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Purpose: 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 in Greece., Competing Interests: Ghetti G and Pradelli L are employees of AdRes, which has received project funding by Boehringer Ingelheim. Ghetti G reports grants from Amgen, AstraZeneca, Biogen, Fresenius Kabi, Janssen-Cilag, Novartis Gene Therapies, and Roche, outside the submitted work. Pradelli L reports grants from Amgen S.r.l, AstraZeneca S.p.A., Brahms GmbH, Biogen Italia S.R.L., Gilead Sciences S.R.L., Ipsen S.p.A., Janssen-Cilag S.p.A., Novartis Farma S.p.A., Novartis Gene Therapy EU Limited, Roche S.p.A., Sanofi S.R.L., and UCB Pharma S.p.A.; grants and personal fees from Fresenius Kabi GmbH, outside the submitted work. Papageorgiou G and Karpouzos G are employees of Boehringer Ingelheim Hellas, Athens, Greece. Arikan Y is an employee of Boehringer Ingelheim, Amsterdam, The Netherlands. The authors report no other conflicts of interest in this work., (© 2023 Ghetti et al.)

Objective: 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 ratio and incremental cost-utility ratio are both widely accepted by the Italian NHS (around €15,500/LY and €17,000/QALY gained, respectively). PSA simulations confirmed the robustness of results given sensible variations in assumptions., Conclusion: O-chemo has superior clinical efficacy compared to rituximab, and should be considered a cost-effective option in first-line treatment of patients with advanced FL at intermediate or high risk in Italy. Incremental cost-effectiveness ratios are below the threshold considered affordable by developed countries., Competing Interests: Dr Marco Bellone is an employee of AdRes, which has received project funding from Roche for the development of this research. Dr Marco Bellone reports grants from Roche during the study and grants from Roche, Sanofi, Janssen-Cilag Spa, Fresenius Kabi Deutschland, Novartis Farma, and Fresenius Kabi Italia outside the submitted work. Dr Lorenzo Pradelli is co-owner and an employee of AdRes, which has received project funding from Roche for the development of this research. Dr Lorenzo Pradelli report grants from Roche Spa during the study and grants from Janssen-Cilag, Sanofi, AstraZeneca, Biogen, and Medtronic outside the submitted work. Drs Stefano Molica and Adele Emanuela De Francesco are consultants for Roche. Drs Daniela Ghislieri, Emanuele Guardalben, and Antonietta Caputo are employees of Roche. The abstract of this paper was presented at the ISPOR Europe 2019 as a poster presentation, and can be viewed here: https://doi.org/10.1016/j.jval.2019.09.352, (© 2021 Bellone et al.)

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 vote in a plenary assembly. The final document contains 26 practice recommendations which leading specialists involved in the management of knee OA in Italy agree upon., Competing Interests: G.A. Checchia has received consultancy fees and/or speaker honoraria from AlfaSigma AlfaWasserman outside this work; F. Franceschi declares no conflict of interest; L. Pradelli and T. Sinigaglia are employees of AdRes, which has been contracted by CDPharma, using an unconditional grant by Mylan for this work, and funding form many pharmaceutical and medical device companies outside this work; B. Frediani declares no conflict of interest; F. Iannone has received consultancy fees and/or speaker honoraria from Pfizer, AbbVie, MSD, BMS, Lilly, Novartis, Sanofi, Celgene, UCB outside this work; E. Romanini declares no conflict of interest. The authors report no other conflicts of interest in this work., (© 2021 Pradelli et al.)

Purpose: 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 expected health-care cost for suspected and confirmed Lyme disease by roughly 40%, ie about $410, €130, and €170 per tested patient in the United States, Germany, and Italy, respectively, compared to sTTT. The results are most sensitive to the infection rate in the tested population, with LDA maintaining a cost advantage for Lyme disease active infection rates ≥0.8-2.5%., Conclusion: LDA early diagnostic testing and subsequent treatment of subjects with early Lyme disease without EM are expected to outperform traditional management strategies both clinically and economically in the US, Germany, and Italy., Competing Interests: We acknowledge the full financial support of DiaSorin SpA for this research manuscript. DiaSorin provided support in the form of salaries for authors Fabrizio Bonelli, Mariella Calleri, Matteo Pinciroli, Beatrice Grassi, and Hirad Houshmand. Lorenzo Pradelli is the co-owner and an employee of AdRes and has received project funding from DiaSorin SpA. Dr Maurizio Ruscio has received consulting honoraria from DiaSorin SpA., (© 2021 Pradelli et al.)

Purpose: 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 of 4.89 LYs and 3.99 QALYs, compared with a platinum-based chemotherapy regimen, resulting in an estimated ICER of 27,821 €/LY gained and an ICUR of 34,110 €/QALY gained. Both ICER and ICUR were below the commonly used Italian SSN willingness to pay thresholds., Conclusion: The use of cemiplimab, compared with a platinum-based chemotherapy regimen, can be considered a cost-effective option for the treatment of aCSCC patients in Italy., Competing Interests: Ghetti G is an employee of AdRes, which has received project funding from Sanofi for the development of this research. D’Avella MC is an employee of Sanofi. Pradelli L is a partner and employee of AdRes, which has received project funding from Sanofi for the development of this research. The authors report no other conflicts of interest in this work., (© 2021 Ghetti et al.)

Background: Meta-analyses of studies comparing transcatheter aortic valve implants (TAVIs) and sutureless aortic valve replacement (SU-AVR) show differing effectiveness and safety profiles. The approaches also differ in their surgical cost (including operating room and device)., Objective: The objective of this study was to assess the incremental cost-utility of SU-AVR vs TAVIs for the treatment of intermediate- to high-risk patients in the US, Germany, France, Italy, UK, and Australia., Methods: A patient-level simulation compares in-hospital pathways of patients undergoing SU-AVR or TAVIs; later, patient history is modeled at the cohort level. Hospital outcomes for TAVIs reproduce data from recent series; in SU-AVR patients, outcomes are obtained by applying relative efficacy estimates in a recent meta-analysis on 1,462 patients. After discharge, survival depends on the development of paravalvular leak and the need for dialysis. A comprehensive third-party payer perspective encompassing both in-hospital and long-term costs was adopted., Results: Due to lower in-hospital (4.1% vs 7.0%) and overall mortality, patients treated with SU-AVR are expected to live an average of 1.25 years more compared with those undergoing TAVIs, with a mean gain of 1.14 quality-adjusted life-years. Both in-hospital and long-term costs were lower for SU-AVR than for TAVIs with total savings ranging from $4,158 (France) to $20,930 (US)., Conclusion: SU-AVR results dominant when compared to TAVIs in intermediate- to high-risk patients. Both in-hospital and long-term costs are lower for SU-AVR than for TAVI patients, with concomitant significant gains in life expectancy, both raw and adjusted for the quality of life., Competing Interests: Disclosure Dr Lorenzo Pradelli is the coowner and an employee of AdRes and has received project funding from LivaNova. Massimiliano Povero is an employee of AdRes and has received project funding from LivaNova. Dr Antonio Miceli, Dr Matteo Ferrarini, and Dr Mattia Glauber are consultants for LivaNova. Matteo Pinciroli is an employee and holds stock options of LivaNova. This study was financially supported by LivaNova. The authors report no other conflicts of interest in this work.

Purpose: This evaluation compares propofol and benzodiazepine sedation for mechanically ventilated patients in intensive care units (ICUs) in order to identify the potential economic benefits from different payers' perspectives., Methods: The patient-level simulation model incorporated efficacy estimates from a structured meta-analysis and ICU-related costs from Italy, Germany, France, UK, and the USA. Efficacy outcomes were ICU length of stay (LOS), mechanical ventilation duration, and weaning time. We calculated ICU costs from mechanical ventilation duration and ICU LOS based on national average ICU costs with and without mechanical ventilation. Three scenarios were investigated: 1) long-term sedation >24 hours based on results from randomized controlled trials (RCTs); 2) long-term sedation based on RCT plus non-RCT results; and 3) short-term sedation <24 hours based on RCT results. We tested the model's robustness for input uncertainties by deterministic (DSA) and probabilistic sensitivity analyses (PSA)., Results: In the base case, mean savings with propofol versus benzodiazepines in long-term sedation ranged from €406 (95% confidence interval [CI]: 646 to 164) in Italy to 1,632 € (95% CI: 2,362 to 880) in the USA. Inclusion of non-RCT data corroborated these results. Savings in short-term sedation ranged from €148 (95% CI: 291 to 2) in Italy to €502 (95% CI: 936 to 57) in the USA. Parameters related to ICU and mechanical ventilation had a stronger influence in the DSA than drug-related parameters. In PSA, propofol reduced costs and ICU LOS compared to benzodiazepines in 94%-100% of simulations. The largest savings may be possible in the UK and the USA due to higher ICU costs., Conclusion: Current ICU sedation guidelines recommend propofol rather than midazolam for mechanically ventilated patients. This evaluation endorses the recommendation as it may lead to better outcomes and savings for health care systems, especially in countries with higher ICU-related costs., Competing Interests: Disclosure LP is a co-owner and employee of AdRes HE&OR, which has received an educational grant from Fresenius Kabi for this project. LP has also received speaker honoraria and travel expenses refund for participating at scientific events. MP is an employee of AdRes. HB received a single honorarium from Fresenius Kabi as an invited speaker and chair of symposium in 2014. TGK received honoraria as a consultant as well as travel reimbursement from Fresenius Kabi. AF, JFB, and MW are employees of Fresenius Kabi. GDR reports no conflicts of interest in this work.

Background/objectives: Parenteral nutrition (PN) incorporating omega-3 fatty-acid-enriched lipid emulsions has been shown to be cost effective in Western populations. A pharmacoeconomic evaluation was performed within the Chinese intensive care unit (ICU) setting. This assessed whether the additional acquisition cost of PN with omega-3 fatty-acid-enriched lipid emulsion (SMOFlipid) vs standard PN was offset by improved clinical outcomes that can reduce subsequent costs., Materials and Methods: A pharmacoeconomic discrete event simulation model was developed, based on an update to efficacy data from a previous international meta-analysis, with China-specific clinical and economic input parameters. Sensitivity analyses were undertaken to assess the effects of uncertainty around input parameters., Results: The model predicted that PN with an omega-3 fatty-acid-enriched lipid emulsion was more effective and less costly than PN with standard lipid emulsions for Chinese ICU patients, as follows: reduced length of overall hospital length of stay (19.48 vs 21.35 days, respectively), reduced length of ICU stay (5.03 vs 6.18 days, respectively), and prevention of 35.6% of nosocomial infections leading to a lower total cost per patient (¥47 189 [US $6937] vs ¥54 783 [US $8053], respectively). Additional treatment costs were offset by savings in overall hospital and ICU stay cost, and antibiotic cost, resulting in a mean cost saving of ¥7594 (US $1116) per patient. Sensitivity analyses confirmed the robustness of these findings., Conclusions: PN enriched with an omega-3 fatty-acid-containing lipid emulsion vs standard PN may be effective in reducing length of hospital and ICU stay and infectious complications in Chinese ICU patients, and also decreases overall treatment costs. This results in a favorable cost-effectiveness ratio. Thus, PN enriched with an omega-3 fatty-acid-containing lipid emulsion can be seen as a win-win situation for patients, hospital administration, and health insurance companies., Competing Interests: Disclosure Dr Lorenzo Pradelli is a director and an employee of AdRes, which has received project funding from Fresenius Kabi. The authors report no conflicts of interest in this work.

Background and Objectives: Clinical evidence supports the use of omega-3 polyunsaturated fatty acid (PUFA)-enriched lipid emulsions in place of standard lipid emulsions in parenteral nutrition (PN) for intensive care unit (ICU) patients, but uptake may be limited by higher costs. We compared clinical and economic outcomes for these two types of lipid emulsion in the Chinese ICU setting., Methods: We developed a pharmacoeconomic discrete event simulation model, based on efficacy data from an international meta-analysis and patient characteristics, resource consumption, and unit costs from a Chinese institutional setting. Probabilistic sensitivity analyses were undertaken to assess the effects of uncertainty around input parameters. Model predictive validity was assessed by comparing results with data observed in a patient subset not used in the modeling., Results: The model predicted that omega-3 PUFA-enriched emulsion (Omegaven(®) 10% fish oil emulsion) would dominate standard lipid emulsions, with better clinical outcomes and lower overall health care costs (mean savings ~10,000 RMB), mainly as a result of faster recovery and shorter hospital stay (by ~6.5 days). The external validation process confirmed the reliability of the model predictions., Conclusion: Omega-3 PUFA-enriched lipid emulsions improved clinical outcome and decreased overall costs in Chinese ICU patients requiring PN.