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Análise da utilização de programas de acesso precoce a medicamentos inovadores em Portugal
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Orientador(es)
Resumo(s)
RESUMO - Introdução: O surgimento de novos fármacos nos últimos anos tem levado as agências reguladoras locais a adaptar-se às novas exigências do mercado, com o intuito de disponibilizar a inovação terapêutica ao doente o mais rapidamente possível. Em 2014, em Portugal, foi aprovado o Regulamento que define os termos e procedimentos de autorização de Programas de Acesso Precoce (PAP), implementados com o objetivo de acelerar o acesso aos medicamentos inovadores.
Metodologia: Neste contexto, com base em dados públicos do site do INFARMED, I.P., de janeiro 2020 a dezembro 2023 para os PAP; e no caso dos relatórios de financiamento público (FP) de janeiro 2020 até maio 2024, pretendeu-se analisar os PAP, quantitativa e qualitativamente, e ainda avaliar de que forma este acesso acelerado influenciou os tempos de financiamento dos medicamentos em Portugal.
Resultados: Os resultados revelaram que o número de PAP submetidos ao INFARMED, I.P. tem vindo a aumentar, de forma considerável ao longo dos anos. Quando analisados os medicamentos com PAP observou-se que estes foram, frequentemente, avaliados com maior celeridade, reduzindo o tempo entre a Autorização de Introdução no Mercado (AIM) e a decisão de FP.
Discussão/Conclusões: Este estudo sugere que, apesar de os tempos entre AIM e PAP terem sido muito longos, os PAP, na mesma, beneficiaram os doentes ao facilitar o acesso antecipado aos medicamentos e ainda, auxiliaram a Autoridade no processo de distribuição dos recursos de forma mais eficaz, funcionando, possivelmente, como uma via temporária para aliviar a pressão do processo convencional de avaliação de tecnologias da saúde.
ABSTRACT - Introduction: The emergence of new drugs in recent years has prompted local regulatory agencies to adapt to new market demands, with the aim of making therapeutic innovations available to patients as quickly as possible. In 2014, in Portugal, the regulation defining the terms and procedures for authorization of Early Access Programs (EAP) was approved and implemented, with the aim of accelerating access to innovative medicines. Methodology: In this context, based on public data shared on the INFARMED, I.P. website, from January 2020 to December 2023 for EAP, and from January 2020 to May 2024 for public funding (FP) reports, the study aimed to analyze EAP, both quantitatively and qualitatively. Additionally, it sought to assess how this access influenced the funding timelines for innovative medicines in Portugal. Results: The results revealed that the number of EAP submitted to INFARMED, I.P. has increased considerably over the years. When analyzing medicines under EAP, it was observed that they were often evaluated more swiftly, reducing the time between the Marketing Authorization (MA) and the FP decision. Discussion/Conclusions: These findings suggest that, despite the long time between MA and EAP, the EAP still benefited patients by facilitating early access to innovative medicines, while also supporting INFARMED, I.P. in distributing resources more efficiently, serving, possibly, as a temporary solution to ease the pressure on the conventional Health Technology Assessment (HTA) process.
ABSTRACT - Introduction: The emergence of new drugs in recent years has prompted local regulatory agencies to adapt to new market demands, with the aim of making therapeutic innovations available to patients as quickly as possible. In 2014, in Portugal, the regulation defining the terms and procedures for authorization of Early Access Programs (EAP) was approved and implemented, with the aim of accelerating access to innovative medicines. Methodology: In this context, based on public data shared on the INFARMED, I.P. website, from January 2020 to December 2023 for EAP, and from January 2020 to May 2024 for public funding (FP) reports, the study aimed to analyze EAP, both quantitatively and qualitatively. Additionally, it sought to assess how this access influenced the funding timelines for innovative medicines in Portugal. Results: The results revealed that the number of EAP submitted to INFARMED, I.P. has increased considerably over the years. When analyzing medicines under EAP, it was observed that they were often evaluated more swiftly, reducing the time between the Marketing Authorization (MA) and the FP decision. Discussion/Conclusions: These findings suggest that, despite the long time between MA and EAP, the EAP still benefited patients by facilitating early access to innovative medicines, while also supporting INFARMED, I.P. in distributing resources more efficiently, serving, possibly, as a temporary solution to ease the pressure on the conventional Health Technology Assessment (HTA) process.
Descrição
Palavras-chave
Programa de Acesso Precoce Medicamentos inovadores Acesso ao medicamento Circuito acelerado Portugal Early Access Program Innovative medicines Access to drugs Accelerated pathway