Cost Effectiveness of Ribociclib Plus Letrozole Versus Palbociclib Plus Letrozole for The Treatment of Post-Menopausal Women with Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced or Metastatic Breast Cancer from A US Private Third-Party Payer Perspective

Cost Effectiveness of Ribociclib Plus Letrozole Versus Palbociclib Plus Letrozole for The Treatment of Post-Menopausal Women with Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced or Metastatic Breast Cancer from A US Private Third-Party Payer Perspective

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VA L U E I N H E A LT H 2 0 ( 2 0 1 7 ) A 3 9 9 – A 8 1 1

time attributed to learning by doing within an indication, thus providing greater consistency in assessing an incremental cost-effectiveness ratio (ICER) against a common standard.  Methods: The clinical effectiveness of three cancer regimens was estimated at product launch using data from pivotal randomized controlled clinical trials: FOLFOX (leucovorin, 5-fluorouracil, oxaliplatin) vs LVFU (leucovorin, 5-fluorouracil) for first- and second-line colorectal cancer, and gemcitabine vs 5-fluorouracil for first-line pancreatic cancer. Trends in clinical effectiveness over time were estimated using 1998–2011 data from the Surveillance, Epidemiology and End Results-Medicare linked database. Incremental costs were based on 1981–2017 time-series price data from AnalySource.  Results: The hazard ratio relative to that of the comparator drug fell over time for all three regimens, suggesting improving relative effectiveness. All three regimens showed the same price patterns with moderate initial rises followed by precipitous declines after loss of exclusivity. The relative effectiveness and price trends caused the cost-effectiveness ratios of each regimen to improve over their lifecycles. For example, the first-line FOLFOX ICER began at $70,000 when launched in 2000, but decreased to $20,000 per life-year gained by 2011.  Conclusions: This study suggests that ICERs estimated at launch based on clinical trial effectiveness data may be unrepresentative of actual costeffectiveness across the lifecycle of therapies, and may underestimate the societal value of therapeutic innovation in cancer. Additionally, it suggests that learning by doing effects can drive changes in incremental effectiveness that outweigh the effects seen in studies looking only at price, indication, and utilization patterns over time. PCN133 Cost Effectiveness of Ribociclib Plus Letrozole Versus Palbociclib Plus Letrozole for The Treatment of Post-Menopausal Women with Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Advanced or Metastatic Breast Cancer from A US Private Third-Party Payer Perspective Suri G1, Mistry R1, Young KC1, Hettle R1, May JR1, Brixner D2, Oderda G2, Biskupiak J2, Tang D3, Bhattacharyya D4, Bhattacharyya S4, Mishra D4, Dalal A3 1PAREXEL International, London, UK, 2Milcreek Outcomes Group, Salt Lake City, UT, USA, 3Novartis, East Hanover, NJ, USA, 4Novartis, Hyderabad, Telangana, India

Objectives: To assess the cost effectiveness of ribociclib+letrozole (Rib) versus palbociclib+letrozole (Pal) for the first-line treatment of post-menopausal women with HR+/HER2- advanced or metastatic breast cancer using a US third-party payer perspective (commercial).  Methods: The lifetime costs and effectiveness of treatment were simulated using a cohort-based, three-state (progression-free [PF], progressed disease [PD], and death) partition survival model with a one-month cycle length. Clinical data were derived from the MONALEESA-2 trial of Rib and a metaanalysis of Pal studies. Cost inputs included costs for wholesale drug acquisition excluding co-payment (28-day treatment cycle price: $10,950, $8,760, and $4,380 for ribociclib 600mg, 400mg and 200mg, respectively, versus $10,963 for palbociclib [all strengths]), administration (Medicare physician fee schedule), disease monitoring, adverse events (treatment-related Grade 3+), and subsequent therapies. The impact of discontinuation and dose reduction on drug costs were considered for both therapies. Effectiveness was valued in quality-adjusted life years (QALYs), with utility weights derived from EQ-5D-5L data collected in MONALEESA-2 for PF and from the literature for PD. Costs and effects were discounted at 3.0% per year. Uncertainty was assessed via deterministic and probabilistic sensitivity analyses.  Results: At lifetime, the total cost of Rib was $432,095 (drug cost= $228,801; health state cost= $203,294) versus $475,132 ($256,509 and $218,623, respectively) for Pal. The QALYs for Rib were 3.07 (PFS= 2.17; PD= 0.90) versus 2.99 (PFS= 1.99; PD= 1.00) for Pal. Rib was less costly (-$43,037) and more effective (+0.086 QALY) than Pal, and was hence the dominant strategy. The probability that Rib was cost-effective versus Pal at $50,000 per QALY was 72.5%. Differences in drug acquisition costs were the key driver of results.  Conclusions: In the US, Rib is a cost-effective alternative to Pal for first-line treatment of post-menopausal women with HR+/HER2- advanced or metastatic breast cancer. PCN135 Cost-Effectiveness of Nivolumab (NIVO) Combined with Ipilimumab (IPI) Compared with Nivo and Ipi Monotherapies in The First-Line Treatment of Advanced Melanoma in The United States: Analysis Using 28-Month Overall Survival (OS) Data from Checkmate 067 Baker T1, Paly VF1, Sabater J2, Gupte-Singh K2, Beyhaghi H2, Kotapati S2, Rao S2, Briggs A3 1ICON, New York, NY, USA, 2Bristol-Myers Squibb, Princeton, NJ, USA, 3University of Glasgow, Glasgow, Scotland, UK

Objectives: The objective of this study was to evaluate the cost-effectiveness of NIVO+IPI versus NIVO and IPI monotherapies in the first-line treatment of patients with advanced melanoma from a US payer perspective, using recently reported 28-month OS data from the CheckMate 067 trial.  Methods: This three-state partitioned survival model was developed from projections of OS and progression-free survival (PFS) to estimate accrued quality-adjusted life-years (QALYs), drug acquisition, follow-up, and toxicity costs over a life span time horizon (30 years). While previous models were informed by network meta-analysis methods, our analysis used survival extrapolations based on within-trial parametric modeling to test model sensitivity. Parametric fits were selected based on statistical and visual goodness of fit and the clinical plausibility and consistency of the OS and PFS combinations (NIVO+IPI: Gompertz for OS and PFS; both NIVO and IPI: log normal for OS and generalized gamma for PFS). General population mortality was also applied. Adverse-event frequencies and utility weights were obtained from CheckMate 067, and all costs from expert input and publically available sources/literature. Incremental cost-utility ratios (ICURs) for NIVO+IPI were estimated. A 3.5% discount rate was applied to costs ($US 2016) and utilities. Deterministic and probabilistic sensitivity analyses were conducted.  Results: Using the best fitting curves, NIVO+IPI was estimated to have 2.46 and 4.23 incremental QALYs and $88,344 and $149,903 incremental costs over NIVO and IPI monotherapies, respectively. The ICURs for NIVO+IPI were $35,893

versus NIVO and $35,431 versus IPI. These findings were found to be consistent in the deterministic and probabilistic sensitivity analyses.  Conclusions: This analysis highlights that NIVO+IPI combination has a longer survival than either monotherapy and, when combined with the incremental costs associated with NIVO+IPI, the ICURs indicate that it is likely to be a cost-effective option compared with monotherapy. PCN136 Cost-Effectiveness of Ponatinib in The Treatment of Patients With Accelerated or Blast Phase - Chronic Myeloid Leukemia in Greece Gourzoulidis G1, Kourlaba G1, Giannoulia P2, Panagiotidis P3, Maniadakis N4 1Evroston LP, Athens, Greece, 2Evangelismos General Hospital, Athens, Greece, 3Laiko General Hospital, Athens, Greece, 4National School of Public Health, Athens, Greece

Objectives: To evaluate the cost-effectiveness of ponatinib compared to bosutinib, allogeneic stem cell transplantation (allo-SCT) and hydroxycarbamide in the treatment of adult patients with accelerated or blast phase - Chronic Myeloid Leukemia (AP/BP-CML) whose disease is resistant/ intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation in the Greek healthcare setting.  Methods: A markov model was locally adapted from a third-party payer perspective over a 50-year time horizon. Efficacy, safety and utility data were extracted from relevant clinical trials and the literature. Resource consumption data were obtained from local experts and were combined with unit costs (in € 2017) obtained from official sources. Primary outcomes were patient quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs) per QALY gained. All the future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis (PSA) was conducted.  Results: Total life time cost per patient in BP-CML was estimated at € 29,895, € 16,038, € 42,893, and € 8,609 for ponatinib, bosutinib, allo-SCT and hydroxycarbamide, respectively. In terms of health outcomes, ponatinib was associated with 0.96, 0.48 and 1.05 increment in QALYs compared with bosutinib, allo-SCT, and hydroxycarbamide respectively, resulting in ICERs of € 14,481 and € 20,288 per QALY gained versus bosutinib and hydroxycarbamide. Similar results were found in AP-CML with ICERs reaching at € 679 and € 13,878 per QALY gained, respectively. Moreover, ponatinib was a dominant alternative over allo-SCT in both AP/BP-CML. PSA revealed that the probability of ponatinib being a cost-effective option at the predetermined threshold of € 51,000 per QALY gained was higher than 95% versus all available comparators in both AP/BP- CML.  Conclusions: The results indicate that, ponatinib seems to be a cost–effective option compared to other alternative therapies in the treatment of AP/BP-CML patients in Greece. PCN137 Pharmacoeconomic Analysis of Enzalutamide and Abiraterone for Treatment of Chemotherapy-Naïve Patients with Metastatic Castration-Resistant Prostate Cancer Avxentyev NA1, Frolov M2 Institute of Finance, Ministry of Finance of the Russian Federation and Russian Presidential Academy of National Economy and Public Administration, Moscow, Russia, 2Volgograd State Medical University of the Ministry of Health Russian Federation and Interregional Association of Clinical Pharmacologists, Volgograd, Russia 1Research

Objectives: Enzalutamide and abiraterone acetate plus prednisone (hereafter referred to as abiraterone) are approved for the treatment of metastatic castrationresistant prostate cancer (mCRPC) in Russia, both for chemotherapy-naïve and postchemotherapy patients. Currently, abiraterone is included in the Vital and Essential Drug List (VEDL) in Russia, while enzalutamide is not. This pharmacoeconomic evaluation compared enzalutamide and abiraterone used prior to chemotherapy in patients with mCRPC from the Russian healthcare system perspective.  Methods: Based on PREVAIL (enzalutamide), COU-AA-302 (abiraterone), TAX327 (docetaxel) and TROPIC (cabazitaxel) data, we proposed an mCRPC Markov chain stochastic process model and calculated medical costs (medications, adverse events treatments, treatments of bone metastases, pre-medications, pain relief and oncologist visits) associated with two options considered as best practise by Russian experts: consecutive use of enzalutamide or abiraterone, followed by docetaxel and then cabazitaxel after progression on docetaxel. We used the 8-year time horizon because > 97% of patients in the model die by the end of this period. Budget impact, cost-effectiveness and cost-utility analyses were conducted for enzalutamide and abiraterone. Each of them was compared with consecutive use of docetaxel and cabazitaxel without the preceding therapy with any of the studied drugs.  Results: Enzalutamide was found to be a cost-saving option compared to abiraterone. Monthly medication costs for enzalutamide were $3760 per patient, 11.7% less than for abiraterone. The 8-year discounted total medical costs for enzalutamide and abiraterone were $114,307 and $121,272 per patient, respectively, indicating that the 8-year health budget could be cut by $696,500 per 100 mCRPC patients through treatment with enzalutamide. Enzalutamide was also found to be cost-effective compared to abiraterone when both were compared against chemotherapy alone.  Conclusions: Enzalutamide is a cost-saving and cost-effective option compared to abiraterone and should be recommended for inclusion into the VEDL in Russia. PCN138 The Impact of Treatment-Free Remission of Tasigna® for Cml Patients in China – A Cost Effectiveness Analysis Chen S1, Xuan JW2, Zhang Y3, Zhu H4, Luo J5, Tan J1, Liu C6, Qiu M7, Qu S7, Xiong T7 First Affiliated Hospital of Soochow University, Suzhou, China, 2Sun Yat-sen University, Guangzhou, China, 3Henan Cancer Hospital, Zhengzhou, China, 4West China Hospital, Sichuan University, Chengdu, China, 5The Second Hospital of Hebei Medical University, Shijiazhuang, China, 6Novartis Pharmaceuticals (China) Oncology, Beijing, China, 7IMS Health China, Shanghai, China 1The

Objectives: Tasigna (TAS) has been approved by CFDA and been recommended as the first-line treatment of CML in China in 2016, since TAS was designed to be a more potent and selective inhibitor of BCR-ABL than Glivec (GLV), and TAS achieves deeper responses earlier. This study aims to conduct a cost effectiveness analysis