Cost effectiveness of difelikefalin for the treatment of patients with chronic kidney disease-associated pruritus undergoing hemodialysis in Italy.

Background: Chronic kidney disease (CKD)-associated pruritus is a condition that strongly impacts CKD patients and is associated with increased morbidity/mortality, and worse health-related quality of life (HRQoL). Difelikefalin is currently the only drug approved in Europe specifically for treating moderate to severe CKD-associated pruritus in patients undergoing hemodialysis. The KALM-1 and KALM-2 trials showed better efficacy of difelikefalin vs placebo and best supportive care.

Efficacy, Safety and Pharmacoeconomic Analysis of Intravenous Ferric Carboxymaltose in Anemic Hemodialysis Patients Unresponsive to Ferric Gluconate Treatment: A Multicenter Retrospective Study.

Patients undergoing hemodialysis with iron deficiency anemia (IDA) receiving treatment with erythropoiesis-stimulating agents (ESAs) who were intolerant or non-responsive to intravenous (i.v.) ferric gluconate (FG) (hemoglobin; Hb values < 10.

Place in therapy of innovative drugs in multiple myeloma in 2021 and 2023 according to an expert panel Delphi consensus.

Introduction: The objective of this study was to understand the potential use of single agents and drug combinations in multiple myeloma (MM) across treatment lines in the years 2021 and 2023.

Methods: The method used was Delphi Panel Method survey, administered to European Myeloma Network (EMN) Italy Working Group centres. Future treatments were identified assessing all available web-based information sources, including therapies (single drugs or combinations) with strong evidence of efficacy, likely to be on the Italian market in 2021 and 2023.

Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study.

No information is available on the efficacy of ferric carboxymaltose (FCM) in real-world CKD patients outside the hemodialysis setting. We prospectively followed 59 non-hemodialysis CKD patients with iron deficient anemia (IDA: hemoglobin <12.0/<13.

[Economic impact of ferric carboxymaltose in haemodialysis patients].

Intravenous iron supplementation is essential in hemodialysis (HD) patients to recover blood loss and to meet the requirements for erythropoiesis and, in patients receiving erythropoietin, to avert the development of iron deficiency. In a recent real-world study, Hofman et al. showed that a therapeutic shift from iron sucrose (IS) to ferric carboxymaltose (FCM) in HD patients improves iron parameters while reducing use of iron and erythropoietin.

Budget impact analysis of extended half-life recombinant factor IX (rFIXFc) in the treatment of haemophilia B.

Introduction: Prophylaxis with factor IX (FIX) concentrates, produced by recombinant DNA technology (rFIX) or human plasma-derived concentrates, is the treatment of choice for haemophilia B (HB); rFIX covalently fused to the Fc domain of human immunoglobulin G1 (rFIXFc) allows for prophylaxis/treatment with one infusion every 7-14 days. The purpose of this study is to quantify the financial impact of prophylaxis with rFIXFc vs. other approved rFIX and reimbursed for treatment of HB in Italy.

New oral anti-coagulants versus vitamin K antagonists in high thromboembolic risk patients.

Background: Oral anticoagulant therapy (VKA) is nowadays the mainstay of treatment in primary and secondary stroke prevention in patients with atrial fibrillation. Given the limited risk-benefit ratio of vitamin K antagonists, pharmacological research has been directed towards the development of products that could overcome these limits, new oral anticoagulants were recently introduced: dabigatran, rivaroxaban, apixaban, and edoxaban.

Aim: Scope of the present study was to examine patterns of use, effectiveness, safety and mean annual cost per patient of anticoagulant treatment for non-valvular AF in real clinical practice.

Appraising the holistic value of Lenvatinib for radio-iodine refractory differentiated thyroid cancer: A multi-country study applying pragmatic MCDA.

Background: The objective of the study was to reveal through pragmatic MCDA (EVIDEM) the contribution of a broad range of criteria to the value of the orphan drug lenvatinib for radioiodine refractory differentiated thyroid cancer (RR-DTC) in country-specific contexts.

Methods: The study was designed to enable comprehensive appraisal (12 quantitative, 7 qualitative criteria) in the current disease context (watchful waiting, sorafenib) of France, Italy and Spain. Data on the value of lenvatinib was collected from diverse stakeholders during country-specific panels and included: criteria weights (individual and social values); performance scores (judgments on evidence-collected through MCDA systematic review); qualitative impacts of contextual criteria; and verbal and written insights structured by criteria.

Patient perspective on the management of atrial fibrillation in five European countries.

Background: Long-term management of chronic conditions, such as atrial fibrillation (AF), require frequent interactions with the healthcare systems. The multinational EUropean Patient Survey in Atrial Fibrillation (EUPS-AF) was conducted to investigate patient satisfaction with AF management in different of five European healthcare systems at a time of changing treatment paradigms for stroke prophylaxis, prior to the advent of newer oral anticoagulants.

Methods: Adults (>18 years) were recruited at random from the total populations of France, Germany, Italy, Spain and the UK using a randomized telephone dialling system.

The costs of mobilisation and collection of peripheral blood stem cells in multiple myeloma and lymphoma in an European country: results from The Gruppo Italiano Trapianto Midollo Osseo (GITMO) and Società Italiana di Emaferesi e Manipolazione Cellulare (SIdEM) survey.

Scarce information is available about the cost of mobilisation/collection of peripheral blood stem cells for patients undergoing autologous transplant for relapsed Lymphoma or Multiple Myeloma. This paper reports the consumption of resources and costs collected through a survey among Italian Centres who adhere to the GITMO and SIdEM scientific societies. General transplant information was extracted from the European Promise database.

Compliance, persistence, costs and quality of life in young patients treated with antipsychotic drugs: results from the COMETA study.

Background: Little data is available on the real-world socio-economic burden and outcomes in schizophrenia. This study aimed to assess persistence, compliance, costs and Health-Related Quality-of-Life (HRQoL) in young patients undergoing antipsychotic treatment according to clinical practice.

Methods: A naturalistic, longitudinal, multicentre cohort study was conducted: we involved 637 patients aged 18-40 years, with schizophrenia or schizophreniform disorder diagnosed ≤10 years before, enrolled in 86 Italian Mental Health Centres and followed-up for 1 year.

Cost of laparoscopy and laparotomy in the surgical treatment of colorectal cancer.

Background: The comparative costs of laparoscopy and laparotomy in surgical resection of colorectal cancer, especially of the hospital provider, have not yet been assessed in the perspective of the Italian National Healthcare System. This paper aims to fill this gap by providing economic information on this research topic of growing relevance at a time of reduced healthcare budgets.

Methods: Three Italian reference centres retrospectively provided from their databases data on 90 cases of laparotomy (OP) or laparoscopy (LAP) interventions for right colon (RCol), left colon/sigma (LCol) and rectum (Rec).

Cost-effectiveness analysis of polymyxin-B immobilized fiber column and conventional medical therapy in the management of abdominal septic shock in Italy.

Introduction: Severe abdominal sepsis and septic shock are common problems in intensive care units (ICUs), and carry high mortality. The purpose of this economic analysis was to determine the cost-effectiveness of polymyxin B immobilized fiber column (PMX-F) plus conventional therapy (CT) (PMX-F-CT) versus CT alone for patients with severe sepsis/septic shock of abdominal origin, in the perspective of the Italian hospital.

Methods: This was a retrospective cost-effectiveness analysis (CEA) based on data of clinical efficacy and consumption of resources collected alongside an Italian randomized clinical trial.

[Catheter ablation of atrial fibrillation: Health Technology Assessment Report from the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)].

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and significantly impact patients' quality of life, morbidity and mortality. The number of affected patients is expected to increase as well as the costs associated with AF management, mainly driven by hospitalizations. Over the last decade, catheter ablation techniques targeting pulmonary vein isolation have demonstrated to be effective in treating AF and preventing AF recurrence.

Specific immunotherapy by the sublingual route for respiratory allergy.

Specific immunotherapy is the only treatment able to act on the causes and not only on the symptoms of respiratory allergy. Sublingual immunotherapy (SLIT) was introduced as an option to subcutaneous immunotherapy (SCIT), the clinical effectiveness of which is partly counterbalanced by the issue of adverse systemic reactions, which occur at a frequency of about 0.2% of injections and 2-5% of the patients and may also be life-threatening.

Risedronate versus alendronate in older patients with osteoporosis at high risk of fracture: an Italian cost-effectiveness analysis.

Background And Aims: This evaluation of the cost-effectiveness of risedronate vs generic alendronate is based on effectiveness data from a large real practice study. Applying a published cost-effectiveness model, we found that risedronate is cost-effective vs generic alendronate in an Italian population aged > or =65 years, and becomes dominant, saving costs and avoiding fractures, in patients aged > or =75 years. The aim of this work was to assess the cost-effectiveness and health utility of risedronate vs generic alendronate in clinical practice in Italy, using effectiveness data from the REAL study.

Economic evaluation of sublingual immunotherapy vs. symptomatic treatment in allergic asthma.

Background: The worldwide increased prevalence of allergic diseases, and especially of respiratory allergy, is paralleled by increased health costs. This requires consideration of the cost to efficacy ratio of the available treatment to identify the optimal choice.

Objective: To compare the different economic relevance, over a long evaluation time, of symptomatic pharmacologic therapy and sublingual immunotherapy (SLIT) in patients with allergic asthma.

Economic studies of immunotherapy: a review.

Purpose Of Review: To analyse and discuss the growing body of evidence on the economic advantages offered by immunotherapy for allergic rhinitis and asthma, in the various perspectives (society, national healthcare system, patients, etc) and according to the various types of standardized economic evaluations.

Recent Findings: This review shows that the economic studies of allergic rhinitis and asthma focus on three main research areas: studies aimed at determining the cost of illness and studies focused either on a simple cost comparison amongst available therapeutic alternatives, or directly comparing alternatives using full economic evaluations (cost-effectiveness, cost-utility measures, etc).

Summary: Studies exploring the full cost of allergic rhinitis and asthma are still lacking; on the contrary, studies on immunotherapy (in its many administration forms, subcutaneous, sublingual, tablet, etc) in comparison with standard pharmaceutical treatment, have shown that immunotherapy may be very beneficial to the healthcare systems, in that either it could bring more clinical outcome at a reduced cost, versus standard therapy alone, or it could bring extra benefit at a very acceptable extra cost.

Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson's disease in Italy.

Economic evaluation (Italian NHS perspective) modeling (123)I-FP-CIT SPECT (DaTSCAN) compared to clinical judgment alone for differentiating essential tremor (ET) from Parkinson's Disease (PD). A 5-year Markov model was constructed to assess the cost-effectiveness of (123)I-FP-CIT SPECT to differentiate ET from PD in patients referred to a movement disorder specialist in Italy. Published data and a double-round, Delphi panel of 12 specialists populated the model.

[Cost-effectiveness of oral ibandronate, i.v. zoledronic acid and i.v. generic pamidronate in the management of metastatic bone disease in breast cancer patients: two parallel studies].

Two parallel cost-effectiveness studies comparing oral ibandronate and i.v. zoledronic acid and generic pamidronate have been performed.

Comparison of costs of sublingual immunotherapy and drug treatment in grass-pollen induced allergy: results from the SIMAP database study.

Objectives: This analysis is focused on the comparison of costs of allergic rhinitis (R) alone or with allergic asthma (R + A) in grass pollen allergy, for subjects treated with sublingual immunotherapy (SLIT) and symptomatic drugs, versus standard care controls.

Methods: The SIMAP (Sublingual IMmunotherapy in Allergic Patients) study is a longitudinal observational database operated by a network of Allergy centers. Patients suffering from grass pollen allergy were included in this analysis and assigned to SLIT (plus drugs as needed) or to treatment with drugs alone.

[Cost analysis of tumor-induced osteolysis treated with intravenous zoledronic acid and pamidronate: a time-motion study].

A time-motion study was performed by evaluating time and use of medical supply resources in the administration of zoledronic acid and pamidronate as palliative care of tumor-induced osteolysis within the clinical setting of three Italian oncology day-hospital sites. The direct medical costs were similar for both treatments (Euro 226 for zoledronic acid versus Euro 231 for pamidronate). With the exclusion of the pharmacological therapy, most of the difference in costs derives from nurses' labor costs, which is related to the longer infusion time for pamidronate (1 h, 47 min versus 28 min for zoledronic acid).

Economic evaluation of sublingual immunotherapy vs symptomatic treatment in adults with pollen-induced respiratory allergy: the Sublingual Immunotherapy Pollen Allergy Italy (SPAI) study.

Background: Few data are available on the pharmacoeconomic aspects of immunotherapy.

Objective: To evaluate, from the health care system and societal perspectives, the costs and consequences of sublingual immunotherapy (SLIT) added to pharmacotherapy compared with drugs alone for respiratory allergy.

Methods: This study compared costs, clinical outcomes, and cost-effectiveness ratios of 2 strategies in the management of allergic rhinitis and asthma, namely, SLIT associated with pharmacotherapy and pharmacotherapy alone (no SLIT).

Cost-effectiveness of bemiparin in the prevention and treatment of venous thromboembolism.

Venous thromboembolism is a major health problem with substantial morbidity, mortality and related health care costs. Low-molecular-weight heparins (LMWHs) are drugs of first choice in the prophylaxis and treatment of venous thromboembolism. Bemiparin is a new LMWH with a higher antithrombotic activity than other LMWHs at equivalent dosing and a low bleeding tendency.