Medicamentos biosimilares: impacto, oportunidades y estrategias. Doce años de experiencia en Europa

Sánchez, Olga Delgado; Vicens, Daniel Ginard; Mayol, Antonia Sampol; Pons, Josefa Terrasa

doi:10.1016/j.medcli.2018.11.013

Cited by 2 publications

(2 citation statements)

References 14 publications

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“…“Prescribers need confidence in outcomes, and they and/or the health system need to benefit financially from using biosimilars” [ 25 ]. Other opinions consider that it is better to motivate physicians through schemes that avoid direct financial incentives [ 26 ].…”

Section: Incentives and Clinical Governancementioning

confidence: 99%

“…Moreover, in the primary care setting, a strategy based on education/information, and constant communication with health professionals, succeeds in improving knowledge about biosimilars and changing prescription patterns [ 67 ]. By contrast, any initiative to promote biosimilars not agreed upon with physicians is doomed to failure [ 26 ].…”

Section: Barriers According To Stakeholdersmentioning

confidence: 99%

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Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

Lobo

Río-Álvarez²

2021

Pharmaceuticals

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Incentives contribute to the proper functioning of the broader contracts that regulate the relationships between health systems and professionals. Likewise, incentives are an important element of clinical governance understood as health services’ management at the micro-level, aimed at achieving better health outcomes for patients. In Spain, monetary and non-monetary incentives are sometimes used in the health services, but not as frequently as in other countries. There are already several examples in European countries of initiatives searching the promotion of biosimilars through different sorts of incentives, but not in Spain. Hence, this paper is aimed at identifying the barriers that incentives to prescribe biosimilars might encounter in Spain, with particular interest in incentives in the framework of clinical governance. Both questions are intertwined. Barriers are presented from two perspectives. Firstly, based on the nature of the barrier: (i) the payment system for health professionals, (ii) budget rigidity and excessive bureaucracy, (iii) little autonomy in the management of human resources (iv) lack of clinical integration, (v) absence of a legal framework for clinical governance, and (vi) other governance-related barriers. The second perspective is based on the stakeholders involved: (i) gaps in knowledge among physicians, (ii) misinformation and distrust among patients, (iii) trade unions opposition to productivity-related payments, (iv) lack of a clear position by professional associations, and (v) misalignment of the goals pursued by some healthcare professionals and the goals of the public system. Finally, the authors advance several recommendations to overcome these barriers at the national level.

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Section: Incentives and Clinical Governancementioning

confidence: 99%

Section: Barriers According To Stakeholdersmentioning

confidence: 99%

Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

Lobo

Río-Álvarez²

2021

Pharmaceuticals

View full text Add to dashboard Cite

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Regulatory aspects of biological medicines in Bosnia and Herzegovina

Tubić

Jungić

2022

Bosn J of Basic Med Sci

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The use of biological medicines (called “biologics”) has contributed to the progress of the treatment of many chronic diseases, such as cancer, rheumatoid arthritis, Crohn’s disease, multiple sclerosis, and psoriasis. However, biologics are expensive for healthcare systems in many countries, and their availability has been an issue for many patients worldwide. A biosimilar medicine (called “biosimilar“) is a medicine with a proven similarity in terms of quality, biological activity, safety, and efficacy as the approved original biological medicine (called “originator biologic“).Biosimilars generate competition in the market by lowering the prices of biologics, thereby increasing access for patients. However, there are barriers to the acceptance and use of biosimilars in respect of their safety and interchangeability with the originator biologic. In this review, we present the national regulatory framework for biologics along with its limitations, the system for monitoring the safety profile of biologics, the interchangeability guideline, and a list of approved and available biologics in Bosnia and Herzegovina. Recommendations were also made here in order to create opportunities for better acceptance of biosimilars and thus better access to biologics. These recommendations include, but are not limited to, strengthening the national regulatory framework for biologics, capacity building, increasing awareness among healthcare providers for reporting adverse drug events and active pharmacovigilance, and better definitions of interchangeability. Finally, awareness of biosimilars and biologics among healthcare providers should be raised through continuous education and workshops, and by including this important topic in graduate and post-graduate curricula in the country.

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Medicamentos biosimilares: impacto, oportunidades y estrategias. Doce años de experiencia en Europa

Cited by 2 publications

References 14 publications

Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

Barriers to Biosimilar Prescribing Incentives in the Context of Clinical Governance in Spain

Regulatory aspects of biological medicines in Bosnia and Herzegovina

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