| Popis: |
After EULAR PARE’s position paper “Biosimilars – what do patients need to consider” published in November 2015 more biosimilars for rheumatic diseases have been approved by EMA (European Medicine Agency), have entered the market in different European countries and more biosimilars will be marketed. New studies and data informing about the use of biosimilars, as well as feedback received from patient organisations and in particular from PARE organisations, have made it necessary to update PARE’s 2015 position. Biological therapies are enormous cost factors for the healthcare system and biological therapies have to be affordable, what is seen as difficult in various countries. But an optimal quality healthcare is enormously important for the individual patient (e.g. fewer sick days, less hospitalisation, less disabilities), prevents early retirement and thus saves costs and contributes to a country’s economic and social system. If so-called naive patients should take a biologic, the less expensive biosimilar can be used, as long as there are no contraindications, the patient has been informed and the decision is based on a shared decision between rheumatologist and patient. But transitioning users from an originator to a biosimilar is very controversial and seen critically by PARE’s patient organisations. The talk will cover the changing views concerning extrapolation, one-time switch, multiple therapy switches, registries and the relevance of the application form for patients. Disclosure of Interest None declared |
