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Dia Mundial das Doenças Raras: pacientes enfrentam barreiras no acesso dos medicamentos

Dia 29 de fevereiro, o dia mais raro de todos – afinal, existe apenas a cada quatro anos – foi o escolhido para comemorar o Dia Mundial das Doenças Raras. Nos anos não bissextos, a data é antecipada para o dia 28, para relembrar anualmente as necessidades não atendidas e os desafios enfrentados por pessoas que sofrem com doenças raras.

 

De acordo com a Organização Mundial de Saúde (OMS), uma doença é considerada rara quando afeta até 65 pessoas em cada 100 mil indivíduos, ou seja, 1,3 para cada duas mil pessoas. O número de pacientes para cada doença pode ser baixo, porém se somado, atinge cerca de 6% a 8% da população mundial, o equivalente a aproximadamente 420 a 560 milhões de pessoas, de acordo com a Associação da Indústria Farmacêutica de Pesquisa (Interfarma). No Brasil, estima-se que 13 milhões de pessoas sofram com alguma doença rara. 75% dessas enfermidades aparecem em crianças de 0 a 5 e contribuem diretamente para casos graves, crônicos ou fatais nos primeiros 18 anos de vida.

Dificuldades

Familiares e pessoas com doenças raras enfrentam caminhos difíceis, que passam pela falta de conhecimento dos próprios médicos sobre a patologia e pela falta de suporte para estes pacientes. Baixo investimento em estudos clínicos, acesso aos tratamentos (quando disponíveis), além de barreiras na incorporação de medicamentos são desafios.  “Outra limitação das doenças raras é o pequeno número de pacientes. Isso impacta na geração de evidências sobre eficácia e segurança – tanto no número de estudos disponíveis como na qualidade metodológica dos mesmos”, destaca Teresa Lemmer, Gerente de Economia da Saúde & Acesso da Evidências – Kantar Health.

Além disso, pela própria natureza das doenças raras, dados epidemiológicos sobre essas patologias são escassos, o que compromete o planejamento de políticas públicas específicas. Assim, pacientes com doenças raras muitas vezes se veem obrigados a recorrer à chamada judicialização para conseguir tratamentos e medicamentos fora da cobertura do Sistema Público de Saúde ou convênio médico. “Um dos motivos pra isso, é que, por mais que os tratamentos estejam incorporados para outras indicações, os pacientes raros não podem recebê-los para suas próprias indicações, então acabam recorrendo ao judiciário”, declara Diego Kashiura, Consultor de Economia da Saúde & Acesso ao Mercado da Evidências – Kantar Health. “Financeiramente, esse processo impacta no orçamento do sistema de saúde – tanto público como privado – e, com isso, afeta indiretamente o acesso à saúde de outros pacientes no sistema. Mas, para a maioria dos casos de alta complexidade, acaba sendo o único modo”.

Encontrar o equilíbrio entre a demanda urgente por novas drogas para o tratamento das doenças raras é outro empecilho para o acesso.  “Não é possível utilizar os mesmos critérios de avaliação para drogas órfãs – medicamentos destinados a pequenos números de pessoas – e para aquelas utilizadas em doenças mais prevalentes, o que não quer dizer de forma alguma que estudos comparando novos medicamentos ao melhor tratamento disponível não devam ser realizados. Para as patologias mais raras, muitas vezes a literatura consiste apenas de relatos de casos”, de acordo com um estudo realizado pela Evidências sobre doenças raras –Kantar Health sobre doenças raras  (vide abaixo).

Avanços

Entretanto, nas últimas décadas, agências regulatórias de várias localidades no mundo têm desenvolvido políticas que contribuam para a evolução de medicamentos de doenças raras. Como o Food and Drug Administration (FDA) que desde os anos 1980 em parceria com o congresso americano promulgou uma lei que oferece exclusividade de mercado de sete anos para a condução de estudos clínicos, além de acesso, subsídios específicos e linha de crédito às novas drogas desenvolvidas para doenças raras. No continente europeu, a European Medicina Agency (EMA) oferece benefícios aos pacientes raros, como redução de tarifas, facilitação na comercialização, distribuição e serviços direcionados.

No Brasil, também são destacadas medidas para facilitar o registro dos medicamentos de doenças raras. O diretor de Autorização e Registros Sanitários da Agência Nacional de Vigilância Sanitária (ANVISA) Fernando Garcia, anunciou em audiência pública na Comissão de Assuntos Sociais (CAS) ocorrida em agosto de 2017. Além disso, o Ministério da Saúde divulgou que irá ampliar o Teste do Pezinho e a inclusão de exames pré-nupciais para permitir o diagnóstico de enfermidades precocemente.

A Evidências – Kantar Health vem colaborando para a divulgação científica das doenças raras, e recentemente contribuiu com a incorporação e o processo de precificação da Câmara de Regulação do Mercado de Medicamentos (CMED) de um medicamento voltado para doença rara que em breve será disponibilizado pela Comissão Nacional de Incorporação de Tecnologias no SUS (CONITEC).

Além disso, a Evidências – Kantar Health já produziu uma série de seis fascículos sobre doenças raras. Os estudos abordam questões como fisiopatologia da doença, quadro clínico, tratamento e parte regulatória. Além das doenças, também há fascículos discutindo um quadro geral das doenças raras e a necessidade de políticas públicas para lidar com este problema.

Todo o material está disponível em nossa aba publicações e pode ser consultado clicando aqui:

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