The Determinants of Out-of-Pocket Expenditure in IBD Italian Patients. Results from the AMICI Survey.

Decision makers are used to consider Out-of-Pocket Expenditure (OOPE) within a health technology assessment framework in order to account for an indicator relying on the level of fairness and on the quality of care of a health system. In this paper, we provide estimates on the determinants of OOPE in Italy by using data coming from an observational cross-sectional study that enrolled a sample of 2526 patients suffering from inflammatory bowel diseases. We explore the association between OOPE and: (1) geographical location; (2) income effects; (3) performances in delivering healthcare. A regression model was used. Individuals' age were in the range of 18-88 (mean 44 ± 14.55). Forty-six percent were females, 54% were married and 19% held a bachelor degree. Ninety-six percent of respondents declared an OOPE >0 whose mean value was €960 ± €950. Individuals belonging to low-income and low-performance regions were more likely to declare an OOPE >0 (99%). Regression findings suggest that increases in OOPE could be considered as a response from patients aiming to compensate for lacks and inefficiencies in the public healthcare offers. Policymakers should consider increases in OOPE in patients with Inflammatory Bowel Diseases (IBDs) as an indicator of poor quality of care and poor fairness.

Multidisciplinary management of the nocebo effect in biosimilar-treated IBD patients: Results of a workshop from the NOCE-BIO consensus group.

The high cost of biological drugs for patients with inflammatory bowel disease (IBD) considerably impacts on health-care budgets. Since the patent of biological products expired, cheaper biosimilars have entered the market. Available data coming from real-world cohorts and clinical trials indicate that the efficacy and safety of biosimilars is comparable to that of the originator drugs. Treating IBD patients with a biosimilar may be complicated by the risk of the nocebo effect, a negative effect of a pharmacological or non-pharmacological treatment, induced by patients's expectations and unrelated to the physiological action of the treatment. The nocebo effect can negatively affect treatment outcomes and hamper the cost-savings of biosimilars. Reducing the nocebo effect requires a multidisciplinary effort of all health-care providers in charge of biosimilar-treated IBD patients. The aim of the review is to reflect the key messages of an international workshop on this topic, including viewpoints from the perspective of physicians, nurses, psychologists, pharmacists and patients.