Budget impact analysis of apixaban versus other NOACs for the prevention of stroke in Italian atrial fibrillation patients

OBJECTIVE: This study aims to perform a budget impact analysis of the use of three available novel oral anticoagulant agents (NOACs) for preventing thromboembolic events in Italian patients with non‑valvular atrial fibrillation (NVAF).METHODS: Estimated Italian population of patients was run through a previously published lifetime decision tree/Markov model simulating their treatment with the available therapeutic options: dabigatran at two dose levels (110 mg/bid for the over 80 years old, 150 mg/bid for younger NVAF patients), rivaroxaban (20 mg/uid), and apixaban (5 mg/bid). Effectiveness and safety estimates derive from an adjusted indirect treatment comparison using warfarin as link. The main clinical events considered in the model are ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Epidemiological data and unit costs, actualized to 2013, are collected from Italian published sources. The budget impact analysis evaluates the financial impact of apixaban introduction by comparing expected 1,2, and 3 years costs in hypothetical scenarios: with and without apixaban. Italian NVAF patient population estimation is based on official apixaban reimbursement criteria, applying the characteristics of the trial population to national epidemiologic data. Numbers of patients for each regimen are estimated by projecting share evolution. Sensitivity analysis is performed on an alternative non‑experimental population of NVAF patients.RESULTS: Among available NOACs, apixaban was expected to be the least expensive in an estimated patient population of 364,000 Italian patients, allowing for savings of € 1,180,549, € 3,841,429 and € 5,368,918 at 1,2, and 3 years, respectively. Results of the simulation run on an alternative non‑experimental population of NVAF patients yields comparable estimates.CONCLUSIONS: The different safety and effectiveness profiles of the three available NOACs emerging from the adjusted indirect comparison indicate that apixaban could improve health care expenditure control while maintaining or increasing therapeutic appropriateness in the Italian NVAF population

Comparative pharmacoeconomic assessment of apixaban vs. standard of care for the prevention of stroke in Italian atrial fibrillation patients

OBJECTIVES: The aim of this study was to evaluate the cost‑effectiveness of apixaban in the prevention of thromboembolic events in patients with non‑valvular atrial fibrillation (NVAF) relatively to standard of care (warfarin or aspirin) from the Italian National Health System (SSN) perspective.METHODS: A previously published lifetime Markov model was adapted for Italian context. Clinical effectiveness data were acquired from head‑to‑head randomized trials (ARISTOTLE and AVERROES); main events considered in the model were ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Expected survival was projected beyond trial duration using national mortality data adjusted for individual clinical risks and adjusted by utility weights for health states acquired from literature. Unit costs were collected from published Italian sources and actualized to 2013. Costs and health gains accruing after the first year were discounted at an annual 3.5% rate. The primary outcome measure of the economic evaluation was the incremental cost effectiveness ratio (ICER), where effectiveness is measured in terms of life‑years and quality adjusted life‑years gained. Deterministic and probabilistic sensitivity analyses (PSA) were carried out to assess the effect of input uncertainty.RESULTS: Apixaban is expected to reduce the incidence of ischemic events relative to aspirin and to improve bleeding safety profile when compared to warfarin. Incremental LYs (0.31/0.19), QALYs (0.28/0.20), and costs (1,932/1,104) are predicted with the use of apixaban relative to aspirin and warfarin, respectively. The ICERs of apixaban were € 6,794 and € 5,607 per QALY gained, respectively. In PSA, the probability of apixaban being cost effective relative to aspirin and warfarin was 95% and 93%, respectively, for a WTP threshold of € 20,000 per QALY gained. Univariate analyses indicate that results were most sensitive to variations of the absolute risk reduction for cardiovascular events with apixaban.CONCLUSIONS: Apixaban is expected to increase life expectancy and quality‑adjusted life expectancy, but also costs dedicated to Italian NVAF patients, as compared to standard of care. The resulting ICERs have high probabilities of being below the conventional thresholds of WTP for health benefits of the SSN, indicating efficient allocation of health care resources

The economic impact associated with cerebrovascular events related to non-valvular atrial fibrillation (NVAF) in Italy: the role of apixaban

<a href="http://dx.doi.org/10.7175/fe.v15i1S.972">http://dx.doi.org/10.7175/fe.v15i1S.972</a

Cost‑effectiveness analysis of apixaban versus other NOACs for the prevention of stroke in Italian atrial fibrillation patients

OBJECTIVES: The study evaluated the cost‑effectiveness of apixaban in preventing thromboembolic events in non‑valvular atrial fibrillation (NVAF) patients, as compared to other three available novel oral anticoagulant agents (NOACs), from the Italian Health System (SSN) perspective.METHODS: A previously published lifetime Markov model was adapted for the Italian context. Baseline clinical risks were assigned based on the demographic and clinical features of the patients; effectiveness and safety parameters derived from adjusted indirect comparison using warfarin as link. The main clinical events considered in the model are ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Expected survival was projected beyond trial duration using national mortality data adjusted for clinical risks and weighted by published utilities. Unit costs were collected from published Italian sources and actualized to 2013. Costs and health gains occurring after the first year were discounted at an annual 3.5% rate. The primary outcome measure of the economic evaluation was the incremental cost effectiveness ratio (ICER), where effectiveness is measured in terms of life‑years and quality adjusted life‑years gained. Deterministic and probabilistic sensitivity analyses (DSA&PSA) were carried out.RESULTS: In the short to medium term, apixaban was associated with marginal LYs and QALYs gains and slight savings, as compared to other NOACs. However, as apixaban extended expected survival versus dabigatran (110mg), dabigatran (150mg) and rivaroxaban (0.13, 0.08, and 0.06 LYs or 0.11, 0.07, and 0.05 QALYs), expected total lifetime costs exceeded those of these comparators (€ 319, € 282, and € 16). Corresponding ICERs were estimated in € 2,911, € 3,882 and € 327 per QALY gained. The most influential parameter according to DSA was daily costs of NOACs, but the corresponding ICERs remained well below commonly accepted WTP values. In PSA, the probabilities of apixaban being cost effective with a WTP threshold of 20,000 €/QALY gained were 99%, 92% and 93% for the same comparisons.CONCLUSIONS: Apixaban is expected to be more effective than dabigatran and rivaroxaban in Italian NVAF population, and marginally more costly due to consume healthcare resources for a longer period of time. The ICERs have a high likelihood of being below conventional thresholds of WTP for health benefits of the SSN and suggest that apixaban is cost‑effective compared with other three available NOACs

Lung nodules: size still matters

The incidence of indeterminate pulmonary nodules has risen constantly over the past few years. Determination of lung nodule malignancy is pivotal, because the early diagnosis of lung cancer could lead to a definitive intervention. According to the current international guidelines, size and growth rate represent the main indicators to determine the nature of a pulmonary nodule. However, there are some limitations in evaluating and characterising nodules when only their dimensions are taken into account. There is no single method for measuring nodules, and intrinsic errors, which can determine variations in nodule measurement and in growth assessment, do exist when performing measurements either manually or with automated or semi-automated methods. When considering subsolid nodules the presence and size of a solid component is the major determinant of malignancy and nodule management, as reported in the latest guidelines. Nevertheless, other nodule morphological characteristics have been associated with an increased risk of malignancy. In addition, the clinical context should not be overlooked in determining the probability of malignancy. Predictive models have been proposed as a potential means to overcome the limitations of a sized-based assessment of the malignancy risk for indeterminate pulmonary nodules

Structured reporting for fibrosing lung disease: a model shared by radiologist and pulmonologist

Objectives: To apply the Delphi exercise with iterative involvement of radiologists and pulmonologists with the aim of defining a structured reporting template for high-resolution computed tomography (HRCT) of patients with fibrosing lung disease (FLD). Methods: The writing committee selected the HRCT criteria\ue2\u80\u94the Delphi items\ue2\u80\u94for rating from both radiology panelists (RP) and pulmonology panelists (PP). The Delphi items were first rated by RPs as \ue2\u80\u9cessential\ue2\u80\u9d, \ue2\u80\u9coptional\ue2\u80\u9d, or \ue2\u80\u9cnot relevant\ue2\u80\u9d. The items rated \ue2\u80\u9cessential\ue2\u80\u9d by &lt; 80% of the RP were selected for the PP rating. The format of reporting was rated by both RP and PP. Results: A total of 42 RPs and 12 PPs participated to the survey. In both Delphi round 1 and 2, 10/27 (37.7%) items were rated \ue2\u80\u9cessential\ue2\u80\u9d by more than 80% of RP. The remaining 17/27 (63.3%) items were rated by the PP in round 3, with 2/17 items (11.7%) rated \ue2\u80\u9cessential\ue2\u80\u9d by the PP. PP proposed additional items for conclusion domain, which were rated by RPs in the fourth round. Poor consensus was observed for the format of reporting. Conclusions: This study provides a template for structured report of FLD that features essential items as agreed by expert thoracic radiologists and pulmonologists

Deep learning for classifying fibrotic lung disease on high-resolution computed tomography: a case-cohort study

Based on international diagnostic guidelines, high-resolution CT plays a central part in the diagnosis of fibrotic lung disease. In the correct clinical context, when high-resolution CT appearances are those of usual interstitial pneumonia, a diagnosis of idiopathic pulmonary fibrosis can be made without surgical lung biopsy. We investigated the use of a deep learning algorithm for provision of automated classification of fibrotic lung disease on high-resolution CT according to criteria specified in two international diagnostic guideline statements: the 2011 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) guidelines for diagnosis and management of idiopathic pulmonary fibrosis and the Fleischner Society diagnostic criteria for idiopathic pulmonary fibrosis

Cavernous venous malformation (cavernous hemangioma) of the orbit: Current concepts and a review of the literature

The cavernous venous malformation of the orbit, previously called cavernous hemangioma, is the most common primary orbital lesion of adults. Cavernous venous malformation occurs more often in women and typically presents in the fourth and fifth decades of life. It is a benign vascular malformation characterized by a well-defined capsule and numerous large vascular channels. The most common sign of cavernous venous malformation is progressive axial proptosis from the preferential involvement of the intraconal orbital space. Optic nerve damage and other signs of orbital pathology may be present, with a variable degree of visual impairment. The combination of ultrasound, computed tomography, and magnetic resonance imaging leads to an accurate diagnosis in the vast majority of cases. Surgical and nonsurgical treatments are required in case of symptomatic lesions, with a characteristic multidisciplinary management influencing optimal outcome. Orbitotomy represents the traditional surgical approach. Recently, the endoscopic transnasal approach to the orbital cavity has gained interest, representing a feasible and safe, less-invasive surgical technique for the management of cavernous venous malformation

Structured Reporting of Lung Cancer Staging: A Consensus Proposal

Background: Structured reporting (SR) in radiology is becoming necessary and has recently been recognized by major scientific societies. This study aimed to build CT-based structured reports for lung cancer during the staging phase, in order to improve communication between radiologists, members of the multidisciplinary team and patients. Materials and Methods: A panel of expert radiologists, members of the Italian Society of Medical and Interventional Radiology, was established. A modified Delphi exercise was used to build the structural report and to assess the level of agreement for all the report sections. The Cronbach’s alpha (Cα) correlation coefficient was used to assess internal consistency for each section and to perform a quality analysis according to the average inter-item correlation. Results: The final SR version was built by including 16 items in the “Patient Clinical Data” section, 4 items in the “Clinical Evaluation” section, 8 items in the “Exam Technique” section, 22 items in the “Report” section, and 5 items in the “Conclusion” section. Overall, 55 items were included in the final version of the SR. The overall mean of the scores of the experts and the sum of scores for the structured report were 4.5 (range 1–5) and 631 (mean value 67.54, STD 7.53), respectively, in the first round. The items of the structured report with higher accordance in the first round were primary lesion features, lymph nodes, metastasis and conclusions. The overall mean of the scores of the experts and the sum of scores for staging in the structured report were 4.7 (range 4–5) and 807 (mean value 70.11, STD 4.81), respectively, in the second round. The Cronbach’s alpha (Cα) correlation coefficient was 0.89 in the first round and 0.92 in the second round for staging in the structured report. Conclusions: The wide implementation of SR is critical for providing referring physicians and patients with the best quality of service, and for providing researchers with the best quality of data in the context of the big data exploitation of the available clinical data. Implementation is complex, requiring mature technology to successfully address pending user-friendliness, organizational and interoperability challenges