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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

Maurizio Benucci,1 Arianna Damiani,1 Mariangela Manfredi,2 Maria Infantino,2 Valentina Grossi,2 Francesca Li Gobbi11Rheumatology Unit, S.Giovanni di Dio Hospital, Florence, Italy; 2Immunology and Allergology Laboratory Unit, S.Giovanni di Dio Hospital, Azienda USL-Toscana Centro, Florence, ItalyAbstract: Rheumatoid arthritis (RA) is a chronic inflammatory disorder that affects joints with swelling and progressive joint destruction. The pathology leads to a progressive disability with an impact on the quality of life of the patients. Strategies to reduce in-patient care costs could have a considerable impact on lowering the direct medical costs of RA in Italy. Abatacept, a selective T-cell costimulation modulator, is a valuable treatment option for patients with moderate-to-severe RA. A search using the keywords “cost-effectiveness analysis", "budget impact model", "abatacept", and "rheumatoid arthritis” was carried out on PubMed. Abatacept in the first- and second-treatment lines has been evaluated in our research. We evaluated patients with inadequate MTX response, inadequate anti-TNF agents response, switch studies and real-world data. Furthermore, in our research, we evaluated the main head-to-head studies published.Keywords: abatacept, budget impact model, cost-effectiveness analysis, rheumatoid arthritis

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

Jesse D Ortendahl,1 Sonia J Pulgar,2 Beloo Mirakhur,3 David Cox,3 Tanya GK Bentley,1 Alexandria T Phan4 1Health Economics, Partnership for Health, LLC, Beverly Hills, CA, USA; 2Health Economics and Outcomes Research, Ipsen Biopharmaceuticals, Basking Ridge, NJ, USA; 3Medical Affairs, Oncology, Ipsen Biopharmaceuticals, Basking Ridge, NJ, USA; 4GI Medical Oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA Objective: With the introduction of new therapies, hospitals have to plan spending limited resources in a cost-effective manner. To assist in identifying the optimal treatment for patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors, budget impact modeling was used to estimate the financial implications of adoption and diffusion of somatostatin analogs (SSAs). Patients and methods: A hypothetical cohort of 500 gastroenteropancreatic neuroendocrine tumor patients was assessed in an economic model, with the proportion with metastatic disease treated with an SSA estimated using published data. Drug acquisition, preparation, and administration costs were based on national pricing databases and published literature. Octreotide dosing was based on published estimates of real-world data, whereas for lanreotide, real-world dosing was unavailable and we therefore used the highest indicated dosing. Alternative scenarios reflecting the proportion of patients receiving lanreotide or octreotide were considered to estimate the incremental budget impact to the hospital. Results: In the base case, 313 of the initial 500 gastroenteropancreatic neuroendocrine tumor patients were treated with an SSA. The model-predicted per-patient cost was US$83,473 for lanreotide and US$89,673 for octreotide. With a hypothetical increase in lanreotide utilization from 5% to 30% of this population, the annual model-projected hospital costs decreased by US$488,615. When varying the inputs in one-way sensitivity analyses, the results were most sensitive to changes in dosing assumptions. Conclusion: Results suggest that factors beyond drug acquisition cost can influence the budget impact to a hospital. When considering preparation and administration time, and real-world dosing, use of lanreotide has the potential to reduce health care expenditures associated with metastatic gastroenteropancreatic neuroendocrine tumor treatments. Keywords: health economics, oncology, model, costs, real-world evidence, lanreotide

Single-nucleotide polymorphisms (SNPs) can severely impact individual drug response and health outcomes in cancer patients. Genetic tests to screen for marker SNPs are available to adjust the drug dose of oncologicals to the patient's needs. However, it is unclear whether the positive effects outbalance the increased costs or even lead to an overall cost reduction. This very pragmatic analysis used three frequently used oncologicals for the treatment of breast cancer to evaluate whether preemptive pharmacogenetic testing may have a cost-reducing impact on health care spending in the Swiss health care system. Our results indicate that oncopharmacogenetics might help to reduce health care costs (ie, by avoiding adverse drug effects) and to increase efficiency of drugs in oncologic patients., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background: Hepatitis C virus (HCV) affects an estimated number of people between 130 million and 210 million worldwide. In the next few years, the Italian National Health Service will face a growing trend of patients requiring HCV antiviral treatments. The aim of the analysis was to estimate the time horizon in which it would be possible to treat HCV-infected patients and the related direct medical costs (antiviral treatment and monitoring activities) from the Italian National Health Service point of view., Methodology: In order to estimate the number of HCV-infected patients in Italy, we considered a top-down (considering published data) and a bottom-up approach. The number of years needed for treatment and related direct costs were estimated through the development of a static deterministic model., Results: The estimated number of HCV-infected patients in Italy varies from 2.7 (estimated through a top-down approach) to 0.6 million (estimated through a bottom-up approach) and 0.3 million (measured through a bottom-up approach). Considering the last two scenarios and the use of interferon-free therapies for 50,000 patients per year, treatment for HCV-infected patients could be at a cost of €13.7 billion and €7.0 billion by 2030 and 2023, respectively., Conclusion: The treatment for HCV-infected patients in Italy is a challenging target for the financial implications of patient care. HCV infection could be controlled or eliminated in a 10- to 15-year time horizon. The cost of treatment can hardly be dealt with using the traditional economic tools but should be faced through multiyear investments, as health benefits are expected in the long period. National Health Service stakeholders (industry, government, insurance, and also patients) will have to identify suitable financial instruments to face the new expenditure required.

Background: Deintensification and less drug regimen (LDR) antiretroviral therapy (ART) strategies have proved to be effective in terms of maintaining viral suppression in human immunodeficiency virus (HIV)-positive patients, increasing tolerability, and reducing toxicity of antiretroviral drugs administered to patients. However, the economic impact of these strategies have not been widely investigated. The aim of the study is to evaluate the economic impact that ART LDR could have on the Italian National Health Service (INHS) budget., Methods: A budget impact model was structured to assess the potential savings for the INHS by the use of ART LDR for HIV-positive patients with a 3 year perspective. Data concerning ART cost, patient distribution within different ARTs, and probabilities for patients to change ART on a yearly basis were collected within four Italian infectious diseases departments, providing ART to 13.7% of the total number of patients receiving ART in Italy., Results: The LDR investigated (protease inhibitor-based dual and monotherapies) led to savings for the hospitals involved when compared to the "do nothing" scenario on a 3 year basis, between 6.7% (23.11 million €) and 12.8% (44.32 million €) of the total ART expenditures. The mean yearly cost per patient is reduced from 9,875 € in the do nothing scenario to a range between 9,218 € and 8,615 €. The use of these strategies within the four departments involved would have led to a reduction of ART expenditures for the INHS of between 1.1% and 2.1% in 3 years., Conclusion: ART LDR simplification would have a significant impact in the reduction of ART-related costs within the hospitals involved in the study. These strategies could therefore be addressed as a sustainable answer to the public financing reduction observed within the INHS in the last year, allowing therapies to be dispensed without affecting the quality of the services provided.