Biological and biosimilar therapies in inflammatory conditions: challenges for the Central and Eastern European countries.

Abstract

This supplement is aimed to give an overview of the current challenges and future prospects of biological and biosimilar drugs in inflammatory conditions in rheumatology (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis) gastroenterology (Crohn’s disease, ulcerative colitis) and dermatology (psoriasis) with specific focus on a group of Central and Eastern European countries (CEE) such as Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia. These inflammatory conditions lead to a considerable functional disability, a lowered quality of life and work capacity as well as significant economic burden on patients, families and society. The first genetically engineered biopharmaceutical drug (called biological) was registered for the treatment of inflammatory conditions 15 years ago and the numbers of these drugs are growing continuously. This group of very effective but very costly new drugs revolutionized the treatment of patients as well as inducing significant development in outcome measures, clinical and financing guidelines and, moreover, speeding up health economic analyses and health technology assessments (HTA) in this field. The first two biosimilar drugs for the treatment of these inflammatory conditions, registered in 2013 by EMA, which are the first marketed in the CEE countries, created a new situation and new challenges for policy makers, funders, professionals, and the patients. In this supplement we are focusing on economic and financing aspects of biological and biosimilar drugs as well as the current stage of HTA and reimbursement decisions in selected CEE countries. Original research articles supplying inputs for costeffectiveness analyses and dealing with health economic issues are also presented in this supplement from various fields of inflammatory conditions (rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease and psoriasis). These are the first studies that provide such data from the CEE region. The first tumor necrosis factor-alpha inhibitor (hereinafter anti-TNF) drug received its marketing authorisation in Europe (EMA) in 1999 (infliximab), then etanercept (2000), adalimumab (2003) and a further six biological drugs (abatacept, certolizumab pegol, golimumab, rituximab, tocilizumab, ustekinumab) were introduced to the EU market. These nine biological drugs have altogether 41 indications (30 adult and 11 pediatric, considering disease subtypes and age restrictions) in inflammatory conditions as of March 2014. The two biosimilar drugs (both infliximab) have six adult and two pediatric indications (Table 1). Clinical evidences confirmed the efficacy and effectiveness of biological drugs in inflammatory conditions. Thus, biologicals became the key treatment options for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and psoriasis. Related to drug registration, there is a considerable harmonisation in Europe. The approval of a pharmaceutical product authorised by the European Medicines Agency (EMA) is binding to all member states.