The Prevention of Postmenopausal Osteoporotic Fractures: Results of the Health Technology Assessment of a New Antiosteoporotic Drug

Objective. The Health Technology Assessment (HTA) approach was applied to denosumab in the prevention of osteoporotic fractures in postmenopausal women. Method. Epidemiological, clinical, technical, economic, organizational, and ethical aspects were considered. Medical electronic databases were accessed to evaluate osteoporosis epidemiology and therapeutical approaches. A budget impact and a cost-effectiveness analyses were performed to assess economic implications. Clinical benefits and patient needs were considered with respect to organizational and ethical evaluation. Results. In Italy around four millions women are affected by osteoporosis and have a higher risk for fractures with 70,000 women being hospitalized every year. Bisphosphonates and strontium ranelate are recommended as first line treatment for the prevention of osteoporotic fractures. Denosumab is effective in reducing vertebral, nonvertebral, and hip/femoral fractures with an advantage of being administered subcutaneously every six months. The budget impact analysis estimated a reduction in costs for the National Health Service with the introduction of denosumab. Furthermore, the economic analysis demonstrated that denosumab is cost-effective in comparison to oral bisphosphonates and strontium ranelate. Denosumab can be administered in outpatients by involving General Practitioners in the management. Ethical evaluation is positive because of its efficacy and compliance. Conclusion. Denosumab could add value in the prevention of osteoporotic fractures

Health Technology Assessment of Belimumab: A New Monoclonal Antibody for the Treatment of Systemic Lupus Erythematosus

Objective. Systemic lupus erythematosus (SLE) is treated with anti-inflammatory and immunosuppressive drugs and off-label biologics. Belimumab is the first biologic approved after 50 years as an add-on therapy for active disease. This paper summarizes a health technology assessment performed in Italy. Methods. SLE epidemiology and burden were assessed using the best published international and national evidences and efficacy and safety of belimumab were synthesized using clinical data. A cost-effectiveness analysis was performed by a lifetime microsimulation model comparing belimumab to standard of care (SoC). Organizational and ethical implications were discussed. Results. Literature review showed that SLE affects 47 per 100,000 people for a total of 28,500 patients in Italy, 50% of whom are affected by active form of the disease despite SoC. These patients, if autoantibodies and anti-dsDNA positive with low complement, are eligible for belimumab. SLE determines work disability and a 2-5-fold increase in mortality. Belimumab with SoC may prevent 4,742 flares in three years being cost-effective with an incremental costeffectiveness ratio of C32,859 per quality adjusted life year gained. From the organizational perspective, the development of clear and comprehensive clinical pathways is crucial. Conclusions. The assessment supports the use of belimumab into the SLE treatment paradigm in Italy

Associations between depressive symptoms and disease progression in older patients with chronic kidney disease: results of the EQUAL study

Background Depressive symptoms are associated with adverse clinical outcomes in patients with end-stage kidney disease; however, few small studies have examined this association in patients with earlier phases of chronic kidney disease (CKD). We studied associations between baseline depressive symptoms and clinical outcomes in older patients with advanced CKD and examined whether these associations differed depending on sex. Methods CKD patients (>= 65 years; estimated glomerular filtration rate <= 20 mL/min/1.73 m(2)) were included from a European multicentre prospective cohort between 2012 and 2019. Depressive symptoms were measured by the five-item Mental Health Inventory (cut-off <= 70; 0-100 scale). Cox proportional hazard analysis was used to study associations between depressive symptoms and time to dialysis initiation, all-cause mortality and these outcomes combined. A joint model was used to study the association between depressive symptoms and kidney function over time. Analyses were adjusted for potential baseline confounders. Results Overall kidney function decline in 1326 patients was -0.12 mL/min/1.73 m(2)/month. A total of 515 patients showed depressive symptoms. No significant association was found between depressive symptoms and kidney function over time (P = 0.08). Unlike women, men with depressive symptoms had an increased mortality rate compared with those without symptoms [adjusted hazard ratio 1.41 (95% confidence interval 1.03-1.93)]. Depressive symptoms were not significantly associated with a higher hazard of dialysis initiation, or with the combined outcome (i.e. dialysis initiation and all-cause mortality). Conclusions There was no significant association between depressive symptoms at baseline and decline in kidney function over time in older patients with advanced CKD. Depressive symptoms at baseline were associated with a higher mortality rate in men

Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study

Background: The impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on postoperative recovery needs to be understood to inform clinical decision making during and after the COVID-19 pandemic. This study reports 30-day mortality and pulmonary complication rates in patients with perioperative SARS-CoV-2 infection. Methods: This international, multicentre, cohort study at 235 hospitals in 24 countries included all patients undergoing surgery who had SARS-CoV-2 infection confirmed within 7 days before or 30 days after surgery. The primary outcome measure was 30-day postoperative mortality and was assessed in all enrolled patients. The main secondary outcome measure was pulmonary complications, defined as pneumonia, acute respiratory distress syndrome, or unexpected postoperative ventilation. Findings: This analysis includes 1128 patients who had surgery between Jan 1 and March 31, 2020, of whom 835 (74·0%) had emergency surgery and 280 (24·8%) had elective surgery. SARS-CoV-2 infection was confirmed preoperatively in 294 (26·1%) patients. 30-day mortality was 23·8% (268 of 1128). Pulmonary complications occurred in 577 (51·2%) of 1128 patients; 30-day mortality in these patients was 38·0% (219 of 577), accounting for 81·7% (219 of 268) of all deaths. In adjusted analyses, 30-day mortality was associated with male sex (odds ratio 1·75 [95% CI 1·28–2·40], p\textless0·0001), age 70 years or older versus younger than 70 years (2·30 [1·65–3·22], p\textless0·0001), American Society of Anesthesiologists grades 3–5 versus grades 1–2 (2·35 [1·57–3·53], p\textless0·0001), malignant versus benign or obstetric diagnosis (1·55 [1·01–2·39], p=0·046), emergency versus elective surgery (1·67 [1·06–2·63], p=0·026), and major versus minor surgery (1·52 [1·01–2·31], p=0·047). Interpretation: Postoperative pulmonary complications occur in half of patients with perioperative SARS-CoV-2 infection and are associated with high mortality. Thresholds for surgery during the COVID-19 pandemic should be higher than during normal practice, particularly in men aged 70 years and older. Consideration should be given for postponing non-urgent procedures and promoting non-operative treatment to delay or avoid the need for surgery. Funding: National Institute for Health Research (NIHR), Association of Coloproctology of Great Britain and Ireland, Bowel and Cancer Research, Bowel Disease Research Foundation, Association of Upper Gastrointestinal Surgeons, British Association of Surgical Oncology, British Gynaecological Cancer Society, European Society of Coloproctology, NIHR Academy, Sarcoma UK, Vascular Society for Great Britain and Ireland, and Yorkshire Cancer Research

Economic issues related to tobacco smoking

The aim of the chapter is to give an overview of the economic aspects related to tobacco smoking, including production and supply of tobacco product

L’uso di nebivololo nell’ipertensione arteriosa e nello scompenso cardiaco: indicazioni e costo-efficacia con glossario di farmacoeconomia

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Il vaccino anti-rotavirus:raccomandazioni, modalità di gestione e proposte per l’offerta vaccinale, in Health Technology Assessment della vaccinazione anti-rotavirus con il vaccino Rotarix

mary Secondo le ultime raccomandazioni della World Health Organization, i vaccini antirotavirus dovrebbero essere inclusi in tutti i programmi di immunizzazione delle nazioni, specialmente nei Paesi con un alto tasso di mortalit\ue0 da gastroenteriti da rotavirus come il Sud-Est asiatico e l\u2019Africa sub-sahariana. L\u2019utilizzo della vaccinazione anti-rotavirus dovrebbe altres\uec essere parte di una pi\uf9 completa strategia per controllare la malattia diarroica, insieme ad altri provvedimenti di igiene e sanit\ue0 pubblica, reidratazione, allattamento materno. I piani per l'introduzione di vaccini contro il rotavirus dovrebbero considerare una serie di aspetti, quali l'epidemiologia della malattia per et\ue0, l\u2019impatto di sanit\ue0 pubblica, una stima dei potenziali rischi, valutazioni di costo-efficacia, accessibilit\ue0 del vaccino, impatto finanziario e operativo sul sistema di erogazione. L\u2019introduzione del vaccino antirotavirus dovrebbe inoltre essere accompagnata da misure per garantire un'alta copertura vaccinale e la somministrazione tempestiva di ogni dose in base all'et\ue0 consigliata. La European Society for Paediatric Infectious Disease (ESPID) e la European Society for Paediatric Gastroenterology, Haepatology and Nutrition (ESPGHAN) raccomandano la vaccinazione anti-rotavirus a tutti i neonati sani in Europa (alto livello delle evidenze, beneficio netto, raccomandazione di grado 1A) con uno dei due vaccini licenziati dalla European Medicines Agency in Europa (Rotarix\u2122 o RotaTeq\u2122), entrambi vaccini mucosali a somministrazione orale caratterizzati da alta efficacia e buon profilo di sicurezza. Rotarix\u2122 \ue8 un vaccino vivo monovalente, derivato dal pi\uf9 frequente ceppo di rotavirus umano, il G1P8, attenuato attraverso una serie di passaggi in coltura. Rotateq\u2122 \ue8 un vaccino vivo attenuato pentavalente, derivato da un ceppo bovino (WC- 3) sottoposto al riassortimento con segmenti di RNA provenienti dai rotavirus umani. Il ciclo completo di vaccinazione prevede 2 dosi con Rotarix\u2122 e 3 con Rotateq\u2122, somministrate a distanza di almeno 4 settimane l'una dall'altra. La prima dose pu\uf2 essere somministrata a partire dalla sesta settimana di et\ue0 e il ciclo della vaccinazione dovrebbe essere effettuato preferibilmente entro la 16\ub0 settimana di et\ue0, ma in ogni caso deve essere completato entro le 24 settimane di et\ue0. Rotarix e Rotateq possono essere somministrati ai neonati prematuri con la medesima posologia e alla stessa et\ue0 cronologica dei bambini nati a termine. Entrambi i vaccini sono pronti all\u2019uso e pertanto non necessitano di ricostituzione o diluizione e devono essere somministrati oralmente senza mescolarli con nessun altro vaccino o soluzione. Quando una tipologia di vaccino viene somministrato al bambino come prima dose, si raccomanda che venga somministrato lo stesso vaccino (e non un altro vaccino anti-rotavirus) anche come dose/i successiva/e. Per quanto riguarda il contesto italiano, la Commissione Federazione Italiana Medici Pediatri (FIMP)/Societ\ue0 Italiana di Pediatria (SIP) sottolinea la necessit\ue0 di introdurre la vaccinazione contro il rotavirus e promuovere la sua offerta attiva nei tempi pi\uf9 brevi, compatibilmente con le altre priorit\ue0 nelle strategie vaccinali sul territorio nazionale, nonch\ue9 quella di promuovere le iniziative pi\uf9 efficaci per rendere accessibile la vaccinazione ai bambini dei Paesi poveri. Analoga risulta essere l\u2019opinione della Societ\ue0 Italiana di Igiene, Medicina Preventiva e Sanit\ue0 Pubblica (SitI) che, in collaborazione con la Federazione Italiana Medici di Medicina Generale (FIMMG),con la Federazione Italiana Medici Pediatri (FIMP) e con la SIP stessa, ha riportato la vaccinazione anti-RV nel recente aggiornamento del Calendario Vaccinale per la Vita. Ad oggi, il Piano Nazionale Prevenzione Vaccinale (PNPV) 2012-2014 non fa riferimento specifico alla vaccinazione anti-rotavirus e, dagli ultimi dati disponibili, il quadro italiano risulta essere alquanto frammentario, caratterizzato da una disomogeneit\ue0 determinata dalla presenza di un gran numero regioni in cui la vaccinazione non \ue8 prevista. Alla luce delle raccomandazioni disponibili ed a partire dal calendario vaccinale completo, la somministrazione di Rotarix\u2122 potrebbe avvenire contestualmente alla vaccinazione esavalente (DTPa, IPV, EpB, Hib) al terzo e al quinto mese d\u2019et\ue0. Rispettando le indicazioni sui tempi di somministrazione, tale schedula, aggiungerebbe una serie di vantaggi di tipo logistico/economico, derivanti dal fatto che entrambe le somministrazioni avverrebbero contemporaneamente alle vaccinazioni tradizionali, senza comportare disagi per i genitori/caregiver, n\ue9 la necessit\ue0 di sedute aggiuntive per gli operatori. I Sistemi Sanitari Regionali, cui \ue8 demandata nel nostro Paese la responsabilit\ue0 in ambito di processi vaccinali, devono farsi garanti di standard di qualit\ue0 omogenei in qualsiasi articolazione del processo di vaccinazione. Il perseguimento di modelli organizzativi basati su logiche di rete e sulla definizione di standard e sistemi di misurazione e valutazione \ue8 pertanto auspicabile in quanto presupposto basilare per il miglioramento continuo della qualit\ue0 dei processi assistenziali e per il successo dei programmi vaccinali

Costi associati a diagnosi e trattamento delle patologie sostenute da S. pneumoniae nei soggetti di et\ue0 6550 anni, in Il vaccino pneumococcico 13-valente per la prevenzione delle infezioni da S. pneumoniae in et\ue0 adulta: una valutazione di HTA

Il capitolo affronta l\u2019analisi dei costi associati alla diagnosi e al trattamento delle patologie sostenute da Streptococcus pneumoniae (S. pneumoniae) nel gruppo di soggetti di et\ue0 6550 anni, attraverso una revisione della letteratura scientifica internazionale e nazionale e una stima dei costi diretti sanitari secondo la prospettiva del Servizio Sanitario Nazionale (SSN). In particolare, \ue8 stata condotta un\u2019analisi dei costi relativi a visite presso medici di medicina generale (MMG), diagnosi, trattamenti farmacologici e ospedalizzazion