Background
Obesity is a complex health disorder that significantly increases the risk of several chronic diseases, and it has been associated with a 5–20-year decrease in life expectancy. The ...prevalence of obesity is increasing steadily worldwide and Italy follows this trend with an increase of almost 30% in the adult obese population in the last 3 decades. Previous studies estimated that 2–4% of the total health expenditure in Europe is attributed to obesity and it is projected to double by 2050. Currently, there is a lack of sufficient knowledge on the burden of obesity in Italy and most relevant estimates are derived from international studies. The aim of this study is to estimate the direct and indirect costs of obesity in Italy, taking 2020 as the reference year.
Methods
Based on data collected from the literature, a quantitative cost-of-illness (COI) study was performed from a societal perspective focussing on the adult obese population (Body Mass Index (BMI) ≥ 30 kg/m
2
) in Italy.
Results
The study indicated that the total costs attributable to obesity in Italy amounted to €13.34 billion in 2020 (95% credible interval: €8.99 billion < µ < €17.80 billion). Direct costs were €7.89 billion, with cardiovascular diseases (CVDs) having the highest impact on costs (€6.66 billion), followed by diabetes (€0.65 billion), cancer (€0.33 billion), and bariatric surgery (€0.24 billion). Indirect costs amounted to €5.45 billion, with almost equal contribution of absenteeism (€2.62 billion) and presenteeism (€2.83 billion).
Conclusions
Obesity is associated with high direct and indirect costs, and cost-effective prevention programmes are deemed fundamental to contain this public health threat in Italy.
Purpose
Over the last few years, the share of public spending for orphan drugs (ODs) has increased in several western countries, raising concern on the exemptions granted to this sector with respect ...to the implementation of health technology assessment (HTA) principles. The aim of this paper is to shed light on both the HTA criteria adopted and the international agreements implemented in the OD regulation, given the new challenges imposed on western countries by a growing number of therapies for rare diseases.
Methods
We carried out a literature review to analyse the development of the international debate on the adaptability of HTA criteria for the OD assessment and regulation. The time span lies between January 1990 and May 2018, and the policies considered relate to both market authorization and reimbursement decisions within western countries. We focus specifically on HTA criteria in some of the dimensions included in the
Core Model
of the European net for HTA (EUnetHTA).
Results
OD high prices, the absence of clarity on the possible high revenues realized by the distribution of a new OD outside the national borders, the risk that – once marketed – a new OD can be used to treat common diseases, are all issues that raise concern on OD regulation and have to be carefully monitored by policymakers in the next future.
Conclusions
Across western countries, the preferential track granted to ODs in the implementation of HTA principles is not homogeneous, but fragmented and differentiated. The need for common rules at an international level is underlined, with a view to assessing the sustainability of a sector which, due to this regulatory void, can lend itself to producers’ strategic and opportunistic behaviours.
This systematic review aims to update the evidence on Duchenne muscular dystrophy (DMD) in Italy, describing the epidemiology, quality of life (QoL) of patients and caregivers, treatment adherence, ...and economic impact of DMD.
Systematic searches were conducted in PubMed, Embase and Web of Science up to January 2023. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol was registered in PROSPERO (CRD42021245196).
Thirteen studies were included. The prevalence of DMD in the general population is 1.7-3.4 cases per 100,000, while the birth prevalence is 21.7-28.2 per 100,000 live male births. The QoL of DMD patients and caregivers is lower than that of healthy subjects, and the burden for caregivers of DMD children is higher than that of caregivers of children with other neuromuscular disorders. The compliance of real-world DMD care to clinical guidelines recommendations in Italy is lower than in other European countries. The annual cost of illness for DMD in Italy is € 35,000-46,000 per capita while, adding intangible costs, the total cost amounts to € 70,000.
Although it is a rare disease, DMD represents a significant burden in terms of quality of life of patients and their caregivers, and economic impact.
This systematic review aims to describe 1) the epidemiology of the diseases indicated for treatment with growth hormone (GH) in Italy; 2) the adherence to the GH treatment in Italy and factors ...associated with non-adherence; 3) the economic impact of GH treatment in Italy; 4) the quality of life of patients treated with GH and their caregivers in Italy.
Systematic literature searches were performed in PubMed, Embase and Web of Science from January 2010 to March 2021. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol has been registered in PROSPERO (CRD42021240455).
We included 25 studies in the qualitative synthesis. The estimated prevalence of growth hormone deficiency (GHD) was 1/4,000-10,000 in the general population of children; the prevalence of Short Stature HOmeoboX Containing gene deficiency (SHOX-D) was 1/1,000-2,000 in the general population of children; the birth prevalence of Turner syndrome was 1/2,500; the birth prevalence of Prader-Willi syndrome (PWS) was 1/15,000. Treatment adherence was suboptimal, with a range of non-adherent patients of 10-30%. The main reasons for suboptimal adherence were forgetfulness, being away from home, pain/discomfort caused by the injection. Economic studies reported a total cost for a complete multi-year course of GH treatment of almost 100,000 euros. A study showed that drug wastage can amount up to 15% of consumption, and that in some Italian regions there could be a considerable over- or under-prescribing. In general, patients and caregivers considered the GH treatment acceptable. There was a general satisfaction among patients with regard to social and school life and GH treatment outcomes, while there was a certain level of intolerance to GH treatment among adolescents. Studies on PWS patients and their caregivers showed a lower quality of life compared to the general population, and that social stigma persists.
Growth failure conditions with approved GH treatment in Italy constitute a significant burden of disease in clinical, social, and economic terms. GH treatment is generally considered acceptable by patients and caregivers. The total cost of the GH treatment is considerable; there are margins for improving efficiency, by increasing adherence, reducing drug wastage and promoting prescriptive appropriateness.
We evaluated the efficacy, safety, adherence, quality of life (QoL) and cost-effectiveness of long-acting growth hormone (LAGH) vs daily growth hormone (GH) preparations in the treatment of growth ...hormone deficiency (GHD) in children. Systematic searches were performed in PubMed, Embase and Web of Science up to July 2022 on randomized and non-randomized studies involving children with GHD receiving LAGH as compared to daily GH. Meta-analyses for efficacy and safety were performed comparing different LAGH/daily GH formulations. From the initial 1393 records, we included 16 studies for efficacy and safety, 8 studies for adherence and 2 studies for QoL. No studies reporting cost-effectiveness were found. Pooled mean differences of mean annualized height velocity (cm/year) showed no difference between LAGH and daily GH: Eutropin Plus® vs Eutropin® − 0.14 (−0.43, 0.15), Eutropin Plus® vs Genotropin® − 0.74 (−1.83, 0.34), Jintrolong® vs Jintropin AQ® 0.05 (−0.54, 0.65), Somatrogon vs Genotropin® − 1.40 (−2.91, 0.10), TransCon vs Genotropin® 0.93 (0.26, 1.61). Also, other efficacy and safety outcomes, QoL and adherence were comparable for LAGH and daily GH.
Our results showed that, although most of the included studies had some concerns for risk of bias, regarding efficacy and safety all the LAGH formulations were similar to daily GH. Future high quality studies are needed to confirm these data. Adherence and QoL should be addressed from real-world data studies for both the mid and long term and in a larger population. Cost-effectiveness studies are needed to measure the economic impact of LAGH from the healthcare payer’s perspective.
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•Therapy with Long-acting GH preparations (LAGH) reduces the frequency of administration of GH.•Pooled mean differences of mean annualized height velocity showed no difference between LAGH and daily GH.•Safety outcomes were comparable for LAGH and daily GH.•Quality of life in children taking LAGH was similar to that of children using daily GH.•As is observed in RCTs, adherence was similarly high with daily GH and weekly GH.
In recent years, accreditation of private hospitals followed by decentralisation of the Italian National Health Service (NHS) into 21 regional health systems has provided a good empirical ground for ...investigating the Tiebout principle of "voting with their feet". We examine the infra-regional trade-off between greater patient choice (due to an increase in hospital services supply) and financial equilibrium, and we relate it to the significant phenomenon of Cross-Border Mobility (CBM) between Italian regions. Focusing on the rules supervising the financial agreements between regional authorities and providers of hospital care, we find incentives for private accredited providers in attracting patient inflows.
The analysis is undertaken from an institutional, regulatory and empirical perspective. We select a sample of five regions with higher positive CBM balance and we examine regional regulations governing the contractual agreements between purchasers and providers of hospital care. According to this sample, we provide a statistical analysis of CBM and apply a Regional Attraction Ability Index (RAAI), aimed at testing patient preferences for private/public accredited providers.
We find that this index is systematically higher for private providers, both in the case of distance/boundary patients and of excellence/general hospitals.
Conclusions address both financial issues regarding the coverage of regional healthcare systems and equity issues on patient healthcare access. They also raise concerns on the new European Union (EU) directive inherent to patient mobility across Europe.
Purpose
Follow-up of automated peritoneal dialysis (APD) has been improved by data transmission by cellular modem and internet cloud. With the new remote patient monitoring (RPM) technology, clinical ...control and prescription of dialysis are performed by software (Baxter Claria-Sharesource), which allows the center to access home operational data. The objective of this pilot study was to determine the impact of RPM compared to traditional technology, in clinical, organizational, social, and economic terms in a single center.
Methods
We studied 21 prevalent APD patients aged 69 ± 13 years, on dialysis for a median of 9 months, for a period of 6 months with the traditional technology and 6 months with the new technology. A relevant portion of patients lived in mountainous or hilly areas.
Results
Our study shows more proactive calls from the center to patients after the consultation of RPM software, reduction of calls from patients and caregivers, early detection of clinical problems, a significant reduction of unscheduled visits, and a not significant reduction of hospitalizations. The analysis also highlighted how the RPM system lead to relevant economic savings, which for the health system have been calculated € 335 (mean per patient-month). With the social costs represented by the waste of time of the patient and the caregiver, we calculated € 685 (mean per patient-month).
Conclusion
In our pilot report, the RPM system allowed the accurate assessment of daily APD sessions to suggest significative organizational and economic advantages, and both patients and healthcare providers reported good subjective experiences in terms of safety and quality of follow-up.
The availability of a new 20-valent pneumococcal conjugate vaccine (PCV) makes it appropriate to assess its cost-effectiveness. This was evaluated by adopting the Italian National Health Service ...perspective, using a cost consequences Markovian model. The expected effects of vaccination with 20-valent PCV were compared with the administration of 13-valent PCV and 15-valent PCV. Assuming a 100% vaccination of cohorts aged 65-74 years, in the (lifetime) comparison between 20-valent PCV and 13-valent PCV, the former is dominant (lower cost for a better health outcome). A reduction in disease events was estimated: -1208 deaths; -1171 cases of bacteraemia; -227 of meningitis; -9845 hospitalised all-cause nonbacteremic pneumonia cases (NBP) and -21,058 non-hospitalised. Overall, in the Italian population, a total gain of 6581.6 life years and of 4734.0 QALY was estimated. On the cost side, against an increase in vaccinations costs (EUR +40.568 million), other direct health costs are reduced by EUR 48.032 million, with a net saving of EUR +7.464 million. The comparison between 20-valent PCV and 15-valent PCV results in an Incremental Cost-Effectiveness Ratio (ICER) of EUR 66 per life year gained and EUR 91 per QALY gained. The sensitivity analyses confirm the robustness of the results. We can conclude that the switch to 20-valent PCV is a sustainable and efficient investment.
Our study's objective was to assess the incidence trends and healthcare resource utilization of hospitalizations for Tick-Borne Encephalitis (TBE) and associated costs in Italy in order to improve ...public awareness and preventive measures.
This retrospective observational study was based on the Italian Ministry of Health's Hospital Discharge Record (HDR) database. Data were gathered across Italy from 2015 to 2019, selecting hospitalizations with ICD-9 code 063 related to TBE, both in primary and secondary diagnoses. For each year, we collected the following variables: number of hospitalizations, hospitalization rate, mortality rate, mean length of hospital stay, hospital ward, and cost of hospitalization.
There were a total of 237 hospitalizations from 2015 to 2019; 62 % of those were male. The lowest number of TBE hospitalizations was in 2015 (21 cases, corresponding to 0.35 per million inhabitants), the highest in 2019 (64 cases, 1.04 per million inhabitants). The summer months saw a greater than average number of hospitalizations. For the years analyzed, the cumulative number of cases peaked in June (54 cases), July (46 cases), and August (35 cases). There were only two deaths registered in our study sample. TBE cases were mostly localized in the North-Eastern regions of Italy. TBE incidence during the study period in the most affected areas were: Autonomous Province of Trento, ranging from 11.2 to 42.3 per million inhabitants, Autonomous Province of South Tyrol, from 0 to 21.1 per million inhabitants, and Veneto Region, from 2.6 to 4.5 per million inhabitants. In the study period, the average length of hospital stay was largely stable ranging from 10.6 days to 12.8 days, with related costs ranging from 5,813.7 € to 7,352.5 €.
According to our data, the majority of TBE hospitalizations occur in North-East Italy with an increasing trend over the analyzed period. Even though Italy has fewer TBE cases than other neighboring European countries, the health and economic impact can be high in the affected areas.
Introduction:
Viscosupplementation with hyaluronic acid (HA) is indicated for non-responders to non-pharmacological therapy, to analgesics or when non-steroidal anti-inflammatory drugs (NSAIDs) are ...contraindicated. The aim of this study is to compare the efficacy, safety and costs of three different HA treatments (Sinovial® Forte, sinovial one and hyalgan).
Patients and methods:
Ninety patients with grade I/II Kellgren–Lawrence knee osteoarthritis were included in three groups, the first was treated with hyalgan (weekly for 5 weeks), the second with Sinovial® Forte (weekly for 3 weeks) and the third group with a single injection of sinovial one.
Results:
All three treatments were effective, with an average reduction in the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score of 18.9 points for hyalgan, 18.04 points for Sinovial® Forte and 17.92 points for sinovial one. The comparison of the three groups did not show any statistical difference in terms of efficacy. National health system (NHS) and social costs are, respectively, €419.12 and €853.43 for hyalgan, €338.64 and €599.22 for Sinovial® Forte, €221.56 and €308.42 for sinovial one.
Conclusion:
All three treatments were equally effective with no statistically significant differences; thus, the treatment with sinovial one may be considered as clinically effective as the other two regimens, but with a very efficient cost profile in early symptomatic knee osteoarthritis.
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