The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

[Guidelines for prevention, control and treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA): changes and updates of chapter 7.0: treatment of patients with MRSA infection]. / Smjernice za prevenciju, kontrolu i lijecenje infekcija koje uzrokuje meticilin-rezistentni Staphylococcus aureus (MRSA): izmjena i dopuna poglavlja 7.0.: lijecenje bolesnika s MRSA - infekcijom.

Methicillin-resistant Staphylococcus aureus (MRSA) is an important pathogen throughout the world, and as well in Croatia. Therefore it was decided to develop guidelines with the aim to reduce the number of patients infected/colonized with MRSA in healthcare facilities and in nursing homes in Croatia, consequently reducing MRSA-related morbidity and mortality. An interdisciplinary team of experts developed these guidelines using existing international guidelines from different countries, and literature reviews about prevention, control, treatment and laboratory diagnosis of MRSA infections. Grades of evidence for specific recommendations were determined using CDC/HICPAC grading system. Categorization is based on existing data, theoretical basis, applicability and economic impact. After a broad discussion in different professional societies, Guidelines were accepted. In the meantime, several new possibilities appeared in the treatment of patients with MRSA infections in Croatia, so the Chapter 7.0 Treatment of patients with MRSA infections is changed and updated according to the new treatment possibilities. The rest of the Guidelines was not changed.

[Guidelines for prevention, control and treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA)]. / Smjernice za prevenciju, kontrolu i lijecenje infekcija koje uzrokuje meticilin-rezistentni Staphylococcus aureus (MRSA).

Methicillin-resistant Staphylococcus aureus (MRSA) is an important pathogen throughout the world, and in Croatia as well. Therefore it was decided to develop guidelines with the aim to reduce the number of patients infected/colonized with MRSA in healthcare facilities and in nursing homes in Croatia, consequently reducing MRSA-related morbidity and mortality. An interdisciplinary team of experts developed these guidelines using existing international guidelines from different countries, and literature reviews about prevention, control, treatment and laboratory diagnosis of MRSA infections. Grades of evidence for specific recommendations were determined using CDC/HICPAC grading system. Categorization is based on existing data, theoretical basis, applicability and economic impact. After a broad discussion in different professional societies, Guidelines were accepted. Guidelines include recommendations for measures in prevention of MRSA spread, role of hospital management, rational use of antibiotics, measures in a case of outbreak, treatment of infections and brief review of community-acquired MRSA. At the end, appendices concerning hospital audit, algorithms of laboratory diagnosis, patient information and form for national MRSA surveillance were added.