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Ying Zheng,1 Ting Yu,2 Rachel H Mackey,3,4 Julie A Gayle,3 Christina L Wassel,3 Hemant Phatak,1 Ruth Kim5 1 EMD Serono, Inc., Rockland, USA; An Affiliate of Merck KGaA, Darmstadt, Germany; 2Global Medical Affairs, EMD Serono, Inc., Rockland, MA, USA; An Affiliate of Merck KGaA, Darmstadt, Germany; 3Premier Applied Sciences, Premier, Inc, Charlotte, NC, USA; 4Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA; 5Pfizer Inc., New York, NY, USACorrespondence: Ruth KimPfizer Inc., New York, NY 10017, USATel +1 212 733-7637Email ruth.kim@pfizer.comPurpose: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer with poor prognosis. This study compared patient characteristics, comorbidities, adverse events (AEs), treatment persistence, healthcare resource utilization (HRU) and costs in patients with metastatic MCC (mMCC) treated with immune checkpoint inhibitors (ICIs) or recommended chemotherapy per 2018 National Comprehensive Cancer Network (NCCN) Guidelines.Patients and Methods: A retrospective, observational study was conducted using data from 3/1/2015 through 12/31/2017 from the Premier Healthcare Database, a US hospital discharge database. The study included patients aged ≥ 12 years with International Classification of Diseases Codes for MCC and metastasis, categorized by their first treatment (index) during the study period (ICI or NCCN-recommended chemotherapy [chemotherapy]). Patient, hospital, and visit characteristics were assessed at the index date and Charlson Comorbidity Index (CCI) score and comorbidities during a 6-month look-back period. Clinical outcomes, including AEs and treatment persistence were assessed over 90 days and HRU and costs over 180 days post-index.Results: Of 75 patients with mMCC receiving ICIs (n=37) or chemotherapy (n=38), mean age was ≈73 years, and 21.3% had a history of immune-related (IR) conditions. Overall, ICI- and chemotherapy-treated patients were similar in most baseline characteristics, IR comorbidities, and CCI score. However, more ICI patients (46%) than chemotherapy patients (26%) persisted on treatment over 90-day follow-up, odds ratio (95% CI): 2.04 (0.93, 4.47), P=0.07. Over 180-day follow-up, 33% of patients had an inpatient admission with mean length of stay (LOS) ≈2 days shorter for ICI vs chemotherapy (not statistically significant). Total costs, primarily driven by pharmacy costs, were higher for ICIs than chemotherapy; other departmental costs were similar between treatment groups.Conclusion: In a real-world setting, patients with mMCC receiving ICIs had higher treatment persistence over 90 days, shorter inpatient LOS and similar departmental cost (excluding pharmacy cost) than those receiving chemotherapy.Keywords: metastatic Merkel cell carcinoma, immune checkpoint inhibitors, chemotherapy

Gurjyot K Doshi,1 Abhijeet Bhanegaonkar,2 Mairead Kearney,3 Murtuza Bharmal,2 Paul Cislo,4 Ruth Kim,4 Marley Boyd,5 Kathleen M Aguilar,5 Hemant Phatak2 1Texas Oncology, Houston, TX, USA; 2EMD Serono Research & Development Institute, Inc., Rockland, MA, USA; an affiliate of Merck KGaA, Darmstadt, Germany; 3Merck KGaA, Darmstadt, Germany; 4Pfizer Inc., New York, NY, USA; 5Data, Evidence and Insights, McKesson Life Sciences, The US Oncology Network, The Woodlands, TX, USACorrespondence: Abhijeet BhanegaonkarDirector, US Health Economics and Outcomes Research – Oncology, North America Medical Affairs, EMD Serono, Inc., One Technology Place, Rockland, MA 02370, USATel +1 781-681-2483Email abhijeet.bhanegaonkar@emdserono.comPurpose: Clinical trial evidence has affirmed the role for immuno-oncology (IO) treatment for locally advanced or metastatic urothelial carcinoma (la/mUC). This Study informing treatment Pathway dEcision in bladder cAnceR (SPEAR-Bladder) aimed to provide insight into the optimal sequencing of IO treatments among la/mUC patients treated in the US Oncology Network.Patients and Methods: This was a retrospective analysis of adult patients with la/mUC who initiated first-line chemotherapy followed by either IO therapy (C-IO subgroup) or chemotherapy (C-C subgroup) between 01/01/2015 and 04/30/2017 and included a potential follow-up period through 06/30/2017. Data were sourced from iKnowMed electronic health records. Patient and treatment characteristics were assessed descriptively, with Kaplan–Meier methods used to evaluate time-to-event outcomes, including overall survival (OS).Results: A total of 117 patients were included in this analysis (median age 69 years, 74.4% male, 88.0% Caucasian): 79 and 38 patients were in the C-IO and C-C subgroups, respectively. The median OS was 19.2 months among patients who received the C-IO sequence and 11.9 months among those who received the C-C treatment sequence.Conclusion: These results suggest that patients who received the C-IO treatment sequence had notable improvement in OS compared with those who received the C-C sequence. In light of the rapidly evolving therapeutic landscape, further investigation will be required to determine how best to select the optimal therapeutic regimen and sequencing for patients with la/mUC.Keywords: urothelial carcinoma, SPEAR-Bladder, real-world clinical outcomes, treatment sequencing, retrospective, community oncology setting

Thitima Kongnakorn,1 Murtuza Bharmal,2 Mairead Kearney,3 Hemant Phatak,4 Agnes Benedict,5 Abhijeet Bhanegaonkar,4 Matthew Galsky6 1Evidence Synthesis, Modeling and Communication, Evidera, London, UK; 2Global Evidence and Value Development, EMD Serono, Inc. (A business of Merck KGaA, Darmstadt, Germany), Rockland, MA, USA; 3Global Evidence and Value Development, Merck KGaA, Darmstadt, Germany; 4US Health Economics and Outcomes Research, EMD Serono, Inc. (A business of Merck KGaA, Darmstadt, Germany), Rockland, MA, USA; 5Evidence Synthesis, Modeling and Communication, Evidera, Budapest, Hungary; 6Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USACorrespondence: Murtuza BharmalGlobal Evidence and Value Development, EMD Serono, Inc. (A business of Merck KGaA, Darmstadt, Germany), Rockland, MA, USAEmail murtuza.bharmal@emdserono.comObjective: To estimate the budget impact of introducing avelumab as a second-line (2L) treatment option for patients with locally advanced or metastatic urothelial cancer (mUC) from the perspective of a US third-party payer (commercial and Medicare).Methods: A budget impact model (BIM) with a three-year time horizon was developed for avelumab. Efficacy and safety data were sourced from published literature and US package inserts. The analysis was conducted in collaboration with a specialist oncologist who validated clinical assumptions. Costs were based on the number of eligible patients, time-to-treatment failure, overall survival, adverse events (AEs), and projected market shares of various treatments.Results: In a hypothetical commercial health plan of 30,000,000 members, 884 patients were estimated to be eligible for 2L treatment over a three-year time period. Without avelumab, the total cost for treating patients with mUC was estimated to be US$70,268,035. The introduction of avelumab increased total costs by $73,438 (0.10% increase). In a hypothetical Medicare health plan of 30,000,000 beneficiaries, a total of 4,705 patients were estimated to be eligible for 2L treatment. Without avelumab, the total cost for treating patients with mUC was estimated to be $292,923,098 from a Medicare perspective; however, with avelumab, there was an increase of $719,324 (0.25% increase) in total costs. Results of the sensitivity analyses demonstrated a cost-neutral impact across all tested scenarios from both perspectives.Conclusion: The BIM estimated that avelumab would have a cost-neutral impact within a US commercial and a Medicare health plan. Overall, avelumab can be an affordable and valuable treatment option for patients with locally advanced or mUC in the 2L setting. These findings demonstrate a consistently favorable budget impact in both populations. Further studies should be conducted to more comprehensively assess the clinical and economic implications of adding avelumab to the treatment armamentarium of 2L mUC.Keywords: urothelial carcinoma, budget impact model, cost analysis, economic analysis, immuno-oncology, chemotherapy

Murtuza Bharmal,1 Mairead Kearney,1 Ying Zheng,2 Hemant Phatak21Global Evidence and Value Development, Merck Healthcare KGaA, Darmstadt, Germany; 2US Health Economics and Outcomes Research, EMD Serono, Inc, Rockland, MA, USAObjective: To estimate the budget impact of avelumab as a treatment option for patients with treatment-naïve first-line (1L) and previously treated second-line or later (2L+) metastatic Merkel cell carcinoma (mMCC) in the US.Methods: A budget impact model was developed to evaluate the addition of avelumab for the treatment of mMCC patients using a hypothetical 30 million-member US health plan over a 3-year time horizon (2019–2021). The comparator treatments included in the analysis were pembrolizumab and nivolumab (other immuno-oncology agents); and the chemotherapies routinely used in the eligible mMCC population. Model inputs included market share uptake of avelumab and other comparators, duration of treatments, and costs (drugs, health care resource utilization, adverse events). The model was evaluated from a commercial payer perspective. Sensitivity analyses were conducted to test uncertainties arising from the input values used in the model.Results: In a hypothetical commercial health plan of 30 million members, 285 patients with mMCC were identified over 3 years; 43 patients received avelumab as a 1L treatment over 3 years. In a world without avelumab, the total health care costs of treating patients with mMCC over 3 years were estimated to be US$11,710,115 from a commercial health plan perspective. With avelumab, there were estimated savings of $2,643,173 considering the total costs related to the treatment of mMCC over 3 years (23% reduction in the budget). The incremental cost per member per month over 3 years was −$0.0025.Conclusion: The model results indicate that the adoption of avelumab as a treatment option for mMCC would likely result in minimal budget impact from a US health plan perspective. Patients with mMCC, a rare condition with a poor prognosis and high unmet need, may benefit greatly from recently approved immunotherapies.Keywords: metastatic merkel cell carcinoma, cost, budget impact model, avelumab