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.
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•• Members with an adjudicated MS
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.
OR 1.8, 95% CI 1.1–2.9
$150 to <$250
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
specialty drug OOP expense and new prescription therapy abandonment; hence,
a direct cause-and-effect link can not be made.
•• Pharmacy claims data are intended for administrative and payment purposes 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.
•• Member OOP expense is not adjusted for pharmaceutical manufacturer coupons
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.
* 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
•• Pharmacy data are limited to commercial populations in the Midwest and South,
therefore it may not be generalized to Medicare or Medicaid populations or other
geographic regions.
•• No significant independent
Figure 1. Unadjusted Multiple Sclerosis (MS)
New Start Abandonment Rate by Out-of-Pocket
Member Expense
and lack of a methotrexate claim
in the previous 180 days were all
independently associated with
higher BAI abandonment rates.
•• Sensitivity analysis requiring
abandonment to be no subsequent
evidence of a paid BAI claim in the
ensuing 180 days did not change
the results.
•• During July 2010 through December 2012 approximately two out 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 80% more likely to be abandoned among members
attempting to newly initiate or re-initiate with an OOP between $100 and $250
compared to an $0 to <$50 OOP, while BAI therapy was 30% to 40% more likely
to be abandoned, however, the BAI findings were not statistically significant.
0
(n
=
(n
<$
0
$5
$1
–
–
$0
<$
–
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)
=
* 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
•• Increasing age, lower income,
50%
40%
Biologic Anti-inflammatory agents
Conclusions
52.3%
50%
abandonment to be no subsequent
evidence of a paid MS claim in the
ensuing 180 days did not change
the results.
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 $2,000 or more.
60%
<$
10
•• Sensitivity analysis requiring
Figure 2. Unadjusted Biologic Anti-Inflammatory (BAI)
New Start Abandonment Rate by Out-of-Pocket
Member Expense
59.9%
60%
0*
associations were found among
the other model covariates: age,
gender, or 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).
18 (10.0%)
$2
50
→→
180 (5.5%)
<$
15
rates by OOP expense group
findings demonstrate:
$100 to <$150
$1
5
•• Unadjusted new start abandonment
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.
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.
45 (6.8%)
(n
•• The Cochran-Armitage Trend Test
•• As shown in Tables 1 and 2 and
662 (20.1%)
–
BAI therapy between 7/1/2010
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.
abandoning therapy in each OOP
expense group were calculated.
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).
$50 to <$100
00
•• Members newly initiating MS or
•• The proportions of members
•• 10,365 (65.0%) of 15,937 BAI and
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.
Unadjusted Abandonment
Members (%)†
97 (6.1%)
1,6
00
if new start specialty drug abandonment
rates have changed since 2009.
glatiramer acetate, interferon
beta‑1a, interferon beta‑1b,
natalizumab, and fingolimod.
one of the nine following OOP
expense groups: $0 – <$50;
$50 – <$100; $100 – <$150;
$150 – <$250; $250 – <$500;
$500 – <$750; $750 – <$1000;
$1000 – <$2000; ≥$2000
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).
•• An MS specialty drug OOP
n =3,293
Members (%)*
1,600 (48.6%)
00
•• There is minimal information to assess
•• MS agents were defined as:
•• Members were then placed into
•• 7,347 (46.1%) of 15,937 BAI and
Out-of-Pocket (OOP)
Member Expense
$0 to <$50
$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 $100.4
to evaluate post period claims in
ensuing 180 days.
12,644 members newly initiated
BAI specialty drug therapy and
1,149 (9.1%) abandoned therapy
with 90-days follow-up.
Multiple Sclerosis agents
=
•• A 2009 study found that when OOP
•• A sensitivity analysis was performed
→→
3,293 members newly initiated
MS specialty drug therapy and
392 (11.9%) abandoned therapy
with 90-days follow-up.
•• The analysis was intended to explore potential associations between MS and BAI
Multivariate Logistic Regression Model‡
Abandonment Odds Ratio (OR)
and 95% Confidence Interval (CI)
Reference Group
<$
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
member share OOP expense was
extracted from the initial identified
paid claim during the 90-day
analysis period or if no paid claim
then the initial adjudicated claim
that was subsequently reversed.
→→
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
abatacept, adalimumab, alefacept,
anakinra, certolizumab pegol,
etanercept, golimumab, infliximab,
tocilizumab, ustekinumab, and
rituximab. BAI utilizers were required
to have one or more medical claims
with an International Classification
of Diseases Ninth Revision (ICD-9)
code for an approved autoimmune
inflammatory disease: rheumatoid
arthritis, plaque psoriasis, psoriatic
arthritis, Crohn’s disease, ulcerative
colitis, ankylosing spondylitis,
or juvenile idiopathic arthritis.
•• 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:
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.
•• 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
$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
Table 2. Biologic Anti-inflammatory (BAI) Specialty Drug Unadjusted and Adjusted Association
between Abandonment and Out-of-Pocket Member Expense
BAI medication cost and would be the minimum expected OOP for members with
a 10% co-insurance benefit.
•• 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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