The incidence of Gestational Diabetes Mellitus (GDM) is rising in all developed countries. This study aimed at assessing the short-term economic burden of GDM from the Italian healthcare system perspective. A model was built over the last pregnancy trimester (i.e., from the 28th gestational week until childbirth included). The National Hospital Discharge Database (2014) was accessed to estimate delivery outcome probabilities and inpatient costs in GDM and normal pregnancies (i.e., euglycemia). International Classification of Disease-9th Revision-Clinical Modification (ICD9-CM) diagnostic codes and Diagnosis-Related Group (DRG) codes were used to identify GDM cases and different types of delivery (i.e., vaginal or cesarean) within the database. Neonatal outcomes probabilities were estimated from the literature and included macrosomia, hypoglycemia, hyperbilirubinemia, shoulder dystocia, respiratory distress, and brachial plexus injury. Additional data sources such as regional documents, official price and tariff lists, national statistics and expert opinion were used to populate the model. The average cost per case was calculated at national level to estimate the annual economic burden of GDM. One-way sensitivity analyses and Monte Carlo simulations were performed to quantify the uncertainty around base case results. The amount of pregnancies complicated by GDM in Italy was assessed at 54,783 in 2014 using a prevalence rate of 10.9%. The antenatal outpatient cost per case was estimated at €43.7 in normal pregnancies compared to €370.6 in GDM patients, which is equivalent to a weighted sum of insulin- (14%; €1034.6) and diet- (86%; €262.5) treated women’s costs. Inpatient delivery costs were assessed at €1601.6 and €1150.3 for euglycemic women and their infants, and at €1835.0 and €1407.7 for GDM women and their infants, respectively. Thus, the overall cost per case difference between GDM and normal pregnancies was equal to €817.8 (+ 29.2%), resulting in an economic burden of about €44.8 million in 2014 at national level. Probabilistic sensitivity analysis yielded a cost per case difference ranging between €464.9 and €1164.8 in 80% of simulations. The economic burden of GDM in Italy is substantial even accounting for short-term medical costs only. Future research also addressing long-term consequences from a broader societal perspective is recommended.

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that will hopefully increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes should be closely coordinated, particularly for promising, highly innovative MDs. Accelerated approval is worth exploring for certain categories of high-risk MDs to keep the EU regulatory process competitive compared to ad-hoc accelerated MD approval processes elsewhere (e.g., US). Areas covered: Problems observed in worldwide accelerated drug and MD regulatory approval programs are reviewed, including greater uncertainty in pre-market clinical evidence generation and lack of oversight for post-approval evidence requirements. Implications for MD approval, HTA and coverage are explored. Expert opinion: Through analysis of two decades of drug and MD accelerated approval programs worldwide, recommendations for an Accelerated Access Pathway for select innovative, high-risk MDs are proposed that can fit the EU context, leverage the two new regulations, increase opportunities for Expert Panels to provide timely advice regarding manufacturers’ evidence generation plans along the MD lifecycle (pre-, post-market), and safely speed patient access while promoting increased collaboration among Member States on coverage decisions.

Common methodologies for analysis of analogous data sets are needed for international comparisons of treatment and outcomes. This study tests using administrative hospital discharge (HD) databases in five European countries to investigate variation/trends in pacemaker (PM) and implantable cardioverter defibrillator (ICD) implant rates in terms of patient characteristics/management, device subtype, and initial implantation vs. replacement, and compares findings with existing literature and European Heart Rhythm Association (EHRA) reports. HD databases from 2008 to 2012 in Austria, England, Germany, Italy and Slovenia were interrogated to extract admissions (without patient identification) associated with PM and ICD implants and replacements, using direct cross-referencing of procedure codes and common methodology to compare aggregate data. 1 338 199 records revealed 212 952 PM and 62 567 ICD procedures/year on average for a 204.4 million combined population, a crude implant rate of about 104/100 000 inhabitants for PMs and 30.6 for ICDs. The first implant/replacement rate ratios were 81/24 (PMs) and 25/7 (ICDs). Rates have increased, with cardiac resynchronization therapy (CRT) subtypes for both devices rising dramatically. Significant between- and within-country variation persists in lengths of stay and rates (Germany highest, Slovenia lowest). Adjusting for age lessened differences for PM rates, scarcely affected ICDs. Male/female ratios remained stable at 56/44% (PMs) and 79/21% (ICDs). About 90% of patients were discharged to home; 85–100% were inpatient admissions. To aid in policymaking and track outcomes, HD administrative data provides a reliable, relatively cheap, methodology for tracking implant rates for PMs and ICDs across countries, as comparisons to EHRA data and the literature indicated.

Immigrants face multiple barriers in accessing healthcare; however, empirical assessment of access presents serious methodological issues, and evidence on undocumented immigrants is scant and based mainly on non-representative samples. We examine avoidable hospitalization (AH) as an indicator of poor access to primary care (PC) in Italy, where a universal healthcare system guarantees access but fails to assign general practitioners to undocumented immigrants. Using anonymized national hospital discharge records in 2019, undocumented immigrants were identified through an administrative financing code. Potential effects of poor access to PC were measured by focusing on the incidence of AH, differentiated among chronic, acute and vaccine-preventable conditions, comparing Italian citizens, documented (foreign nationals with residence permits) and undocumented immigrants. We estimated odd ratios (ORs) through logistic regression models, controlling for individual and contextual confounders. Compared with Italians, undocumented and documented immigrants adjusted odd ratios (OR) for the risk of AH were 1·422 (95% CI 1·322-1·528) and 1·243 (95% CI 1·201-1·287), respectively. Documented immigrants showed ORs not significantly greater than 1 for AH due to chronic diseases compared with Italians, while undocumented immigrants registered higher adjusted OR for all AH categories – chronic (OR 1·187; 95% CI 1·064-1·325), acute (OR 1·645; 95% CI 1·500-1·803) and vaccine-preventable (OR 2·170; 95% CI 1·285-3·664). Documented and undocumented immigrants face considerably higher risk of AH compared to Italians. Considering the burden of AHs, access to PC (including preventive and ambulatory care) should be provided to undocumented immigrants, and additional barriers to care for all immigrants should be further explored. None.

Policymakers everywhere struggle to introduce therapeutic innovation while controlling costs, a particular challenge for the universal Italian National Healthcare System (SSN), which spends only 8.8% of GDP to care for one of the world's oldest populations. Oncology provides a telling example, where innovation has dramatically improved care and survival, transforming cancer into a chronic condition. However, innovation has also increased therapy duration, adverse event management, and service demand. The SSN risks collapse unless centralized cancer planning changes gear, particularly with Covid-19 causing treatment delays, worsening patient prognosis and straining capacity. In view of the 750 billion Euro "Next Generation EU", released by the European Union to relieve Member States hit by the pandemic, the SSN tapped a multidisciplinary research team to identify key strategies for equitable uptake of innovations in treatment and delivery, with emphasis on data-driven technological and managerial advancements - and lessons from Covid-19.

Background: The success of antiretroviral therapies has made human immunodeficiency virus (HIV) a chronic disease, changing the care scenario dramatically. This study aimed to measure adherence to diabetes mellitus standards of care provided for people living with HIV (PLWH). Diabetes represents a paradigmatic case for tackling chronic care management in this target group. Methods: This retrospective observational study was performed on administrative health data retrieved from 2014 to 2016, with a validated algorithm to identify patients with HIV using: (i) hospital discharge records (ICD9-CM codes); (ii) drug dispensing records (with ATC codes); and (iii) disease-specific exemptions from co-payments for healthcare services. HIV-related treatments, comorbidities and health service utilization were measured, as was adherence to clinical guidelines-recommended standards of care for diabetes. Results: A population of 738 cases were identified in two Local Health Authorities in Italy, representing a prevalence of 0.14% of the general population, in line with the expected prevalence. Thirty-one cases of HIV patients diagnosed with diabetes were identified, a prevalence ratio of 4.2% compared to the 8% in the overall population. Adherence to diabetes standards of care tested within the same population was low, with the exception of those tests commonly administered for standard HIV follow-up care. Conclusions: The use of administrative data, combined with a Population Health Management approach represents a powerful tool for evaluating system capacity to manage HIV comorbidities. Study findings prove that it is time to design new care models for PLWH, affected by one or more chronic conditions, both to prevent their onset and to manage their comorbidities.