Association of Specialty Drug Prescription Abandonment with

Association of Specialty Drug Prescription Abandonment
with Increasing Member Out of Pocket Expense
Catherine I. Starner, PharmD, CGP, BCPS1,2, Kevin Bowen, MD, MBA1, Yang Qiu, MS1, Patrick P. Gleason, PharmD, FCCP, BCPS1,2 1Prime Therapeutics LLC, Eagan, MN, USA; 2University of Minnesota, Minneapolis, MN, USA
Objective
Identify members attempting to
newly initiate or re-initiate MS or BAI
specialty drug therapy and assess if
the association between abandonment
and OOP expense has changed.
•• Separate analyses for MS and
BAI therapy were performed to
assess the association between
member OOP expense and
abandonment rate.
•• For the BAI analysis, we also
identified members who had a
final paid methotrexate claim during
the 180 days prior to their initial
BAI claim.
•• Members with an adjudicated MS
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or BAI claim were then classified
as either initiating therapy, defined
as a paid claim, or as abandoning
therapy (i.e. not initiating therapy).
•• The association of MS or BAI
abandonment rate and OOP expense
was tested with logistic regression
models using $0–$50 OOP as the
reference group and adjusting for
age, gender, income using ZIP codelevel census data, education using
ZIP code-level census data, race
using ZIP code-level census data,
and methotrexate use for the BAI
analysis.
•• For all statistical tests, the
significance level was set a priori
at p < 0.05.
→→
BAI specialty drug therapy was
significantly more likely to be
abandoned at an OOP ≥$250
compared to < $50 (Figure 2).
•• An OOP of $2,000 or more was
associated with over half of
members abandoning their initial
prescription for MS or BAI therapy.
146 (4.4%)
15 (10.3%)
OR 1.8, 95% CI 1.1–3.2
$250 to <$500
120 (3.6%)
15 (12.5%)
OR 2.3, 95% CI 1.3–4.1
$500 to <$750
136 (4.1%)
23 (16.9%)
OR 3.2, 95% CI 1.9–5.3
$750 to <$1,000
102 (3.1%)
25 (24.5%)
OR 5.2, 95% CI 3.1–8.5
$1,000 to <$2,000
215 (6.5%)
75 (34.9%)
OR 8.5, 95% CI 6.0–12.1
≥$2,000
132 (4.0%)
79 (59.8%)
OR 23.8, 95% CI 15.9–36.0
Figure 1. Unadjusted Multiple Sclerosis (MS) New Start
Abandonment Rate by Out-of-Pocket Member Expense
abandonment to be no subsequent
evidence of a paid BAI claim in the
ensuing 180 days did not change
the results.
or patient assistance programs. Therefore, actual member OOP expense may have
been lower resulting in misclassification bias. Coupons and patient assistance
amounts are not a part of the pharmacy benefit manager adjudication process
and therefore unavailable.
therefore it may not be generalized to Medicare or Medicaid populations or other
geographic regions.
Conclusions
52.3%
50%
40%
•• During July 2010 through December 2012 approximately two of three members
40%
34.9%
30%
30%
10%
6.1% 6.8%
10.0% 10.3%
17.9%
20%
16.9%
13.9%
12.5%
10%
5.3% 5.4%
7.5% 6.8% 7.2%
•• MS specialty drug therapy was a significant 80% more likely to be abandoned among
(n
0
(n
=
members attempting to newly initiate or re-initiate with an OOP between $100 and
$250 compared to an $0 to <$50 OOP, while BAI therapy was 30% to 40% more likely
to be abandoned, however, the BAI findings were not statistically significant.
0
$5
$1
–
<$
10
<$
–
$0
<$
–
50
(n
=
25
18
0)
0*
(n
–
<$
=
50
14
$5
6)
0*
00
(n
–
<$
=
$7
12
75
50
0)
0*
–
(n
<$
$1
=
1,0
,0
13
00
00
6)
*(
–
<$
n
2,
=
00
10
2)
0*
(n
>$
2,
=
00
21
0*
5)
(n
=
13
2)
66
2)
=
0*
* p < 0.05 compared to $0–$50 group
5,7
47
)
00
=
–
2
<$
,39
15
$1
6)
0
50
(
n
–
=
<$
64
$2
2
50
3)
50
(n
–
<$
=
50
65
$5
0*
1)
00
(n
–
=
<$
$7
93
75
50
0
7)
–
*(
<$
$1
n
1,0
,0
=
00
43
00
1)
–
*(
<$
n
2,
=
00
60
0*
5)
(n
>$
2,
=
00
92
0*
4)
(n
=
31
0)
0%
0%
who attempted to newly initiate or re-initiate MS or BAI specialty drug therapy had
an OOP expense per 30-day supply claim of <$100 with an abandonment rate of
one in 18. No differences in abandonment rates were found between the $0 to
<$50 and $50 to <$100 groups.
24.8%
24.5%
20%
•• A BAI specialty drug OOP expense
•• Sensitivity analysis requiring
•• Member OOP expense is not adjusted for pharmaceutical manufacturer coupons
60%
50%
Biologic Anti-inflammatory agents
and lack of a methotrexate claim
in the previous 180 days were all
independently associated with
higher BAI abandonment rates.
and as such they may not represent informed member decisions on the basis of
cost alone at the time the claim was reversed. The analysis assumes that the
member is presented their OOP expense at the time of intended purchase and
the reversed claim without a subsequent paid claim indicates the member
abandoned specialty drug therapy.
Figure 2. Unadjusted Biologic Anti-Inflammatory (BAI) New
Start Abandonment Rate by Out-of-Pocket Member Expense
59.9%
60%
abandonment to be no subsequent
evidence of a paid MS claim in the
ensuing 180 days did not change
the results.
•• Increasing age, lower income,
•• Pharmacy claims data are intended for administrative and payment purposes
•• Pharmacy data are limited to commercial populations in the Midwest and South,
•• Sensitivity analysis requiring
of between $100 and $499 was
associated with 1.3 to 1.4 greater
likelihood of new start abandonment
compared to an OOP expense <$50,
however, statistical significance
was found only in the $250 to
<$500 group. As the OOP expense
increased over $500, abandonment
increased at a non‑linear rate,
reaching 19.2 fold greater rate of
new start abandonment at an OOP
expense of $2,000 or more.
specialty drug OOP expense and new prescription therapy abandonment; hence,
a direct cause-and-effect link can not be made.
* members newly initiating MS specialty drug, defined as no MS specialty drug claims in prior 180 days
†
test for trend, p < 0.001
‡
model adjusts for age, gender, and zip code derived race, income, and education
0
MS specialty drug therapy was
significantly more likely to be
abandoned at an OOP ≥$100
compared to < $50 (Figure 1).
$150 to <$250
$2
50
→→
OR 1.8, 95% CI 1.1–2.9
<$
15
rates by OOP expense group
findings demonstrate:
18 (10.0%)
$1
5
•• Unadjusted new start abandonment
180 (5.5%)
)
Figures 1 and 2, the abandonment
rate increased as OOP increased
with a significant trend test,
p < 0.001, for both MS and
BAI agents.
$100 to <$150
(n
•• As shown in Tables 1 and 2 and
associations were found among
the other model covariates: age,
gender, or zip-code derived race,
income, and education.
OR 1.1, 95% CI 0.8–1.6
–
was performed to evaluate the
trend in abandonment rates as
the OOP expense increased (SAS
Institute Inc., version 9.1.3, Cary,
NC). Univariate abandonment rates
were compared for each of the OOP
expense groups to the $0 to $50
reference group using the Pearson
chi-square statistic.
MS members attempting to newly
initiate therapy had an OOP of
$0 to <$100, with an unadjusted
abandonment rate of 5.5%
(573 members abandoned).
•• No significant independent
45 (6.8%)
00
•• The Cochran-Armitage Trend Test
•• 10,365 (65.0%) of 15,937 BAI and
662 (20.1%)
1,6
00
if new start specialty drug abandonment
rates have changed since 2009.
and 12/31/2012 were defined
as having no paid or reversed
pharmacy or medical claim for any
MS or BAI drug in the previous 180
days. Members were required to
be continuously enrolled in the
180 days prior to their initial MS
or BAI specialty drug claim and
for 180 days thereafter.
MS members attempting to newly
initiate therapy had an OOP of
$0 to < $50, with an unadjusted
abandonment rate of 5.4%
(399 members abandoned).
expense between $100 and $499
was associated with a significant
1.8 to 2.3 greater likelihood of
new start abandonment compared
to an expense OOP <$50. As the
OOP expense increased over
$500, abandonment increased at
a non‑linear rate, reaching 23.8
fold greater rate of new start
abandonment at an OOP expense
of $2,000 or more.
$50 to <$100
00
•• There is minimal information to assess
•• 7,347 (46.1%) of 15,937 BAI and
•• An MS specialty drug OOP
Unadjusted Abandonment
Members (%)†
97 (6.1%)
$1
expense was more than $150, members
newly initiating MS or BAI specialty drug
therapy were two to 3.7 times more likely
to abandon their MS or BAI drug therapy
compared to members paying less
than $100.4
12,644 members newly initiated
BAI specialty drug therapy and
1,149 (9.1%) abandoned therapy
with 90-days follow-up.
Multiple Sclerosis agents
n =3,293
Members (%)*
1,600 (48.6%)
Out of Pocket (OOP)
Member Expense
$0 to <$50
=
•• A 2009 study found that when OOP
→→
3,293 members newly initiated
MS specialty drug therapy and
392 (11.9%) abandoned therapy
with 90-days follow-up.
•• The analysis was intended to explore potential associations between MS and BAI
Multivariate Logistic Regression Model‡
Abandonment Odds Ratio (OR)
and 95% Confidence Interval (CI)
Reference Group
<$
1
products, utilization, and expenditures
has resulted in insurers focusing on
methods to best manage specialty
agents which may include increasing
member cost share or out-of-pocket
(OOP) expense.3
abatacept, adalimumab, alefacept,
member share OOP expense was
anakinra, certolizumab pegol,
extracted from the initial identified
etanercept, golimumab, infliximab,
paid claim during the 90-day
tocilizumab, ustekinumab, and
analysis period or if no paid claim
rituximab. BAI utilizers were required
then the initial adjudicated claim
to have one or more medical claims
that was subsequently reversed.
with an International Classification
•• A sensitivity analysis was performed
of Diseases Ninth Revision (ICD-9)
to evaluate post period claims in
code for an approved autoimmune
ensuing 180 days.
inflammatory disease: rheumatoid
arthritis, plaque psoriasis, psoriatic •• Members were then placed into
one of the nine following OOP
arthritis, Crohn’s disease, ulcerative
expense groups: $0–<$50; $50–
colitis, ankylosing spondylitis, or
<$100; $100–<$150; $150–<$250;
juvenile idiopathic arthritis. MS
$250–<$500; $500–<$750; $750–
agents were defined as: glatiramer
<$1000; $1000–<$2000; ≥$2000
acetate, interferon beta-1a, interferon
beta‑1b, natalizumab, and fingolimod. •• The proportions of members
abandoning therapy in each OOP
•• Members newly initiating MS or
expense group were calculated.
BAI therapy between 7/1/2010
→→
Table 1. Multiple Sclerosis (MS) Specialty Drug Unadjusted and Adjusted Association
between Abandonment and Out-of-Pocket Member Expense
(n
•• The increasing number of specialty
•• The 30-day specialty drug supply
December 2012:
Multivariate Logistic
Regression Model (Tables 1 and 2)
–
multiple sclerosis (MS) and biologic
anti‑inflammatory (BAI) agents
accounted for 46% of pharmacy benefit
specialty expenditures in 2012.2
•• BAI agents were defined as:
•• During July 2010 through
<$
50
•• Two classes of specialty drugs,
from 11 Blue Cross and Blue Shield
Plans with 10.3 million commercially
insured lives’ medical and pharmacy
data from 1/1/2010 through
6/30/2013.
Abandoning therapy was defined
as reversal of the adjudicated claim
with no subsequent evidence
of additional adjudicated paid
claim(s) for MS or BAI in the
ensuing 90 days.
$5
0
10.9 million member commercial book
of business, had a 19.1% trend in 2012
compared to 2011 and accounted for
22.2% of all pharmacy expenditures
in 2012.1
•• Observational cross-sectional study
Limitations
Results
–
•• Specialty drugs, within Prime Therapeutics
Methods
$0
Background
No external funding provided for this research
•• For both the MS and BAI groups, an OOP expense of $250 or more was associated
with significantly more therapy abandonment than <$50 OOP. As OOP increased
beyond $250, abandonment increased at a non-linear rate.
* p < 0.05 compared to $0–$50 group
•• The $250 OOP is an important value as it equates to less than 10% of the MS or BAI
medication cost and would be the minimum expected OOP for members with a 10%
co-insurance benefit.
Table 2. Anti-inflammatory (BAI) Specialty Drug Unadjusted and Adjusted Association
between Biologic Abandonment and Out of Pocket Member Expense
•• Health insurers should consider these findings when designing pharmacy benefits
Out of Pocket (OOP)
Member Expense
$0 to <$50
n = 12,644
Members (%)*
5,747 (45.5%)
Unadjusted Abandonment
Members (%)†
302 (5.2%)
Multivariate Logistic Regression Model‡
Abandonment Odds Ratio (OR)
and 95% Confidence Interval (CI)
Reference Group
$50 to <$100
2,396 (18.9%)
129 (5.4%)
OR 1.0, 95% CI 0.8–1.3
$100 to <$150
643 (5.1%)
48 (7.5%)
OR 1.4, 95% CI 1.0–2.0
$150 to <$250
651 (5.1%)
44 (6.8%)
OR 1.3, 95% CI 0.9–1.8
$250 to <$500
937 (7.4%)
67 (7.2%)
OR 1.4, 95% CI 1.1–1.8
$500 to <$750
431 (3.4%)
60 (13.9%)
OR 3.0, 95% CI 2.2–4.0
$750 to <$1,000
605 (4.8%)
108 (17.8%)
OR 3.8, 95% CI 3.0–4.9
1.
$1,000 to <$2,000
924 (7.3%)
229 (24.8%)
OR 5.9, 95% CI 4.9–7.2
2. Prime Therapeutics. Internal Data.
≥ $2,000
310 (2.5%)
162 (52.3%)
OR 19.2, 95% CI 14.9–24.7
* members newly initiating BAI specialty drug, defined as no BAI claims in prior 180 days
†
test for trend, p < 0.001
‡
model adjusts for age, gender, methotrexate claim, and zip code derived race, income and education
with contemplation of a maximum OOP cost per claim for preferred formulary
specialty drugs.
References
Prime Therapeutics 2013. Specialty Today + Tomorrow. https://www.primetherapeutics.com/PDF/specialtydtr2013/index.html
3. Gleason, P.P., G.C. Alexander, C.I. Starner, et al. Health Plan Utilization and Costs of Specialty Drugs within Four Chronic
Conditions. Journal of Managed Care Pharmacy 2013;19(7):542–48
4. Gleason, P.P., C.I. Starner, B.W. Gunderson, et al. Association of Prescription Abandonment with Cost Share for High-Cost
Specialty Pharmacy Medications. Journal of Managed Care Pharmacy 2009;15(8):648–58.

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