Background: Mounting pressures on the healthcare system, such as budget constraints and new, costly health technologies reaching the market, have pushed payers and manufacturers to engage in managed entry agreements (MEAs) to address uncertainty and facilitate market access.Objectives: This study was conducted to illustrate the current landscape of MEAs in Europe and to analyze the main hurdles they face in implementation, providing a policy perspective.Methods: We conducted a health policy analysis based on a literature review and described the emergence, classification, current use, and implementation obstacles of MEAs in Europe.Results: Throughout Europe, uncertainty and high prices of health technologies have pushed stakeholders towards MEAs. Two main types of MEAs were applied heavily, finance-based agreements (FBAs) and performance-based agreements, including individual performance-based agreements and coverage with evidence development (CED). Service-based agreements have not been as heavily considered so far, yet are increasingly used. Many European countries are turning to CEDs to address uncertainty and facilitate market access while negotiating the pricing and reimbursement rates of products. Despite the interest in CEDs, European countries have moved toward FBAs due to the complexities and burdens associated with PBAs.Conclusions: Ultimately, in Europe, with the exception of Italy, where MEAs have proven to be inefficient, MEAs are predominantly FBAs dedicated to addressing cost containment from payers' perspective and external reference pricing from the manufacturers' perspective. It has been speculated that MEAs will disappear in the medium-term as they are counterproductive for extending patient access and emergence of innovation. To inform value-based decision making and allow early access to innovative medicines, CEDs should be revisited.

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.

In Poland, two proposed amendments to the reimbursement act are currently in preparation; these are likely to substantially change the pricing and reimbursement landscape for both drugs and medical devices. Proposed changes include: alignment of medical device reimbursement with that of pharmaceuticals; relaxing the strict reimbursement criteria for ultra-orphan drugs; establishment of an additional funding category for vaccines; introduction of compassionate use, and a simplified reimbursement pathway for well-established off-label indications; appreciation of manufacturers’ innovation and research and development efforts by creating a dedicated innovation budget; introduction of a mechanism preventing excessive parallel import; prolonged duration of reimbursement decisions and reimbursement lists; and increased flexibility in defining drug programmes. Both amendments are still at a draft stage and many aspects of the new regulations remain unclear. Nonetheless, the overall direction of some of the changes is already evident and warrants discussion due to their high expected impact on pharmaceutical and device manufacturers. Here we evaluate the main changes proposed to the reimbursement of drugs, vaccines, and medical devices, and examine the impact they are likely to have on market access and pharmaceutical industry in Poland.

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.

Methods: Workshops, conducted by newly established HTA department and SAFEMd projects in May 2019 with groups of stakeholders (Ministry of Health of Ukraine (MoH), pharmaceutical companies, academic institutions), gave the idea about needs assessment in creation of ecosystem in Ukraine. Risks assessment was used in the form of splitting factors in groups of existing and potential ones. This allowed defining stakeholders', system's requires and potential threats of initiating changes. Results: During meetings, the participants came up with the needto identify the main role of HTA Department in Ukraine. Needs assessment helped to define criteria of HTA capacity building with emphasis on the cooperation, education and access to data. Clear timeframes, timeliness, understanding functions of HTA by all stakeholders were chosen as the main needs. There is a need to create a platform for communication between HTA, MoH and stakeholders to achieve single approach and understanding of HTA for decision-making. On the other hand, well-defined procedures of assessment and liability of experts can reduce risk of conflict of interest among experts who carry out assessment. Risk assessment resulted in creation of risk reduction strategy coming from the update of legal regulation of the Departments work and functional responsibilities of experts. Conclusions: The analysis revealed needs and opportunities to the implementation of HTA in Ukraine and helped to outline current situation and key challenges for the system. The results of these analyzes should be interpreted in order to implement action plan for launching the HTA in Ukraine.