Abstract This study attempted to describe the disease modifying therapies (DMTs) use patterns and related adverse events in multiple sclerosis (MS) patients assisted by the Brazilian Unified Health System (SUS). This is a cross-sectional study conducted at a reference center in the Midwestern Brazil. Demographic, socioeconomic, and clinical data, and adverse events associated with DMTs were collected. We observed 291 patients with a mean age of 41.4 years, and mostly (68.6%) women. Most patients (58.8%) were using first-line treatment. Fingolimod (29.9%) and beta interferons (23.7%) were the most used drugs. About 74.2% of patients used DMTs for more than six months. In 26.5% of patients, 238 adverse events were reported, 67.2% of which were mild and 32.8% of which were moderate. The most frequent adverse events were headaches (6.9%), myalgia (3.8%), and flu-like symptoms (3.1%). The proportion of adverse events proportion ranged from 17.3% (natalizumab) to 41.2% (dimethyl fumarate). Most MS patients treated by SUS used first-line DMTs. After adjustment, there was noticed that adverse events associated with DTMs are twice as likely to occur in users of the first-line treatment than other lines (OR 1.99, p=0.01). It is essential to develop DMTs safety monitoring strategies to promote their rational use. (DMTs (MS SUS. . (SUS) crosssectional cross sectional Brazil Demographic socioeconomic data collected 29 414 41 4 41. years 68.6% 686 68 6 (68.6% women 58.8% 588 58 8 (58.8% firstline first line 29.9% 299 9 (29.9% 23.7% 237 23 7 (23.7% drugs 742 74 2 74.2 months 265 26 5 26.5 reported 672 67 67.2 328 32 32.8 moderate 6.9%, 69 6.9% , (6.9%) 3.8%, 38 3.8% 3 (3.8%) flulike flu like 3.1%. 31 3.1% 1 (3.1%) 173 17 17.3 natalizumab (natalizumab 412 41.2 dimethyl fumarate. fumarate fumarate) adjustment OR 199 99 1.99 p=0.01. p001 p p=0.01 0 01 p=0.01) (SUS 68.6 (68.6 58.8 (58.8 29.9 (29.9 23.7 (23.7 74. 26. 67. 32. 6.9 (6.9% 3.8 (3.8% 3.1 (3.1% 17. 19 1.9 p00 p=0.0 68. (68. 58. (58. 29. (29. 23. (23. 6. (6.9 3. (3.8 (3.1 1. p0 p=0. (68 (58 (29 (23 (6. (3. p=0 (6 (5 (2 (3 p= (

Resumo O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Abstract Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil’s Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.

Resumo O cumprimento dos prazos legais para incorporação e disponibilização de tecnologias no Sistema Único de Saúde (SUS) é fundamental para o acesso da população aos medicamentos considerados essenciais. Objetivou-se analisar o cumprimento destes prazos comparando a Oncologia e o Componente Especializado de Assistência Farmacêutica (CEAF). Comparou-se os processos de incorporação de medicamentos no SUS da Oncologia e do CEAF que foram submetidos à Conitec no período de 01 de janeiro de 2017 a 30 de abril de 2020. No período, 83 processos de incorporação de medicamentos foram recomendados para incorporação pela Conitec, dos quais 13 (15,66%) eram da Oncologia e 70 (84,34%) eram do CEAF. Verifica-se que o tempo de análise e recomendação pela Conitec até a publicação da decisão pelo Ministério da Saúde foi, em média, 15 dias maior para processos que continham medicamentos oncológicos e o tempo para disponibilização das tecnologias incorporadas da área da oncologia foi, em média, 389 dias maior que do CEAF. Reconhece-se o importante avanço obtido com a criação da Conitec no Brasil, porém os resultados deste estudo apontam para a necessidade de aprimoramento do processo de disponibilização de tecnologias incorporadas no SUS, em especial da Oncologia.

Abstract Compliance with legal deadlines for the assessment and incorporation of technologies in Brazil’s Unified Health System (SUS) is essential to ensure public access to essential medicines. The scope of this paper was to analyze the compliance with legal deadlines for incorporation and availability of medicines in the SUS, comparing Oncology and the Specialized Component of Pharmaceutical Assistance (SCPA). A comparison was made of the drugs incorporated that were submitted to Conitec in the period from January 1, 2017, to April 30, 2020. A total of 85 drugs were recommended for incorporation by Conitec, of which 15 (17.64%) were for Oncology and 70 (82.36%) were for SCPA. The time between analysis and recommendation by Conitec until the publication of the decision by the Ministry of Health was, on average, 86 days longer for oncological drugs and the availability timeframe of technologies incorporated in the oncology area was, on average, 389 days longer than for SCPA. The major progress achieved with the creation of Conitec in Brazil is acknowledged, but the results of this study point to a pressing need to improve the process of making available technologies incorporated into the SUS, especially in oncology.