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Drozd Mariola (Medical University of Lublin, Poland), Szkultecka-Dębek Monika (Roche Polska Sp. z o.o., Warsaw, Poland)
Biosimilar Drugs - Reimbursement Regulations. Polish ISPOR Chapter's Therapeutic Programs and Pharmaceutical Care (TPPC) Task Force Report
Journal of Health Policy and Outcomes Research, 2013, nr 1, s. 84-91, bibliogr. 19 poz.
Słowa kluczowe
Leki, Odpłatność za leki, Zdrowie
Drugs, Payment for drugs, Health
Objectives: Due to the increased number in biosimilar drugs getting marketing authorization, there is a question to be answered which reimbursement procedure should be followed. Methods: The TPPC task force has checked the approach to biosimilar drugs by WHO, at the EMA level and in a few countries worldwide. Among other aspects discussed, we concentrated on the production process of the reference (original) drugs and biosimilars and looked for differences. An internet search was performed checking the definitions as well as regulatory and reimbursement processes worldwide, with focus on the countries having HTA procedure in place. Findings: It was found that due to specifics of biosimilars, detailed and comprehensive regulatory processes have been established centrally for EU states. No reimbursement guidelines have been identified. Due to lack of specific reimbursement guidelines TPPC agreed on a need to define a biosimilar drugs reimbursement process in Poland. TPPC task force also agreed that due to central European registration process the definitions for biosimilar drug in Poland should be in line with the EMA guidelines. The reimbursement process is different in each EU member state and it should be defined for these products on a country level. Probably, it also requires specific guidelines to be developed, especially in countries such as Polandwith "HTA dependent reimbursement process". Conclusions: TPPC task force has only identified regulatory guidelines and its opinion is that in Poland, a detailed reimbursement process should be developed in the way it also includes the biosimilar drugs.(original abstract)
Pełny tekst
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