantly higher than oral ChEI (59.8 vs. 56.4, P = 0.01).
The difference was large among those who switched within the first year
after initiating oral ChEI (61.4 vs. 44.0, P < 0.01). In multivariate logistic
regression model, only time to switch from an oral ChEI to patch significantly predicted higher patch adherence compared to an oral ChEI
(OR = 2.2; 95% CI = 1.6-3.0: patients who switched within a year reference to those who switched after a year).
Conclusions: Switching AD patients from oral ChEI to rivastigmine
patch appears to be associated with increased adherence. This effect may
be more pronounced among those who switch within the first year of
initiating ChEI therapy.
Methods: Marketscan Commercial Claims and Encounters and
Marketscan Medicare Supplemental and Coordination of Benefits
datasets were used. Patients with 24 months of continuous insurance
coverage, newly initiated on antidepressant medication (i.e., index medication; no use in prior 12 months) and at least 1 MDD diagnosis in the
baseline period were included. Patients were placed into 2 groups based
on the presence or absence of insomnia medication during the first 12
months post-index. Multivariate analyses were conducted to compare
all-cause and MDD-specific hospitalization, emergency room (ER) visits
and costs in the year post the index date between patients with and
without insomnia medication (logistic regression for hospitalization and
ER visits, and linear gamma regression for costs). Covariates for adjustment included age, gender, baseline health care costs, hospitalizations,
comorbidity, and medication burden.
Results: Total sample size was 87,461 newly treated MDD patients
with an average age of 43.5 (SD = 15.1); 67% were female. Among them,
10,339 (11.8%) patients took insomnia medication. Multivariate results
showed that patients with insomnia medication were significantly more
likely to be hospitalized (OR = 1.86, 95% CI = 1.75-1.98 for all-cause;
OR = 3.41, 95% CI = 2.99-3.88 for MDD-specific) and have ER visit
(OR = 1.52, 95% CI = 1.45-1.59 for all-cause; OR = 2.54, 95% CI = 2.272.85 for MDD specific), and had higher adjusted all-cause costs ($10,957
vs. $6,976) and MDD specific costs ($1,439 vs. $863), compared to those
without insomnia medication. All these differences were statistically
significant at P = 0.01.
Conclusions: The use of insomnia medications in newly treated MDD
patients appears to be associated with increased health care resource
utilization and higher total and depression-related direct medical costs.
Sleep disturbances among newly treated MDD patients may be indicative of a more complex and costly disease state that may be less responsive to standard therapies.
SPONSORSHIP: This research was conducted by Novartis
Pharmaceuticals, East Hanover, NJ, without external funding.
■■  Titration with Gabapentin and Pregabalin Therapy
in Patients with Post-Herpetic Neuralgia (PHN)
Johnson P,* Halpern R, Becker L, Sathyanarayana R, Sweeney M.
OptumInsight, 12125 Technology Dr., Eden Prairie, MN 55344;
[email protected], 952.833.6613
SPONSORSHIP: This research was conducted by Novartis
Pharmaceuticals, East Hanover, NJ, without external funding.
Background: Gabapentin and pregabalin are recommended as firstline treatments for postherpetic neuralgia (PHN) by the American
Academy of Neurology. Both therapies are given 2-4 times per day and
must be titrated to an effective dose over several weeks. It is not known
how many patients with a confirmed diagnosis of PHN complete titration to an effective dose and continue therapy in real-world practice.
■■  Resource Utilization and Costs Associated with Insomnia
Treatment in Patients with Major Depressive Disorder
Objective: To examine success with titration of gabapentin and
pregabalin therapy among patients with PHN.
Gabriel S, Tian H, Kim E, Kahler K, Abouzaid S.* Novartis
Pharmaceuticals, USEH, 405-2097B, One Health Plaza, East Hanover,
NJ 07936; [email protected], 862.778.0493
Background: Sleep disturbances are common in major depressive
disorder (MDD) and are a frequently reported residual symptom in
patients with partial response to antidepressant treatment. Certain
www.amcp.org
Methods: Using administrative claims data from a large U.S. health
plan from July 2005 to February 2010, commercial and Medicare
Advantage enrollees with PHN who initiated treatment with gabapentin or pregabalin were identified. The date of the first gabapentin or
pregabalin pharmacy claim was designated as the index date. Patients
were required to have at least 6 months of complete data preceding
and 12 months following the index date (pre-treatment and follow-up,
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respectively) and to have evidence of PHN (ICD-9-CM code 053.1x
) during pre-treatment or on the index date. Patients with epilepsy
(ICD-9-CM code 345.XX) were excluded. Mean daily dose, duration of
therapy, number of fills and time to reach maximal dose were examined
during the 12-month follow-up period.
Results: A total of 1,645 patients (gabapentin = 939; pregabalin = 706)
met all study entry criteria. The mean (SD) daily dose during the followup period was 826 mg (559) for gabapentin versus 187 mg (103) for
pregabalin, and the mean (SD) number of days on therapy over the
12-month period was 73 days (94) for gabapentin versus 80 days (97)
for pregabalin. The mean maximum dose (SD) of patients with at least
14 days on 1 dose was 970 mg (738) for gabapentin versus 222 mg (147)
for pregabalin with an average time to reach maximum dose of 30 days
in both cases. Full titration of gabapentin was infrequently achieved,
with only 134 (14.3%) of patients reaching the FDA-approved dose for
gabapentin ( > 1,800 mg) during the observation period. For pregabalin,
611 (86.5%) patients reached the approved dose ( > 150 mg). There was
an average of 3.08 and 3.30 fills for gabapentin and pregabalin, respectively; with 52.6% and 57.0% of gabapentin and pregabalin patients
having only 1 fill.
Conclusions: In a real-world setting, few patients with PHN reached
an effective dose of gabapentin. A notably higher success rate was seen
with pregabalin, however the average time to reach maximal dose and
average number of refills was comparable to gabapentin.
SPONSORSHIP: This research was funded by Depomed Inc, Menlo
Park, CA.
■■  Treatment Patterns, Resource Utilization, and
Costs Associated with Atypical Antipsychotics Versus
Nonantipsychotics Added to or Switched from Stimulants Among
Children with Attention Deficit/Hyperactivity Disorder (ADHD)
Sikirica V,* Betts K, Erder MH, Xie J, Samuelson T, Hodgkins P, Wu EQ.
Shire Pharmaceuticals, Inc., 725 Chesterbrook Blvd., Wayne, PA 19087;
[email protected], 484.595.8579
Background: Atypical antipsychotics (AAPs) are not indicated for
attention deficit/hyperactivity disorder (ADHD). However, they are
sometimes prescribed for ADHD patients whose symptoms cannot be
adequately controlled by stimulants. The treatment patterns, resource
utilization and costs associated with AAPs in children with ADHD have
not been evaluated.
Objective: To compare treatment patterns, resource utilization, and
costs between children treated with AAPs and nonantipsychotic medications (stimulants, guanfacine, atomoxetine, and clonidine) that were
added to or switched from stimulants.
Methods: Patients aged 6-12 with a diagnosis of ADHD (ICD-9-CM
code 314.0x) and at least 1 claim for a stimulant medication between
January 2005 and December 2009 were identified from a large U.S.
commercial claims database. Patients were classified into the AAP or
comparison group based on whether they had a subsequent claim for
an AAP or nonantipsychotic medication, respectively. Patients with
a psychiatric diagnosis for which AAPs are indicated were excluded.
Patients in the AAP cohort were propensity score matched 1:1 to patients
in the comparison group based on demographics, baseline treatments,
resource utilization and comorbidities. Treatment patterns, resource utilization and costs were compared using Cox proportional hazards analyses, Poisson regression, and Wilcoxon signed-rank tests, respectively.
Results: A total of 1,857 patients were included in each of the matched
cohorts with well-balanced baseline characteristics. In the 12 months
post-treatment initiation, children treated with AAPs were more likely
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to experience switching and augmentation (16.2% vs. 10.4% and 70.7%
vs. 52.4% at 12 months, respectively; hazard ratio [HR] = 1.75 and 1.86,
respectively; both P < 0.001) and had similar rates of discontinuation
(71.8% vs. 71.7%, HR = 0.98, P = 0.619) as the comparison group. The
AAP cohort also had higher incidence of hospitalization, emergency
room, and outpatient visits (0.08 vs. 0.03, 0.34 vs. 0.25, 14.1 vs. 12.7
per patient, respectively; incident rate ratio [IRR] = 2.61, 1.33 and 1.11,
respectively; all P < 0.001), and incurred higher all-cause medical, prescription drug, and total health care costs ($3,090 vs. $2,238; $3,844 vs.
$2,509; $6,934 vs. $4,748, respectively; all P < 0.001).
Conclusions: Children treated with stimulants had significantly
higher rates of switching and augmentation and greater resource utilization and health care costs, when switched to or augmented with AAPs
versus nonantipsychotics.
SPONSORSHIP: This research was conducted by Shire Pharmaceuticals,
Inc., Wayne, PA, and Analysis Group, Inc., New York, NY, without
external funding.
■■  Utilization of a Smoking Cessation Platform
(ASSIST) in an Ambulatory Care Setting
Elder JL,* Iacobellis D, Satkowiak M, Thompson K. Ferris State University,
College of Pharmacy, 1925 Breton SE, Grand Rapids, MI 49506;
[email protected], 616.252.4698
Background: Tobacco use is the leading preventable cause of death in
the United States and is the primary causal factor for at least 30% of all
cancer deaths and nearly 80% of deaths from chronic obstructive pulmonary disease (COPD). By identifying a patient’s position in the change
process, health care providers can tailor their interventions. Advanced
Stop Smoking Intervention Strategies and Techniques (ASSIST) is a
platform designed to improve the quality of medical group and patient
smoking cessation engagement.
Objective: To (a) provide education for medical office staff and
physicians regarding current tobacco cessation guidelines, insights on
the barriers to and motivators for quitting, and methods for assisting
patients to stop smoking; (b) provide and document individual interventions used by the medical group by implementing the Ask and Act
model to improve effectiveness of smoking cessation counseling; and (c)
assess the effectiveness of individual smoking cessation interventions.
Methods: The ASSIST platform includes an educational program
delivered by a clinical pharmacist for health care providers and staff.
Fifty patients aged 18 to 89 years were identified as current smokers or
smokers that had quit within the last year during a routine office visit.
Patients were administered a brief questionnaire assessing smoking
status, smoking history, and readiness to quit. Individualized smoking
cessation interventions consistent with current Public Health Service
(PHS) guidelines were selected, implemented, and documented by the
medical group based on results of the patient’s readiness to quit.
Results: 47 patients were evaluated in this assessment of the ASSIST
platform. At the initial evaluation, 51% of patients were currently
attempting to quit, 68% were ready to discuss quitting with their doctors, and 57% were ready to set a quit date within the next 30 days.
Follow-up to determine smoking cessation rates 6 months after intervention is ongoing.
Conclusions: The brief questionnaire utilized in the ASSIST platform
helped to identify patients that may benefit from smoking cessation
interventions and allowed providers to tailor interventions based on
patient readiness to quit. Final data including interventions performed and patient follow-up outcomes will be presented at the AMCP
Conference.
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SPONSORSHIP: This research was conducted by researchers at Ferris
State University, Grand Rapids, MI, without external funding.
■■  Utilization of Health Care in Patients
Treated with Natalizumab for 1 Year
Kern DM, Stephenson JJ,* Agarwal S, Kamat S. HealthCore, Inc., 800
Delaware Ave., 5th Fl., Wilmington, DE 19801; [email protected],
302.230.2142
Background: Multiple sclerosis (MS) is a chronic disease that imposes
a substantial economic burden on the health care system and society.
While the efficacy of natalizumab as a treatment for MS is well established, the impact of natalizumab treatment on all-cause and MS-related
hospitalizations and emergency room (ER) visits has not been well
characterized.
Objective: To assess patient-reported all-cause and MS-related hospitalizations and ER visits after 1 year of natalizumab treatment.
Methods: Patients reported MS-related and all-cause hospitalizations and ER visits that occurred during the 3-month period prior
to natalizumab initiation (baseline), and after 3, 6, and 12 months of
natalizumab treatment. At each time point, the percentages of patients
who reported at least 1 hospitalization and at least 1 ER visit were calculated. Logistic regression models with repeated measures were used
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to assess change in resource utilization rates over time adjusting for age,
baseline-level of MS disability, baseline functional status, years since MS
diagnosis, number of comorbidities, and number of MS drugs used prior
to natalizumab.
Results: A total of 333 patients (mean age 46.8 ± 10.4 years; median
years since diagnosis = 9) completed all 4 assessments. The proportion
of patients who reported MS-related hospitalizations was highest at
baseline (7.6%) and decreased between baseline and the third infusion
(4.8%), the third and sixth infusions (3.2%), and the sixth and twelfth
infusions (1.9%; P = 0.001). After 1 year of natalizumab treatment, there
was a significant reduction in the proportion of patients reporting
MS-related ER visits (baseline = 8.9%; 3 months = 7.9%; 6 months = 3.2%;
12 months = 3.2%; P = 0.001). Similar results were observed for all-cause
hospitalizations (baseline = 11.7%; 3 months = 8.5%; 6 months = 7.3%; 12
months = 6.7%; P = 0.018) but not for all-cause ER visits (baseline = 13.6%;
3 months = 14.2%; 6 months = 7.0%; 12 months = 13.0%; P = 0.495).
Conclusions: Natalizumab-treated MS patients reported significantly
fewer MS-related hospitalizations and ER visits over 1 year of treatment.
As a result of this reduction in hospitalizations and ER visits, natalizumab may reduce the economic burden of MS.
SPONSORSHIP: This research was funded by Biogen Idec, Inc., Weston,
MA, and Elan Pharmaceuticals, Inc., Gainesville, GA.
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