Daniela Koleva

The Burden of Moderate to Severe Psoriasis

Psoriasis is a chronic, immune-mediated skin disorder that affects 1–3% of the general population worldwide. While considered a non-life-threatening disease, psoriasis represents a social and financial burden for patients and the healthcare system. Individuals suffer from disfigurement and from social stigmatization. Because the disease is usually persistent, patients with a diagnosis of psoriasis usually need lifelong care, which also means a lifetime of expenses. We aimed to conduct a comprehensive review of the evidence available concerning the social burden and costs of psoriasis.A search for the keywords ‘quality of life’ (QOL) or ‘burden’ or ‘stigmatization’ or ‘psychological factors’ in PubMed up to January 2010 yielded a total of 817 studies. QOL was affected by psoriasis to a degree comparable with diabetes or cancer. A search for ‘cost-of-illness analyses’, in the same period, yielded only seven papers satisfying entry criteria. All the studies but one were performed before biologics became available for psoriasis treatment. Direct costs were higher than indirect costs, with hospitalization representing the most significant item. Treatment costs showed wide variations between different studies. Reasons for these discrepancies are manifold including differences in the selection of the sample, as well as in the methods for calculating costs. There is a need to harmonize methodologies. For a final conclusive judgement of the cost effectiveness of innovative therapies such as biological agents, long-term economic consequences have to be evaluated and long-term remission rates and complications considered.

Economic evaluation of human papilloma virus vaccination in the European Union: a critical review

The human papilloma virus (HPV) vaccine is a new and expensive vaccine potentially effective in the prevention of a cancer. We reviewed the economic evaluations (EEs) on the vaccine in the EU to assess their potential contribution to public decision-making in a fairly homogeneous setting where HPV vaccination has been widely adopted. A literature search on PubMed selected EEs on HPV vaccines in the EU for the period 2007–2010 using the terms “HPV vaccines” and “Costs and cost analysis.” Fifteen articles were eventually selected. All studies were based on modelling techniques, either “cohort” or “dynamic transmission”: three were cost utility, three cost-effectiveness, and the remainder included both. The ten studies explicitly assessing one of the two vaccines were all sponsored by their manufacturer, while the five studies unrelated to the vaccine type were funded by public agencies. Apart from two studies, utility estimates were always obtained from three US sources. Direct costs were always vaccination, diagnosis and treatment of related pathologies. Incremental cost-effectiveness ratio (ICER) results were less favourable when life years gained were valued rather than quality-adjusted life years, genital warts were excluded, and booster doses and extension of vaccination to men were included in the base-case analysis. All but one of the sponsored EEs recommend in favour of the vaccination strategy, which is dominant in one English study. The ICER results were very sensitive to discount rates, followed by duration of protection and vaccine price. At such an early stage, when the vaccines’ efficacy have been demonstrated by well-designed studies, it is not possible (and not even reasonable) to wait for several years to measure their effectiveness; public decision-makers might benefit more from EEs designed to indicate sustainable prices using realistic estimates of crucial variables like coverage rates, rather than referring to a large number of assumptions in order to show acceptable cost-effectiveness.

Medical Costs of Glaucoma and Ocular Hypertension in Italian Referral Centres: A Prospective Study

Aim: This study analyzes the resource utilization and costs of ocular hypertension and glaucoma (staged by severity) in Italian ophthalmology departments. Methods: The project was a multi-centre observational study conducted in 17 Italian ophthalmology departments throughout the country. A total of 659 patients were recruited and followed prospectively for 1 year. For the purpose of analysis, the patients were divided into 3 groups according to the severity at onset: ocular hypertension, glaucoma and advanced glaucoma. Results:The subgroups differed significantly in the main demographic and clinical variables. As expected, greater severity was associated with older mean age and worse visual acuity, and with higher resource consumption and costs. The annual average cost per patient was EUR 788.7 and rose significantly with disease severity (EUR 572.0 for ocular hypertension, EUR 734.3 for glaucoma and EUR 1,054.9 for advanced glaucoma). Drugs and specialist consultations were by far the largest cost components. Conclusions: This study offers some information on the medical costs of glaucoma in Italy potentially useful for decision-making in the health care services. Health care resources and costs increased with disease severity.

Cost minimisation analysis of 12 or 24 weeks of peginterferon alfa-2b + ribavirin for hepatitis C virus

Abstract Background: Pegylated interferon and ribavirin are at present the standard treatment for chronic hepatitis C virus (HCV) patients. Objective: The present economic evaluation compared 12 vs. 24 weeks of peginterferon alfa-2b + ribavirin treatments for HCV genotypes 2 or 3. Shortening the period of antiviral therapy is important in terms of adverse events and costs. Methods: Clinical evidence was based on the results of a multicentre, randomised controlled clinical trial (RCCT) conducted in Italy, which found that the shorter course of therapy was as effective as the 24-week course for patients with HCV genotypes 2 or 3 responding to treatment at 4 weeks. A cost minimisation analysis was performed. The analysis took the Italian National Health Service (INHS) point of view, thus only healthcare costs (drugs, medical consultations, diagnostic tests, hospital admissions) were considered. Healthcare activities were estimated by the RCCT principal investigators and were priced by applying the INHS tariffs and prices. Results: The total mean cost per patient was estimated at €9,785 for the standard group and €7,508 for the variable-duration group. Sensitivity analysis confirmed the robustness of the baseline results. Conclusions: This study showed that the variable-duration regimen can be recommended as an efficient use of resources for patients from the INHS perspective.

Medical Costs of Chronic Musculoskeletal Pain in Italy

AbstractBackground and objectives: Musculoskeletal system problems are responsible for more than two-thirds of painful conditions in primary care. However, only one published study, conducted in Finland, has analysed the costs of managing musculoskeletal pain as a whole in primary care. This study analysed the costs of diagnosing and treating chronic musculoskeletal pain in primary care in Italy. A secondary aim of the study was to assess the impact of different drug treatment patterns on medical costs associated with musculoskeletal pain. Methods: Chronic pain of musculoskeletal origin was defined as continuous or recurrent pain persisting over 3 months with involvement of the musculoskeletal system, i.e. arising from primary musculoskeletal disorders or from the late consequences of external events (injuries, medical care or surgery). A total of 52 general practitioners (GPs) recruited 581 patients. We focussed on the differences between patients treated (410) and not treated (171) with drugs. Within the treated group, we also analysed subgroups given non-selective NSAID-based therapy (subgroup A, 169 patients) or cyclo-oxygenase-2 (COX-2) inhibitor-based therapy (subgroup B, 52 patients). Results: The annual average cost of treating a patient with chronic musculoskeletal pain was €212.60. Hospital admissions and GP consultations were the largest cost components, both accounting for around a quarter of the total cost. Not surprisingly, the treated group included older patients, who had more co-morbidities and more severe pain. This was associated with annual costs more than four times those of untreated patients (€274.50 vs €63.90, respectively). Subgroups A and B did not differ with respect to major demographic and clinical variables except in relation to mean age (63 vs 70 years, respectively; p = 0.037). They had similar per-patient costs (€186.20 vs €172.90), although these totals comprised a different mix of components. Conclusion: The analysis showed that the annual average cost of treatment of chronic musculoskeletal pain in Italy varied considerably depending on whether drug treatment was used. COX-2 inhibitors and traditional NSAIDs had similar per-patient costs, although this similarity stemmed from a different mix of components.

Utilities and QALYs in health economic evaluations: glossary and introduction.

Economics studies the optimal allocation of resources for the production of benefits to the society. By definition, resources are limited, and healthcare systems must face this condition every day. This may explain why economic evaluations are increasingly used as a key component of decision making. For instance, they represent a mainstay in any Health Technology Assessment (HTA) exercise and are subject to a guidelines’ development process [1]. After the assessment of the efficacy and safety of health interventions, economic evaluations enter to compare alternative options in terms of costs and consequences. Full economic evaluations consist of a comparison of both costs (resource use) and consequences (outcomes, effects) of alternative strategies [2]. If Cochrane reviews are intended to help providers, practitioners and patients in making informed decisions about health care interventions, they cannot afford to ignore their economic aspects. Cochrane reviews assemble, select, critique and combine reliable data from multiple research studies on the effectiveness and other issues related to healthcare interventions. The latest version of the Cochrane Handbook for Systematic Reviews of Interventions [3], freely accessible at http://www.cochrane-hand book.org, acknowledges that incorporating economic perspectives and evidence into Cochrane reviews can enhance their usefulness and applicability for healthcare decisionmaking. An entire chapter (‘‘Incorporating economics evidence’’), provides guidance on how authors of systematic reviews can collect the best evidence on the economic aspects of interventions in addition to the best evidence on their clinical effectiveness [4]. A leading point here is to expand our knowledge on efficiency (optimal use of resources) after having established effectiveness (whether treatments work) [5]. The main types of full economic evaluations (costeffectiveness, cost-utility and cost-benefit analyses) compare alternative interventions in terms of both costs (resource use) and consequences (effects) and can be included in Cochrane reviews, as well as studies that only focus on costs and resource use, without comparing health alternatives, i.e. partial economic evaluations [4]. Cost-effectiveness analyses measure the effects of an intervention and its comparators in identical units of outcome (e.g. mortality), thus comparing them in terms of ‘cost per unit of effect’ [5]. In a cost-benefit analysis both resource use and effects of alternative interventions are G. Virgili (&) Department of Specialised Surgical Sciences, University of Florence and Azienda Ospedaliero-Universitaria Careggi, Florence, Italy e-mail: gianni.virgili@unifi.it