Objective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs.Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries.Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician’s responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs.Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake.
intellectual. Traditionally, interventions for individuals with disability are influenced by how disability is perceived by the society and professionals, which could either be based on the social or medical model. Neither model used alone is effective to improve the health outcomes of these individuals holistically. This study examined the various ways in which disability is perceived in the society. METHODS: Literature review was used looking at relevant journal articles and google search to examine medical and social model of disability, attitude of the public towards people with disability and how these individuals are treated in the society was critically assessed. Medical and social model of disability were used as the search term. RESULTS: Perceptions about disability most times determine how they relate to or treat individuals with disability. In addition, a large part of the population has negative attitudes towards people with disability, underpinned by lack of understanding about the needs of people with disability. Also, results showed that there is need to include what it is like to be a disabled person by treating the experiences and views of people with disabilities as valid, relevant and significant as opinions of Medical and Social experts. CONCLUSIONS: People with disability should be treated better by the society, this can be achieved through educating the public about disability. Good understanding of the social and medical model of disability may help to facilitate resource allocation to improve the health outcomes of individuals with disability through access to holistic intervention. Future studies on disability should assess professional perception of disability and the combined use of medical and social models; this research should include people with disability, to having their voice represented.
Objectives: Risankizumab (RIS) is an innovative drug registered by EMA in 2019 for the treatment of moderate-to-severe psoriasis. It has demonstrated high efficacy, best characterized by a response rate of PASI90 achieved by 75% of patients in a clinical trials. The aim of this study was to evaluate the cost-effectiveness of RIS compared with ustekinumab (UST) for the treatment of severe psoriasis from the perspective of a Polish public payer. Methods: An excel-based Markov model was developed to simulate a cohort of patients over 5-year horizon. Transition matrices were fitted to the aggregate-level data from UltIMMA-1 and UltIMMA-2 trials. Relapse rate was assumed to be the same for both treatments. The treatment regimens of both treatments were assumed to be intermittent. In line with current Polish clinical practice, time limit for a single cycle of treatment with UST was set at 48 weeks and with RIS at 96 weeks. The outcome was incremental cost-effectiveness ratio (ICER), calculated in two ways: as a ratio of incremental cost to incremental quality-adjusted life years (EUR/QALY) or a ratio of incremental cost to incremental symptom-free life years (EUR/PASI100 LY). Results: The model indicates that patients treated with RIS will gain an additional 0.91 life years with a response of PASI 100 compared to UST. The incremental health benefit expressed in QALYs was 0.14. ICER was 211.8K EUR/QALY and 33.3K EUR/PASI100 LY. Conclusions: ICER expressed in QALYs is above the current cost-effectiveness threshold in Poland, however it falls in a range of ICERs that is typical for this class of drugs reimbursed in the treatment of psoriasis. Other anti-interleukin agents (ixekizumab, ustekinumab, secukinumab) given their list prices have demonstrated ICERs from 50K to 280K EUR which were all beyond the acceptability threshold for reimbursement in Poland.
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