Parameter Assumption
Target Population Patients with relapsed/refractory (R/R) chronic
lymphocytic leukemia (CLL) with or without 17p deletion, who have
received at least one prior therapy
Cycle Length 4-week / 28-day cycle
Time Horizon Base case: 3 years (39 cycles total, 13 cycle per
year, one year = 364 days)
Perspective U.S. health plan, Medicare and Commercial coverage with
1,000,000 members
Market Share AbbVie internal projections
Epidemiology Prevalent + incident cases
Efficacy (PFS/OS) Not considered
Adverse Events Grade 3 or higher adverse events were included based
on package inserts
PFS: Progression free survival; OS: Overall survival
MODEL INPUTS Target Population Identification
Parameter Value Source Mean start age, years 64.2 MURANO
trial1
% male 73.8% MURANO trial1 Body surface area, m2 1.92 MURANO
trial1
Health plan population, n 1,000,000 Assumption Population growth
factor, % 0.7% World Bank2
Patients covered by Medicare, % 60% Assumption, similar to data
from Guerin et al3
CLL prevalence rate (per 100,000) 41.50 SEER statistics4
CLL incidence rate (per 100,000) 4.43 SEER statistics4
Patients with treated R/R CLL, % 17.30% AbbVie, data on file5
Drug Costs Drug WAC Pack Cost Product Unit / NDC
Venetoclax $2,407 $11,151
Starting pack (NDC 00074-0579-28); 100 mg 120 tablets (NDC
00074-0576-22)
Ibrutinib $12,180 140 mg 90 tablets (NDC: 57962-0140-09)
Idelalisib $10,217 150 mg 60 tablets (NDC: 61958-1702-01)
Rituximab $904 10 mg/ml,10 ml vial (NDC: 50242-0051-21)
Bendamustine $2,426 25 mg/ml, 4 ml vial (NDC: 63459-0348-04)
NDC = National Drug Code; WAC = wholesale acquisition cost; dosing
schedules for treatment regimens are based on each drug's package
insert
Drug Costs by Cycle Cycle* Venclexta + R Venclexta Ibrutinib
Idelalisib + R† BR‡
1 $2,406.66 $2,406.66 $11,368 $27,329 $14,830
2 $18,401 $10,407 $11,368 $29,136 $16,637
3 – 6 $20,207 $10,407 $11,368 $19,336 $16,637
7 $20,207 $10,407 $11,368 $9,535 $0
8+ $10,407 $10,407 $11,368 $9,535 $0 * Each cycle in the model
includes 28 days. The model is run for 39 cycles (i.e., 3 years,
364 days/year) in the base case (4 years in a scenario analysis). †
Due to the dosing schedule, the 8th infusion of rituximab is given
at the start of the 6th cycle. (R= rituximab); ‡ Due to Bendeka
being a multi-dose vial, it was assumed to have zero wastage.
Therefore, the wastage cost is assumed to come solely from
rituximab. Treatment, wastage and administration costs, were
applied for as long as treatment continues.
RESULTS Table 1. Cumulative Total Cost of Care and Net Budget
Impact
Budget Impact Year 1 Year 2 Year 3 Total Current scenario
$19,511,584 $18,939,592 $20,608,782 $59,059,958 Projected scenario
$20,485,703 $19,634,782 $18,209,967 $58,330,451 Net budget impact
$974,119 $695,190 -$2,398,816 -$729,507 Net PMPM $0.0801 $0.0571
-$0.1971 -$0.0200
PMPM = per-member per-month budget impact
• In Table 1, the venetoclax expanded label is associated with a
cost saving of $729,507 over the three-year time horizon,
translating into an average PMPM net budget impact of -$0.02 over
3-year time horizon for a US payer with 1,000,000 members.
• In Figure 1, significant cost savings occur in the third year
largely due to 24 months fixed duration therapy with venetoclax +
R, which has lower total cost of care than other novel agents
(i.e., venetoclax monotherapy, ibrutinib, and idelalisib + R) that
are administered continuously.
Figure 1. Total Cost of Care Stratified by Cost Category
ABSTRACT BACKGROUND Venetoclax label was recently expanded in the
United States (US) to include the use of 24-months fixed duration
venetoclax in combination with rituximab (R) in patients with
chronic lymphocytic leukemia (CLL), with or without 17p deletion,
who have received at least one prior therapy. Our study aims to
estimate the 3-year budgetary consequence of the expanded
indication from the perspective of a US payer with 1,000,000
members.
METHODS The model included venetoclax monotherapy, ibrutinib, and
idelalisib + R as comparators. Dosing regimen, treatment duration,
and safety data were extracted from package inserts. Total cost of
care was estimated for each regimen and included drug costs,
wastage, drug administration, adverse events, monitoring, and
routine care. Drug costs were obtained from the Truven Health
Analytics Red Book whereas other costs were based on published
literature and a MarketScan analysis (Copyright ©2018 Truven Health
Analytics LLC. All Rights Reserved). Monitoring costs were applied
to venetoclax monotherapy and venetoclax + R for ramp up management
and idelalisib + R for liver function monitoring and pneumonitis.
Scenario analyses explored uncertainty in influential parameters.
Outcomes were presented in absolute incremental budget impact and
per-member per-month budget impact (PMPM).
RESULTS Over the three-year time horizon, the expanded indication
of venetoclax was associated with total cost savings of $729,507 or
an average PMPM of -$0.0200 for a US payer with 1,000,000 members.
By Year 3, the cumulative difference in total cost of care of
venetoclax + R compared with idelalisib + R and ibrutinib is
-$107,238, and -$98,518, respectively. Scenario analyses supported
the base case findings.
CONCLUSION From a US payer’s perspective, the expanded indication
of venetoclax for a 24 month fixed duration was associated with
cost savings of $729,507 in patients with R/R CLL over a three-year
period. The 24-month fixed duration of venetoclax + R was a key
driver in reducing total cumulative treatment costs.
OBJECTIVE • To compare total cost of care of venetoclax + R,
venetoclax monotherapy,
ibrutinib, and idelalisib +R across a 3 year time horizon. • To
estimate budget impact of the expanded indication of venetoclax +
R
compared to the scenario without the label expansion • To compare
the total cost of care attributable to tumor lysis syndrome
by
tumor burden
• In Figure 2, by Year 3, the cumulative differences in total cost
of care of venetoclax + R compared to idelalisib + R, ibrutinib,
and venetoclax monotherapy are -$107,238, -$98,518, and -$67,942,
respectively.
Figure 2. Cumulative Total Cost of Care Over the 3-Year Time
Horizon
Figure 3. % of Total Cost of Care Attributable to Monitoring for
TLS at Month 1, Year 1, Over 3 Years Stratified by Tumor
Burden
Low tumor burden: Nodal mass ≤ 5 cm and ALC < 25,000; Medium
tumor burden: Nodal mass ≥ 5 cm to < 10 cm or ALC ≥ 25,000; High
tumor burden: Nodal mass ≥ 10 cm or nodal mass ≥ 5 cm and ALC ≥
25,000. *ALC: absolute lymphocyte count.
• During venetoclax ramp-up, the total cost of care is higher among
high tumor burden patients due to monitoring costs for tumor lysis
syndrome (High: $17,350 Medium: $6,789 Low: $2,154). However, the
total cost of care becomes comparable across three tumor burden
categories because the cost of managing TLS accounts for relatively
small fraction of the total cost of care.
Table 2. Scenario Analysis Scenario Years 1 – 3
Budget Impact* PMPM† % Change‡
Base case -$729,507 -$0.0200 N/A Venclexta price: +5% -$423,998
-$0.0116 41.9% Venclexta price: +10% -$118,489 -$0.0032 83.8%
Venclexta price: -5% -$1,035,016 -$0.0284 -41.9% Venclexta price:
-10% -$1,340,525 -$0.0367 -83.8% Adverse event rates doubled
-$747,834 -$0.0205 -2.5% Adverse events removed -$751,451 -$0.0206
-3.0% 0% hospitalization among medium tumor burden patients
-$745,331 -$0.0204 -2.2% 100% hospitalization among medium tumor
burden patients -$692,584 -$0.0190 5.1% Hospitalization cost based
on 100% inpatient stay -$726,616 -$0.0199 0.4% 4-year time horizon§
-$3,730,020 -$0.0766 -411.3%
* Corresponds to the total net budget impact over the three-year
time horizon except in one scenario analysis where the time horizon
is extended to four years (see “4-year time horizon”).
† Corresponds to the average PMPM net budget impact over the
three-year time horizon except in one scenario analysis where the
time horizon is extended to four years (see “4-year time
horizon”).
‡ Corresponds to the percent change in total net budget impact vs.
the base case budget impact results over the three-year time
horizon except in one scenario analysis where the time horizon is
extended to four years (see “4-year time horizon”).
§In this scenario, the time horizon is extended to four years. The
market shares are assumed to be the same as those of Year 3
DISCLOSURES Design, study conduct and financial support for the
study were provided by AbbVie Inc. and Genentech. Genentech is a
member of the Rosche group. AbbVie Inc. and Genentech participated
in the interpretation of data, and review and approval of the
review of the poster. All authors contributed to the development of
the publication and maintained control over the final content.
Jennifer Samp and Holger Keim are employees of AbbVie Inc. and may
own stocks and/or options of the company. Sang Kyu Cho is a Health
Economics and Outcomes Research fellow of AbbVie Inc. Scott Johnson
and Helene Parise are employees of Medicus Economics, LLC. Medicus
Economics, LLC received consulting fees for research from AbbVie.
Anthony Masaquel is an employee of Genentech, Inc. and may own
stocks/and or options from Roche.
Total Cost of Care and Budget Impact of Treatment with 24 Months
Fixed Duration of Venetoclax + Rituximab in Patients with CLL Sang
Kyu Cho1, Jennifer Samp1, Holger Keim1, Anthony Masaquel2, Scott
Johnson3, Helene Parise3
1Health Economics and Outcomes Research, AbbVie Inc.; 2Genentech
Inc.; 3Medicus Economics, LLC
Presented at 2018 ISPOR Europe Annual Meeting, 10 – 14 November
2018, Barcelona, Spain
REFERENCES 1. Seymour JF, Kipps TJ, Eichhorst B, et al.
Venetoclax–Rituximab in Relapsed or Refractory Chronic
Lymphocytic Leukemia. N Engl J Med 2018; 378:1107-1120 2. World
Bank. Population Growth (Annual %). 2016;
http://data.worldbank.org/indicator/SP.POP.
GROW. Accessed March 29, 2018. 3. Guerin A, Ray S, Gauthier G, et
al. Economic burden of relapsed/ refractory chronic
lymphocytic
leukemia. Journal of Clinical Oncology.
2015;33(15_suppl):e18065-e18065. 4. National Cancer Institute.
Surveillance, Epidemiology and End Results Program (SEER)
Cancer
Statistics. Cancer Stat Facts: Chronic Lymphocytic Leukemia. 2017
http://seer.cancer.gov/. Accessed February 16, 2017.
5. AbbVie. Data on file: H15.DoF.068. 6. AbbVie. Data on file:
H18.DoF.019
CONCLUSIONS § 24 months fixed duration therapy with venetoclax + R
offers cost savings over
other novel agents that are administered continuously. § The
venetoclax label expansion was associated with cost savings of
$729,507
or $0.02 PMPM for a US payer with 1,000,000 members over three
years § The base case results were robust in scenario analyses. §
Costs of managing tumor lysis syndrome had negligible impact on the
total
cost of care for venetoclax +/- R.
For questions, please contact Cho, Sang Kyu
[email protected]
Year 1
Year 3
* For Year 2, total costs of care include treatment cost and
routine costs of care; Drug cost are: Venetoclax +/- R ($135,293),
Ibrutinib ($147,783), Idelalisib + R ($123,961).
** In Year 3, the treatment cost ($13,009) for Venetoclax + R is
for the 24th cycle following the first month of ramp up in Year 1.
Routine costs of care were applied continuously throughout the
model, and assumed to be consistent across treatment regimens. AE
and monitoring costs were applied once only, in the first cycle of
the model.
LIMITATIONS • This model did not include PFS and OS effects to
retain transparency and
simplicity with regard to cost estimates. This may have impact on
the cost estimates as the total cost of care by treatment regimen
depends on duration of treatment, response, and survival.
• Market penetration estimates are based on AbbVie internal
projection and may be subject to a degree of uncertainty.
Current Scenario Projected Scenario