Total Cost of Care and Budget Impact of Treatment with 24 ...
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MODEL STRUCTURE AND KEY ASSUMPTIONS 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 Populaon Idenficaon Parameter Value Source Mean start age, years 64.2 MURANO trial 1 % male 73.8% MURANO trial 1 Body surface area, m 2 1.92 MURANO trial 1 Health plan population, n 1,000,000 Assumption Population growth factor, % 0.7% World Bank 2 Patients covered by Medicare, % 60% Assumption, similar to data from Guerin et al 3 CLL prevalence rate (per 100,000) 41.50 SEER statistics 4 CLL incidence rate (per 100,000) 4.43 SEER statistics 4 Patients with treated R/R CLL, % 17.30% AbbVie, data on file 5 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 = Naonal Drug Code; WAC = wholesale acquision 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 mul-dose vial, it was assumed to have zero wastage. Therefore, the wastage cost is assumed to come solely from rituximab. Treatment, wastage and administraon costs, were applied for as long as treatment connues. RESULTS Table 1. Cumulave 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 me horizon, translang into an average PMPM net budget impact of -$0.02 over 3-year me 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 duraon therapy with venetoclax + R, which has lower total cost of care than other novel agents (i.e., venetoclax monotherapy, ibrunib, and idelalisib + R) that are administered connuously. Figure 1. Total Cost of Care Strafied by Cost Category ABSTRACT BACKGROUND Venetoclax label was recently expanded in the United States (US) to include the use of 24-months fixed duraon venetoclax in combinaon with rituximab (R) in paents with chronic lymphocyc leukemia (CLL), with or without 17p deleon, who have received at least one prior therapy. Our study aims to esmate the 3-year budgetary consequence of the expanded indicaon from the perspecve of a US payer with 1,000,000 members. METHODS The model included venetoclax monotherapy, ibrunib, and idelalisib + R as comparators. Dosing regimen, treatment duraon, and safety data were extracted from package inserts. Total cost of care was esmated for each regimen and included drug costs, wastage, drug administraon, adverse events, monitoring, and roune care. Drug costs were obtained from the Truven Health Analycs Red Book whereas other costs were based on published literature and a MarketScan analysis (Copyright ©2018 Truven Health Analycs LLC. All Rights Reserved). Monitoring costs were applied to venetoclax monotherapy and venetoclax + R for ramp up management and idelalisib + R for liver funcon monitoring and pneumonis. Scenario analyses explored uncertainty in influenal parameters. Outcomes were presented in absolute incremental budget impact and per-member per-month budget impact (PMPM). RESULTS Over the three-year me horizon, the expanded indicaon 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 cumulave difference in total cost of care of venetoclax + R compared with idelalisib + R and ibrunib is -$107,238, and -$98,518, respecvely. Scenario analyses supported the base case findings. CONCLUSION From a US payer’s perspecve, the expanded indicaon of venetoclax for a 24 month fixed duraon was associated with cost savings of $729,507 in paents with R/R CLL over a three-year period. The 24-month fixed duraon of venetoclax + R was a key driver in reducing total cumulave treatment costs. OBJECTIVE • To compare total cost of care of venetoclax + R, venetoclax monotherapy, ibrunib, and idelalisib +R across a 3 year me horizon. • To esmate budget impact of the expanded indicaon of venetoclax + R compared to the scenario without the label expansion • To compare the total cost of care aributable to tumor lysis syndrome by tumor burden • In Figure 2, by Year 3, the cumulave differences in total cost of care of venetoclax + R compared to idelalisib + R, ibrunib, and venetoclax monotherapy are -$107,238, -$98,518, and -$67,942, respecvely. Figure 2. Cumulave Total Cost of Care Over the 3-Year Time Horizon Figure 3. % of Total Cost of Care Aributable to Monitoring for TLS at Month 1, Year 1, Over 3 Years Strafied 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 paents 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 relavely small fracon 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 me horizon except in one scenario analysis where the me horizon is extended to four years (see “4-year me horizon”). †Corresponds to the average PMPM net budget impact over the three-year me horizon except in one scenario analysis where the me horizon is extended to four years (see “4-year me horizon”). ‡Corresponds to the percent change in total net budget impact vs. the base case budget impact results over the three-year me horizon except in one scenario analysis where the me horizon is extended to four years (see “4-year me horizon”). §In this scenario, the me 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 parcipated in the interpretaon of data, and review and approval of the review of the poster. All authors contributed to the development of the publicaon and maintained control over the final content. Jennifer Samp and Holger Keim are employees of AbbVie Inc. and may own stocks and/or opons of the company. Sang Kyu Cho is a Health Economics and Outcomes Research fellow of AbbVie Inc. Sco Johnson and Helene Parise are employees of Medicus Economics, LLC. Medicus Economics, LLC received consulng fees for research from AbbVie. Anthony Masaquel is an employee of Genentech, Inc. and may own stocks/and or opons from Roche. Total Cost of Care and Budget Impact of Treatment with 24 Months Fixed Duraon of Venetoclax + Rituximab in Paents with CLL Sang Kyu Cho 1 , Jennifer Samp 1 , Holger Keim 1 , Anthony Masaquel 2 , Sco Johnson 3 , Helene Parise 3 1 Health Economics and Outcomes Research, AbbVie Inc.; 2 Genentech Inc.; 3 Medicus Economics, LLC Presented at 2018 ISPOR Europe Annual Meeng, 10 – 14 November 2018, Barcelona, Spain REFERENCES 1. Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax–Rituximab in Relapsed or Refractory Chronic Lymphocyc Leukemia. N Engl J Med 2018; 378:1107-1120 2. World Bank. Populaon Growth (Annual %). 2016; hp://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 lymphocyc leukemia. Journal of Clinical Oncology. 2015;33(15_suppl):e18065-e18065. 4. Naonal Cancer Instute. Surveillance, Epidemiology and End Results Program (SEER) Cancer Stascs. Cancer Stat Facts: Chronic Lymphocyc Leukemia. 2017 hp://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 duraon therapy with venetoclax + R offers cost savings over other novel agents that are administered connuously. § 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 quesons, please contact Cho, Sang Kyu sangkyu.cho@abbvie.com Year 1 Year 3 *For Year 2, total costs of care include treatment cost and roune costs of care; Drug cost are: Venetoclax +/- R ($135,293), Ibrunib ($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. Roune costs of care were applied connuously 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 esmates. This may have impact on the cost esmates as the total cost of care by treatment regimen depends on duraon of treatment, response, and survival. • Market penetraon esmates are based on AbbVie internal projecon and may be subject to a degree of uncertainty. Current Scenario Projected Scenario
Transcript of Total Cost of Care and Budget Impact of Treatment with 24 ...
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
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
