Reimbursement of biosimilars in Poland: is there a link to health technology assessment?

Abstract

ABSTRACTIntroduction: Due to their complex structures, biosimilars are not generics. The differences between them are considered during market authorization processes but remain unclear during reimbursement decision-making.Methods: We analyzed the reimbursement of biopharmaceuticals in Poland with an emphasis on biosimilars and compared the health technology assessment (HTA) process with that defined in other countries. Recommendations provided by the Polish HTA organization and those in other countries were included as source documents. The period of interest covered January 2012 to December 2014.Results: The reimbursement process for biosimilars in Poland is the same as that for generics. In contrast to other countries, a HTA is not involved in decision-making in Poland.Discussion: The short administrative procedure for reimbursement of biosimilars in Poland accelerates the decision-making process; therefore, therapies can be made available to patients more quickly. However, this procedure can potentially lead to underestimation of aspects concerning the effectiveness and safety of biosimilars.