The risk sharing agreement (RSA) was applied to anticancer and rare disease drugs as a policy to improve patient accessibility in Korea. The purpose of this study is to analyze the achievement of the implementation and the status of system operation since the implementation of RSA. Methods: 422 drugs evaluated from 2009 to 2018 by the Pharmaceutical Benefits Committee were analyzed. We divided the period into before and after the introduction of RSA (2009 w 2013 vs. 2014 w 2018) and compared the reimbursement recommendation rate and the time required for evaluation at HIRA focused on anticancer and rare drugs. In addition, the ratio, type, and characteristics (improvement of clinical usefulness, renewal of contract, etc.) of RSA applied drugs were analyzed among the listed drugs within five years. Results: Anticancer and rare disease drugs have increased their recommendation rate(51.7%/74.2%, 73.2%/83%, respectively) and review period was shortened after the introduction of the system. 17 drugs have been listed through RSA for 5 years, which accounted for 20% (17/87) of the listed anticancer and rare disease drugs (N=87). Most of the RSA applied drugs were reviewed as economic evaluation (N=15) because of the improvement in their clinical usefulness, accounting for 51.7% (15/29) of the total economic evaluation drugs over the same period. As for the RSA types, there were refund (N=12), utilization cap (N=4) and coverage with evidence development (N=1). After the listing, some changes occurred like the termination of contracts for the development of evidence (N=1) or listing of alternative drugs (N=3). Conclusions: After the implementation of RSA, patients have better accessibility to medicines with the improvement in reimbursement recommendation rate and shortened review period. It especially seems to have had a positive impact on improving the accessibility of drugs with improved effects.
Em 1920, no ano do seu encerramento, o jornal Polak w Brazylii ficou na posse da Congregação dos Vicentinos de Curitiba. No mesmo ano, o periódico ressurgiu com um nome novo – Lud, mudando radicalmente o perfil para eclesiástico- -conservador, com o primeiro redator Pe. José Joaquim Góral (Malczewski, 2008: 217). No período entre 1930 a 1938, o jornal fornece as informações pertinentes tanto à sua mãe-pátria, para estimular o sentimento de pertença à mesma etnia, como ao Brasil, incentivando a integração na sociedade de acolhimento. O contexto da referida época, da crise económica global até à campanha de nacionalização de Getúlio Vargas, afeta, sem dúvida, o discurso veiculado nas publicações dos missionários, não só a sua visão do Outro, mas também a imagem da sua etnia. Assim sendo, o objetivo do nosso trabalho é apresentar e analisar a heteroimagem da sociedade brasileira, caracterizada pela diversidade étnica, conforme o periódico Lud, numa época marcante entre 1930 a 1938, tendo em consideração a influência da autoimagem dos poloneses.
A lack of knowledge among stakeholders about biosimilars and their regulatory framework may act as barrier for the use of biosimilars. This study aims to (i) map regulatory guidance and information dissemination for biosimilars by the European Medicines Agency (EMA) and the National Competent Authorities (NCAs) in Europe and (ii) investigate the perspectives of healthcare professionals (HCPs) and industry about regulatory information for biosimilars. Methods: The study consisted of a (i) review of the literature, (ii) screening of the EMA and NCA websites and (iii) semi-structured interviews with HCPs and industry across Europe. Interviews were audio-recorded and transcribed ad verbatim. Transcripts were analysed using the thematic framework approach. Results: Almost half (13/31) of the reviewed NCA websites in Europe contained no information about biosimilars. Fifteen NCA websites displayed educational materials about biosimilars, of which almost half relied partially or completely upon EMA's educational material. In total, 14 semi-structured interviews were conducted (seven interviews for each stakeholder group). HCPs and industry identified that both EMA and NCAs play a crucial role in informing and guiding stakeholders about (the development/evaluation/use of) biosimilars. EMA was considered a primary information source by most interviewees, acknowledging the comprehensive and trustworthy nature of the information and guidance provided. Opinions about the transparency and insight provided in the evaluation of biosimilars by the European Public Assessment Report varied. On a national level, a need for more guidance by NCAs, specifically regarding interchangeability, (multiple) switching and substitution, was identified. This gap was considered to be partially compensated by information from HCP associations. Conclusions: Whereas stakeholders recognize the role of EMA in guiding and informing them about biosimilars, room for improvement about the guidance by NCAs about the use of biosimilars in clinical practice was identified. In addition to the role of regulatory bodies, peer-topeer information can help consolidating confidence about biosimilars.
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