Lorlatinib as a first-line treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer: Α cost-effectiveness analysis in Greece.

OBJECTIVES: To evaluate the cost-effectiveness of lorlatinib compared to 1st generation anaplastic lymphoma kinase (ALK) TKI crizotinib, and 2nd generation TKIs alectinib and brigatinib, for previously untreated patients with ALK+ advanced Non-Small Cell Lung Cancer (aNSCLC). METHODS: A partitioned survival model was locally adapted from a Greek payer perspective over a lifetime horizon. Clinical, safety and utility data were extracted from literature. Direct medical costs reflecting the year 2023 were included in the analysis (€). Model outcomes were patients' life years (LYs), quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs). RESULTS: Total cost per patient with lorlatinib, alectinib, crizotinib, and brigatinib was estimated to be €188,205, €183,343, €75,028, and €145,454 respectively. Lorlatinib appeared to yield more LYs and QALYs gained versus alectinib, crizotinib, and brigatinib. Hence, lorlatinib resulted in ICERs of €4,315 per LY gained and €4,422 per QALY gained compared to alectinib, €34,032 per LY gained and €48,256 per QALY gained versus crizotinib and €16,587 per LY gained and €26,271 per QALY gained compared to brigatinib. CONCLUSION: Lorlatinib provides substantial clinical benefit and appears to be a cost - effective treatment option compared to 1st and 2nd generation TKIs for previously untreated patients with ALK+ aNCSLC in Greece.

Cost Effectiveness of Tofacitinib for the Treatment of Active Ankylosing Spondylitis in Greece.

BACKGROUND AND OBJECTIVE: Ankylosing spondylitis is a chronic, progressive, inflammatory, multidimensional, musculoskeletal disease primarily involving the axial skeleton. In addition, ankylosing spondylitis is associated with increased morbidity and mortality, significantly affecting productivity and overall quality of life. The aim of the present study was to evaluate the cost effectiveness of tofacitinib compared to currently marketed biologic treatment in patients with active ankylosing spondylitis who have responded inadequately to conventional therapy (biologic-naïve population) or previous biologic therapy (biologic-experienced population) in Greece. METHODS: A published model comprising a decision tree and a three-state Markov model was adapted from a public payer perspective over a lifetime horizon. Adalimumab and secukinumab, having the highest market shares among biologics for the treatment of ankylosing spondylitis in Greece (standard practice), were selected as comparators in the analysis. Clinical parameters captured treatment response defined per Assessment of Spondyloarthritis International Society 20 response, short-term and long-term changes in Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores, long-term biologic treatment discontinuation, and adverse events. Efficacy, safety data, and utility values were elicited from the published literature. Direct costs pertaining to drug acquisition, monitoring, adverse events, and disease management costs were considered in the analysis (€2022). Model outcomes were patients' quality-adjusted life-years, total costs, and incremental cost-effectiveness ratios. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty. RESULTS: In a biologic-naïve population, compared with adalimumab, tofacitinib produced an estimated 0.06 additional quality-adjusted life-years [QALYs] (10.67 vs 10.73), at additional costs of €2403 (€147,096 vs €149,500) resulting in an incremental cost-effectiveness ratio of €41,378 per QALY gained. In a biologic-experienced population, the total cost per patient for tofacitinib and secukinumab was estimated to be €151,371 and €145,757, respectively. In terms of health outcomes, tofacitinib was associated with a 0.13 increment in QALYs compared with secukinumab resulting in an incremental cost-effectiveness ratio of €42,784 per QALY gained. The probabilistic sensitivity analysis confirmed the deterministic results for both populations. CONCLUSIONS: Tofacitinib was estimated to be a cost-effective option for the treatment of active ankylosing spondylitis in Greece for both biologic-naive and biologic-experienced patients.

Health and economic outcomes of 20-valent pneumococcal conjugate vaccine compared to 15-valent pneumococcal conjugate vaccine strategies for adults in Greece.

Objective: Higher valency pneumococcal conjugate vaccines (PCVs) are expected to improve protection against pneumococcal disease through coverage of additional serotypes. The aim of the present study was to evaluate the cost-effectiveness of 20-valent pneumococcal conjugate vaccine (PCV20) compared to 15-valent pneumococcal conjugate vaccine (PCV15) alone or followed by 23-valent polysaccharide vaccine (PPV23) for adults in Greece. Methods: A published Markov model was adapted to simulate lifetime risk of clinical and economic outcomes from the public payer's perspective. The model population was stratified based on age and risk profile (i.e., low, moderate, or high-risk of developing pneumococcal disease). Epidemiologic parameters, serotype coverage and vaccines' effectiveness were based on published literature, while direct medical costs (prices €, 2022) were obtained from official sources. Main model outcomes were projected number of invasive pneumococcal disease (IPD) and all-cause non-bacteremic pneumonia (NBP) cases and attributable deaths, costs and quality-adjusted life-years (QALY) for each vaccination strategy. Sensitivity analyses were performed to ascertain the robustness of model results. Results: Over the modeled time horizon, vaccination with PCV20 compared to PCV15 alone or PCV15 followed by PPV23 prevents an additional 747 and 646 cases of IPD, 10,334 and 10,342 cases of NBP and 468 and 455 deaths respectively, resulting in incremental gain of 1,594 and 1,536 QALYs and cost savings of €11,183 and €48,858, respectively. PSA revealed that the probability of PCV20 being cost-effective at the predetermined threshold of €34,000 per QALY gained was 100% compared to either PCV15 alone or the combination of PCV15 followed by PPV23. Conclusion: PCV20 is estimated to improve public health by averting additional pneumococcal disease cases and deaths relative to PCV15 alone or followed by PPV23, and therefore translates to cost-savings for the public payer. Overall results showed that vaccination with PCV20 was estimated to be a dominant vaccination strategy (improved health outcomes with reduced costs) over PCV15 alone or followed by PPV23 for prevention of pneumococcal disease in adults in Greece.

Estimating the Clinical and Economic Impact of Switching from the 13-Valent Pneumococcal Conjugate Vaccine (PCV13) to Higher-Valent Options in Greek Infants.

In June 2010, Greece introduced the 13-valent pneumococcal conjugate vaccine (PCV13) for pediatric vaccination and has since observed a large decrease in pneumococcal disease caused by these vaccine serotypes, yet the disease prevalence of non-vaccine serotypes has increased. Two higher-valent conjugate vaccines, a 15-valent (PCV15) and a 20-valent (PCV20), were developed to improve serotype coverage and combat serotype replacement. A decision-analytic model was adapted to the Greek setting using historical pneumococcal disease trends from PCV13 to forecast future clinical and economic outcomes of higher-valent PCVs over a 10-year period (2023-2033). The model estimated outcomes related to invasive pneumococcal disease (IPD), hospitalized and non-hospitalized pneumonia, and otitis media (OM) resulting from a switch in vaccination programs to PCV15 in 2023 or switching to PCV20 in 2024. Cost-effectiveness was evaluated from the third-party payer's perspective in the Greek healthcare system. Compared to implementing PCV15 one year earlier, switching from PCV13 to PCV20 in 2024 was estimated to be a cost-saving strategy by saving the Greek health system over EUR 50 million in direct medical costs and averting over 250 IPD cases, 54,800 OM cases, 8450 pneumonia cases, and 255 deaths across all ages over a 10-year period.

Does a Standard Cost-Effectiveness Threshold Exist? The Case of Greece.

OBJECTIVES: This study aimed to systematically review the use of cost-effectiveness (CE) threshold for evaluating pharmacological interventions in Greece. METHODS: A systematic search of PubMed and ScienceDirect was conducted between January 2009 and June 2022. The data of selected studies were extracted using a relevant form and consequently were synthesized. Qualitative variables were presented with relative frequencies (%) and quantitative variables with median and interquartile range (IQR). RESULTS: From the 302 identified studies, 83 satisfied the inclusion criteria. Studies were categorized to oncology (26.5%) and a nononcology related (73.5%) based on drug treatment. The most frequently reported outcome associated with CE threshold was the "per quality-adjusted life-year gained." A total of 32.5% of the studies with a reported threshold did not specify the origin of the threshold. From the rest of studies, the vast majority (92.8%) adopted thresholds equal to 1 to 3 times the gross domestic product (GDP) per capita, whereas the rest similar to National Institute for Health and Care Excellence guidelines. The median CE threshold was differentiated between oncology (€51 000 [IQR €50 000-€60 000]) and nononcology studies (€34 000 [IQR €30 000-€36 000]; P < .001). In both type of studies, the median CE thresholds were not statistically significantly different among GDP, National Institute for Health and Care Excellence, and not specified approaches. CONCLUSIONS: Aligned with other countries where there is no standard CE threshold to promote efficient use of healthcare resources, the most prominent practice in Greece was found to be that of 1 to 3 times the GDP per capita irrespective of type of treatment or outcome studied.

EFOMP policy statement 17: The role and competences of medical physicists and medical physics experts in the different stages of a medical device life cycle.

MPPs are trained in the branches of physics associated with the practice of medicine. Possessing a solid scientific background and technical skills, MPPs are well suited to play a leading role within each stage of a medical device life cycle. The various stages of the life cycle of a medical device include establishment of requirements with use-case assessment, investment planning, procurement of medical devices, acceptance testing especially regarding safety and performance, quality management, effective and safe use and maintenance, user training, interfacing with IT systems, and safe decommissioning and removal of the medical devices. Acting as an expert within the clinical staff of a healthcare organisation, the MPP can play an important role to achieve a balanced life cycle management of medical devices. Given that the functioning of medical devices and their clinical application in routine clinical practice and research is heavily physics and engineering based, the MPP is strongly associated with the hard science aspects and advanced clinical applications of medical devices and associated physical agents. Indeed, this is reflected in the mission statement of MPP professionals [1]. PURPOSE: The life cycle management of medical devices is described as well as the procedures involved. These procedures are performed by multi-disciplinary teams within a healthcare environment. The task of this workgroup was focused on clarifying and elaborating the role of the Medical Physicist and Medical Physics Expert - here collectively referred to as the Medical Physics Professional (MPP) - within these multi-disciplinary teams. This policy statement describes the role and competences of MPPs in every stage of a medical device life cycle. If MPPs are an integral part of these multi-disciplinary teams, the effective use, safety, and sustainability of the investment is likely to improve as well as the overall service quality delivered by the medical device during its life cycle. It leads to better health care quality and reduced costs. Furthermore, it gives MPPs a stronger position in health care organisations throughout Europe.

Indicators to assess physiological heat strain - Part 3: Multi-country field evaluation and consensus recommendations.

In a series of three companion papers published in this Journal, we identify and validate the available thermal stress indicators (TSIs). In this third paper, we conducted field experiments across nine countries to evaluate the efficacy of 61 meteorology-based TSIs for assessing the physiological strain experienced by individuals working in the heat. We monitored 372 experi-enced and acclimatized workers during 893 full work shifts. We continuously assessed core body temperature, mean skin temperature, and heart rate data together with pre/post urine specific gravity and color. The TSIs were evaluated against 17 published criteria covering physiological parameters, practicality, cost effectiveness, and health guidance issues. Simple meteorological parameters explained only a fraction of the variance in physiological heat strain (R2 = 0.016 to 0.427; p < 0.001), reflecting the importance of adopting more sophisticated TSIs. Nearly all TSIs correlated with mean skin temperature (98%), mean body temperature (97%), and heart rate (92%), while 66% of TSIs correlated with the magnitude of dehydration and 59% correlated with core body temperature (r = 0.031 to 0.602; p < 0.05). When evaluated against the 17 published criteria, the TSIs scored from 4.7 to 55.4% (max score = 100%). The indoor (55.4%) and outdoor (55.1%) Wet-Bulb Globe Temperature and the Universal Thermal Climate Index (51.7%) scored higher compared to other TSIs (4.7 to 42.0%). Therefore, these three TSIs have the highest potential to assess the physiological strain experienced by individuals working in the heat.

Cost-Utility Analysis of Pegaspargase for the Treatment of Acute Lymphoblastic Leukemia in Greece.

BACKGROUND AND OBJECTIVE: Acute lymphoblastic leukemia (ALL) is an acute, rapidly progressing and life-threatening form of cancer involving immature lymphocytes called lymphoblasts. ALL is the most common subtype of leukemia in children and adolescents. The aim of the present study was to assess the cost-utility of pegaspargase versus L-asparaginase, both followed by Erwinase in the therapy sequence, as a treatment option for pediatric, adolescent, and adult patients with ALL in Greece. METHODS: A published cost-utility model comprising a decision tree and a state-transition Markov model was adapted from a public payer perspective to compare a pegaspargase treatment sequence with an L-asparaginase sequence. Efficacy and safety data, as well as utility values, were extracted from the published literature. Direct costs pertaining to drug acquisition, administration, and management of hypersensitivity were considered in the analysis (€2020). Model-extrapolated outcomes included quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICER). All future outcomes were discounted at 3.5% per annum. Sensitivity analyses were used to explore the impact of changing input data. RESULTS: The analysis showed that the pegaspargase sequence was estimated to produce 0.05 additional QALYs (18.12 vs. 18.07) and lower cost of - €1698 compared with L-asparaginase, indicating that the pegaspargase sequence was a dominant treatment strategy (improved outcomes with reduced costs) compared with L-asparaginase. Deterministic sensitivity analysis confirmed the cost-effective profile of pegaspargase. At the defined willingness-to-pay threshold of €54,000/QALY gained, probabilistic sensitivity analysis showed that pegaspargase had a 100% probability of being cost effective relative to the L-asparaginase sequence. CONCLUSION: The pegaspargase sequence was found to be less costly and more effective (in terms of QALYs) in relation to the L-asparaginase sequence, representing a dominant strategic option for Greek public payers in ALL.

Indicators to assess physiological heat strain - Part 2: Delphi exercise.

In a series of three companion papers published in this Journal, we identify and validate the available thermal stress indicators (TSIs). In this second paper of the series, we identified the criteria to consider when adopting a TSI to protect individuals who work in the heat, and we weighed their relative importance using a Delphi exercise with 20 experts. Two Delphi iterations were adequate to reach consensus within the expert panel (Cronbach's α = 0.86) for a set of 17 criteria with varying weights that should be considered when adopting a TSI to protect individuals who work in the heat. These criteria considered physiological parameters such as core/skin/mean body temperature, heart rate, and hydration status, as well as practicality, cost effectiveness, and health guidance issues. The 17 criteria were distributed across three occupational health-and-safety pillars: (i) contribution to improving occupational health (55% of total importance), (ii) mitigation of worker physiological strain (35.5% of total importance), and (iii) cost-effectiveness (9.5% of total importance). Three criteria [(i) relationship of a TSI with core temperature, (ii) having categories indicating the level of heat stress experienced by workers, and (iii) using its heat stress categories to provide recommendations for occupational safety and health] were considered significantly more important when selecting a TSI for protecting individuals who work in the heat, accumulating 37.2 percentage points. These 17 criteria allow the validation and comparison of TSIs that presently exist as well as those that may be developed in the coming years.

Cost-effectiveness Analysis of Lorlatinib in Patients Previously Treated with Anaplastic Lymphoma Kinase Inhibitors for Non-small Cell Lung Cancer in Greece.

Background: Non-small cell lung cancer (NSCLC), which accounts for about 80%-85% of lungcancer cases, is a leading cause of cancer-related death worldwide. Lorlatinib is a potent third-generation anaplastic lymphoma kinase (ALK) inhibitor approved for the treatment of patients with advanced, ALK-positive NSCLC previously treated with at least one second-generation ALK tyrosine kinase inhibitor. Objective: The present study assessed the cost-effectiveness of lorlatinib vs pemetrexed with platinum combination of carboplatin or cisplatin (P-ChT) in Greece. Methods: A partitioned survival model with three health states, referring to pre-progression, progressed disease, and death, was locally adapted from a Greek payer perspective over a lifetime horizon. Clinical and safety data and utility values applied in the model were extracted from the literature. A matching-adjusted indirect comparison of lorlatinib and P-ChT was performed. Only direct medical costs (€) from 2020 were included in the analysis. Primary outcomes were patient life years (LYs), quality-adjusted life years (QALYs), total costs, and incremental cost-effectiveness ratios per QALY and LY gained. All future outcomes were discounted at 3.5% per annum. A probabilistic sensitivity analysis was conducted to account for model uncertainty. Results: The analysis showed that, over a lifetime horizon, the estimated total costs of lorlatinib and P-ChT were €81 754 and €12 343, respectively. Lorlatinib was more effective than P-ChT with 2.4 and 1.5 more LYs and QALYs gained, respectively. The generated incremental cost-effectiveness ratios of lorlatinib compared with P-ChT were €28 613 per LY gained and €46 102 per QALY gained. Probabilistic sensitivity analysis confirmed the deterministic results. Conclusion: The present analysis suggests that lorlatinib may be considered as a cost-effective option compared with P-ChT in Greece for the treatment of patients with advanced, ALK-positive NSCLC whose disease has progressed after at least one second-generation ALK tyrosine kinase inhibitor. In addition, this option addresses a significant unmet medical need.

Occupational electromagnetic spectrum hazards and the significance of artificial optical radiation: country report for Greece.

BACKGROUND: The electromagnetic spectrum spans over an enormous range from 0 up to more than 1020 Hz in the deep ionizing region, significant exposures exist in specific occupational environments. Between the ionizing and the electromagnetic fields (EMF) part of the spectrum, the 'optical radiation' (OR) region has specific properties. Comparative and concise evaluation enables action prioritization. METHODS: Following the transposition and implementation periods of the artificial optical radiation (AOR) and EMF European Directives, the Hellenic Ministry of Labour in collaboration with the Greek Atomic Energy Commission (EEAE) and the National Technical University of Athens, conducted thorough occupational exposure investigation in Greece. Using dedicated measuring equipment and procedures, the majority of EMF emitting installations in Greece and also AOR emitting installations including arc welding, lasers and PC monitors has been assessed. RESULTS: Measurement results from occupational settings reveal that it is the non-coherent metal arc welding AOR that can pose even sub-second overexposures. Rare EMF overexposures are manageable and EMF concern is not justified. Maintenance procedures demand proper attention. Preliminary laser safety assessment reveals OHS gaps and potential eye and skin hazards. Blue light exposure from computer monitors is well below safety limits. CONCLUSIONS: This electromagnetic spectrum risk assessment conducted in Greece enables the justification of the real occupational hazards, in this sense: i) EMF exposure assessment has to be concentrated to maintenance procedures; ii) AOR measuring setups are challenging and standardized measurement procedures are missing, and iii) AOR overexposures from arc welding pose significant eye and skin hazards.

Cost-effectiveness of trifluridine/tipiracil as a third-line treatment of metastatic gastric cancer, including adenocarcinoma of the gastrohesophageal junction, among patients previously treated in Greece.

OBJECTIVE: To evaluate the cost-effectiveness of trifluridine/tipiracil (FTD/TPI) compared with best supportive care (BSC) for the treatment of patients with metastatic gastric cancer(mGC), including gastroesophageal junction adenocarcinoma(GEJ), who have received at least two prior therapies for metastatic disease and are eligible for third-line treatment, in Greece. METHODS: A partitioned survival model was locally adapted from a public payer perspective over a 10-year time horizon. Clinical, safety and utility data were extracted from literature. Resource consumption data obtained from a panel of local experts using a questionnaire developed for the study was combined with unit costs obtained from official sources. All costs reflect the year 2020 (€). Outcomes of the model were patients' life years (LYs) and quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratio (ICER) per QALY and LY gained. RESULTS: The total cost per patient was estimated to be €6,965 for FTD/TPI and €1,906 for BSC, while FTD/TPI was associated with 0.180 and 0.107 increments in LYs and QALYs, respectively, compared with BSC, resulting in an ICER of €47,144 per QALY gained and €28,112 per LY gained. CONCLUSION: FTD/TPI was estimated to be a cost-effective treatment option for eligible third line mGC patients, including GEJ in Greece.

Application of Multicriteria Decision Analysis to Determine the Value of Prophylaxis Relative to On-Demand Treatment in Hemophilia A and Emicizumab versus Replacement Therapy in the Greek Healthcare Setting.

BACKGROUND AND OBJECTIVE: Hemophilia A (HA) is a rare disease that is characterized by congenital underproduction or dysfunction of the endogenous coagulation factor VIII (FVIII). The aim of the present study was to determine the value of prophylaxis versus on-demand treatment strategies for moderate to severe HA (MtSHA) patients and the value of emicizumab in the prophylaxis of MtSHA in Greece, compared with short half-life (SHL) FVIII and extended half-life (EHL) FVIII through multicriteria decision analysis (MCDA). METHODS: A literature review was performed to identify a set of criteria relevant to the therapeutic approaches and therapies under investigation. A performance matrix was populated by two literature reviews and meta-analyses. The criteria selected were hierarchically classified by allocating weights on a 0-100 scale. The performances of therapies were scored at the 100-point scale. The value judgments utilized for weighing and scoring were sourced via a survey among independent multidisciplinary system stakeholders. A linear additive value function was used for the calculation of total value estimates. RESULTS: The participants ranked 'annual number of bleedings per patient' and 'percentage of target joint bleeds' as the most important criteria, while the least important criterion was the 'annual treatment cost' for both assessments. Based on the weights elicited and the performance in each criterion, the overall value score was higher for prophylaxis treatment (58.27) compared with on-demand treatment (40.13). In the other comparison, the most valued treatment was emicizumab (77.05) followed by EHL FVIII (71.52) and SHL FVIII (19.88). According to the participants, the most important factors for managing MtSHA patients are those related to successful management of bleeding events given their contribution to improved quality of life (QoL) and reduced morbidity. CONCLUSIONS: This MCDA has shown that the prophylaxis strategy was perceived as a more valuable option for managing MtSHA patients when compared with the on-demand strategy. Moreover, emicizumab adds higher value and improves patient QoL compared with replacement therapy for MtSHA in Greece. Emicizumab addresses important unmet needs due to its improved efficacy and mode of administration.

The Significance of Echo Time in fMRI BOLD Contrast: A Clinical Study during Motor and Visual Activation Tasks at 1.5 T.

Blood Oxygen Level Dependent (BOLD) is a commonly-used MR imaging technique in studying brain function. The BOLD signal can be strongly affected by specific sequence parameters, especially in small field strengths. Previous small-scale studies have investigated the effect of TE on BOLD contrast. This study evaluates the dependence of fMRI results on echo time (TE) during concurrent activation of the visual and motor cortex at 1.5 T in a larger sample of 21 healthy volunteers. The experiment was repeated using two different TE values (50 and 70 ms) in counterbalanced order. Furthermore, T2* measurements of the gray matter were performed. Results indicated that both peak beta value and number of voxels were significantly higher using TE = 70 than TE = 50 ms in primary motor, primary somatosensory and supplementary motor cortices (p < 0.007). In addition, the amplitude of activation in visual cortices and the dorsal premotor area was also higher using TE = 70 ms (p < 0.001). Gray matter T2* of the corresponding areas did not vary significantly. In conclusion, the optimal TE value (among the two studied) for visual and motor activity is 70 ms affecting both the amplitude and extent of regional hemodynamic activation.

Cost-effectiveness of Empagliflozin Compared with Dapagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus and Established Cardiovascular Disease in Greece.

BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) accounts for approximately 95% of all diabetes cases and is associated with a substantially elevated risk for cardiovascular disease (CVD) that is 2- to 4-times higher in patients with T2DM compared to those without. The aim of present study was to evaluate the cost effectiveness of empagliflozin compared to dapagliflozin for the treatment of patients with T2DM and established CVD in Greece. METHODS: A published health economic model was used to project clinical and economic outcomes of T2DM patients receiving empagliflozin compared to those receiving dapagliflozin. Individual patient-level discrete-event simulation was conducted to predict time-to-event for CV, renal, and adverse events over patients' lifetimes. Hazard ratios for dapagliflozin versus empagliflozin on each clinical event was estimated from DECLARE-TIMI 58 and EMPA-REG OUTCOME trials' data using an indirect treatment comparison. Following a public payer perspective, only direct medical costs related to drug acquisition, fatal/non-fatal diabetes-related complications and adverse events were considered (€2020). Model extrapolated outcomes included life years (LY), quality-adjusted life years (QALYs), costs as well as incremental cost-effectiveness ratio (ICER). Sensitivity analyses explored the impact of changes in input data. RESULTS: Over a patient's lifetime, empagliflozin was associated with longer mean survival (17.23 LY with empagliflozin vs 16.07 LY with dapagliflozin) and reduced rate of CV mortality resulting in 0.48 more QALYs (9.27 vs 8.79), at additional costs of €462. The generated ICER of empagliflozin was €965 per QALY gained. Deterministic sensitivity analysis confirmed empagliflozin's cost-effective profile. Probabilistic sensitivity analysis revealed that the probability of empagliflozin being cost effective over dapagliflozin was 100%, at the defined threshold of €36,000 per QALY gained. CONCLUSION: Empagliflozin was estimated to be a highly cost-effective treatment option compared to dapagliflozin for the treatment of T2DM patients with established CVD in Greece.

End-of-life cost for lung cancer patients in Greece: a hospital-based retrospective study.

Objective: The aim of the present study was to estimate the cost of treating patients with lung cancer at their end-of-life (EOL) phase of care in Greece. Materials & methods: A hospital-based retrospective study was conducted in the Oncology Unit of 'Sotiria' Hospital, in Athens, Greece. All lung cancer patients who died between 1 January 2015 and 31 December 2018 with at least 6 months follow-up were enrolled in the study. Healthcare resource utilization data, including inpatient and outpatient ones, during the last 6 months before death was extracted from a registry kept in the unit. This data were combined with the corresponding local unit costs to calculate the 6, 3 and 1-month EOL cost in €2019 values. Results: A total of 122 patients met the inclusion criteria. The mean (standard deviation) age at diagnosis was 67.8 (8.9) years with 78.7% of patients being male and 55.0% diagnosed at stage IV. About 52.5% of patients had been diagnosed with adenocarcinoma, 28.7% with squamous non-small-cell lung cancer types and 18.9% with small-cell-lung cancer. The median overall survival of these patients was 10.8 months. During the EOL periods, the mean cost/patient in the last 6, 3 and 1 month were €7665, €3351 and €1009, respectively. Pharmaceutical cost was the key driver of the total cost (75% of the total 6-month) followed by radiation therapy (16.2%). The median EOL 6-month cost was marginally statistically significantly higher among patients with adenocarcinoma (€9031) compared with squamous (€6606) and to small-cell-lung cancer (€5474). Conclusion: The findings of the present study indicate that lung cancer treatment incurs high costs in Greece, mainly attributed to pharmaceutical expenses, even at the EOL phase.

Cost-effectiveness of tofacitinib for the treatment of moderate to severe active ulcerative colitis in Greece.

OBJECTIVE: To evaluate the cost-effectiveness of tofacitinib versus other treatment options currently available for the management of adult patients with moderate-to-severe ulcerative colitis, who have had an inadequate response, loss of response, or were intolerant to conventional therapy or a biologic agent, in Greece. METHODS: A Markov model was adapted for projecting lifetime costs and outcomes, for a cohort of patients with moderate-to-severe ulcerative colitis from a Greek payer perspective. Patients entered the model in the active ulcerative colitis state and transitioned to a remission or response state or they underwent colectomy. Following an initial 8-week induction treatment period, patients received maintenance therapy until loss of response. Nonresponders could switch to up to two subsequent biologic lines. Clinical efficacy, adverse event rates and utilities derived from OCTAVE trials and a network-meta-analysis (NMA), while adverse event-related disutilities were obtained from the literature. Information on treatment pathways and resource use was provided by an advisory board due to a lack of local data. Unit costs derived from official national sources (€, 2018). RESULTS: Over a life-time horizon, treating moderate-to-severe active ulcerative colitis with tofacitinib resulted in additional quality-adjusted life-years (QALYs) and lower total costs compared to vedolizumab (0.018; €6408), infliximab (biosimilar) (0.009; €3031), golimumab (0.042; €1988) and infliximab (originator) (0.009; €6724). Hence, tofacitinib was estimated to be dominant over all comparators. CONCLUSION: The results of the analysis suggest that in the Greek setting, tofacitinib could be considered a cost-effective (dominant) treatment option for the treatment of patients with moderate-to-severe active ulcerative colitis.

Economic evaluation of trifluridine and tipiracil hydrochloride in the treatment of metastatic colorectal cancer in Greece.

AIM: To evaluate the cost-effectiveness of trifluridine and tipiracil hydrochloride (FTD/TPI) compared with best supportive care (BSC) or regorafenib for the treatment of patients with metastatic colorectal cancer who have been previously treated with or are not considered candidates for available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents and anti-EGFR agents in Greece. METHODS: A partitioned survival model was locally adapted from a third-party payer perspective over a 10 year time horizon. Efficacy data and utility values were extracted from published studies. Resource consumption data were obtained from local experts using a questionnaire developed for the purpose of the study and was combined with unit costs obtained from official sources. All costs reflect the year 2017 in euros. Primary outcomes were patients' life years (LYs), quality-adjusted life years (QALYs), total costs and incremental cost-effectiveness ratios (ICERs) per QALY and LYs gained. RESULTS: Total life time cost per patient for FTD/TPI, BSC and regorafenib was estimated to be €10,087, €1,879 and €10,850, respectively. In terms of health outcomes, FTD/TPI was associated with 0.25 and 0.11 increment in LYs compared with BSC and regorafenib, respectively. Furthermore, FTD/TPI was associated with 0.17, and 0.07 increment in QALYs compared with BSC and regorafenib, resulting in ICERs of €32,759 per LY gained and €49,326 per QALY gained versus BSC. Moreover, FTD/TPI was a dominant alternative over regorafenib. CONCLUSION: The results indicate that FTD/TPI may represent a cost-effective treatment option compared with other alternative therapies as a third-line treatment of metastatic colorectal cancer in Greece.

Cost-Effectiveness of Empagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus at Increased Cardiovascular Risk in Greece.

BACKGROUND AND OBJECTIVE: Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece. METHODS: A health economic model was used to project clinical and economic outcomes of patients receiving empagliflozin plus SoC compared with those receiving SoC alone over a lifetime horizon. CV and renal event rates were derived from patient level data from the EMPA-REG-OUTCOME® trial by fitting time-dependent parametric survival functions. 5000 individual patient profiles randomly sampled from the trial were simulated using a time-to-event approach. Model extrapolated outcomes included life years (LYs), quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER). Following a Greek third-party payer perspective, only direct medical costs related to drug acquisition as well as fatal and non-fatal diabetes-related complications were considered (€2016). Cost units and utility data were extracted from the literature and publicly available official sources. Sensitivity analyses explored the impact of changes in input data. RESULTS: Over a patient's lifetime, empagliflozin was predicted to result in longer mean survival (14.01 LY vs. 11.87 LY with SoC) and reduced rate of clinical events accumulating 7.75 QALYs versus 6.83 QALYs on SoC alone at additional costs of €4235. The generated ICER of empagliflozin was €4633 per QALY gained. One-way sensitivity analysis confirmed empagliflozin's cost-effective profile. At the defined willingness-to-pay threshold of €34,000 per QALY gained, probabilistic sensitivity analysis showed that empagliflozin was estimated to have a 100% probability of being cost-effective relative to SoC. CONCLUSIONS: Empagliflozin added to SoC was estimated to be a highly cost-effective treatment option for the treatment of T2DM in adults with increased CV disease risk in Greece.