Cost, outcomes, treatment pathways and challenges for diabetes care in Italy

Background: In Italy both incidence and prevalence of diabetes are increasing and age at diagnosis is decreasing in type 2 diabetes. Diabetes is one of the major causes of morbidity in Italy, causing several disabilities and affecting the economically active population. The objective of this paper is to identify and discuss costs, outcomes and some of the challenges of diabetes care in Italy in the context of recent policy changes. Methods: The study collected data and evidence from both primary and secondary sources. A total of 10 experts, including clinicians (diabetologists/endocrinologists) and decision makers, both at national and regional levels, were interviewed through face-to-face semi-structured interviews. The secondary sources include peer review literature from Medline, grey literature, reports from national and international sources, including professional bodies and organizations. Results: The total direct cost of diabetes for the Italian NHS in 2012 is estimated to be above €9 billion, of which more than half for hospital admissions (57%), and the remaining half for drugs (30%) and outpatient care (13%). However, there is scant evidence on indirect and intangible costs of diabetes in Italy. The quality of care addressed via the AMD Annals found overall good performance with both process and intermediate outcome indicators showing positive and improving results from 2004 to 2011, except for few parameters, including renal function and foot monitoring, which are still inadequate. Major challenges are the rising diabetes prevalence, the difficulty in meeting the rising demand for care and the scant development of multidisciplinary delivery of care, especially in the predominantly ambulatory setting of the Southern diabetes centres. Conclusions: Prevention of diabetes, especially adopting a multi-sectorial approach, should be further empowered by policy makers through promoting healthy lifestyles and specifically targeting child obesity. Other key strategies include more information and education, better diabetes management through the adoption of a chronic model of care, more focus on appropriateness and efficiency of care and better communication between diabetes centres within every Region

Using IMPrESS to guide policy change in multiple sclerosis

The International MultiPlE Sclerosis Study (IMPrESS) studied the significant impact of multiple sclerosis (MS) on the health and well-being of both people with the disease and their caregivers, along with its broader socioeconomic impact. Results confirmed that there is an urgent need to achieve better outcomes for people with MS. This paper uses results from the IMPrESS to present new international evidence on the socioeconomic burden of MS and discuss the merits of a likely paradigm shift in the management of MS towards the use of better (and more accurate) diagnostic follow-up to monitor disease progression and the earlier use of disease-modifying treatments (DMTs) to achieve better clinical, quality-of-life and socioeconomic results for individuals

Pars plana vitrectomy for diabetic macular edema: a systematic review, meta-analysis, and synthesis of safety literature

Purpose. To assess the risk and benefit of pars plana vitrectomy for diabetic macular edema (DME). Methods. We conducted a systematic literature review using PubMed, EMBASE, Web of Science, and Cochrane Central Database of Controlled Trials until September 2014. The population was patients with DME, intervention vitrectomy, comparator macular laser or observation, and efficacy outcome visual acuity and central retinal thickness (CRT). Safety outcomes were intra- and postoperative surgical complications. The efficacy meta-analysis included only randomized controlled trials. The safety analysis included prospective, retrospective, controlled and uncontrolled studies. Results. Five studies were eligible for the efficacy meta-analysis (n = 127 eyes) and 40 for the safety analysis (n = 1,562 eyes). Combining follow up intervals from 6 to 12 months, the meta-analysis found a non-significant 2 letter visual acuity difference favoring vitrectomy, and a significant 102 micron greater reduction in CRT favoring vitrectomy, but a post-hoc subgroup analysis found that a 6 month CRT benefit reversed by 12 months. The most frequent complications were retinal break (7.1%), elevated intraocular pressure (5.2%), epiretinal membrane (3.3%), and vitreous hemorrhage (2.4%). Cataract developed in 68.6% of 121 phakic eyes. Conclusions. Vitrectomy produces structural and functional improvements in select eyes with DME, but the visual gains are not significantly better than with laser or observation. No major safety concerns were identified

Direct cost of pars plana vitrectomy for the treatment of macular hole, epiretinal membrane and vitreomacular traction: a bottom-up approach

Purpose The direct cost to the National Health Service (NHS) in England of pars plana vitrectomy (PPV) is unknown since a bottom-up costing exercise has not been undertaken. Healthcare resource group (HRG) costing relies on a top-down approach. We aimed to quantify the direct cost of intermediate complexity PPV. Methods Five NHS vitreoretinal units prospectively recorded all consumables, equipment and staff salaries during PPV undertaken for vitreomacular traction, epiretinal membrane and macular hole. Out-of-surgery costs between admission and discharge were estimated using a representative accounting method. Results The average patient time in theatre for 57 PPVs was 72 min. The average in-surgery cost for staff was £297, consumables £619, and equipment £82 (total £997). The average out-of-surgery costs were £260, including nursing and medical staff, other consumables, eye drops and hospitalisation. The total cost was therefore £1634, including 30 % overheads. This cost estimate was an under-estimate because it did not include out-of-theatre consumables or equipment. The average reimbursed HRG tariff was £1701. Conclusions The cost of undertaking PPV of intermediate complexity is likely to be higher than the reimbursed tariff, except for hospitals with high throughput, where amortisation costs benefit from economies of scale. Although this research was set in England, the methodology may provide a useful template for other countries

Clinical, ethical, and socioeconomic considerations for prescription drug use during pregnancy in women suffering from chronic diseases

The increasing proportion of women conceiving later in life, associated with the higher probability of contracting a chronic disease, highlights an increasing need to understand the impact of drug use for chronic diseases pre- and postpartum. In this study, the authors report the results of systematic reviews of drug use during pregnancy by focusing on pregnant women with a chronic disease, specifically, epilepsy, rheumatoid arthritis (RA), or schizophrenia. The authors studied the clinical impact of drug use in these chronic diseases on the mother and fetus, as well as the ethical issues and socioeconomic impact of drug use during pregnancy for women with these conditions. The results indicate that treatment discontinuation in epilepsy and schizophrenia can lead to serious adverse effects, whereas pregnancy can have an ameliorating effect on RA symptoms. Delivery and neonatal complications were associated with the use of older generation drugs across the 3 diseases. Newer generation drugs were deemed safer but more expensive. Ethical considerations for physicians and patients involved mainly the potential risks of drug use for the fetus. In conclusion, treatment guidelines need to be developed in the future; additionally, better insight into the economics of pregnancy for women with chronic diseases will improve value for money in obstetric care

Symptomatic vitreomacular adhesion

Background: Symptomatic vitreomacular adhesion describes symptomatic loss of visual function as a result of vitreous traction at the macula. Methods: Literature review. Results: Symptomatic vitreomacular adhesion can occur in isolation as vitreomacular traction, which may lead to the development of a macular hole, or it may occur alongside epiretinal membrane. It is likely to be associated with age-related macular degeneration and possibly diabetic maculopathy, although this is less certain. The treatment depends largely on the cause, but options include observation, vitrectomy, and pharmacologic vitreolysis. Small uncontrolled trials have also explored the use of an intravitreal gas bubble as a means of releasing VMA. If all cases of sVMA are considered together, then the burden of illness is substantial, with a prevalence of ∼0.35 per 100 population (excluding epiretinal membrane). Furthermore, there may be many more cases of undiagnosed sVMA. Conclusion: The recent introduction of ocriplasmin is likely to increase interest in sVMA. Clinical trials suggest that it has a role in the treatment of vitreomacular traction and Stages 1 to 3 macular holes but not primarily as a treatment of epiretinal membrane. Its role in other diseases associated with VMA remains to be determined