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Reimbursement And Claims Processing In European Health Insurance Systems
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By Michele Ciulla Michele Ciulla Scilit Preprints.org Google Scholar , Fiorenzo Santoleri Fiorenzo Santoleri Scilit Preprints.org Google Scholar 2, Alberto Costantini Alberto Costantini Scilit Preprints.org Google Scholar 2, Marilisa Pia Dimmito Marilisa Pia Dimmito Scilit Preprints.org Google Scholar 1 and Antonio Di Stefano Antonio Di Stefano Scilit Preprints Google.org Student 1, *
Received: 25 October 2022 / Revised: 27 December 2022 / Accepted: 30 January 2023 / Published: 3 February 2023
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This systematic review aims to analyze the differences between the European healthcare approach to the pharmaceutical market and the American one. This paper presents the opportunities and limitations presented by the use of controlled entry agreements (MEAs) in European countries against the US market, which does not control drug prices. Data were collected from the Organization for Economic Co-operation and Development (OECD), the European Medicines Agency, and the national health agencies of the US and European countries. A literature review was conducted on PubMed, Scopus, MEDLINE, and Google for a period of ten years (2010-2019). The period 2020 to 2021 was considered as a comparison of health expenditure before and after the SARS-CoV-2 epidemic. Limited information from national agencies has been provided regarding MEAs related to the COVID-19 pandemic. A comparison between the approach of the United States and Europe shows the importance of managing access to the market to reduce medical costs, increase the efficiency of national health care systems and benefits in terms of quality and accessibility to end users: patients. However, it seems that the golden age of European MEAs was a period of experimentation. Outside of Italy, countries will move to other methods of recovery to obtain higher benefits, reduce the cost of effective implementation and results in the medium term.
Health is priceless, but it has certain costs. Health care systems play an important role in countries to ensure equal access to basic and primary services for all people, improving well-being and quality of life in general. Evidence can be found by analyzing health care expenditure as a percentage of the gross domestic product (GDP) of the Organization for Economic Co-operation and Development (OECD) countries. In 2015, the middle year of the period examined (2010-2019), OECD countries spent 9% of GDP on health care on average, and the United States (US) almost doubled this amount, the highest rate among developed nations. (Figure 1) [1].
From the average period examined up to the beginning of the COVID-19 epidemic (2019), in OECD countries the average health expenditure as a % of GDP decreased from 9.2% to 8.7%, while in the US the same parameter remained is it. both years at 16.7% [2].
Since medicines play an important role in the cost panel of health care systems, regulation is of vital importance to ensure access to new and effective medicines for patients. Regulation is often able to reduce the health budget and give the right incentives to manufacturers to develop new generations of drugs. Among OECD countries, spending on over-the-counter medicines represents a large portion of health care costs. It is ranked second only to inpatient and outpatient care. In 2019, it accounted for more than six (15%) of health expenditure on average without considering expenditure on hospital medicines (Figure 2). In the last decade, the pharmaceutical market has grown at a slower rate than before, due to the expiration of several patents and the economic crisis, which also influenced national health policies to contain costs [2].
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In 2015, countries spent an average of more than USD 550 per person on commercial pharmaceuticals (Figure 1). The US showed a per capita expenditure more than twice the average of OECD countries, and this high level can be attributed to a different approach to health policies that will be analyzed later in this paper.
In 2019, the US spent USD 1277 per capita, with an increase of more than USD 100 compared to 2015, while other OECD countries maintained trade spending per capita [2]. The 2020–2021 season is examined further in the following section.
The increase in demand for medicines and the introduction of new treatments in the market are the main factors driving the growth of expenditure on medicines. Newer and newer drugs show high prices for a single treatment, setting a significant barrier to patient access. Furthermore, the increasing aging of the population and the prevalence of many chronic diseases (cancer, diabetes, cholesterol-related pathologies, neurodegenerative diseases) have pushed several countries to policies to contain costs in the pharmaceutical market in order to influence and reduce spending. At the same time, they have worked to increase the efficiency of their health care systems [3]. European policy makers recognize high drug prices as the main challenge to overcome in order to access new treatments, staying within the limits of national health budgets. A range of policy measures have been used to reduce drug costs [4]. Among possible restrictive measures, many states have shifted part of the burden of drug spending to private payers. Another strategy was the implementation of measures to increase the discount authorized by pharmaceutical companies, giving a key role to the health technology assessment (HTA) in the reimbursement and/or pricing system [5]. Moreover, many European countries have introduced the use of controlled entry agreements (MEAs) as important tools for clinical and cost-effective evaluation of new drugs. Simply put, MEAs are arrangements between manufacturers and payers that allow coverage/reimbursement of new treatments under defined conditions. These arrangements can use different methods to address uncertainty about new technologies and decide on the adoption of new medicines, taking into account their economic impact. This can lead to a reasonable reduction of costs, increase the access of patients to new drugs, and at the same time contain the expenditure of drugs within the budget of the national health system [6]. This study aims to analyze the differences between the European healthcare approach to the pharmaceutical market and the American one.
This paper highlights the opportunities and limitations presented by the use of MEAs in European countries versus the US market which does not regulate drug prices. Data were collected from the OECD, the European Medicines Agency, and the national health agencies of the US and European countries. A literature review was conducted on PubMed, Scopus, MEDLINE, and Google for a period of ten years (2010-2019). The period 2020–2021 was considered to compare changes in pharmaceutical spending related to the COVID-19 pandemic. Additional materials, based on data collection about MEAs, are used in European and international research managed by private or public organizations.
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Several keywords used to describe MEAs were identified through the initial literature review mentioned above. The following words and terms were retained and used in the search: patient access plans, drug risk sharing, risk sharing plans, risk sharing agreements, managed access agreements, MEAs, payment by outcome, performance-based risk sharing agreements, evidence-based coverage. , and price volume contracts. The search was limited to articles in English.
The inclusion process specified that the title of the article includes or refers to at least one of the researched terms and related payment of performance and/or risk sharing agreements and/or international MEA experience, including systematic or joint studies.
The exclusion criteria include articles about capitation (allocation of money to doctors, physicians, nurses, and hospitals), vaccines, medical equipment, diagnostic equipment, financial schemes for hospitals, and / or clean financial schemes. Notes, comments; letters to the editor; guidelines; and studies that did not identify MEAs were excluded from this review.
Initially we collected 1329 articles among the selected data. A total of 879 pages remained after removing duplicates
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