Budget impact of prophylactic treatment of rVIII-SingleChain in moderate and severe hemophilia A in Italy.

INTRODUCTION: rVIII-SingleChain, a recombinant factor VIII (rFVIII), has demonstrated safety and efficacy in patients with hemophilia A in clinical trials and real-world evidence. This analysis aimed to estimate the potential budget impact of increasing the usage of rVIII-SingleChain for the prophylactic treatment of hemophilia A over 3 years in Italy. METHODS: Patients with moderate and severe hemophilia A receiving prophylaxis were included in the analysis. Epidemiological data were obtained from published literature. Mean product consumption and mean annual bleeding rate for rVIII-SingleChain, rFVIIIFc, octocog alfa and BAY 81-8973 were based on pooled real-world data from Italy, Germany and US. A budget impact model has been developed in order to compare two scenarios: a base-case scenario where current rVIII-SingleChain shares are kept constant over 3 years and an alternative scenario where rVIII-SingleChain shares increase by taking from other rFVIII products. Analysis 1 was based on the current Italian list prices and Analysis 2 considered current regional acquisition prices for both scenarios. RESULTS: Annually, adult patients treated with rVIII-SingleChain prophylaxis are expected to consume 324,589 units per patient, resulting in annual costs of €240,196 per patient. In Analysis 1, comparing the base case (constant market share of 9% rVIII-SingleChain over time) with the alternative scenario (higher rVIII-SingleChain market share and increasing from 15% in the first year to 25% in the third year), the total expenditure for prophylaxis using rFVIII products is expected to decrease by €1.4 million in Year 1, by €3.1 million in Year 2 and by €5.4 million in Year 3. In Analysis 2 based on regional prices, the results remained consistent. DISCUSSION/CONCLUSION: This analysis suggests that increasing utilization of rVIII-SingleChain in hemophilia A patients may lead to cost savings as a result of reduced consumption with uncompromised efficacy in bleed protection.

Why was the study done? Hemophilia A is a rare inherited bleeding disorder. People with severe hemophilia are more likely to bleed compared to people without hemophilia and bleeds can occur spontaneously or in response to trauma. Patients are treated with medication to reduce the chance of bleeding. However, the cost of treating patients with hemophilia can be high and place demands on the healthcare system.What did we do and find?This study looked at the cost of treating people with hemophilia in Italy and used a type of economic analysis (called budget impact modelling) to estimate the effect of increasing the use of a particular medication (rVIII-SingleChain), compared to other medications that are available. Different variations of the model were tested to compare a range of scenarios.The results of this analysis suggested that increasing the use of rVIII-SingleChain may lead to cost-savings for the Italian healthcare system, compared to using the other currently available treatments. This analysis suggests that the use of rVIII-SingleChain enables people with hemophilia A to remain protected from bleeds, whilst using less product compared to other available medications.What is the influence of this study on the wider field?This type of analysis can be useful to healthcare systems, to guide the decision-making process regarding which medications to use or when making decisions related to healthcare policy.

The Value of Diagnostic Information in Personalised Healthcare: A Comprehensive Concept to Facilitate Bringing This Technology into Healthcare Systems.

Health systems around the world seek to address patients' unmet health needs for a range of acute and chronic diseases. Simultaneously, governments strive to keep healthcare spending sustainable, while providing equal access to high-quality care. This has fuelled debate around what constitutes a valuable healthcare intervention in a health system and the corollary consideration of what governments are willing to pay for a certain health intervention. Until recently, the value of information in general, and the value of diagnostic information (VODI) specifically, was not part of the discussion.However, investment in diagnostic information can be a key development as information may guide more effective and efficient healthcare and help maintain an affordable health system. This paper therefore explores ways to best define, evaluate, and reward the value created from diagnostics in healthcare and how to include these value considerations in decision-making processes for diagnostics. The authors ultimately call for a holistic VODI framework that accounts for the full range of potential benefits of diagnostic testing, beyond the traditional clinical and health economic domains, and that is essential to recognise, measure, and fully leverage the benefits of diagnostics for patients, health systems, and society.

Back to the future: a new topical approach for mild-to-moderate psoriasis.

Psoriasis is a chronic-relapsing skin disorder which requires long-term treatments. Therapeutic options for psoriasis include topical treatments, phototherapy and systemic therapy. However, those treatments, and particularly the topical drug therapies, may present some limitations, including poor efficacy/tolerability ratio and lack of adherence. Recently, the supersaturated aerosol foam formulation of the fixed combination calcipotriene plus betamethasone dipropionate (Cal/BD) has gained major attention because it overcomes some of the limitations associated with other topical treatments. This fixed-combination has increased efficacy compared with its individual components. Moreover, the alcohol-free aerosol foam formulation allows a higher penetration of the active ingredients into the skin, resulting in enhanced bioavailability and, consequently, in better clinical outcomes than other products with the same components. Given the short duration of therapy course and the fast onset of action, a reduced amount of Cal/BD foam formulation would be required for the treatment of psoriasis patients, resulting also in cost saving. Therefore this novel formulation could represent an alternative to other topical agents and a first-line therapy in the treatment of mild and mild-to-moderate psoriasis.

Unfolding similarity in interphysician networks: the impact of institutional and professional homophily.

BACKGROUND: Modern healthcare is characterized by high complexity due to the proliferation of specialties, professional roles, and priorities within organizations. To perform clinical interventions, knowledge distributed across units, directorates and individuals needs to be integrated. Formal and/or informal mechanisms may be used to coordinate knowledge and tasks within organizations. Although the literature has recently considered the role of physicians' professional networks in the diffusion of knowledge, several concerns remain about the mechanisms through which these networks emerge within healthcare organizations. The aim of the present paper is to explore the impact of institutional and professional homophilies on the formation of interphysician professional networks. METHODS: We collected data on a community of around 300 physicians working at a local health authority within the Italian National Health Service. We employed multiple regression quadratic assignment procedures to explore the extent to which institutional and professional homophilies influence the formation of interphysician networks. RESULTS: We found that both institutional and professional homophilies matter in explaining interphysician networks. Physicians who had similar fields of interest or belonged to the same organizational structure were more likely to establish professional relationships. In addition, professional homophily was more relevant than institutional affiliation in explaining collaborative ties. CONCLUSIONS: Our findings have organizational implications and provide useful information for managers who are responsible for undertaking organizational restructuring. Healthcare executives and administrators may want to consider the structure of advice networks while adopting new organizational structures.

Economic assessment of an anti-HCV screening program in Italy.

BACKGROUND: The progression of hepatitis C virus (HCV) disease usually occurs over a 10-year period. HCV-related complications as well as the highly debilitating effects on patients represent a significant item of expenditure for the National Health Service. Early detection of HCV infection is an excellent opportunity to improve patients' quality of life and to rationalize resource allocation. OBJECTIVE: The aim of this study was to provide a cost-effectiveness evaluation of an anti-HCV screening program in the Italian National Health Service perspective. METHODS: We built a Markov model made up of two arms. The ''Test Strategy'' arm involves a screening program based on the enzyme immunoassay for detection of antibodies as first-level test and the research of HCV RNA as second-level detection; patients with positive test results are treated with peg-interferon alfa in combination with ribavirine. Parameters were derived from the literature and validated through experts' opinion. Costs and benefits were discounted by 3.5%. Results were expressed as cost/quality-adjusted life-year (QALY) gained through the screening program compared with the treatment of symptomatic patients. Deterministic and probabilistic sensitivity analysis was performed. RESULTS: The incremental cost-effectiveness ratio of the ''Test Strategy'' is €5171/QALY, definitively below the cost/QALY of other approved treatments in Italy. Model results turned out as sensitive to the age of the target population, the prevalence of HCV infection, and the time horizon adopted. CONCLUSIONS: The anti-HCV screening program is a valid health-related investment improving patients' quality of life and survival with an acceptable expenditure increase for the National Health Service.

Dynamic analysis of interhospital collaboration and competition: empirical evidence from an Italian regional health system.

BACKGROUND: Policymakers stimulate competition in universalistic health-care systems while encouraging the formation of service provision networks among hospital organizations. This article addresses a gap in the extant literature by empirically analyzing simultaneous collaboration and competition between hospitals within the Italian National Health Service, where important procompetition reforms have been implemented. PURPOSE: To explore how rising competition between hospitals relates to their propensity to collaborate with other local providers. METHODS: Longitudinal data on interhospital collaboration and competition collected in an Italian region from 2003 to 2007 are analyzed. Social network analysis techniques are applied to study the structure and dynamics of interhospital collaboration. Negative binomial regressions are employed to explore how interhospital competition relates to the collaborative network over time. RESULTS: Competition among providers does not hinder interhospital collaboration. Collaboration is primarily local, with resource complementarity and differentials in the volume of activity and hospital performance explaining the propensity to collaborate. CONCLUSIONS: Formation of collaborative networks among hospitals is not hampered by reforms aimed at fostering market forces. Because procompetition reforms elicit peculiar forms of managed competition in universalistic health systems, studies are needed to clarify whether the positive association between interhospital competition and collaboration can be generalized to other health-care settings.

The cost-effectiveness of alternative strategies against HBV in Italy.

INTRODUCTION: Nowadays, guidelines for the management of HBV infection in Italy, recommend using vaccines but the screening test among non-vaccinated people is useful to detect people that have a clear presence of the virus without symptoms of the disease. Thanks to the screening test, people infected with HBV are administered traditional therapy in order to stop the progression to cirrhosis, liver failure and hepatocellular carcinoma (HCC). These diseases cause the decrease of Qol and cause a high consumption of resources for the health system. The aim of this study is to evaluate the cost-effectiveness of a strategy (test strategy) involving the administration of the screening test to patients at risk and the treatment of the infected according to the protocol therapy. This programme is compared with a strategy (no test strategy) which does not include a screening and treats patients affected by cirrhosis or HCC. METHODS: We created a Markov model following the natural history of the disease and considering the antigen HBeAg to evaluate the cost effectiveness of the test strategy. The analysis was carried out considering a third-party payer perspective. The time horizon considered was 40 cycles of one year. Patients who resulted positive to the test were administered either interferon treatment; or lamivudine or adefovir or entecavir or tenofovir, consistently with the Italian guidelines. Treatments were administered to patients included in the no-test arm after cirrhosis symptoms or HCC. RESULTS: The results of the base case analysis show that patients following the test strategy compared with patients of the no-test approach cost €17,179/QALY. The Monte Carlo simulation based on a probabilistic sensitivity analysis points out that in 95% of the scenarios assumed, the cost per QALY would be under a hypothetical threshold of €40,000 which is the amount that international guidelines for decision makers are likely to consider sustainable for a health system. In conclusion, anti-hbv test to all high-risk categories should be highly recommended.