[Update of the Pdta Net Observatory of the ReS Foundation with all regional Care Pathways approved until 2023.] / Aggiornato l'Osservatorio Pdta Net di Fondazione ReS con tutti i Pdta regionali approvati fino al 2023.

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.

Chronic Kidney Disease Eligible for SGLT2 Inhibitors Through the Integration of Italian Administrative and Primary Care Data.

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.

[The domino effect of drug distribution channels on the management of chronicity.] / L'effetto domino dei canali distributivi dei farmaci sulla gestione della cronicità.

Drug distribution channels affect all actors in the drug supply chain: healthcare institutions, healthcare professionals, patients, pharmacies, pharmaceutical companies and distributors. They should be redesigned in line with the new proximity care model planned in the Pnrr and DM 77, while avoiding a negative domino effect on the management of chronic diseases. A guide recently published by the MaCroScopio project is useful to shed light on this issue and to understand the relationship between the distribution channels present in Italy (distribuzione diretta - DD; distribuzione per conto - Dpc; distribuzione convenzionata) and the management of chronic diseases. Analysis of OsMed data showed that the majority of medicines dispensed in DD and Dpc are for chronic patients; therefore, a change in distribution channels inevitably affects chronicity management and could lead to increased expenditure. It is necessary to evaluate the transfer of drugs from one channel to another on a case-by-case basis according to the specifics of each drug. Proximity care reform requires a redesign of drug distribution channels, but this must be done with respect to the clinical, social and economic sustainability of the system.

Italian healthcare resource consumption for patients on hemodialysis treated for chronic kidney disease-associated pruritus (CKD-aP).

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.

To retrieve values of albuminuria to define the size of CKD patients eligible to SGLT-2Is: An explorative analysis using a primary care database.

PURPOSE: To address missingness of albuminuria values, which establish the eligibility to SGLT-2Is for patients with CKD, using the multiple imputation (MI) method. METHODS: We selected patients aged 18 or older and diagnosed with CKD in a primary care database. Those with severe CKD and/or previously treated with SGLT-2Is were excluded. Then, we collected all available information on albuminuria within 90 days the measure of GFR. A value of albumin-creatinine ratio (ACR) ranging 200-5000 mg/g or otherwise was the response variable on which we ran MI. Using logistic regression, odds ratios (OR) and related 95% confidence intervals (CI) were estimated for each covariate toward the response variable for both full and imputed dataset. RESULTS: The determinants showed consistent estimates between the full and imputed datasets as demonstrated by the overlaps of the CIs and the similar point estimates. As expected, there were some exceptions, such as diabetes (OR of 1.2 vs. 0.5) and use of diabetic medications (OR of 1.0 vs. 2.1) and/or statins (OR of 1.1 vs. 1.8). CONCLUSIONS: Besides being a reminder for GPs to prescribe and register albuminuria in certain patients' categories, these determinants might be translated into an operational algorithm to input ACR values in administrative data sources. Scenarios for the reimbursement criteria regulating SGLT-2Is to treat CKD would be therefore simulated on more inferable estimates.

[The population affected by neovascular age-related macular degeneration and treated with anti-Vegf through Italian administrative healthcare data.] / La popolazione con degenerazione maculare neovascolare correlata all'età trattata con anti-Vegf attraverso i dati amministrativi sanitari.

INTRODUCTION: The neo-vascular age-related macular degeneration (nAmd) is a frequent cause of vision loss, although the intravitreal (Ivt) injections of anti-Vegf (vascular endothelial growth factor) have improved functional outcomes. This study has assessed the healthcare and economic burden on the Italian national health service (Inhs) for patients with nAmd and new users of anti-Vegf. METHODS: From the database of Fondazione Ricerca e Salute (ReS), people aged ≥55 and with an in-hospital diagnosis of nAmd and/or an injection of anti-Vegf (aflibercept, ranibizumab, pegaptanib; index date) in 2018 are selected. Those with other conditions treated with anti-Vegf and with an Ivt injection before 2018 are excluded. New users of anti-Vegf are analyzed by sex, age, comorbidities, Ivt administrations, switch of anti-Vegf, local outpatient specialist services (with some focuses) and direct healthcare costs charged to the Inhs Results. In 2018, of 8125 inhabitants aged ≥55 with nAmd (4.6x1000 inhab.; mean age 76±9; F: 50%), 1513 (19%) are new users of Ivt anti-Vegf (mean age 74±9), whose incidence (0.9x1000) increased with age until 84 years old. A proportion of 60.7% had ≥2 comorbidities (mainly hypertension, dyslipidemia and diabetes). Within the 2nd follow-up year, only 598 patients are still treated (60% were lost). On average, 4.8 Ivt injections in the first and 3.1 in the second year are registered. On average, the total cost charged to the Inhs per new user of anti-Vegf was € 6726 (Ivt anti-Vegf accounted for the 76%) and € 3282 (hospitalizations for causes different from nAmd accounted for the 47%), during the first and the second year, respectively. CONCLUSIONS: This analysis suggests that in Italy people with nAmd and new users of anti-Vegf are elderly, affected by many comorbidities, treated with Ivt anti-VEGF less than what is required and authorized to achieve a benefit, undergo very few follow-up outpatient specialist visits and tests and, within the 2nd year, their hospitalizations for causes different from nAmd mainly weighs on the total expenditure charged to the Inhs.

To support the use of NT-proBNP to better detect heart failure in patients with type 2 diabetes.

PURPOSE: Heart failure (HF) is a chronic disease that causes approximately 300,000 and 250,000 deaths per year in Europe and United States, respectively. Type 2 Diabetes Mellitus (T2DM) is one the major risk factors of HF, and the investigation of NT-proBNP might support the early identification of HF in T2DM sufferers. Nevertheless, this parameter is poorly investigated. Thus, we aimed to demographically and clinically characterize diabetic patients which were prescribed with NT-proBNP in the primary care setting. METHODS: Using a primary care database, we formed a cohort of patients aged ≥18 years diagnosed with T2DM between 2002 and 2021. A multivariate Cox model was adopted to assess the determinants associated with the prescription of NT-proBNP. RESULTS: Among 167,961 T2DM patients, 7558 (4.5%, 95% CI: 4.4-4.6) were prescribed with NT-proBNP. Males and increasing age were expectedly associated with a higher propensity to be prescribed with NT-proBNP. In addition, a significant association was found for those suffering from obesity, ischemic cardiomyopathy, stroke, atrial fibrillation, hypertension, and with a Charlson Index of 2+. CONCLUSION: These determinants might contribute to investigate the NT-proBNP in T2DM sufferers. A decision support system to appropriately ease the prescription of NT-proBNP might be therefore implemented in primary care settings.

Do more targets allow more cancer treatments, or not?

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.

A methodology to assess the population size and estimate the needed resources for new licensed medications by combining clinical and administrative databases: The example of glycated haemoglobin in type 2 diabetes.

PURPOSE: To develop and validate a model to estimate glycated haemoglobin (HbA1c) values in patients with type 2 diabetes mellitus (T2DM) using a clinical data source, with the aim to apply this equation to administrative databases. METHODS: Using a primary care and administrative Italian databases, namely the Health Search database (HSD) and the ReS (Ricerca e Salute) database, we selected all patients aged 18 years or older on 31 December 2018 being diagnosed with T2DM and without prior prescription of sodium-glucose cotransporter-2 (SGLT-2) inhibitors. We included patients prescribed with and adherent to metformin. HSD was used to develop and test (using 2019 data as well) the algorithm imputing HbA1c values ≥7% according to a series of covariates. The algorithm was gathered by combining beta-coefficients being estimated by logistic regression models using complete case (excluding missing values) and imputed (after multiple imputation) dataset. The final algorithm was applied to ReS database using the same covariates. RESULTS: The tested algorithms were able to explain 17%-18% variation in assessing HbA1c values. Good discrimination (70%) and calibration were obtained as well. The best algorithm (three) cut-offs, namely those providing correct classifications ranging 66%-70% was therefore calculated and applied to ReS database. By doing so, from 52 999 (27.9, 95% CI: 27.7%-28.1%) to 74 250 (40.1%, 95% CI: 38.9%-39.3%) patients were estimated with HbA1c ≥7%. CONCLUSION: Through this methodology, healthcare authorities should be able to quantify the population eligible to a new licensed medication, such as SGLT-2 inhibitors, and to simulate scenarios to assess reimbursement criteria according to precise estimates.

[Inclusion of vaccination into clinical pathways for COPD and asthma: current challenges and future perspectives in Italy]. / La vaccinazione dei pazienti con BPCO e Asma nei PDTA in Italia: gap da colmare e prospettive future.

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.

Acute myeloid leukemia: Incidence, transplantation and survival through Italian administrative healthcare data.

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.

[Community acquired pneumoniae and chronic obstructive pulmonary disease: the RWE analysis of events that required hospitalizations, and healthcare integrated costs.] / Polmonite acquisita in comunità e broncopneumopatia cronica-ostruttiva: analisi RWE degli eventi che hanno richiesto il ricovero ospedaliero e dei costi assistenziali associati.

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.

Safety of drugs used for the treatment of migraine during pregnancy: a narrative review.

INTRODUCTION: Migraine is common in females of childbearing age and negatively impacts quality of life. The majority of those with migraine who become pregnant see an improvement in their condition but not all do. Providing evidence-based recommendations for the pharmacological management of migraine in pregnancy is challenging. AREAS COVERED: This narrative review provides an update on the safety of drugs used for migraine in pregnancy. National and international guidelines on the management of episodic migraine in adults were used to select the drugs of relevance to pregnant women. The final list of drugs was chosen by a pain specialist who categorized them according to drug class and use in acute management or prevention. PubMed was searched from inception to 31st July 2022 for evidence on drug safety. EXPERT OPINION: Obtaining high-quality drug safety data in pregnant migraineurs is difficult not least because exposing a fetus to research-related risks is often considered unethical. There is reliance on observational studies which often group drugs together and lack specificities pertinent to drug prescribing like timing, dosing and duration. Improved statistical tools, study designs and the creation of international collaborative frameworks are ways to advance knowledge on drug safety in pregnancy.

[Occurrence of cardiovascular events within a large population of patients affected by rheumatoid arthritis with or without diabetes.] / Sviluppo di eventi cardiovascolari in un'ampia popolazione di pazienti affetti da artrite reumatoide con o senza diabete.

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.

[A view of care pathways approved by Italian Regions, to face the challenge of the community-based healthcare: a quali-quantitative analysis of the Pdta Net database.] / Conoscere i percorsi diagnostico-terapeutici assistenziali (Pdta) regionali approvati in Italia per affrontare il cambiamento della assistenza di prossimità: analisi quali-quantitativa del database Pdta Net.

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.

How many and who are patients with heart failure eligible to SGLT2 inhibitors? Responses from the combination of administrative healthcare and primary care databases.

BACKGROUND: Recent successful findings (i.e. DAPA-HF trial) in patients with heart failure (HF) with/without diabetes treated with sodium-glucose co-transporter inhibitors (SGLT2-I) have fostered real-world data analyses. Fondazione Ricerca e Salute's (ReSD) administrative and Health Search's (HSD) primary healthcare databases were combined in the ReS-HS DB Consortium, to identify and characterize HF-patients eligible to SGLT2-I, and assess their costs charged to the Italian National Health Service (INHS). METHODS AND RESULTS: Eligibility to SGLT2-I was HF diagnosis, age ≥ 18 years, reduced (≤40%) ejection fraction (HFrEF) and glomerular filtration rate (GFR) ≥30 ml/min. The HSD, including 13,313 HF-patients (1.5% of the total HSD population) was used to develop and test the algorithms for imputing HFrEF and GFR ≥ 30 ml/min, based on a set of covariates, to the ReSD, including 67,369 (1.5% of the total ReSD population). Subjects eligible to SGLT2-I were 2187 in HSD (61.1% of HFrEF); after the imputation, 15,145 in ReSD (58.8% of HFrEF). Prevalence of eligibility to SGLT2-I was higher in males then in females and increased with age; diabetic patients were 44.3% and 33.4% of HSD and ReSD populations eligible to SGLT2-I, respectively. Estimated from ReSD, the mean annual cost charged to the INHS per patient with HF eligible to SGLT2-I was €7122 (68% due to hospitalizations). CONCLUSIONS: Approximately 20% of patients with HF was eligible to SGLT2-I. Real-world data can identify, quantify and characterize patients eligible to SGLT2-Is and assess related costs for the health care system, thus providing useful information to Regulatory Decision makers.

Antiplatelet Therapy during the First Year after Acute Coronary Syndrome in a Contemporary Italian Community of over 5 Million Subjects.

Background: Patterns of real-world antiplatelet therapy (APT) are reported to differ from guideline recommendations. This study describes patterns of APT during the year following a hospital diagnosis of acute coronary syndrome (ACS) and possible implications in terms of revascularization rates, rehospitalizations, and costs for the Italian National Health Service. Methods: From >5 million people, patients discharged (=index date) with primary/secondary ACS diagnosis in 2017 were identified by cross-linkage of administrative health data collected by the Ricerca e Salute (ReS) Foundation. Patients were characterized by revascularization rates at index date, APT at one month and one year (with appropriate coverage defined as ≥80% of defined daily doses), and rehospitalizations and healthcare costs during follow-up. Results: From the 2017 ReS database, 7966 (1.46 × 1000 inhabitants) were discharged alive with an ACS diagnosis. Most were >69 years and male. Of these, 83% (6640/7966) received ≥1 recommended antiplatelet agent within one month (treated group): 23% (1870/7966) as single and 60% (4770/7966) as dual APT. Among the 53% undergoing revascularization, 81% received dual APT at one month. Of the 78% with the same APT at one year, 66% showed appropriate coverage. For subjects treated and untreated with APT at one month, one-year rehospitalization rates were 54% and 66%, respectively, and mean per capita costs were EUR 14,316 and EUR 16,552, respectively (hospitalization driving >80% of costs). Conclusions: Among survivors of a hospitalized ACS diagnosis, this analysis shows relatively high APT under-treatment at one month and one year, associated with fewer index revascularization rates, more rehospitalizations, and greater costs. Further initiatives to understand undertreatment and poor adherence should lead to improved health management and savings.

Prescription Pattern of Monoamine Oxidase B Inhibitors Combined with Levodopa: A Retrospective Observational Analysis of Italian Healthcare Administrative Databases.

BACKGROUND: Parkinson's disease is still incurable, and several factors are considered when defining pharmacological therapy. OBJECTIVE: The aim of this study was to describe the prescription pattern of monoamine oxidase B inhibitors (MAO-BIs) marketed in Italy (selegiline, rasagiline, safinamide) as an add-on to levodopa among new users of MAO-BIs, from the perspective of the Italian National Health Service. PATIENTS AND METHODS: Through cross-linkage of administrative healthcare data in the Ricerca e Salute (ReS) database, adults with a supply of one or more MAO-BIs in 2017, and with no other MAO-BI use since 2013, were selected. Levodopa had to be supplied within 30 days before/after the MAO-BI. The incidence, use, sex, age, comorbidities, 2-year prescription patterns (i.e., switches, proportion of treated patients per semester/year, mean daily milligrams/monthly tablets supplied, discontinuation, change to other anti-Parkinson drug) of patients taking MAO-BIs were provided. RESULTS: In 2017, 1059 new users received an MAO-BI (incidence 22.6 × 100,000 adults) combined with levodopa: 502 subjects (10.7 × 100,000) were treated with selegiline, 161 (3.4 × 100,000) were treated with rasagiline, and 396 (8.4 × 100,000) were treated with safinamide. The cohorts mainly consisted of males with a median age of ≥ 74 years. Treatment incidences increased with age. Switches occurred in 18.0%, 11.0%, and 4.3% of the selegiline, rasagiline, and safinamide cohorts, respectively. Most of the patients switching from selegiline/safinamide changed to rasagiline, while most of the patients switching from rasagiline changed to safinamide. From the first to second years, patient numbers reduced by ≤ 50%, and the daily milligrams/monthly tablets slightly increased. Six-month discontinuation occurred in > 50% of all cohorts, and ≥ 65% of discontinuing patients changed to another anti-Parkinson drug. CONCLUSIONS: This analysis described the heterogeneous use of MAO-BIs as an add-on to levodopa in Italy. Further clinical trials and real-world studies are encouraged to update the few existing guidelines and to align clinical practice strategies.

[Uremic pruritus through healthcare administrative data].

Background: This retrospective observational study aimed at describing patients on hemodialysis with/without uremic pruritus (UP), their healthcare resource consumption and costs from the perspective of the Italian National Health Service (INHS). Methods: Through the cross-linkage of the healthcare administrative data collected in the ReS (Ricerca e Salute) database from 2015 to 2017, patients undergoing in-hospital/outpatient hemodialysis (index date) for ≥2 years were selected. After the exclusion of subjects with other causes of pruritus, UP/non-UP cohorts were created based on the presence/absence of UP-related treatment supplies and characterized. Treatments, hospitalizations and costs were analyzed. Results: Of 1239 patients on hemodialysis for ≥2 years (20.2% of all hemodialysis subjects), 218 (17.6%) were affected by UP. Both cohorts were mostly males and elderly. One year before and after the index date, 58.1% and 65.1% of UP patients received UP-related treatments, of which >50% were treated with antihistamines (mostly cetirizine), 10% gabapentin and 1.4% ultraviolet light therapy. The mean annual overall cost per patient with/without UP was €37,065/€35,988. Outpatient specialist services accounted for 80% (>77% hemodialysis), hospitalizations for 10% (>60% hemodialysis). Conclusions: Though the prevalence of UP and related healthcare costs charged to the INHS were underestimated, the burden of UP was not negligible. High-efficiency dialytic therapies performed 3 to UP patients seemed to largely weigh on the overall mean annual cost. The availability of specific and effective treatments for UP might offer cost and healthcare offsets.