EXTENDING THE USE OF BIOSIMILAR DRUGS- ARE WE WILLING TO ACCEPT THE UNCERTAINTY RELATED TO SWITCHING IN ORDER TO IMPROVE PATIENT ACCESS TO MODERN MEDICINES?
Author(s)
Duša Hlade Zore, MD, Ministry of Health, Government of the Republic of Slovenia, Ljubljana, Slovenia; Rok Hren, PhD, MSc IHP(HE), University of Ljubljana, Ljubljana, Slovenia; Andras Inotai, PharmD, PhD, Syreon Research Institute, Budapest, Hungary; Tomas Tesar, PharmD, PhD, MBA, Union Health Insurance Fund, Bratislava, Slovakia
Presentation Documents
ISSUE: As prices of modern biological treatments are established in high income countries, they are often not justifiable in Central Eastern Europe (CEE). Therefore many of these drugs are only available with various access limits in the region. Increased use of biosimilar drugs, especially in countries with limited healthcare resources may contribute to improved patient access. Biosimilars offer therapeutic equivalence with original biologics at reduced drug price for treatment naive patients. However, as opposed to small-molecule generic drugs, biosimilars cannot be considered identical to their originators. Therefore, switching patients receiving maintenance drug therapy with original biological drugs to biosimilars may not be an obvious option for clinicians, regulators and payers due to fear of adverse immunological reactions or reduced therapeutic effect.
OVERVIEW: Mandatory phase III trials test equivalent efficacy and safety of biosimilar drugs compared to original biological drugs in treatment naive patients in one indication. Even if biosimilars are tested among maintenance patients, these trials may not be adequately powered to detect adverse immunologic reactions due to limited number of patients and follow-up period. Extensive use of biosimilars may pose a trade-off for decision makers: either taking the risk of uncertain effects related to switching biopharmaceuticals or accepting the opportunity cost from unrealised savings and improvement in patient access. Panelists will discuss: 1. how to improve the evidence-based reimbursement decision-making on biosimilars, 2. how to balance handling risks of switching and benefits from potential savings, and 3. how to implement this decision-making process in practice. The first panelist is a payer and member of reimbursement committee of a CEE country. The second panelist will represent the perspective of a researcher. The third panelist is a patients’ rights expert appointed by government from one of the most developed jurisdictions in CEE and who will present the perspective of patients.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Code
IP14
Topic
Clinical Outcomes, Specialized Treatment Areas