Cost-Effectiveness of Nivolumab vs. Docetaxel as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer

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astatic breast cancer (MBC) at a high risk of cardiac events with prior adjuvant anthracycline therapy.  Methods: а Markov model was developed to estimate the effectiveness: overall survival, fatal and non-fatal cardiac events - for two treatment arms: PLD versus doxorubicin in patients with metastatic breast cancer. Treatment effectiveness data were derived from the clinical trials. Time horizon of the analysis was 6 years, costs and benefits were discounted by 3.5%. One-way sensitivity analyses were performed to test model robustness. A cost-effectiveness analysis was performed from the Russian Healthcare System perspective. The course 1 EUR – 74.7 RUB.  Results: based on results of Markov modeling, PLD therapy for MBC patients provides additional 1.30 incremental life years gained (LYG) versus doxorubicin (in case of cardiac mortality events). Cost-effectiveness analysis showed that PLD is a preferred, cost-effective therapy option for Russian National Health Service: an incremental cost-effectiveness ratio (ICER) - 619 539 RUB (8,294 EUR) at willingness to pay (WTP) threshold 1 648 924 RUB (22,000 EUR). Sensitivity analyses showed that results are not sensitive to price for PLD (±20%), costs of health care resource use (±20%) and discount rates (5-10%), but sensitive to time horizon. For all sensitivity analyses scenarios, ICERs remained within the Russian WTP threshold  Conclusions: cost-effectiveness analysis determined that PLD is a cost-effective treatment option for MBC patients at high risk of cardiac events within Russian healthcare system. PCN132 Economic Evaluation of Everolimus as Second-Line Treatment of Metastatic Renal Cell Carcinoma in Greece Solakidi A1, Kourlaba G1, Kontovinis L2, Koutsoukos K3, Bournakis E4, Boutis A5, Syrios J6, Tzovaras A7, Michailidi C8, Kalogeropoulou M8, Maniadakis N9 1EVROSTON LP, Athens, Greece, 2Medical Oncology Department, Oncomedicare, Thessaloniki, Greece, 3Medical Oncology Department, Alexandra Hospital, Athens, Greece, 4Oncology Unit, 2nd Department of Surgery, Aretaieion Hospital, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece, 51st Oncology Department, Theagenio Cancer Hospital, Thessaloniki, Greece, 6Medical Oncology Department, Hygeia Hospital, Marousi, Greece, 7Medical Oncology Department, Hippokrateion Hospital, Athens, Greece, 8Novartis (Hellas) S.A.C.I., Athens, Greece, 9National School of Public Health, Athens, Greece

Objectives: The objective of this study was to conduct a cost-effectiveness analysis of everolimus versus axitinib for the treatment of metastatic RCC (mRCC) in Greece. Everolimus and axitinib were the only approved therapies with category 1 recommendation for second-line treatment of metastatic renal cell carcinoma (RCC) following TKI therapy, according to NCCN guidelines, by the time this analysis was conducted (Dec. 2015).  Methods: A Markov model was used to evaluate the cost-effectiveness of everolimus versus axitinib from a third-party payer perspective over a 10-year time horizon. Efficacy and safety inputs were based on a weight-adjusted indirect comparison of the therapies using the respective phase 3 trial data, RECORD1 and AXIS (Motzer et al., 2010; Rini et al., 2013). Utility values were calculated based on a time trade-off (TTO) study and adverse events rates from RECORD-1 and AXIS trials (Swinburn et al., 2010). Resource use and adverse events management data were collected by DELPHI method from an expert panel of clinicians from private and public hospitals in Greece. Direct medical costs were included (i.e. pharmaceutical, physician visits, lab and imaging tests and management of AEs). An annual discount rate of 3.5% was applied to the health state costs and efficacy values. The incremental cost-effectiveness ratio (ICER) was calculated. A threshold of € 35,000 per QALY gained was used, per WHO Guidelines. Probabilistic sensitivity analysis (PSA) was conducted.  Results: Everolimus was less costly and more effective (“dominant”) compared with axitinib, with € 5,495 lower lifetime costs per patient and 0.017 greater discounted QALYs (€ 10,175 vs € 15,671 and 0.617 vs 0.599). PSA suggests these results are robust; the probability that everolimus is cost-effective vs axitinib was estimated to be 72.5% given the ICER threshold.  Conclusions: Everolimus is likely to be dominant compared with axitinib as second-line treatment of mRCC in the Greek healthcare setting. PCN133 Cost-Effectiveness of Nivolumab in Patients with Advanced or Metastatic Renal Cell Carcinoma in Portugal Verleger K1, Almeida AJ2, Verheggen B3, Schoeman O1, Klijn S3, Doan J4, Lees M5, Malcolm B6 1Pharmerit International, Berlin, Germany, 2Bristol-Myers Squibb, Paço de Arcos, Portugal, 3Pharmerit International, Rotterdam, The Netherlands, 4Bristol-Myers Squibb, Wallingford, CT, USA, 5Bristol-Myers Squibb, Princeton, NJ, USA, 6Bristol-Myers Squibb, Middlesex, UK

Objectives: Recent phase III clinical trial evidence has demonstrated that nivolumab improves overall survival (OS) and health-related quality of life (HRQoL) versus everolimus in advanced renal cell carcinoma (RCC) patients who have received prior therapy. This study aimed to evaluate the cost-effectiveness of nivolumab versus everolimus for the treatment of these patients from a Portuguese societal perspective.  Methods: A validated partitioned survival model with states for progression-free survival (PFS), progressed disease (PD), and death was used to simulate the follow-up of advanced RCC patients. The proportion of patients in each state over time was calculated based on PFS and OS survival data from NCT01668784. PFS and OS data were extrapolated, respectively using a dependent 2-spline hazard model and log-logistic distribution. Adverse events and subsequent treatments were incorporated based on trial data. Drug costs were based on list prices; disease management costs on Portuguese input data and expert panel feedback. Time to treatment discontinuation data from the trial were used to estimate nivolumab drug costs. QoL weights were obtained from within-trial EQ-5D information. The time horizon was 25 years with costs and outcomes discounted 5% annually. Scenario and sensitivity analyses were conducted to assess uncertainty.  Results: Compared with the current standard of care in Portugal, everolimus, treatment with nivolumab provided an additional 0.615 quality-adjusted life-years (QALYs), CI: 0.317-0.914 and

0.667 life-years at an incremental cost of €  37,820, CI: €  27,736-44,384. The resulting incremental cost-effectiveness ratio was €  56,667 per QALY.  Conclusions: These economic analysis results demonstrate that although treatment with nivolumab is associated with higher costs of treatment, nivolumab provides significant survival benefits, improved quality-of-life, and a favorable toxicity profile versus everolimus. The ICER results above might be subject to change during negotiations with local authorities. This analysis aims to inform coverage and reimbursement decisions in Portugal. PCN134 Economic Evaluation of Olaparib In Patients with Brca – Mutated Psroc in Greece Mylonas C1, Aravantinos G2, Bamias A3, Kourlaba G4, Maniadakis N1 1National School of Public Health, Athens, Greece, 2Agioi Anargyroi Anticancer Hospital of Athens, Athens, Greece, 3University of Athens School of Medicine, Athens, Greece, 4Collaborative Center of Clinical Epidemiology and Outcomes Research (CLEO), Non-Profit Civil Partenrship, Athens, Greece

Objectives: To conduct an economic evaluation comparing Olaparib (Lynparza®) with “Watch and Wait” treatment strategy, the common clinical practice in Greece, for the treatment of patients with BRCA – mutated Platinum Sensitive Recurrent Ovarian Cancer (PSROC).  Methods: A validated global Markov model was locally adapted to describe disease progression and evaluate the cost – utility of comparators from a third – party payer perspective over a lifetime horizon. Efficacy and safety data as well as utility values applied in the model were extracted from relevant clinical trials. Direct treatment costs referring to the year 2016 were incorporated in the model from local sources. A probabilistic sensitivity analysis was conducted to account for uncertainty in the model. Primary outcomes were patient survival (Life-Years, LY), quality-adjusted life years (QALYs), years spent free of chemotherapy (YSCFs), total costs and incremental cost-effectiveness ratios (ICERs). All outcomes were discounted at 3.5%  Results: The discounted QALYs and the YSFC of patients treated with Lynparza®  were greater by 0.89 and by 1.34 respectively, compared to “Watch and Wait” strategy. The total lifetime cost per patient was estimated at 85,716€  and 12,144€  for Lynparza® and “Watch and Wait”, respectively. The ICERs associated with the administration of Olaparib were 63,046€ /LY gained and 82,799€ /QALY gained. The probabilistic analysis confirmed the deterministic results.  Conclusions: There is no official cost-effectiveness acceptance threshold in Greece. Local economic evaluations often reference the WHO upper threshold of three times the annual per capita income, being about 60.000€ . Nonetheless, cancer therapies in many jurisdictions are accepted for reimbursement at higher thresholds than the above. Hence, recently cancer therapies which much higher ICERs than that of Lynparza® have been reimbursed locally. In this light, Olaparib may be considered as a good value for money option for patients in Greece. PCN135 Cost-Effectiveness of Nivolumab vs. Docetaxel as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer Shah S1, Matthews SE1, Sarasani S1, Noel S1, Blanchette CM2 1University of North Carolina at Charlotte, Charlotte, NC, USA, 2Precision Health Economics, Davidson, NC, USA

Objectives: Non-small cell lung cancer (NSCLC) accounts for 27% of all cancer deaths, making it the leading cause of cancer mortality. Treatments for advanced NSCLC have been a constant challenge; recent studies have indicated immunotherapy as a promising therapeutic option for second-line therapy after platinum-based chemotherapy. We assessed the cost-effectiveness of Nivolumab compared to Docetaxel in patients with advanced NSCLC.  Methods: A MarkovDecision tree model was developed to estimate costs and benefits for patients with advanced NSCLC. The model consisted of two states: progression-free survival and death. Transition probabilities were estimated using results from a phase 3 clinical trial study comparing Nivolumab and Docetaxel. Published data and expert opinion were used as sources for costs adverse events. The time horizon was set at 2 years. We estimated the incremental cost-effectiveness ratio (ICER) of Nivolumab versus Docetaxel per additional month of progression-free survival.  Results: We estimated the initial cost of Nivolumab at $32,732 per cycle (3 months) based on a dose of 3 mg per kilogram of body weight every 2 weeks. Similarly, the initial cost of Docetaxel per cycle was $6,165 based on a dose of 75mg per square meter of body-surface area every 3 weeks. The overall cost of Nivolumab for the entire term was estimated at $130,308.34, compared to Docetaxel at $16,756.86. Adverse events in the Nivolumab arm accounted for $12,510.92 for the entire term, versus $48,128.46 in the Docetaxel arm. The clinical trial study showed median progression-free survival of 3.5 months for Nivolumab compared to 2.8 months for Docetaxel. We estimated the ICER at $159,048.86 per additional month of progression-free survival in the Nivolumab arm.  Conclusions: Nivolumab showed superior progression-free survival compared to Docetaxel but at a substantial cost. Future work to include sensitivity analyses and determine payer willingness to pay will be conducted.

PCN136 Words (Excluding Tãtle and Authors: 300) Title: Cost-Effectiveness Analysis of Nivolumab for the Treatment of Second-Line Advanced Squamous Non-Small Cell Lung Cancer (Nsclc) in Spain González García P1, Felip E2, Garrido P3, Trigo J4, Ortega-Joaquin N5, Echave M5, Jiménez S1, Oyagüez I6 1Bristol-Myers Squibb, Madrid, Spain, 2H. Universitario Vall d’Hebron, Barcelona, Spain, 3H. Universitario Ramón y Cajal, Madrid, Spain, 4H. Universitario Virgen de la Victoria, Málaga, Spain, 5Pharmacoeconomics & Outcomes Research Iberia, Madrid, Spain, 6Pharmacoeconomics & Outcomes Research Iberia, Pozuelo de Alarcón, Spain