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Gianni Ghetti,1 Lorenzo Pradelli,1 Giannis Papageorgiou,2 George Karpouzos,2 Yelda Arikan3 1AdRes Health Economics and Outcome Research, Turin, Italy; 2Boehringer Ingelheim Hellas, Athens, Greece; 3Boehringer Ingelheim, Amsterdam, the NetherlandsCorrespondence: Gianni Ghetti, AdRes Health Economics and Outcome Research, Via Vittorio Alfieri, 17, Turin, 10121, Italy, Email g.ghetti@adreshe.comPurpose: Globally, the prevalence of diabetes is on the rise, with the number of affected individuals predicted to cross 700 million by 2045. In Greece, in 2015, almost 700,000 people received prescribed medication for type 2 diabetes. The CELESTIA study aims to assess the cost-effectiveness of empagliflozin compared to branded sitagliptin in type 2 diabetes patients both with and without established cardiovascular disease in Greece from a third payer perspective.Methods: The IQVIA Core Diabetes Model was used and analyses were conducted from the Greek healthcare payer perspective. Patients received either empagliflozin or sitagliptin until HbA1c threshold of 8.5% (69 mmol/mol) was exceeded. Subsequently, patients were assumed to intensify to insulin therapy. Baseline cohort characteristics and treatment effects were derived from clinical trial data. Literature data were used for input (utilities, treatment costs and costs of diabetes-related complications costs). A lifetime time horizon (50 years) was applied, and costs and benefits were discounted at an annual rate of 3.5%.Results: Over a lifetime horizon, for empagliflozin, the estimated ICER was of € 6,587 and € 966 per quality-adjusted life years gained versus sitagliptin, in patients without established cardiovascular disease and in patients with established cardiovascular disease, respectively. Probabilistic sensitivity analysis confirmed the robustness of the analysis.Conclusion: The analysis demonstrated that for type 2 diabetes patients, empagliflozin is a cost-effective treatment option versus branded sitagliptin

Lorenzo Pradelli,1 Matteo Pinciroli,2 Hirad Houshmand,2 Beatrice Grassi,2 Fabrizio Bonelli,2 Mariella Calleri,2 Maurizio Ruscio3 1AdRes Health Economics and Outcomes Research, Torino, Italy; 2DiaSorin SpA, via Crescentino, Saluggia, 13040, Italy; 3Division of Laboratory Medicine, University Hospital Giuliano Isontina (ASU GI), Trieste, ItalyCorrespondence: Hirad HoushmandDiaSorin SpA, via Crescentino, Saluggia, 13040, ItalyTel +39 348 3311409Fax +39 016 1487670Email hirad.houshmand@diasorin.itPurpose: This Lyme disease early detection economic model, for patients with suspected Lyme disease without erythema migrans (EM), compares outcomes of standard two-tier testing (sTTT), modified two-tier testing (mTTT) and the DiaSorin Lyme Detection Algorithm (LDA), a combination of both serology tests and Interferon-ɤ Release Assay.Patients and Methods: A patient-level simulation model was built to incorporate effectiveness estimation from a structured focused literature review, and health-care cost inputs for the United States, Germany, and Italy. Simulated clinical outcomes were 1) percent of patients with timely and correct diagnosis, 2) patients appropriately treated and exposed to antibiotics therapy, and 3) patients with late Lyme disease manifestations. Expected health outcomes were expressed in terms of differences in quality-adjusted life years (QALYs) due to disseminated Lyme disease and persisting symptoms, and economic outcomes were analyzed from a third-party payer perspective.Results: The DiaSorin LDA resulted in a better sensitivity compared to sTTT and mTTT, 84% vs 49% and 45%, respectively, in the base case (13% of infected patients in the tested population). Due to the improved diagnostic performance, the LDA-based strategy is expected to be more effective, providing mean incremental 0.024 QALYs per tested patient, or 0.19 per infected patient. Furthermore, from a third-party payer perspective, the adoption of the LDA-based strategy would reduce the expecte

Marco Bellone,1 Lorenzo Pradelli,1 Stefano Molica,2 Adele Emanuela De Francesco,3 Daniela Ghislieri,4 Emanuele Guardalben,5 Antonietta Caputo4 1Department of Health Economics and Outcome Research, AdRes Health Economics and Outcomes Research, Turin, Italy; 2Dipartimento Onco-ematologico, Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy; 3Hospital Pharmacy, Mater Domini Azienda Ospedaliero Universitaria, Catanzaro, Italy; 4Market Access Department, Roche SpA, Monza, Italy; 5Medical Department, Roche SpA, Monza, ItalyCorrespondence: Marco BelloneAdRes Health Economics and Outcomes Research, 17 Via Vittorio Alfieri, Turin 10121, ItalyTel +39 011 765-1239Email m.bellone@adreshe.comObjective: To assess the cost-effectiveness of obinutuzumab (O-chemo) in comparison to rituximab (R-chemo) in patients with untreated advanced follicular lymphoma (FL) at intermediate or high risk from an Italian National Health Service (NHS) perspective.Methods: A previously developed four-state Markov model was adapted to estimate lifetime clinical outcomes and costs of Italian patients with advanced FL and an FL international predictive index score ≥ 2 in treatment with O-chemo and R-chemo. Life expectancy was derived from the GALLIUM and PRIMA clinical trials. Progression-free survival (PFS), early progressive disease (PD), and treatment duration were extrapolated by fitting parametric distributions to empirical data in GALLIUM and late PD to data in PRIMA. Expected survival was weighed by published utilities. Costs updated to 2020 Euros and health gains occurring after the first year were discounted at an annual 3% rate. Probabilistic sensitivity analysis (PSA) was carried out.Results: O-chemo was associated with an incremental survival increase (0.97 life-years [LYs]), even when weighted for quality (0.88 quality-adjusted LYs [QALYs]), and incremental costs (around € 15,000), driven by longer treatment during PFS state relative to R-chemo. The incremental cost-effectiveness rat

Lorenzo Pradelli,1 Tiziana Sinigaglia,1 Alberto Migliore,2 Giovanni Antonio Checchia,3 Francesco Franceschi,4 Bruno Frediani,5 Florenzo Iannone,6 Emilio Romanini7 1AdRes HE&OR, Torino, Italy; 2Saint Peter Hospital, Rome, Italy; 3Hospital of Monselice, Padua, Italy; 4University Hospital of Rome, Rome, Italy; 5Hospital of Siena, Siena, Italy; 6University of Bari, Bari, Italy; 7RomaPro Center for Hip and Knee Arthroplasty, polo Sanitario San Feliciano, Rome, ItalyCorrespondence: Lorenzo Pradelli Email l.pradelli@adreshe.comAbstract: The aim of this document is to provide a set of indications on the national best practice management of knee osteoarthritis based on an analysis of the existing literature and the contribution of experts in the field. During the first phase of the project, in agreement with the multidisciplinary panel of experts, the main guidelines on the topic were selected. Each guideline was assessed through the AGREEII system to identify their strong/weak points and a summary of the recommendations contained in the various documents was drawn up. The panel drew up a list of therapeutic options to be included in the document and some of these topics were selected for in-depth analysis and review. The search strategy for the required literature reviews was constructed using the PICOS approach. The results obtained from the literature reviews, the in-depth analyses conducted by the members of the scientific societies involved and the analysis of the existing guidelines enabled an initial draft of the consensus document to be elaborated. This document was examined at the consensus conference held on 28 May 2019, in the presence of a multidisciplinary group consisting of members of the various scientific societies involved. Single recommendations were discussed in work groups with a view to combining the indications given by the literature examined with the experience of the specialists involved. The recommendations discussed were then put to the vo

Gianni Ghetti,1 Maria Claudia D’Avella,2 Lorenzo Pradelli1 1Department of Health Economics and Outcome Research, AdRes, Turin, Italy; 2Department of Market Access, Sanofi, Milan, ItalyCorrespondence: Gianni GhettiDepartment of Health Economics and Outcome Research, AdRes, Via Vittorio Alfieri 17, Turin, 10121, ItalyTel +39 011 765 1239Email g.ghetti@adreshe.comPurpose: Cutaneous squamous cell carcinoma (CSCC) is a common cancer that in most cases is curable with surgery. About 3– 5% of patients develop advanced CSCC (aCSCC) and are no longer responsive to surgery or radiation therapy. The aim of this study was to assess the cost-effectiveness and cost-utility of cemiplimab, the first systemic therapy approved in Italy for patients with aCSCC, vs platinum-based chemotherapy from the Italian National Health Service (SSN) perspective.Methods: A partitioned survival model, which included three mutually exclusive health states, was developed to estimate costs and outcomes for patients with aCSCC, over a 30-year time horizon (lifetime). No direct evidence of the comparative efficacy and safety of cemiplimab versus other therapies currently exists. Therefore, a simulated treatment comparison (STC) was conducted to estimate the comparative efficacy of cemiplimab versus chemotherapy. Individual patient data for cemiplimab were collected from the EMPOWER-CSCC 1 trial whereas chemotherapy data were derived from a retrospective study. In the STC a regression model was used to predict outcomes for cemiplimab in the population observed in the comparator study. Costs of drug acquisition/administration and management of adverse events were included. Costs and outcomes were discounted at 3% per year. Incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) were calculated; sensitivity and scenario analyses were performed to assess the robustness of results.Results: In the base-case, treatment with cemiplimab was associated with a gain