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OBJECTIVES: to describe the importance given to vaccination as a preventive measure in the clinical pathways (CPWs) of patients affected by chronic obstructive pulmonary disease (COPD) and asthma in the Italian regional healthcare services. DESIGN: a comparative analysis was conducted to assess the presence/absence of vaccination recommendations among the available regional CPWs for the management of COPD and asthma. SETTING AND PARTICIPANTS: all the regional CPWs for COPD and asthma available in the "Fondazione ReS" database between 2008 and 2019 have been analysed. MAIN OUTCOME MEASURES: the role attributed to vaccination was assessed in terms of type of recommended vaccinations, management step indicated for administration, vaccination schedules, healthcare professionals involved in the vaccination pathway, potential contraindications, use of indicators for the monitoring of the offer. RESULTS: thirteen CPWs for COPD and only 3 for asthma were published between 2008 and 2019. Twelve of the CPWs for COPD included recommendation for influenza vaccination, 11 of which including also pneumococcal vaccination. The most recent CPW also contained recommendations for measles-mumps-rubella, varicella, Herpes Zoster, and tetanus-diphtheria-acellular pertussis vaccinations. Two of the CPWs related to asthma in adults recommended influenza vaccination. All CPWs provided for the vaccination recommendations during the patient follow-up step. CONCLUSIONS: Italian CPWs still pay little attention to the topic of vaccinations in patients with COPD and asthma. CPWs are required to be updated in the future being compliant with the national immunization schedule recommendations.
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Asma , Vías Clínicas , Enfermedad Pulmonar Obstructiva Crónica , Vacunación , Adulto , Humanos , Asma/epidemiología , Italia/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/epidemiologíaRESUMEN
OBJECTIVE: This observational retrospective analysis aimed to describe antibiotic prescription pattern in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and community-acquired pneumonia (CAP) and their costs, from the Italian National Health Service perspective. METHODS: From the ReS database, a cross-linkage of Italian healthcare administrative databases through a unique anonymous code allowed to select subjects aged ≥12 years, supplied with at least an antibacterial for systemic use (ATC code: J01) from 01/01/2017 to 12/31/2017 and evaluable until the end of 2018. Prescriptions of different antibiotics on the same date were excluded. The prescription pattern was assessed for patients with an AECOPD (aged ≥50) or a CAP event (aged ≥12) in 2017. A 30-day cost analysis after the antibacterial supply and according to absence/presence (15 days before/after the supply) of AECOPD/CAP hospitalization was performed. RESULTS: In 2017, among patients aged ≥12 (~5 million), 1,845,268 were supplied with ≥1 antibacterial (37.2%). Antibacterial prescriptions potentially related to AECOPD were 39,940 and 4,059 to CAP: quinolones were the most prescribed (37.2% and 39.0%, respectively), followed by third-generation cephalosporins (25.5%; 27.5%), penicillins (15.4%; 14.9%), and macrolides (14.4%; 11.3%); the 30-day mean cost was 709 and 2,889. An association AECOPD/CAP-antibacterial supply costed more when the hospitalization occurred 15 days after the antibiotic supply (5,006 and 4,966, respectively). CONCLUSIONS: Findings confirmed the very high use of antimicrobials in Italy and highlighted the urgent need of improving current prescribing practices and developing new molecules, to stop the incessant spread of antimicrobial resistance and related socioeconomic impacts.
Through this retrospective observational analysis of the Fondazione ReS (Ricerca e Salute) database, collecting Italian healthcare administrative data, antibacterial for systemic use supplied to subjects aged ≥12 years in 2017 were identified as potentially prescribed to treat an acute exacerbation of chronic obstructive pulmonary disease (AECOPD) (39,940; 91%) or an event of community-acquired pneumonia (CAP) (4,059; 9%). The most used antimicrobials were quinolones (37.2% and 39.0% of antibiotics related to AECOPD and CAP, respectively), third-generation cephalosporins (25.5%; 27.5%), penicillins (15.4%; 14.9%), and macrolides (14.4%; 11.3%). Costs of each patient supplied with the antibacterial to treat AECOPD/CAP were assessed within 30 days after the antibacterial supply. Overall, the integrated cost of the association AECOPD/CAP-antibacterial was higher if the patient was hospitalized due to AECOPD/CAP before the antibacterial supply (5,006/4,966, respectively). The integrated expenditure of a patient treated for AECOPD not requiring hospitalization was 647. Findings showed a substantial antimicrobial use in Italy for the 2 acute lower respiratory tract infections, highlightening the need of improving the current prescribing practice or developing new molecules. This study also provided healthcare integrated costs of these associations as a proxy of the complexity and frailty of patients experiencing an AECOPD/CAP event.
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Infecciones Comunitarias Adquiridas , Enfermedad Pulmonar Obstructiva Crónica , Infecciones del Sistema Respiratorio , Antibacterianos/uso terapéutico , Infecciones Comunitarias Adquiridas/tratamiento farmacológico , Humanos , Prescripciones , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Estudios Retrospectivos , Medicina EstatalRESUMEN
BACKGROUND: Hyperkalaemia is a potential life-threatening electrolyte abnormality. Although renin-angiotensin-aldosterone system inhibitors (RAASi) are potentially life-saving, they may contribute to hyperkalaemia. METHODS: The prevalence, comorbidities, comedications and 1-year outcomes of patients admitted or treated for hyperkalaemia were investigated in a large healthcare administrative database including 12 533 230 general population inhabitants. A similar analysis was performed in the Italian Network on Heart Failure (IN-HF), a cardiology registry of 1726 acute and 7589 chronic HF patients, stratified by serum potassium. General practice healthcare costs related to hyperkalaemia were also assessed. Hyperkalaemia was defined by hospital coding, potassium-binder prescription or serum levels (mild: 5-5.4, moderate-severe: ≥5.5 mmol/L). RESULTS: In the general population, the prevalence of hyperkalaemia was 0.035%. After excluding patients on haemodialysis, hyperkalaemia in the community (n = 2314) was significantly and directly associated with diabetes, chronic kidney disease, HF, RAASi prescriptions, 1-year hospitalisations and threefold annual healthcare costs, compared to age- and sex-matched non-hyperkalaemic subjects (n = 2314). In the IN-HF registry, hyperkalaemia affected 4.3% of acute and 3.6% of chronic patients and was significantly associated with diabetes, kidney disease and lesser use of RAASi, compared to normokalaemic patients. Among patients hospitalised for acute HF, those with hyperkalaemia at entry had significantly higher 1-year all-cause mortality compared with normokalaemic patients, even after adjustment for available confounders. CONCLUSIONS: Hyperkalaemia in the general population, although uncommon, was associated with increased hospitalisations and tripling of healthcare costs. Among HF patients, hyperkalaemia was common and associated with underuse of RAASi; in acutely decompensated patients, it remained independently associated with 1-year all-cause mortality.
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Costos de la Atención en Salud , Insuficiencia Cardíaca/epidemiología , Hiperpotasemia/economía , Hiperpotasemia/epidemiología , Anciano , Anciano de 80 o más Años , Antagonistas de Receptores de Angiotensina/uso terapéutico , Inhibidores de la Enzima Convertidora de Angiotensina/uso terapéutico , Diabetes Mellitus/epidemiología , Femenino , Insuficiencia Cardíaca/mortalidad , Hospitalización , Humanos , Italia/epidemiología , Masculino , Persona de Mediana Edad , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Prevalencia , Sistema de Registros , Insuficiencia Renal Crónica/epidemiologíaRESUMEN
BACKGROUND: Administrative data were used to investigate changes in hospitalizations for atrial fibrillation (AF), AF-related stroke, and treatment patterns between 2012 and 2016. METHODS: From the 'Ricerca e Salute' database, a population- and patient-based repository involving >12 million inhabitants and linking demographics, prescriptions, and hospital discharge records, all patients discharged alive with a diagnosis of AF between 2012 and 2015 were followed for 1â¯year. RESULTS: A total of 194,030 AF patients were included. The number of AF cases increased ~10% over time, from 4.0 per 1,000 inhabitants in 2012 to 4.4 per 1,000 in 2015. At 1â¯year, hospitalizations for ischemic stroke decreased from 21.3 per 1,000 patients with AF in 2012-2013 to 14.7 per 1,000 in 2015-2016 (-31%, 95% CI -18 to -41). Over the same period, oral anticoagulant (OAC) use increased from 56.7% to 64.4% (+14%, 95% CI +8 to +26), vitamin K antagonist use decreased (from 55.9 to 36.7%; -34%, 95% CI -21 to -44), whereas direct OACs (DOACs) increased (from <1% in 2012 to 27.7% in 2015). Antiplatelet prescriptions fell from 42.6% in 2012 to 28.1% in 2015. Hospitalizations for major bleeds, mainly gastrointestinal, increased from 1.5 in 2012-2013 to 2.3 in 2015-2016, whereas hemorrhagic stroke admissions decreased from 6.5 to 4.1. CONCLUSIONS: There was a slight increase in the prevalence of AF between 2012 and 2015, whereas the overall use of antiplatelet agents decreased and that of OAC, particularly DOACs, increased. Over the same period, 1-year hospitalizations for ischemic stroke declined substantially, with a declining rate of hemorrhagic strokes.
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Anticoagulantes/administración & dosificación , Fibrilación Atrial/epidemiología , Hospitalización/tendencias , Accidente Cerebrovascular/epidemiología , Accidente Cerebrovascular/prevención & control , Administración Oral , Anciano , Anticoagulantes/economía , Antitrombinas/administración & dosificación , Antitrombinas/economía , Fibrilación Atrial/complicaciones , Fibrilación Atrial/economía , Áreas de Influencia de Salud/estadística & datos numéricos , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/economía , Femenino , Hemorragia Gastrointestinal/inducido químicamente , Hemorragia Gastrointestinal/epidemiología , Gastos en Salud , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Hospitalización/estadística & datos numéricos , Humanos , Italia/epidemiología , Masculino , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/economía , Estudios Retrospectivos , Accidente Cerebrovascular/economía , Accidente Cerebrovascular/etiología , Factores de Tiempo , Vitamina K/antagonistas & inhibidoresRESUMEN
BACKGROUND: The combination of two long acting bronchodilators with an inhaled corticosteroid, known as Triple Therapy (TT), is a usual clinical practice for patients affected by chronic obstructive pulmonary disease (COPD). This analysis aimed to identify subjects with COPD treated with extemporaneous combination of ICS/LABA and LAMA (namely open TT) and to describe the pharmacological strategy, the spirometry use, the exacerbations occurrence and the costs, in the perspective of the Italian National Health System (NHS). METHODS: Through record linkage of administrative data (ReS database) of about 12 million inhabitants in 2014, a cohort of patients aged ≥45, without asthma and treated with open TT (index date) was selected. Specific drugs, oxygen supply and exacerbations were described in one year before the index date, while spirometry tests over two years before the index date. All these resources utilization, the persistence to the open TT, and integrated costs of the above healthcare services were analysed for 1-year follow-up. RESULTS: In 2014, 10,352 patients (mean age 74 ± 9; males 66.0%) with COPD and treated with open TT were identified (prevalence 160.6 per 100,000 inhabitants aged ≥45). During the previous year, the 44.0% of this cohort was already treated with open TT, 7.0% did not received any drugs for obstructive airway diseases, 11.1% needed home oxygen therapy, and 28.7% experienced at least an exacerbation. In the follow-up year, the 37.5% of the cohort was found persistent to the open TT, 17.0% needed oxygen therapy, and the 30.9% underwent an exacerbation. Spirometry was performed on 45.7% of patients in the two previous years, while on 33.3% in the subsequent year. In the follow-up, on average, every patient of the cohort costed to the NHS 5,295: 48.2% for hospitalizations, 41.2% for drugs and 10.6% for outpatient services. CONCLUSIONS: This large observational study based on claims data reliably identified subjects with COPD treated with open TT and their burden on the NHS. Moreover, it could describe the real clinical management of the open TT, before the marketing of the fixed one. These findings are useful for health policymakers in order to promote the appropriate utilization of both currently marketed and future therapies.
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Broncodilatadores/uso terapéutico , Costos de la Atención en Salud/estadística & datos numéricos , Prescripciones/estadística & datos numéricos , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Enfermedad Pulmonar Obstructiva Crónica/economía , Administración por Inhalación , Corticoesteroides/uso terapéutico , Agonistas de Receptores Adrenérgicos beta 2/uso terapéutico , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Italia , Masculino , Persona de Mediana Edad , Antagonistas Muscarínicos/uso terapéutico , EspirometríaRESUMEN
PURPOSE: To describe new users of atypical antipsychotics (APs) in terms of sociodemographic characteristics, cardio-metabolic risk profile, prescription patterns, healthcare costs and cardio-metabolic events over the 24 months after treatment initiation. METHODS: Atypical AP new users were selected from the ReS database and grouped into three: patients already affected by cardio-metabolic diseases (group A), patients without these clinical conditions but with predisposing conditions (group B) and patients without cardio-metabolic diseases and predisposing conditions (group C). Annual prescription patterns and healthcare costs were analysed. Subjects of groups B and C were matched with controls to compare the occurrences of cardio-metabolic events over 24 months. RESULTS: Thirty-two thousand thirty-four new users of atypical APs were selected (median age 69). The 22.3% had cardio-metabolic diseases, 14.8% had predisposing conditions and 62.9% had none of these. The 99.3% received monotherapy. The mean annual cost per patient was 2785, and the median cost was 1108. After 24 months, a cardio-metabolic event occurred in 11.5% of group B vs. 8.7% of the controls (p < .01), and in 5.0% of group C vs. 2.1% of the controls (p < .01). CONCLUSION: Patients treated with atypical AP were on average old and, in a non-negligible amount, with cardio-metabolic disease or predisposing conditions. New users of atypical APs showed a significantly higher likelihood to develop a cardio-metabolic event early after treatment initiation.
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Antipsicóticos/administración & dosificación , Enfermedades Cardiovasculares/epidemiología , Costos de la Atención en Salud/estadística & datos numéricos , Enfermedades Metabólicas/epidemiología , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Antipsicóticos/efectos adversos , Factores de Riesgo Cardiometabólico , Enfermedades Cardiovasculares/economía , Bases de Datos Factuales , Femenino , Humanos , Italia/epidemiología , Masculino , Enfermedades Metabólicas/economía , Persona de Mediana Edad , Adulto JovenRESUMEN
BACKGROUND: Although migraine is a disabling neurological condition that causes important disability, it remains an area of underdiagnosis and undertreatment worldwide. The aim of this study was to depict the burden of the unmet medical needs in migraine treated with triptans in a large Italian population. METHODS: A 2-year longitudinal analysis of migraineurs with unmet medical needs on treatment with triptans was performed. The studied cohort consisted of subjects with ≥4 triptan dose units per month, selected from the general population These patients were stratified into: possible Low-Frequency Episodic Migraine (pLF-EM: 4-9 triptan dose units per month), possible High-Frequency Episodic Migraine (pHF-EM: 10-14 triptan dose units per month) and possible Chronic Migraine (pCM:> 14 triptan dose units per month). The first follow-up year was analysed to describe the use of preventive therapies, the second year to describe the ≥50% reduction in triptan use. RESULTS: Of 10,270,683 adults, 8.0 per 1000 were triptan users and, of these, 38.2% were migraineurs with unmet medical needs, corresponding to 3.1 per 1000 adults. By stratifying for the number of triptan dose units per month, 72.3% were affected by pLF-EM, 17.4% by pHF-EM, and 10.3% by pCM. In this cohort, 19.1% of individuals used oral preventive drugs and 0.1% botulinum toxin. Triptan use reduction was found in 22.3% individuals of the cohort, decreasing with the intensification of need levels (25.8% pLF-EM, 13.6% pHF-EM, 12.0% pCM). CONCLUSIONS: This real-life analysis underlined that the unmet medical needs concern a large part of patients treated with triptans and there is an undertreatment with preventive therapies whose benefit is insufficient, which may be due to the lack of effective preventive strategies, probably still reserved to severe patients. This study allows forecasting the actual impact of newest therapeutic strategies aimed to fill this gap.
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Necesidades y Demandas de Servicios de Salud/estadística & datos numéricos , Trastornos Migrañosos/tratamiento farmacológico , Triptaminas/administración & dosificación , Adulto , Estudios de Cohortes , Personas con Discapacidad , Femenino , Humanos , Italia/epidemiología , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Trastornos Migrañosos/epidemiología , Trastornos Migrañosos/prevención & control , PrevalenciaRESUMEN
PURPOSE: This observational study was aimed to identify patients who experienced non-deferrable surgery and/or uncontrolled severe bleeding following dabigatran administration and then are potentially eligible to the use of the specific antidote idarucizumab in a real-world setting. METHODS: From the big Italian real-world database ARCO, a cohort of adult patients treated with dabigatran and hospitalized due to diagnoses attributable to urgent interventions and/or major bleeding was selected in 2014. Baseline characteristics and all-cause hospitalizations, specialist/diagnostic outpatient services, and healthcare costs over the 1-year follow-up were described. RESULTS: Out of 16,756,843 Italian citizens, 271,540 (1.9%) were prescribed with oral anticoagulants, and specifically, 17,450 with dabigatran. Patients identified to be hospitalized for non-deferrable surgery (n = 106) and/or uncontrolled severe bleeding (n = 190) following dabigatran use were 289 (1.7%) [mean age (± SD) 79 ± 7, 50% of female sex]. On average, patients stayed in hospital 13.7 and 17.0 days, respectively. The per patient and per year cost to the Italian National Health System was on average 19,708 (specifically 1487 for drugs, of which 311 for dabigatran, 17,353 for all-cause hospitalizations, and 869 for outpatient care), about four times more than the mean healthcare integrated cost of a single patient treated with dabigatran (4775). CONCLUSIONS: This analysis of the ARCO database reliably describes the population potentially eligible to the dabigatran reversal agent, idarucizumab. These data may be useful for Healthcare Decision Makers to organize, define, and improve present and future emergency healthcare, mainly as starting point for cost-effectiveness analyses of new reversal agents.
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Anticuerpos Monoclonales Humanizados/uso terapéutico , Antídotos/uso terapéutico , Antitrombinas/efectos adversos , Coagulación Sanguínea/efectos de los fármacos , Pérdida de Sangre Quirúrgica/prevención & control , Dabigatrán/efectos adversos , Hemorragia Posoperatoria/prevención & control , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales Humanizados/economía , Antídotos/economía , Antitrombinas/administración & dosificación , Antitrombinas/economía , Toma de Decisiones Clínicas , Análisis Costo-Beneficio , Dabigatrán/administración & dosificación , Dabigatrán/economía , Bases de Datos Factuales , Costos de los Medicamentos , Femenino , Costos de Hospital , Humanos , Italia , Masculino , Persona de Mediana Edad , Selección de Paciente , Hemorragia Posoperatoria/sangre , Hemorragia Posoperatoria/inducido químicamente , Hemorragia Posoperatoria/economía , Estudios Retrospectivos , Adulto JovenRESUMEN
Epidemiological data on primary progressive multiple sclerosis (PPMS) are scarce. This study was aimed to evaluate the burden of PPMS in Italy with healthcare resources utilisation and costs for Italian National Health System (INHS). A 2-year cross-sectional analysis of real-world data collected in the ARCO database, covering > 10 million Italian inhabitants, was performed. From a cohort of patients affected by MS in 2014, those supposedly affected by PPMS were defined by the concurrent matching of absence of disease-modifying treatments and use of rehabilitation services. Any other drug prescriptions, outpatient services and hospitalisations were analysed in 2015 for each subject. The average annual cost per patient was provided both for each expenditure item and by integrating these. Of 13,253,591 inhabitants, 18,453 resulted affected by MS (prevalence 139 × 100,000). Of these, 1849 agreed with additional criteria to identify PPMS (10% of MS population). The 26.8% of these experienced at least one admission in 1 year, 97.3% used at least one outpatient service and 94.3% received at least one reimbursed drug. In the perspective of INHS, PPMS generated an average annual cost of 3783 per person: 49% for hospitalisations, 28% for outpatient services and 23% for drugs. This study provides a reliable estimation of the PPMS burden in Italy, in terms of healthcare utilisation and direct costs. These findings could be useful to estimate the changes in health expenditure following the incoming of new drugs to treat PPMS with increase of pharmaceutical cost and potential decrease of rehabilitation and hospitalisation costs.
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Esclerosis Múltiple Crónica Progresiva/economía , Esclerosis Múltiple Crónica Progresiva/terapia , Aceptación de la Atención de Salud , Adulto , Estudios de Cohortes , Costo de Enfermedad , Estudios Transversales , Femenino , Costos de la Atención en Salud , Humanos , Italia/epidemiología , Masculino , Esclerosis Múltiple Crónica Progresiva/epidemiología , PrevalenciaRESUMEN
Pdta Net, established and managed by Research and Health Foundation (ReS), is a database aimed at gathering and analysing the Regional Care Pathways (CPs) approved in Italy. A comprehensive search was conducted within institutional websites to retrieve all CPs approved by Italian Regions and Autonomous Provinces until December 2023, by utilizing specific keywords. Compared to the previous year, 51 new approvals were recorded. By now, Pdta Net collects 856 CPs, of which 476 are for high-impact chronic diseases and 380 for rare diseases.
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Enfermedades Raras , Humanos , Italia , Enfermedades Raras/terapia , Enfermedad Crónica , Bases de Datos Factuales , Vías Clínicas/organización & administración , Fundaciones , Atención a la Salud/organización & administraciónRESUMEN
OBJECTIVES: Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease with significant impact on morbidity, mortality, and quality of life. This study aimed to evaluate epidemiology, healthcare needs and related costs of pSS patients from the Italian National Health Service perspective. METHODS: From the Fondazione Ricerca e Salute's database (â¼5 million inhabitants/year), pSS prevalence in 2018 was calculated. Demographics, mean healthcare consumptions and direct costs at one year following index date (first in-hospital diagnosis/disease waiver claim) were analysed through an individual direct matched pair case-control analysis (age, sex, residency). RESULTS: In Italy, 3.8/10,000 inhabitants were identified as affected by pSS (1,746 case: 1,746 controls) in 2018. In the year following index date, 53.7% of cases and 42.7% of controls received ≥1 drug (p<0.001); mean per capita cost was 501 and 161, respectively (p<0.01). At least one hospitalization occurred to 7.8% of cases and 3.9% of controls (p<0.001) with mean per capita costs of 416 and 129, respectively (p = 0.46). At least one outpatient specialist service was performed in 49.8% of cases and 30.6% of controls (p<0.001); mean per capita costs were 200 and 75, respectively (p<0.01). Overall, mean annual costs were 1,171 per case and 372 per control (p < 0.01). CONCLUSION: According to results of this population-based study, the prevalence of pSS in Italy appears to be consistent with the definition of rare disease. Patients with pSS have higher pharmacological, in-hospital and outpatient specialist care needs, leading to three-times higher overall cost for the INHS, compared to the general population.
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Hospitalización , Enfermedades Raras , Síndrome de Sjögren , Humanos , Síndrome de Sjögren/epidemiología , Síndrome de Sjögren/economía , Italia/epidemiología , Femenino , Masculino , Persona de Mediana Edad , Anciano , Adulto , Estudios de Casos y Controles , Enfermedades Raras/epidemiología , Enfermedades Raras/economía , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Costos de la Atención en Salud/estadística & datos numéricos , Prevalencia , Bases de Datos Factuales , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: Exacerbations of chronic obstructive pulmonary disease (COPD) can increase the risk of severe cardiovascular events. OBJECTIVE: Assess the crude incidence rates (IR) of cardiovascular events and the impact of exacerbations on the risk of cardiovascular events within different time periods following an exacerbation. METHODS: COPD patients aged ≥45 years between 01/01/2015 and 12/31/2018 were identified from the Fondazione Ricerca e Salute administrative database. IRs of severe non-fatal and fatal cardiovascular events were obtained for post-exacerbation time periods (1-7, 8-14, 15-30, 31-180, 181-365 days). Time-dependent Cox proportional hazard models compared cardiovascular risks between periods with and without exacerbations. RESULTS: Of 216,864 COPD patients, >55 % were male, mean age was 74 years, frequent comorbidities were cardiovascular, metabolic and psychiatric. During an average 34-month follow-up, 69,620 (32 %) patients had ≥1 exacerbation and 46,214 (21 %) experienced ≥1 cardiovascular event. During follow-up, 55,470 patients died; 4,661 were in-hospital cardiovascular-related deaths. Among 10,269 patients experiencing cardiovascular events within 365 days post-exacerbation, the IR was 15.8 per 100 person-years (95 %CI 15.5-16.1). Estimated hazard ratios (HR) for the cardiovascular event risk associated with periods post-exacerbation were highest within 7 days (HR: 34.3, 95 %CI: 33.1-35.6), especially for heart failure (HR 50.6; 95 %CI 48.6-52.7) and remained elevated throughout 365 days (HR 1.1, 95 %CI 1.02-1.13). CONCLUSIONS: COPD patients in Italy are at high risk of severe cardiovascular events following exacerbations, suggesting the need to prevent exacerbations and possible subsequent cardiovascular events through early interventions and treatment optimization.
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Background: Chronic kidney disease-associated pruritus (CKD-aP) affects patients on hemodialysis. This study identified hemodialysis patients presumably affected or not affected by CKD-aP and integrated healthcare costs, from the perspective of the Italian administrative healthcare data. Methods: Through cross-linkage of Italian administrative healthcare data collected between 2015 and 2017 (accrual period) in the database of Fondazione ReS (Ricerca e Salute), patients undergoing in-hospital/outpatient hemodialysis were selected. Cohorts with and without CKD-aP were created based on the presence/absence of CKD-aP-related treatment (according to common clinical practice and guidelines) supplies and assessed in terms of CKD-aP-related treatments and mean healthcare costs per capita paid by the Italian National Health Service (INHS). Results: Of 1,239 people on hemodialysis for ≥2 years, CKD-aP affected 218 patients. Patients with CKD-aP were older and with more comorbidities. During the follow-up year, on average, the INHS spent 37,065 per case, 31,286 per control and 35,988 per non-CKD-aP subject. High-efficiency dialytic therapies performed to people on hemodialysis with CKD-aP largely weighed on the overall mean annual cost. Conclusions: This real-world study identified patients on chronic hemodialysis potentially treated for CKD-aP. Interestingly, high-efficiency dialysis seems the most frequent and expensive choice for the treatment of CKD-aP. The discovery of appropriate and effective treatments for this condition might offer cost offsets.
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BACKGROUND: Atopic dermatitis (AD) is a heterogeneous disease, associated with comorbidities, and high healthcare consumptions and costs. This study assessed the burden before and after treatment with dupilumab in adults with severe AD from 2018 to 2020, from the perspective of the Italian National Health Service (SSN). METHODS: From Fondazione Ricerca e Salute's administrative healthcare database (~5 million inhabitants/year), adults treated with dupilumab from 09/01/2018 to 31/12/2020 (index date) and a five-year lookback were identified. Age, sex and comorbidities at baseline, concomitant drugs, overnight hospitalizations, outpatient specialist services and direct costs charged to the SSN one year before/after index date were assessed. RESULTS: Of 337 adults treated with dupilumab (5.8x100,000 adult inhabitants/2019; 8.0x100,000/2020; 55% males; mean age 43±19), 68% (228/337) had ≥12-month follow-up available. Asthma was a common comorbidity (23% patients). Rates of patients treated with nearly all concomitant AD-related therapies reduced from 12 months before to 12 months after dupilumab treatment: antibacterials (from 59% to 50%), systemic corticosteroids (55% to 29%), antihistamines (54% to 38%) and cyclosporine (52% to 7%). A similar trend was observed among patients with asthma as comorbidity. Within 12 months before/after dupilumab, patients hospitalized halved from 14% to 7%, and patients receiving outpatient specialist care reduced from 72% to 65%. Annual mean direct total costs per patient treated with dupilumab charged to the SSN, net of dupilumab cost, were 1384 and 773, before and after dupilumab dispensation, respectively. CONCLUSIONS: Before dupilumab, observed patients had higher healthcare resource consumptions and direct SSN costs than after dupilumab.
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Anticuerpos Monoclonales Humanizados , Dermatitis Atópica , Humanos , Dermatitis Atópica/tratamiento farmacológico , Dermatitis Atópica/economía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Anticuerpos Monoclonales Humanizados/economía , Masculino , Femenino , Adulto , Italia , Persona de Mediana Edad , Costos de la Atención en Salud/estadística & datos numéricos , Hospitalización/economía , Hospitalización/estadística & datos numéricos , Comorbilidad , Adulto Joven , Asma/tratamiento farmacológico , Asma/economía , Recursos en Salud/economía , Recursos en Salud/estadística & datos numéricosRESUMEN
Background. Patients with chronic kidney disease (CKD) can be successfully treated with sodium-glucose cotransporter-2 inhibitors (SGLT2-Is), regardless of diabetes. Fondazione Ricerca e Salute's (ReSD) administrative and Health Search's (HSD) primary care databases were combined in the Database Consortium ReS-HS to quantify and describe patients with CKD potentially eligible for SGLT2-Is and assess costs charged to the Italian National Health Service (SSN). Methods. Patients aged ≥18 with CKD and estimated glomerular filtration rate (eGFR) <60 ml/min in 2018, without dialysis and/or renal transplantation, were included. HSD was used to develop and validate algorithms for estimating eGFR, based on covariates, within the ReSD. Comorbidities, dispensed drugs, and direct healthcare costs were assessed. Results. In 2018, 66,297 (5.0% of HSD population) and 211,494 (4.4% of ReSD population) patients with CKD potentially eligible for SGLT2-Is were identified (females ≥58%). Prevalence increased with age with a peak at 75-84 years. Within HSD and ReSD cohorts, respectively: 31.0% and 41.5% had diabetes; in the observation periods, >82% and >96% received ≥1 pharmacological treatment, of which ≥50% and ≥25% received cardiovascular/blood agents and antidiabetics, respectively. From ReSD, mean per capita direct SSN cost was 3,825 (CI 95%, 3,655- 4,000): 50.1% due to hospitalizations, and 40.2% to pharmaceuticals (31.6% to cardiovascular drugs and 10.1% to antidiabetics). Conclusion. The Database Consortium ReS-HS methodology found 5% of adult SSN beneficiaries with CKD potentially eligible for SGLT2-Is bringing with them a high cardio-metabolic burden which increases the risk of CKD progression.
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Bases de Datos Factuales , Atención Primaria de Salud , Insuficiencia Renal Crónica , Inhibidores del Cotransportador de Sodio-Glucosa 2 , Humanos , Inhibidores del Cotransportador de Sodio-Glucosa 2/uso terapéutico , Italia , Insuficiencia Renal Crónica/tratamiento farmacológico , Anciano , Persona de Mediana Edad , Masculino , Femenino , Anciano de 80 o más Años , Adulto , Tasa de Filtración GlomerularRESUMEN
The three current oncology models (histological, agnostic and mutational) mainly differ in clinical, technological and organisational aspects, leading to different regulatory procedures and implications in antineoplastic therapy access by patients. Within the histological and agnostic models, Regulatory Agencies authorise target therapies and define their price, reimbursement, prescription and access based on results from clinical trials including patients affected by the same tumour (histological) or subjects with specific genetic mutations regardless of the tumour site or the histology (agnostic). The mutational model has been developed to identify specific actionable molecular alterations found by next-generation sequencing test-based large platforms on solid and liquid biopsies. Nevertheless, due to the highly uncertain efficacy and possible toxicity of drugs tested within this model, regulatory procedures based on histological or agnostic oncology cannot be followed. Multidisciplinary skills are required (e.g. the molecular tumour board's (MTB) representatives) to identify the best association between the genomic profile and the drug planned to be used, but quality requirements, practices and procedures of these discussions still need to be standardised. Real-world evidence from clinical practice (i.e. genomic findings, clinical data and MTBs' choices) lacks, therefore, it is urgently needed as opposed to limited findings from clinical trials. A potential solution for an appropriate access to the therapy chosen by the mutational model can be the indication-value-based sub iudice procedure of authorisation. The access to therapies suggested by extensive molecular profiling could be easily implementable within the Italian national health system, thanks to the existing regulatory procedures, i.e. the managed-entry agreements and the antineoplastic drug monitoring registries, alongside those granted by conventional studies (phase I, II, III, IV) conducted according to the histological and agnostic models.
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Antineoplásicos , Neoplasias , Humanos , Neoplasias/tratamiento farmacológico , Neoplasias/genética , Antineoplásicos/uso terapéutico , Genómica , Oncología Médica , MutaciónRESUMEN
INTRODUCTION: The adoption of a Care Pathway (CP) allows the healthcare management of patients suffering from high-epidemiological impact chronic diseases. The continuity of care of these patients is one of the main purposes of the community-based healthcare reform, foreseen in the 6th Mission of the National recovery and resilience plan. Fondazio-ne Ricerca e Salute (ReS) collects and analyses regional CPs approved in Italy, through the Pdta Net database. METHODS: Fondazione ReS has retrieved all the CPs approved by Italian Regions and Autonomous provinces until 12/31/2021 within institutional websites, through specific keywords. The quali- and quantitative analysis of CPs was based on the approving Region, the publication year, the disease (distinguishing between high-epidemiological impact chronic diseases and rare conditions) and clinical area. Following the 5-year experience gained by Fondazione ReS in terms of CPs' aims and organization for the full realization of an evidence-based healthcare of chronic patients, all data collected until 12/31/2021 underwent an in-depth double-blinded quality control. This control was aimed to make the Pdta Net database as representative as possible of the existing documents closest to a real CP. RESULTS: From 2005 to 2021, 729 regional CPs have been approved: 404 on high-impact chronic diseases and 220 on rare conditions. The CPs of chronic diseases, mostly edited by Piemonte (45 CPs), Campania (34) and Toscana (33) Regions, mainly concern on diabetes (19), chronic obstructive pulmonary disease (15), heart failure (13), stroke, multiple sclerosis and colorectal neoplasms (12 each one), breast cancer (11), dementia and chronic kidney disease (10 each one). Most of the CPs on rare diseases have been edited by Regions with an established Rare Disease Network, i.e., Lombardia (125 CPs), Lazio (74) and Toscana (40): neurology (61) and oncology (52) were the most represented clinical areas. CONCLUSIONS: The high number of CPs approved in Italy confirms an increasing interest of the healthcare institutions. The collected CPs show an extreme variety of titles, text structures and disease choices. Given the absence of an institutional observatory and of devotees of shared and harmonized CPs, annually Pdta Net makes available an updated and complete overview of these governance tools, which are essential for the upcoming changes of the Italian national health service.
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Vías Clínicas , Medicina Estatal , Humanos , Italia , Atención a la Salud , Enfermedad CrónicaRESUMEN
INTRODUCTION: Rheumatoid arthritis (Ra) and diabetes are often associated with chronic multimorbidity and share the high risk of development of major cardiovascular events (Mace). This study aimed to identify and analyse patients with only Ra, Ra + diabetes, and only diabetes, in terms of comorbidities and new occurrence of Cv events, from the perspective of the Italian national health service (Inhs). METHODS: Starting from the Fondazione ricerca e salute (ReS)'s database, through the record linkage of administrative healthcare data, cohorts with only Ra, Ra + diabetes and only diabetes have been selected, characterized (age and sex), and analysed by comorbidity (depression, dyslipidemia, hypertension, hemorrhagic stroke and ischemic stroke/transient ischemic attack - Tia, coronary artery disease - Cad, heart failure - Hf, chronic liver disease, periphery artery disease - Pad, chronic kidney disease, asthma/chronic obstructive pulmonary disease - Copd, neoplasia) and by new Cv events (Hf, Cad and ischemic stroke/Tia) within two follow-up years (Kaplan-Meier curves). A logistic regression model defined contribution and type of association of some variables on new Cv events. RESULTS: In 2018, from 5.375.531 Inhs beneficiaries in the ReS database, 13.698 (0.25%) were affected by only Ra, 1728 (0.03%) by Ra + diabetes, 347,659 (6.8%) by only diabetes. The only Ra cohort was composed by more females, younger and with less comorbidities patients. Proportions of 79.3%, 70.8% and 38.5% of patients with Ra + diabetes, only diabetes and only Ra were affected by 2 to ≥4 comorbidities: among patients with Ra + diabetes, comorbidities showed the highest frequencies, mainly hypertension, dyslipidemia and asthma/Copd. Within two follow-up years, about 8% of patients with diabetes with/without Ra developed a new Cv event (vs 3% with only Ra). The presence of Ra/diabetes or Ra + diabetes, male sex, older age and comorbidities of interest resulted significantly (p<0.01) associated with a higher Cv risk. CONCLUSIONS: Comorbidities and the co-presence of diabetes in patients with Ra determine a complicated framework with high risk of Cv events. It is worthy include more complex patients in clinical trials, in order to generate evidence useful for even more multidisciplinary medical teams.
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Artritis Reumatoide , Asma , Enfermedades Cardiovasculares , Diabetes Mellitus , Dislipidemias , Hipertensión , Ataque Isquémico Transitorio , Accidente Cerebrovascular Isquémico , Enfermedad Pulmonar Obstructiva Crónica , Femenino , Humanos , Masculino , Factores de Riesgo , Ataque Isquémico Transitorio/complicaciones , Ataque Isquémico Transitorio/epidemiología , Medicina Estatal , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Artritis Reumatoide/complicaciones , Artritis Reumatoide/epidemiología , Artritis Reumatoide/tratamiento farmacológico , Comorbilidad , Diabetes Mellitus/epidemiología , Dislipidemias/complicaciones , Dislipidemias/epidemiología , Enfermedad Pulmonar Obstructiva Crónica/epidemiología , Accidente Cerebrovascular Isquémico/complicaciones , Accidente Cerebrovascular Isquémico/epidemiología , Asma/epidemiologíaRESUMEN
OBJECTIVE: To identify newly diagnosed patients with acute myeloid leukemia in 2017 treated with intensive chemotherapy or unfit for intensive chemotherapy, and to assess their probability of receiving allogeneic stem cell transplantation and survival, from the Italian National Health Service perspective. PATIENTS AND METHODS: From the Ricerca e Salute database, adults with an in-hospital diagnosis of acute myeloid leukemia (International Classification of Disease-9th version-Clinical Modification code 205.0x) in 2017 (index date), without any identifying acute myeloid leukemia criteria within the preceding year, were selected. Among them, subjects treated with intensive chemotherapy (chemotherapy during an overnight hospitalization) within one year after index date were identified. The remaining were considered unfit for intensive chemotherapy. Gender, age and comorbidities were described. Within the follow-up period, probabilities of in-hospital allogeneic stem cell transplantation and overall survival were assessed through Kaplan Meier analyses. RESULTS: From 4,840,063 beneficiaries of the Italian National Health Service, 368 newly acute myeloid leukemia diagnosed adults (9.0 *100,000) were selected. Males comprised 57%. Mean age was 68±15. There were 197 patients treated with intensive chemotherapy. The remaining 171 unfit for intensive chemotherapy were older (72±14) and with more comorbidities (e.g. hypertension, chronic lung diseases and chronic kidney disease). Only patients treated with intensive chemotherapy underwent an allogeneic stem cell transplantation (41; 33%) during the one year after the index date. Within the first and second follow-up year, respectively: 41.1% and 26.9% of subjects treated with intensive chemotherapy (144) survived (median survival time: 7.8 months); 25.7% and 18.7% of those unfit for intensive chemotherapy (139) survived (1.2 months). Difference was significant (p<0.0001). Within one and two years after transplantation (41 patients), 73.5% and 67.3% of subjects survived, respectively. CONCLUSION: This study, by showing the incidence of acute myeloid leukemia in Italy in 2017, the proportion of patients treated with intensive chemotherapy from the new diagnosis, the use of allogeneic stem cell transplantation and two-year survival, integrated evidence on large and unselected populations and may help to improve treatment strategies of older acute myeloid leukemia patients.
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Trasplante de Células Madre Hematopoyéticas , Leucemia Mieloide Aguda , Adulto , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Femenino , Incidencia , Medicina Estatal , Trasplante Homólogo , Leucemia Mieloide Aguda/epidemiología , Leucemia Mieloide Aguda/terapia , Trasplante de Células Madre Hematopoyéticas/efectos adversos , Atención a la Salud , Estudios RetrospectivosRESUMEN
INTRODUCTION: The community-acquired pneumonia (Cap) and the acute exacerbation of chronic obstructive pulmonary disease (Aecopd) frequently receive wrong therapies, leading to the increase of healthcare consumption resources, direct and indirect costs, and antimicrobial resistance. This study identified Cap and Aecopd hospitalized events, and analyzed them in terms of comorbidities, antibiotic use, re-hospitalizations, diagnostics and costs, from the perspective of the Italian national health service (Inhs). METHODS: From the database of Fondazione Ricerca e Salute (ReS), hospitalizations for Cap and Aecopd from 2016 to 2019. Demographics, comorbidities and mean in-hospital stay at the baseline, antibiotics reimbursed by the Inhs within 15 days before and after the index event, outpatient diagnostics performed before the event and in-hospital diagnostics, and direct costs charged to the Inhs, are assessed. RESULTS: From 2016 to 2019 (~5 million inhabitants/year), 31,355 events of Cap (1.7x1000/year) and 42,489 events of Aecopd (4.3x1000 inhabitants aged ≥45/year) were identified, of which 32% and 26.5%, respectively, were treated with antibiotics before the hospitalization. The highest frequency of hospitalizations and comorbidities, and the longest mean in-hospital stays are found among elderly. Events not treated before and after the hospitalization showed the longest in-hospital stay. More than 12 Ddd (defined daily dose) are dispensed after the discharge. Local outpatient diagnostics are performed before the admission to <1% of the events; in-hospital diagnostics are registered in 5.6% and 1.2% of Cap and Aecopd, respectively, discharge forms. About 8% and 24% of Cap and Aecopd, respectively, are re-hospitalized during one subsequent year, mainly within one month. The mean expenditures per event of Cap and Aecopd were 3646 and 4424, respectively: hospitalizations, antibiotics and diagnostics accounted for the 99%, 1% and <0.1% of the total expense, respectively. CONCLUSIONS: This study provided a very high dispensation of antibiotics after the hospitalization for Cap and Aecopd, while a very low use of differential diagnostics available within the observed periods, to the detriment of the enforcement actions proposed at institutional levels.