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5511 ispor poster_v1

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5511 ispor poster_v1

  1. 1. Budget Impact of Ribociclib Plus Letrozole for Treatment-Naive Post-Menopausal Women With HR+/HER2- Advanced or Metastatic Breast Cancer From a US Third-Party Payer Perspective Mistry R,1 Suri G,1 Young KC,1 Hettle R,1 May JR,1 Brixner D,2 Oderda G,2 Biskupiak J,2 Tang D,3 Bhattacharyya D,4 Bhattacharyya S,4 Mishra D,4 Dalal A3 * 1 PAREXEL, London, UK; 2 University of Utah, Salt Lake City, UT, USA; 3 Novartis, East Hanover, NJ, USA; 4 Novartis, Hyderabad, Telangana, India *Corresponding author (anand.dalal@novartis.com) Background • Treatmentoptionsforhormonereceptor-positive(HR+),humanepidermal growthfactorreceptor2-negative(HER2-)advancedormetastaticbreast cancerinpost-menopausalpatientsincludearomataseinhibitors(e.g., letrozole),selectiveestrogenreceptormodulators(e.g.,tamoxifen),estrogen receptorantagonists(e.g.,fulvestrant)and,mostrecently,theoral,highly- selective,cyclin-dependentkinase4and6(CDK4/6)inhibitorsribociclib (KISQALI® ;Novartis)andpalbociclib(IBRANCE® ;PfizerInc.)1,2 • Clinical studies have shown that the combination of a CDK 4/6 inhibitor with letrozole is a tolerable, safe and efficacious alternative to letrozole monotherapy for first-line HR+/HER2- advanced breast cancer3-5 Objective • To estimate the budget impact of introducing ribociclib + letrozole as a first-line treatment option for post-menopausal patients with HR+/HER2- advanced or metastatic breast cancer in the United States from a third- party payer perspective Methods Model Structure • A cohort-based budget impact model was developed using Microsoft Excel® 2010 to calculate the incremental cost of introducing ribociclib + letrozole over 3 years for a target population of treatment-naïve post- menopausal patients with HR+/HER2- advanced or metastatic breast cancer (Table 1) • Direct medical costs related to treatment acquisition, treatment administration, treatment monitoring, adverse events, and subsequent therapy were included • The model compared two scenarios: treatment options for this patient population excluding ribociclib + letrozole versus a scenario where ribociclib + letrozole was included • Three lines of therapy were included, as this was the expected average number of lines of therapy this patient population would receive. In alignment with the ASCO guideline on endocrine therapy6 , patients who received CDK 4/6 inhibitor in the first-line setting were assumed not to receive a subsequent CDK inhibitor Table 1. Model Cohort Characteristics Cohort characteristics A hypothetical cohort of 1,000,000 health plan members: • Female: 50.8%7 • Post-menopausal (age ≥50 years): 33.9%7 • Post-menopausal with breast cancer: 3%8 • Proportion with advanced/metastatic breast cancer: 6.9%9 • HR+/HER2- subtype: 74%9 • HR+/HER2- patients eligible for CDK 4/6 inhibitor treatment: 100% Sources: See table content. First-line Treatment • Market shares for treatments in both scenarios were supported by market research (user modifiable) (Figure 1) • The launch of CDK 4/6 inhibitors is assumed to derive market share from existing therapies, from 47.7% in Year 1 to 64.6% in Year 3 • Ribociclib was assumed to gain market share from palbociclib (Year 1 onwards); the market share of ribociclib + letrozole increased from 3.3% in Year 1 to 19.3% in Year 3 • Treatment duration was based on the median time to treatment discontinuation (TTD) or median PFS5,10-13 Figure 1. Treatment Market Shares in Year 1 for Scenario Including Ribociclib + Letrozole Ribociclib + Letrozole, 3% Palbociclib + Letrozole, 36% Letrozole, 7% Fulvestrant, 6% Exemestane, 7% Tamoxifen, 7% Anastrozole, 7% Palbociclib + fulvestrant, 8% Fulvestrant + letrozole, 6% Chemotherapy (Eribulin), 6% Fulvestrant + Anastrozole, 6% Source: Novartis, data on file Second-line Treatment • 83% of patients received endocrine therapies and 17% of patients received chemotherapy • The duration of treatment for endocrine therapies and chemotherapy was sourced from randomized controlled trials (RCTs) for the target population (Novartis, data on file).4, 11-13 All chemotherapies in the analysis (represented by eribulin) were assigned a 4.9-month treatment duration9 Third-line Treatment • 39% of patients received endocrine therapies and 30% of patients received chemotherapy, while 31% of patients received no treatment (Novartis, data on file) • The duration of treatment for endocrine therapies and chemotherapy was sourced from RCTs for the target population.4,11-13 All chemotherapies were assigned a 4.7-month treatment duration9 due to the absence of treatment duration data in the third-line setting Adverse Events • Themodelincludedseriousadverseevents(AEs)(CTCAE(Common terminologycriteriaforadverseevents)Grade≥3)reportedmorefrequently withribociclib5 orpalbociclib3 versusplacebo(anemia,diarrhea,fatigue, infection,nausea,febrileneutropenia,pulmonaryembolism,andvomiting) andthat(frompreviousHTAsubmissionsandconsultationswithmodelling experts)weredeemedrelevantandrelatedtotreatment,werelikelytoresult inhospitalization,orhadameaningfulimpactonpatientwell-being Cost Inputs • Allcostswerein2016USdollarsinflatedusingtheConsumerPriceIndex(CPI)14 • The acquisition costs represented the lowest wholesale acquisition cost (WAC) of each medication within Medi-Span Price Rx® (Table 2)15 and allowed for patient co-payments. Eribulin was chosen to represent first-line chemotherapy options because it was the highest cost first-line chemotherapy • A patient co-payment was applied to the monthly treatment acquisition cost (Table 2) • The cost of each AE was assumed to reflect an average hospitalization related to that event (Table 2).16,17 The frequency of each AE for each treatment was obtained from the literature3,5,11,13,18-21 • Monthly treatment administration costs were derived from the 2016 Medicare Physician Fee Schedule using Medicare facility prices ($179 for fulvestrant and $771 for chemotherapy)22 • Monitoring costs included outpatient management, hospitalization, laboratory monitoring, and imaging (PFS health state only), and palliative care costs (progressed disease only) (total cost per month: $686 for PFS and $6,199 for PD)14,23 • Monitoring costs also included monthly add-on monitoring costs (hepatic enzymes, complete blood count, and ECG) for ribociclib and palbociclib upon treatment initiation ($138.48 vs. $42.36) and regularly thereafter ($21.72 vs. $10.59)15,24,25 Table 2. Cost Inputs Drug Dose (mg) WAC cost/ month ($) Copayment ($) Adverse event cost, total ($) Ribociclib 600.0 10,950 567 1,348.79400.0 8,760 567 200.0 4,380 567 Add-on letrozole 2.5 7 11 Palbociclib 125/100/75 10,963 567 1,734.76 Add-on letrozole 2.5 7 11 Letrozole (monotherapy) 2.5 7 11 572.75 Fulvestrant 500.0 1,863 373 831.00 Add-on anastrozole 1.0 4 11 Fulvestrant 500.0 1,863 373 Exemestane 25.0 304 11 639.90 Tamoxifen 20.0 21 11 959.14 Anastrozole (monotherapy) 1.0 4 11 572.75 Palbociclib 125/100/75 10,963 567 911.40 Add-on fulvestrant 500.0 1,863 373 Fulvestrant 500.0 1,863 373 789.36 Add-on letrozole 2.5 7 11 Chemotherapy (eribulin) 1.23 4,200 827 1,026.78 Sources: 3, 5, 11, 13, 15-22 WAC, Wholesale acquisition cost Deterministic Sensitivity Analysis (DSA) • A one-way DSA was performed to assess the influence of key model input parameters (acquisition cost, monitoring cost, first-line treatment duration, progression-free health state costs, and post-progression health state costs; ±10% variation) on budget impact Results • Out of 1,000,000 health plan members, 263 were post-menopausal patients with HR+/HER2- advanced/metastatic breast cancer were eligible for CDK 4/6 inhibitor therapy • Within both scenarios, drug acquisition cost was the major component of total cost (Table 3) • The introduction of ribociclib resulted in $3.01M cumulative total savings over three years, attributed to reduced costs (drug acquisition, $2.72M; subsequent therapy, $96K; AEs, $82K) (Table 4) • Savings per year increased over the time horizon with increased market share of ribociclib: $125K, $1.04M, and $1.85M in Years 1–3, respectively ($0.01, $0.09, and $0.15 incremental cost savings per member per month, respectively) • The introduction of ribociclib resulted in a cost saving per treated patient per month of $39.57 in Year 1, $327.73 in Year 2, and $525.28 in Year 3, yielding a cumulative incremental cost saving of $318.11 per member treated per month • The key drivers of the net budget impact included the acquisition, 2+ months, of ribociclib, which resulted in a change of 31% (increase/ decrease) following a reduction/increase in the base case parameter. Other drivers included the acquisition palbociclib + letrozole at 2+ months (+/- 28%), treatment duration of ribociclib (-4%, -10%), and treatment duration of palbociclib + letrozole (-28%, 17%) (Figure 2) • The results were not sensitive to assumptions about the treatment duration of ribociclib + letrozole, likely due to the magnitude of cost savings achieved with the introduction of ribociclib into the marketplace Table 3. Cumulative and Disaggregated Costs Both Scenarios Cost ($) Without ribociclib With ribociclib Year 1 Year 2 Year 3 Cumu- lative Year 1 Year 2 Year 3 Cumu- lative Total drug acquisition costs 18M 28M 31M 76M 17M 27M 29M 73M Ribociclib + letrozole 0K 0K 0K 0K 896K 4M 7M 12M Palbociclib +letrozole 13M 21M 22M 56M 12M 16M 14M 42M Other comparators 4.65M 6.88M 8.22M 19.74M 4.65M 6.88M 7.87M 19.39M Total drug administration costs 107K 116K 110K 334K 107K 116K 109K 332K Total drug monitoring costs 10K 17K 19K 47K 12K 27K 36K 75K Total disease management costs/ non-drug medical costs 3M 7M 7M 17M 3M 7M 7M 17M Total adverse event cost 303K 651K 1M 2M 299K 627K 953K 2M Total subsequent therapy costs 2M 8M 8M 18M 2M 8M 8M 18M Second line 2M 6M 6M 14M 2M 6M 6M 14M Third line 240K 2M 2M 4M 313K 2M 2M 4M Total indirect costs 0K 0K 0k 0K 0K 0K 0K 0K Total cost 23M 44M 47M 23M 43M 45M Cumulative total cost 23M 66M 113M 23M 65M 110M Total costs per member per month 1.90 3.64 3.90 1.89 3.55 3.74 1K, 1000; 1M, 1 million Table 4. Incremental Cost Results for the Scenario with Ribociclib versus the Scenario without Ribociclib Incremental cost, $ (%) Cost center Year 1 Year 2 Year 3 Cumulative Drug acquisition -197K (-1.1) -943K (-3.5) -1575K (-5.4) -2716K (-3.7) Drug administration 0 0 -1K (-1.0) -1K (-0.3) Drug monitoring 2K (+16.4) 10K (+36.3) 16K (+45.4) 28K (+37.3) Disease monitoring/non-drug medical 0 -60K (-0.9) -85K (-1.2) -145K (-0.9) Adverse events -3K (-1.1) -24K (-3.9) -54K (-5.7) -82K (-4.4) Subsequent therapy 73K (+3.6) -19K (-0.2) -151K (-1.9) -96K (-0.5) Second line 0 (0) 0 (0) 0 (0) 0 (0) Third line 73K (+23.4) -19K (-1.1) -151K (-8.7) -96K (-2.5) Total -125K -1036K -1850K -3012K Total PMPM -0.01 -0.09 -0.15 Total PMTM -39.57 -327.73 -585.28 1K, 1000; PMPM, Per member per month; PMTM, Per member treated per month Figure 2. Deterministic Sensitivity Analysis -5000 -4000 -3000 -2000 -1000 0 Monitoring costs for Ribociclib Health state costs, PFS Health state costs, PPS Acquisition, 1stmonth, Ribociclib Acquisition, 1st month, Palbociclib + Letrozole Acquisition, 2+months, Ribociclib Treatment duration, Ribociclib Treatment duration, Palbociclib + Letrozole Acquisition, 2+ months, Palbociclib + Letrozole $, Thousands BI Low BI High Conclusions • The introduction of ribociclib as a first-line treatment option for post- menopausal women with HR+/HER2- advanced or metastatic breast cancer in the US offers a cost-saving option with reduced drug acquisition, adverse event, and subsequent treatment costs for commercial payers • Key drivers of the net budget impact include the acquisition cost of palbociclib + letrozole, the acquisition cost of ribociclib + letrozole, and the acquisition cost of palbociclib Acknowledgements Editorial support was provided by Lorena Tonarelli and by Nick Rusbridge (PAREXEL) References 1. Cardoso, F. Ann Oncol. 2017; 28:16-33. 2. Gradishar, W.J. J Natl Compr Canc Netw. 2016; 14:324-54. 3. Finn, R.S. Lancet Oncol. 2015; 16:25-35. 4. Finn, R.S. N Engl J Med. 2016; 375:1925-1936. 5. Hortobagyi, G.N. N Engl J Med. 2016; 375:1738-1748. 6. Rugo, H.S. J Oncol Pract. 2016; 12:583-7. 7. Howden, L.M., Meyer, J.A. 2010. 8. SEER, SEER Cancer Statistical Review, 1975-2013. 2016. 9. Xie, J. J Med Econ. 2013; 16:278-88. 10. Bachelot, T. J Clin Oncol. 2012; 30:2718-24. 11. Baselga, J. N Engl J Med. 2012; 366:520-9. 12. Ellis, M.J. J Clin Oncol. 2015; 33:3781-7. 13. Johnston, S.R. Lancet Oncol. 2013; 14:989-98. 14. U.S. Bureau of Labor Statistics. 2016. 15. Medispan Price Rx. [cited 2017; Available from: https://pricerx.medispan.com/IngredientName. aspx]. 16. HCUP, N. HCUP NIS. 2013. 17. Michels, S.L. Pharmacoeconomics 2012; 30:809-23. 18. Finn, R.S. J Clin Oncol. 2016; 34:507. 19. Turner, N.C. N Engl J Med. 2015; 373:1672-3. 20. Cortes, J. Lancet 2011; 377:914-23. 21. Paridaens, R.J. J Clin Oncol. 2008; 26:4883-90. 22. Medicare. Medicare facility prices 2016. 23. Xie, J. Clin Breast Cancer 2015; 15:e263-76. 24. EMA. Ibrance (palbociclib). 2016. 25. Healthcare Bluebook. [cited 2017; Available from: https://www.healthcarebluebook.com/]. Presented at the ISPOR 20th Annual European Congress, 4-8 November, Glasgow, UK. This study was funded by Novartis. PCN62 Text: Q30f78 To: 8NOVA (86682) US Only +18324604729North,CentralandSouthAmericas;Caribbean;China +447860024038 UK,Europe Russia +46737494608 Sweden, Europe Visit the webat: http://novartis.medicalcongressposters.com/Default.aspx?doc=30f78 Scan this QR code Copies of this poster obtained through Quick Response (QR) Code are for personal use only and may not be reproduced without permission from the author of this poster.

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