Acordos de compartilhamento de riscos para aquisição do medicamento Spinraza® no Brasil: novas perspectivas sobre a proteção jurídica dos pacientes

Ramos, Thiago de Menezes; Thomasi, Tanise Zago; Júnior, Dimas Pereira Duarte

doi:10.17566/ciads.v9i2.656

Cited by 3 publications

(2 citation statements)

References 8 publications

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“…Due to the Covid 19 pandemic, special criteria in the implementation of CEAF related to the documentation renewal and dispensing anticipation were advocated. Also, patients with Gaucher disease assisted by the MS, through the provision of enzymatic therapy by Bio-Manguinhos/Fiocruz, started to be given the medicines infusion via home care service 20 .…”

Section: Axes According To Pnaidrmentioning

confidence: 99%

Initiatives to Promote Access to Medicines After the Publication of National Policy on Comprehensive Care of People With Rare Diseases in Brazil

Cunico

Vicente

Leite

2021

Preprint

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BackgroundRare diseases affect a small number of people compared to prevalent diseases' estimates. The vast majority of these diseases are of genetic origin, have no cure, are chronic and can lead to death. Although the right to access to medicines is included in the constitutionally guaranteed right to health in Brazil, problems in the supply of medicines for rare diseases are reported in the country. ObjectiveThis study aimed to describe and analyze the initiatives to promote access to medicines for treating rare diseases in Unified Health System, Brazil, after the publication of the National Policy on Comprehensive Care of People with Rare Diseases.MethodsBased on the model published by The WHO Regional Office for Europe, which described access to medicines in pre-launch, per-launch and post-launch policies, the initiatives referring to each category were summarized, based on documentary research searched in online databases, in the period from January 2014 to December 2020. ResultsDifferent actions and policy interventions were identified, which went through the expansion of resources for research and development, health regulations, incorporation of new drugs, review and publication of clinical guidelines, expansion of the network of care facilities by the Ministry of Health. On the other hand, aspects related to care policies, pricing methods, technological development, and development of pharmaceutical services processes were not implemented. ConclusionsAlthough it is impossible to determine the explicit motivation of such actions concerning the Policy, its publication certainly was a landmark in Brazilian society, allowing greater recognition of the needs of rare diseases patients and the treatment's specificities. However, the study suggests that the steps that make up the life cycle of medicines are not linked, lacking articulation and integration of the care network and, consequently, there is no evidence that the rare diseases policy publication has generated broad impact on the promotion of access to medicines to treat rare diseases in Brazil.

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Section: Axes According To Pnaidrmentioning

confidence: 99%

Initiatives to Promote Access to Medicines After the Publication of National Policy on Comprehensive Care of People With Rare Diseases in Brazil

Cunico

Vicente

Leite

2021

Preprint

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“…Dicho convenio se suscribió teniendo en cuenta el costo y efectividad del medicamento, la estimación del consumo, considerando la calidad de dosis y el impacto presupuestario, todo en miras de posibilitar la incorporación del medicamento para los AME II y III en el ámbito del SUS. Se tuvo en vista también, promover el balance del costo del vial, recopilar evidencia adicional sobre el uso del medicamento en condiciones reales, posibilitar reevaluar la incorporación de la tecnología ante evidencias adicionales, subsidiar la publicación de una futura norma general sobre el acuerdo de riesgo compartido para la incorporación de tecnologías sanitarias y, por último, promover la investigación en atrofia muscular tipos II y III para orientar políticas de salud pública (40).…”

Section: Derecho Comparado: La Situación De Brasil Y La Aceptación De...unclassified

Estrategia de Estado para el tratamiento de la atrofia muscular espinal: un desafío del sistema de salud en Argentina

Carignani

Flores²

2020

Cad. Ibero Am. Direito Sanit.

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Objetivo: analisar a implantação e comercialização de medicamentos de alto custo no sistema de saúde argentino, tomando como referência o tratamento médico da doença atrofia muscular espinhal; e analisar a regulamentação aplicável, demonstrando o paralelismo legislativo com a República Federativa do Brasil. Metodologia: foi realizada uma pesquisa descritiva analítica, identificando os critérios previstos nas normas ou regulamentos para a implantação de um medicamento de alto custo. Resultados: obtivemos o marco regulatório do medicamento denominado nusinersen na Argentina e na República Federativa do Brasil. Conclusão: os altos custos da tecnologia impactam diretamente no seu acesso. Acreditamos que, além dos instrumentos de negociação interna de cada país, a cooperação internacional é uma ferramenta fundamental para transformar essa realidade em oportunidade de acesso.

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Initiatives to promote access to medicines after publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases

Cunico,

Vicente,

Leite

2023

Orphanet J Rare Dis

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Background Rare diseases affect a small number of people compared to prevalent diseases. The vast majority of these diseases are of genetic origin, have no cure, are chronic and can lead to death. Although the right to access medicines is included in the constitutionally guaranteed right to health in Brazil, problems in the supply of medicines for rare diseases are reported in the country. This study aimed to describe and analyse the initiatives to promote access to medicines for treating rare diseases in the Unified Health System, Brazil, after the publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases. Based on the model published by the WHO Regional Office for Europe, which described access to medicines in prelaunch, perilaunch and postlaunch policies, the initiatives referring to each category were summarized based on documentary research searched in online databases from January 2014 to December 2020. Results Different actions and policy interventions were identified, which went through the expansion of resources for research and development, health regulations, incorporation of new drugs, review and publication of clinical guidelines, and expansion of the network of care facilities by the Ministry of Health. On the other hand, aspects related to care policies, pricing methods, technological development, and development of pharmaceutical service processes were not implemented. Conclusions Although it is impossible to determine the explicit motivation of such actions concerning the Policy, its publication certainly was a landmark in Brazilian society, allowing greater recognition of the needs of rare disease patients and the specificities of treatment’. However, this study suggests that the steps that make up the life cycle of medicines are not linked, lacking articulation and integration of the care network, and consequently, there is no evidence that rare disease policy publication has generated a broad impact on the promotion of access to medicines to treat rare diseases in Brazil.

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Acordos de compartilhamento de riscos para aquisição do medicamento Spinraza® no Brasil: novas perspectivas sobre a proteção jurídica dos pacientes

Cited by 3 publications

References 8 publications

Initiatives to Promote Access to Medicines After the Publication of National Policy on Comprehensive Care of People With Rare Diseases in Brazil

Initiatives to Promote Access to Medicines After the Publication of National Policy on Comprehensive Care of People With Rare Diseases in Brazil

Estrategia de Estado para el tratamiento de la atrofia muscular espinal: un desafío del sistema de salud en Argentina

Initiatives to promote access to medicines after publication of the Brazilian Policy on the Comprehensive Care of People with Rare Diseases

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