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A JUDICIALIZA=C3=87=C3=83O DO PEDIDO DE CONCESS=C3=83O DO MEDICAMENTO OFEV (N= INTEDABINE)

The Judicialization of the Request for the Concession of the Medicine Ofev (Nintedanib)<= /o:p>

Erika Maeoka= * = =C2=A0

 =

 =

Resumo: A presente pesquisa analisa a pertin=C3=AAncia da judicializa=C3=A7=C3=A3o de pol=C3=ADticas p=C3=BAblica= s de fornecimento de medicamento OFEV (Nintedabine), utilizado pelos pacientes portadores de Fibrose Pulmonar Idiop=C3=A1tica (FPI), de acordo c= om a decis=C3=A3o do Supremo Tribunal Federal no julgamento do RE 566471, dado q= ue o medicamento ainda n=C3=A3o foi incorporado =C3=A0 lista do Sistema =C3=9Ani= co de Sa=C3=BAde. Para tanto, examina a decis=C3=A3o do Relat=C3=B3rio n=C2=BA 419/2018 da CONITEC= , que indeferiu o pedido de incorpora=C3=A7=C3=A3o do medicamento OFEV (= Nintedabine) frente =C3=A0s diversas recomenda=C3=A7=C3=B5es emitidas pelas Ag=C3=AAncia= s de Tecnologia em Sa=C3=BAde estrangeiras, no intuito de avaliar a razoabilidade da demora na reavalia= =C3=A7=C3=A3o do pedido de incorpora=C3=A7=C3=A3o pela Ag=C3=AAncia Brasileira. Por fim, con= clui que a judicializa=C3=A7=C3=A3o do pedido de concess=C3=A3o do medicamento pelos p= ortadores da Fibrose Pulmonar Idiop=C3=A1tica (FPI) =C3=A9 apropriada, pois a postura da= Ag=C3=AAncia Brasileira de Tecnologia em Sa=C3=BAde encontra-se obsoleta frente =C3=A0s = resolu=C3=A7=C3=B5es das diversas ag=C3=AAncias estrangeiras, o que demonstra que existe a omiss=C3= =A3o do =C3=B3rg=C3=A3o t=C3=A9cnico na revis=C3=A3o do pedido de incorpora=C3=A7=C3=A3o do medicam= ento em quest=C3=A3o.

 

Palavras-chave: judicializa=C3=A7=C3=A3o; medicamento OFEV (Nintedabine); CONITEC; Ag=C3=AAncia de Tecnologia em Sa=C3=BAde estrangeira.

 

Abstract: This research analyzes the relevance of judicialization of public policies regarding the supply of the drug OFEV (<= span class=3DSpellE>Nintedabin), used by patients with Idiopathic Pulmona= ry Fibrosis (IPF), according to the decision of the Brazilian Supreme Court in= the judgment of RE 566471, given the fact that the drug has not yet been incorporated into the list of the Unified Health System (SUS). To this end,= and in order to assess the reasonableness of the delay in the re-evaluation of = the incorporation request by the Brazilian Agency, it examines the decision of CONITEC Report no. 419/2018, which rejected the request for incorporation of the drug OFEV (Nintedabin), in light of various recommendations issued by foreign Health Technology Agencies. Finally, it concludes that judicialization of the matter by those suffering from Idiopa= thic Pulmonary Fibrosis (IPF) is appropriate for the granting of the medication,= since the stance of the Brazilian Health Technology Agency is obsolete in relatio= n to the resolutions of various foreign agencies, which demonstrates that there = is an omission on the part of the technical body in reviewing the request for = the incorporation of the medication in question.=

Keywords: = judi= cialization; drug OFEV (Nintedabin); CONITEC; Foreign Health Technology Agency.=

 

 

INTRODU=C3=87=C3=83O

 

A judicializa=C3=A7=C3=A3o da pol=C3=ADtica p=C3=BAblica de fornecimento de m= edicamento tornou-se um fato recorrente, visto que nem sempre o Sistema =C3=9Anico de Sa=C3=BAde (S= US) atende os usu=C3=A1rios respeitando os princ=C3=ADpios da igualdade e da universalida= de de acesso. Entretanto, o excessivo controle judicial tamb=C3=A9m est=C3=A1 inviabiliza= ndo a observ=C3=A2ncia dos mesmos princ=C3=ADpios. Dessa forma, para equalizar as= demandas, restou ao Poder Judici=C3=A1rio estipular certos par=C3=A2metros para tanto= .

Assim, de um lado, frente aos limites or=C3=A7ament=C3=A1rios e, de outro lado, visando = a respeitar as diretrizes que balizam o acesso aos recursos do Sistema =C3=9Anico de Sa=C3= =BAde (SUS), o Supremo Tribunal Federal, no julgamento do RE 566471, estabeleceu determina= dos requisitos para o fornecimento de medicamento via decis=C3=A3o judicial, de= vido =C3=A0 necessidade de estipular as pol=C3=ADticas e os par=C3=A2metros que observe= m o princ=C3=ADpio da igualdade.

Segundo a decis=C3=A3o, a concess=C3=A3o de medicamentos pela via judicial dever=C3= =A1 estar fundamentada em avalia=C3=A7=C3=A3o t=C3=A9cnica baseada em evid=C3=AAncias= , dado que os =C3=B3rg=C3=A3os t=C3=A9cnicos =C3=A9 que s=C3=A3o dotados de conhecimentos especializados p= ara julgar a efic=C3=A1cia e a seguran=C3=A7a, bem como o custo-efetividade do medicamen= to.

Com efeito,= o Supremo Tribunal Federal formulou a Tese de Repercuss=C3=A3o Geral, cuja re= gra geral =C3=A9 a inexigibilidade do fornecimento dos medicamentos n=C3=A3o constant= es nas listas de dispensa=C3=A7=C3=A3o do Sistema =C3=9Anico de Sa=C3=BAde. Contudo, a co= ncess=C3=A3o excepcional =C3=A9 poss=C3=ADvel desde que preenchidas determinadas condi=C3=A7=C3=B5es.<= /o:p>

Dentre os requisitos, enumera a exist=C3=AAncia de ilegalidade do ato de n=C3=A3o inc= orpora=C3=A7=C3=A3o do medicamento pelo =C3=B3rg=C3=A3o t=C3=A9cnico, aus=C3=AAncia de pedido de i= ncorpora=C3=A7=C3=A3o ou da mora na sua aprecia=C3=A7=C3=A3o, tendo em vista os prazos e crit=C3=A9rios prev= istos nos artigos 19-Q e 19-R da Lei n=C2=BA 8.080/1990 e no Decreto n=C2=BA 7.646/2011.=

Por outro l= ado, exige do julgador, sob pena de nulidade, que a decis=C3=A3o seja devidamente fundamentada de acordo com o artigo 489, =C2=A7 1=C2=BA, incisos V e VI, e = artigo 927, inciso III, =C2=A7 1=C2=BA, do C=C3=B3digo de Processo Civil, ao julgar o p= edido de concess=C3=A3o de medicamentos n=C3=A3o incorporados, devendo obrigatoriamente: (a) analis= ar o ato administrativo comissivo ou omissivo de n=C3=A3o incorpora=C3=A7=C3=A3o pel= a CONITEC ou da negativa de fornecimento da via administrativa, =C3=A0 luz das circunst=C3= =A2ncias do caso concreto e da legisla=C3=A7=C3=A3o de reg=C3=AAncia, especialmente a p= ol=C3=ADtica p=C3=BAblica do SUS, n=C3=A3o sendo poss=C3=ADvel a incurs=C3=A3o no m=C3=A9rito do ato adm= inistrativo.

Dentre as v=C3=A1rias demandas envolvendo o direito =C3=A0 sa=C3=BAde, existem os ple= itos dos pacientes que sofrem da Fibrose Pulmonar Idiop=C3=A1tica (FPI), uma vez que o Sistema= =C3=9Anico de Sa=C3=BAde (SUS) n=C3=A3o oferece nenhuma alternativa de tratamento, pois n= =C3=A3o existe, junto ao Minist=C3=A9rio da Sa=C3=BAde, o Protocolo Cl=C3=ADnico e Diretriz= Terap=C3=AAutica (PCDT) para a doen=C3=A7a. Assim sendo, o presente trabalho prop=C3=B5e analisar s= e existem elementos suficientes para fundamentar o pedido de concess=C3=A3o judicial = do medicamento OFEV (Nintedabine) =C3=A0 luz da de= cis=C3=A3o do Supremo Tribunal Federal estabelecida no julgamento do RE 566471.

A pesquisa parte do princ=C3=ADpio de que a natureza das demandas envolvendo a concess= =C3=A3o de medicamento tem como alicerce o questionamento da exist=C3=AAncia de defici= =C3=AAncia no gerenciamento da pol=C3=ADtica p=C3=BAblica de sa=C3=BAde e, no caso em esp= ec=C3=ADfico, a falha no processo de distribui=C3=A7=C3=A3o dos medicamentos. Desse modo, prop=C3=B5= e investigar se existem poss=C3=ADveis limita=C3=A7=C3=B5es question=C3=A1veis na pol=C3=AD= tica brasileira, que exclui o seguimento em quest=C3=A3o dos cuidados oferecidos pelo Sistema =C3=9Anico = de Sa=C3=BAde (SUS).

Para tanto, pretende estudar a decis=C3=A3o exarada no Relat=C3=B3rio n=C2=BA 419/2018,= que examinou o pedido de incorpora=C3=A7=C3=A3o do medicamento, em conjunto com a postura = das diversas Ag=C3=AAncias de Tecnologia em Sa=C3=BAde (ATS) estrangeiras, a fim de conf= rontar as diretrizes que conduzem as pol=C3=ADticas p=C3=BAblicas estrangeiras e a po= l=C3=ADtica p=C3=BAblica brasileira de distribui=C3=A7=C3=A3o de medicamentos, para estimar o n=C3= =ADvel de pertin=C3=AAncia da decis=C3=A3o da Ag=C3=AAncia nacional, sob a perspectiva comparada entre= os seus pares.

Sendo assim= , em s=C3=ADntese, o presente estudo tem como meta investigar a exist=C3=AAncia = de requisitos para a judicializa=C3=A7=C3=A3o do pedido da citada tecnologia, de acordo c= om a decis=C3=A3o do Supremo Tribunal Federal, que permite a concess=C3=A3o judicial de medic= amentos n=C3=A3o listados pelo Sistema =C3=9Anico de Sa=C3=BAde (SUS), com fundamen= to na falta de uma nova avalia=C3=A7=C3=A3o em tempo oportuno.

 

1 A JUDICIALIZA=C3=87=C3=83O DO PEDIDO DE CONCESS=C3=83O D= O MEDICAMENTO OFEV (NINTEDABINE)

 

Como mencio= nado em notas introdut=C3=B3rias, o grupo de pessoas acometido pela doen=C3=A7a = em apre=C3=A7o, que =C3=A9 estimado entre 13 a 18 mil casos no Brasi= l (Brasil, 2025a), n=C3=A3o disp=C3=B5e, no presente momento, de= nenhum tratamento voltado =C3=A0 respectiva enfermidade. Entretanto, de acordo com= as Diretrizes Brasileiras para o Tratamento Farmacol=C3=B3gico da Fibrose Pulm= onar Idiop=C3=A1tica, existe uma =C3=BAnica classe de medicamento que foi desenv= olvida para o tratamento, que s=C3=A3o os antifibr=C3=B3ticos= : um deles =C3=A9 o OFEV (Nintedabine) e o outro =C3=A9 o Pirfenidone (Amaral; Kairalla; Colares, 2023).

A FPI =C3=A9 classifi= cada como uma doen=C3=A7a rara, que se enquadra nos par=C3=A2metros da Portaria n=C2= =BA 199, de 30 de janeiro de 2014, que instituiu a Pol=C3=ADtica Nacional de Aten=C3=A7=C3=A3= o Integral =C3=A0s Pessoas com Doen=C3=A7as Raras, e que no seu artigo 3=C2=BA disp=C3=B5e que= : =E2=80=9Cconsidera-se doen=C3=A7a rara aquela que afeta at=C3=A9 65 pessoas em cada 100.000 indiv= =C3=ADduos, ou seja, 1,3 pessoas para cada 2.000 indiv=C3=ADduos=E2=80=9D.=

Os dois medicamentos avaliados pela CONITEC em 2018, Relat=C3=B3rios n=C2=BA 419/20= 18 e n=C2=BA 420/2018, e receberam pareceres contr=C3=A1rios aos respectivos pedidos de incorpora=C3=A7=C3=A3o, motivo pelo qual os pacientes em quest=C3=A3o est= =C3=A3o demandando os medicamentos judicialmente (Brasil, 2018a; Bras= il, 2018b).

Em virtude = da n=C3=A3o recomenda=C3=A7=C3=A3o, os dados estat=C3=ADsticos do Sistema Natjus mostram que o OFEV (Nintedabine) figura entre o= s 10 (dez) medicamentos mais pedidos, com o total de 3.981 notas t=C3=A9cnicas e= mitidas, sendo 585 favor=C3=A1veis e 3.396 desfavor=C3=A1veis, e, dentre os 10 (dez)= , =C3=A9 o =C3=BAnico com a designa=C3=A7=C3=A3o de =C3=B3rf=C3=A3o. Ou seja, =C3=A9 o medicament= o =C3=B3rf=C3=A3o mais demandado segundo a compila=C3=A7=C3=A3o de dados do sistema (Brasil, 2026).

Ainda que u= ma parte dos interessados venha obtendo =C3=AAxito nas suas demandas[1]= , essa n=C3=A3o =C3=A9 a realidade para todos os = demais, que veem seus pedidos negados com base no custo-efetividade do medicamento, que =C3= =A9 diuturnamente questionado sem maiores considera=C3=A7=C3=B5es, mesmo que a = doen=C3=A7a seja rara e o medicamento seja =C3=B3rf=C3=A3o. Portanto existem diverg=C3=AAnci= as jurisprudenciais acerca da quest=C3=A3o, e os julgados contr=C3=A1rios =C3=A0 causa muitas v= ezes s=C3=A3o embasados na decis=C3=A3o de n=C3=A3o recomenda=C3=A7=C3=A3o em an=C3=A1lise.

Ocorre que o recente par=C3=A2metro fixado pelo Supremo Tribunal Federal (RE 566471), que condicionou como regra geral a incorpora=C3=A7=C3=A3o do medicamento =C3=A0= lista do RENAME, =C3=A9 um divisor de =C3=A1guas para as demandas envolvendo a concess=C3=A3o de me= dicamento (Brasil, 2024). A nova regra geral trouxe desafios ainda mais severos aos demandante= s, que passaram a carregar o =C3=B4nus de questionar, com =C3=AAxito, o ato ad= ministrativo comissivo ou omisso de n=C3=A3o recomenda=C3=A7=C3=A3o. Sem tal questioname= nto as demandas est=C3=A3o fadadas ao insucesso.[2]=

Em s=C3=ADn= tese, o grupo sob an=C3=A1lise n=C3=A3o conta com nenhum tratamento fornecido pelo = Estado, mas existe uma =C3=BAnica classe de medicamento com efic=C3=A1cia comprovada ci= entificamente, que passou pela avalia=C3=A7=C3=A3o da ag=C3=AAncia e n=C3=A3o foi recomend= ada. Os que necessitam do tratamento precisam, em vista da negativa, judicializar a causa. N=C3=A3o obstante, devido =C3=A0s exig=C3=AAncias decorrentes da delibera=C3=A7=C3= =A3o tomada no RE 566471, resta aos pacientes o desafio de comprovar que existem fundamentos suficien= tes para que a atual decis=C3=A3o seja revista, e o medicamento, incorporado.

<= o:p> 

<= b>2 A CONITEC E O POSICIONAMENTO DAS AG=C3=8ANCIAS DE TECNOLOGIA EM SA=C3=9ADE ESTRANGEIRAS

 

A decis=C3= =A3o de n=C3=A3o incorpora=C3=A7=C3=A3o de determinado medicamento no programa de f= ornecimento est=C3=A1 inserida no contexto da pol=C3=ADtica p=C3=BAblica de distribui=C3=A7=C3=A3= o adotada pelo Estado Brasileiro. Dessarte, para fundamentar a necessidade da atualiza=C3=A7=C3= =A3o da decis=C3=A3o inicial de n=C3=A3o recomenda=C3=A7=C3=A3o, o estudo prop=C3=B5e a compara= =C3=A7=C3=A3o da pol=C3=ADtica p=C3=BAblica brasileira, que permanece estagnada desde 2018, com os avan=C3=A7os obtidos= pelas pol=C3=ADticas estrangeiras.

A an=C3=A1l= ise t=C3=A9cnica sobre a viabilidade de introduzir os medicamentos que comp=C3= =B5em a lista do Sistema =C3=9Anico de Sa=C3=BAde =C3=A9 efetuada no =C3=A2mbito brasilei= ro pela CONITEC. Assim, o medicamento OFEV (Nintedabine) foi avaliado e= m 2018 e n=C3=A3o foi recomendado, apesar de n=C3=A3o existir nenhum outro tratame= nto dispon=C3=ADvel para al=C3=A9m das medidas paliativas, pois segundo o relat=C3=B3rio:<= /o:p>

&nbs= p;

[...] o Minist=C3=A9rio da Sa=C3=BAde do Brasil n=C3=A3o possui Protocolo Cl=C3=ADn= ico e Diretrizes Terap=C3=AAuticas (PCDT) para tratamento da FPI. Atualmente, os tratamentos dispon=C3=ADveis no SUS s=C3=A3o antituss=C3=ADgenos, morfina, corticoterapia, oxigenoterapia, todos paliativos e transplante de pulm=C3=A3o=E2=80=9D, a s= ua incorpora=C3=A7=C3=A3o n=C3=A3o foi recomendada pela Ag=C3=AAncia Brasileira de acordo com o Relat= =C3=B3rio n=C2=BA 419/2018. (Brasil, 2018a, p. 39)

 

A ag=C3=AAn= cia brasileira, que, nas suas avalia=C3=A7=C3=B5es, costuma mencionar os posici= onamentos de outras estrangeiras,=C2=A0 no Relat= =C3=B3rio n=C2=BA 419/2018, elegeu 5 (cinco) como refer=C3=AAncia, ou seja, a National Institute for Health and Care Excellence= (NICE), do Reino Unido; a Canadian Agency for Drugs & Technologies in Health (CADTH), do Canad=C3=A1; a Pharmaceutical Benefits Advisory Committee (PBAC), da Austr=C3=A1lia; a Scottish Medicines Consortium (SMS), da Esc=C3=B3cia; e a Autor= idade Nacional do Medicamento e Produtos de Sa=C3=BAde (INFARMED), de Portugal, q= ue, ao contr=C3=A1rio do Estado brasileiro, incorporaram o medicamento em quest=C3= =A3o (Brasil, 2018a).

A ag=C3=AAn= cia National Institute= for Health and Care Excellence (NICE), que =C3=A9 a mais referenciada= nos relat=C3=B3rios brasileiros, bem como a mais citada nas decis=C3=B5es judic= iais, nos laudos periciais e nas notas t=C3=A9cnicas, analisou o medicamento em 2016 e publicou o Relat=C3=B3rio de Recomenda=C3=A7=C3=A3o= NICE/2016 de uso para o tratamento da FPI (Reino Unido, 2016).

Em 2021, pa= ssou inclusive a ampliar a recomenda=C3=A7=C3=A3o do uso do medicamento para o t= ratamento da doen=C3=A7a pulmonar intersticial fibrosante progressiva, afirmando, no rel= at=C3=B3rio NICE/2021, que as estimativas de custo-efetividade estar=C3=A3o dentro do q= ue o instituto considera um uso aceit=C3=A1vel dos recursos no =C3=A2mbito do Re= ino Unido e das diretrizes para a respectiva implementa=C3=A7=C3=A3o (Reino Unido, 2021). <= o:p>

Na sequ=C3= =AAncia, em 2023, por meio da recomenda=C3=A7=C3=A3o NICE/2023, novamente a pol=C3= =ADtica foi ampliada com a inclus=C3=A3o dos portadores FPI com capacidade vital for=C3=A7ada ac= ima de 80%, com a mesma afirma=C3=A7=C3=A3o anterior de que considera o custo-efetivida= de adequado (Reino Unido, 2023).

N=C3=A3o ob= stante, a consolida=C3=A7=C3=A3o do programa foi condicionada =C3=A0 redu=C3=A7=C3=A3= o do pre=C3=A7o do medicamento e, uma vez preenchidas as condi=C3=A7=C3=B5es, foi concretizada a efetiva impl= ementa=C3=A7=C3=A3o do benef=C3=ADcio. As recomenda=C3=A7=C3=B5es da National Institute for Health and = Care Excellence NICE/= 2021 e NICE/2023 informam que o Reino Unido tem um acordo comercial com a empresa fornecedora, o que permite um desconto na aquisi=C3=A7=C3=A3o (Reino Unido,= 2021; Reino Unido, 2023).

J=C3=A1 a a= g=C3=AAncia canadense Canadian Agency for Drugs & Technologies in Health (CAD= TH), igualmente bastante mencionada nos relat=C3=B3rios, nas decis=C3=B5es judic= iais, nos laudos periciais e nas notas t=C3=A9cnicas, em 2015, embora tivesse recomen= dado o uso, n=C3=A3o havia ainda aprovado o seu reembolso completo, dado que a ag= =C3=AAncia realiza somente a recomenda=C3=A7=C3=A3o, que foi condicionada =C3=A0 redu= =C3=A7=C3=A3o do custo (Canad=C3=A1, 2015). Em 2021, o uso foi ampliado, pois foi recomendado tamb= =C3=A9m para o tratamento da doen=C3=A7a pulmonar intersticial fibrosante progressiva.=C2=A0 Com isso, o programa de reembolso = foi expandido (Canad=C3=A1, 2021).

As negocia= =C3=A7=C3=B5es junto ao fabricante s=C3=A3o efetuadas pela Pan-Canadian Pharmaceutical Alliance (pCPA), que finaliz= ou as tratativas mediante acordo de redu=C3=A7=C3=A3o do pre=C3=A7o. Assim, houve= a reavalia=C3=A7=C3=A3o da recomenda=C3=A7=C3=A3o em rela=C3=A7=C3=A3o =C3=A0 FPI, e hoje o medicament= o =C3=A9 completamente reembols=C3=A1vel (Canad=C3=A1, 2016).

Por sua vez= , a ag=C3=AAncia da Austr=C3=A1lia, Pha= rmaceutical Benefits Advisory Committee (PBAC), em 2016, j=C3=A1 havia incorporado a tecnologia no programa somente= para o tratamento da FIP (Austr=C3=A1lia, 2016). Ao longo do ciclo seguinte, em 20= 22, seguindo a trajet=C3=B3ria do Canad=C3=A1 e do Reino Unido, ampliou o rol, = que passou a beneficiar, igualmente, os portadores da doen=C3=A7a pulmonar intersticial fibrosante progressiva (Austr=C3=A1lia, 2022).

Na mesma li= nha, a ag=C3=AAncia da Esc=C3=B3cia, Sco= ttish Medicines Consortium (SMS), em 2015, recomendou o uso para o tratamento da FPI (Esc=C3=B3cia, 2015). Em 2021, tamb=C3=A9m ampliou a disponibilidade para o= tratamento da doen=C3=A7a pulmonar intersticial fibrosante progressiva, vencendo o proble= ma do custo do medicamento por meio de um acordo comercial para redu=C3=A7=C3=A3o= do valor (Esc=C3=B3cia, 2021).

Dando continuidade, em 2023, ocorreu mais um avan=C3=A7o na pol=C3=ADtica, pois a= ag=C3=AAncia efetuou uma nova avalia=C3=A7=C3=A3o e incluiu a recomenda=C3=A7=C3=A3o de = uso para o tratamento da FPI voltado aos pacientes com capacidade vital for=C3=A7ada acima de 80% e = afirmou, ainda, que, levando-se em considera=C3=A7=C3=A3o a natureza do medicamento,= entendeu que =C3=A9 aceit=C3=A1vel uma maior incerteza econ=C3=B4mica (Esc=C3=B3cia, 202= 3).

Por fim, a ag=C3=AAncia de Portugal, Autoridade Nacional do Medicamento e Produtos de = Sa=C3=BAde, em 2017, recomendou o uso hospitalar, via financiamento p=C3=BAblico, para o t= ratamento da FPI (Portugal, 2017a). No mesmo ano de 2017,= o medicamento passou a integrar a lista de medicamentos subsidiados via coparticipa=C3=A7=C3=A3o dos usu=C3=A1rios para o tratamento da FPI (Portug= al, 2017b). J=C3=A1 em 2022, ampliou o uso em ambiente ho= spitalar para o tratamento da doen=C3=A7a pulmonar intersticial fibrosante progressi= va (Portugal, 2022).

Al=C3=A9m d= as j=C3=A1 mencionadas, existem outros v=C3=A1rios exemplos que incorporam o f=C3=A1rm= aco, como as ag=C3=AAncias: Institut National D'excellence en San= t=C3=A9 et en Services Sociaux (= INESSS), de Queb=C3=A9c, em 2017 (Canad=C3=A1, 2017); Institut f=C3=BCr= Qualit=C3=A4t und Wirtschaftlichkeit im Gesundheitswesen= (IQWiG), da Alemanha, em 2015 (Alemanha, 2015); Austrian Institute For Health Technology Assessment (= AIHTA), da =C3=81ustria, em 2015 (=C3=81ustria, 2015);= Institut National= D'assurance Maladie-Invali= dit=C3=A9 (INAMI), da B=C3=A9lgica, em 2016 (B=C3=A9lgica= , 2016); Hrvatski zavod za zdravstveno osiguranje=C2=A0 (HZZO), da Cro=C3=A1cia, em 2016 (Cro=C3=A1cia, 2016); Medicinr=C3=A5det - Danish Medicines Council=C2=A0 (DMC), da Dinamarca, em 2017 (Dina= marca, 2023); Agencia Espa= =C3=B1ola de Medicamentos y Productos Sanitarios = (AEMPS), da Espanha, em 2015 (Espanha, 2015)= ; Haute Autorit=C3= =A9 de Sant=C3=A9, da Fran=C3=A7a, em 2016 (Fran=C3=A7a, 2016); L=C3=A4=C3=A4kkeiden hintalautakunta (HILA), da Finl=C3=A2ndia, em 2015 (Finl=C3=A2ndia, 2015); Ethnikos Organis= mos Parochis Ypiresion Ygeias (= EOPYY), da Gr=C3=A9cia, em 2016 (Gr=C3=A9cia, 2016); Zorginstituut Nederland (ZIN), da Holanda, em 2015 (Holanda, 2015); Nemzeti N=C3=A9peg=C3=A9= szs=C3=A9g=C3=BCgyi =C3=A9s Gy=C3=B3gyszer=C3=A9szeti K=C3=B6zpont (NNGYK), da Hungria, em 2016 (Hungria, 2016); H= ealth Service Executive (NCPE), da Irlanda, em 20= 17 (Irlanda, 2017); Agenzia Italiana Del Far= maco (AIFA), <= /span>da It=C3=A1lia, em 2016 (It=C3=A1lia, 2016); Pharmaceuticals = and Medical Devices Agency (PMDA), = do Jap=C3=A3o, em 2015 (Jap=C3=A3o, 2015); Conseil Scientifique de Sant=C3=A9= (CNS), de Luxemburgo, em 2015 (Luxemburgo, 2026); Norwegian Medical Products Agency (NOMA), da Noruega, em 2016 (Noruega, 2016); Pharmacology and Therapeutics Advisory= Committee, da Nova Zel=C3=A2ndia (PTAC), em 2017 (Nova Zel=C3=A2ndia, 2021); Agen=C8=9Bia Na=C8=9Bional=C4=83 a Medicament= ului =C8=99i a Dispozitivelor = Medicale din Rom=C3=A2nia= (ANMDMR), da Rom= =C3=AAnia, em 2016 (Rom=C3=AAnia, 2016); Tandv=C3=A5rds- och l=C3=A4kemedelsf=C3=B6= rm=C3=A5nsverket (TLV), da Su=C3=A9cia, em 2016 (Su=C3=A9cia, 2016); e = o Bundesamt f=C3=BCr Gesundheit (BAG), da Su=C3=AD=C3= =A7a, em 2015 (Su=C3=AD=C3=A7a, 2015).

Ademais, o estudo, que realizou a pesquisa entre os pa=C3=ADses da regi=C3=A3o =C3=81s= ia-Pac=C3=ADfico, verificou que pa=C3=ADses como a Mal=C3=A1sia, Singapura, a Tail=C3=A2ndia,= Hong Kong e a Cor=C3=A9ia do Sul tamb=C3=A9m recomendaram e passaram a fornecer o medicam= ento em quest=C3=A3o (Chua et al., 2025).

A aprecia= =C3=A7=C3=A3o dos posicionamentos adotados pelas ag=C3=AAncias selecionadas como par=C3= =A2metro indica que os Estados n=C3=A3o s=C3=B3 recomendaram, mas, na sequ=C3=AAncia, ampli= am o uso incluindo os pacientes da FPI com capacidade vital for=C3=A7ada acima de 80% e estend= em tamb=C3=A9m a recomenda=C3=A7=C3=A3o para o tratamento da doen=C3=A7a pulmonar intersti= cial fibrosante progressiva, e os demais referenciais, selecionados no =C3=A2mbito desse es= tudo, indicam que diversos outros pa=C3=ADses tamb=C3=A9m deferiram o uso entre 2= 015, 2016 e 2017, reafirmada a decis=C3=A3o.

Assim sendo, enquanto o Estado brasileiro manteve-se inerte, o mapeamento indica os avan= =C3=A7os nas pol=C3=ADticas de concess=C3=B5es pelos pa=C3=ADses utilizados como nor= te pelo =C3=B3rg=C3=A3o nacional, e a inclus=C3=A3o da tecnologia por outros v=C3=A1rios pa=C3=ADse= s molda a discuss=C3=A3o acerca do reconhecimento da evid=C3=AAncia dos benef=C3=ADcios do medicamen= to em quest=C3=A3o.

Isso porque= =C3=A9 pouco prov=C3=A1vel que v=C3=A1rios pa=C3=ADses adotassem, conjuntamente, u= ma pol=C3=ADtica p=C3=BAblica de sa=C3=BAde temer=C3=A1ria. Dessarte, pela pr=C3=B3pria l=C3=B3gica dos f= atos apresentados, a necessidade da revis=C3=A3o do relat=C3=B3rio da ag=C3=AAncia nacional most= ra-se significativamente mais veross=C3=ADmil do que a exist=C3=AAncia de equ=C3= =ADvoco coletivo por parte das demais ag=C3=AAncias estrangeiras.

<= span style=3D'mso-bidi-font-weight:bold'> 

3 A AVALIA=C3=87=C3=83O DA EVID=C3=8ANCIA CIENT=C3=8DFICA E CUS= TO-EFETIVIDADE PELAS AG=C3=8ANCIAS DE TECNOLOGIA EM SA=C3=9ADE ESTRANGEIRAS=C2=A0

<= b> 

A negativa = do pedido de concess=C3=A3o judicial do f=C3=A1rmaco fundamenta-se no baixo n= =C3=ADvel de evid=C3=AAncia cient=C3=ADfica e na incompatibilidade de custo-efetividade = frente =C3=A0s diretrizes or=C3=A7ament=C3=A1rias. Tanto a falta de evid=C3=AAncia como a = aus=C3=AAncia de custo-efetividade s=C3=A3o baseadas, principalmente, no Relat=C3=B3rio n=C2= =BA 419/2018, bem como refor=C3=A7adas com base no condicionamento =C3=A0 redu=C3=A7=C3=A3o d= o custo imposto por alguns pa=C3=ADses, notadamente com fundamento nas decis=C3=B5es do Canad= =C3=A1 e do Reino Unido.

Ocorre que o condicionamento do fornecimento =C3=A0 redu=C3=A7=C3=A3o dos valores impost= os pelo Reino Unido e pelo Canad=C3=A1 ainda =C3=A9 diuturnamente mencionado nas decis=C3=B5es = judiciais, laudos periciais e, principalmente, em notas t=C3=A9cnicas, com a pretens=C3=A3o d= e refor=C3=A7ar a decis=C3=A3o contr=C3=A1ria ao fornecimento. Como, por exemplo, a Nota T=C3= =A9cnica n=C2=BA 3090 do Distrito Federal (2024, p. 18), emitida pelo Natjus que faz refer=C3=AAncia =C3=A0 ag=C3=AAncia National Institute for Health and = Care Excellence ao me= ncionar que as concess=C3=B5es =E2=80=9Cs=C3=A3o condicionadas =C3=A0 redu=C3=A7=C3= =A3o no custo de tais medicamentos=E2=80=9D. Todavia, os acordos comerciais realizados e as amplia=C3=A7=C3=B5es das con= cess=C3=B5es de uso s=C3=A3o sempre omitidos.

As leituras= das recomenda=C3=A7=C3=B5es iniciais de algumas ag=C3=AAncias de fato mostram q= ue o deferimento do tratamento estava atrelado =C3=A0 redu=C3=A7=C3=A3o dos valores, devido ao = alto custo do medicamento. Entretanto, a restri=C3=A7=C3=A3o j=C3=A1 foi resolvida median= te acordos comerciais com o respectivo laborat=C3=B3rio, a exemplo do Reino Unido, da = Esc=C3=B3cia, da Austr=C3=A1lia e do Canad=C3=A1 (Reino Unido, 2016; Esc=C3=B3cia, 2021; = Austr=C3=A1lia, 2016; Canad=C3=A1, 2016).

Sendo assim= , a men=C3=A7=C3=A3o do acordo de redu=C3=A7=C3=A3o de pre=C3=A7o, sem levar em= considera=C3=A7=C3=A3o um contexto mais amplo da pol=C3=ADtica adotada por cada Estado, pode levar a equ=C3=AD= vocos na interpreta=C3=A7=C3=A3o da cl=C3=A1usula, como sendo uma circunst=C3=A2ncia= desfavor=C3=A1vel, quando na verdade a condi=C3=A7=C3=A3o =C3=A9 que possibilitou a incorpora=C3=A7=C3= =A3o dos medicamentos de alto custo nesses Estados.

O caso da Irlanda =C3=A9 um exemplo claro dos efeitos positivos da exig=C3=AAncia da = redu=C3=A7=C3=A3o de custo, mesmo a ag=C3=AAncia <= span class=3DSpellE>National Centre for Pharmacoeconomics (NCPE) entendendo que o custo-efetividade = n=C3=A3o era apropriado no pre=C3=A7o original (Irlanda, 2016). Entretanto, o =C3=B3= rg=C3=A3o executivo Health Serv= ice Executive incluiu o f=C3=A1= rmaco posteriormente na lista de medicamentos reembols=C3=A1veis mediante acordo comercial (Irlanda, 2017). =

O =C3=AAxit= o das tratativas comerciais no estrangeiro indica que o Estado Brasileiro n=C3=A3= o envidou esfor=C3=A7os suficientes para negociar a redu=C3=A7=C3=A3o do pre=C3=A7o, = que teria inclusive vantagem devido ao fato da soma da popula=C3=A7=C3=A3o do Reino Unido englo= bada pela National Institute= for Health and Care Excellence, com cerca 65 milh=C3=B5es habitantes,= a Esc=C3=B3cia com aproximadamente 5 milh=C3=B5es de habitantes, o Canad=C3=A1 pr=C3=B3xim= o de 40 milh=C3=B5es de habitantes e a Austr=C3=A1lia com cerca 27 milh=C3=B5es de habitantes, que = atinge em torno de 138 milh=C3=B5es de pessoas, =C3=A9 significativamente menor que a= popula=C3=A7=C3=A3o do Brasil, estimada em mais de 200 milh=C3=B5es de habitantes. Essa disparidade demogr=C3=A1fica posiciona o mercado brasileiro como um cen=C3=A1rio altame= nte promissor para as ind=C3=BAstrias farmac=C3=AAuticas.

Al=C3=A9m d= isso, a rela=C3=A7=C3=A3o dos pa=C3=ADses que passaram a custear o medicamento sina= liza tamb=C3=A9m que n=C3=A3o somente as grandes economias mundiais, mencionadas com frequ=C3=AAncia, com= o o Reino Unido e o Canad=C3=A1, mas diversos outros pa=C3=ADses com dota=C3=A7=C3=B5= es or=C3=A7ament=C3=A1rias menores, quando comparados com o Estado brasileiro, igualmente incorporam a tecnologia. Esse fato enfraquece a tese da aus=C3=AAncia de custo-efetivida= de, dado que esse indicador =C3=A9 medido levando-se em conta a dimens=C3=A3o econ= =C3=B4mica dos Estados.

Outrossim, ainda cabe lembrar que os medicamentos voltados ao tratamento de doen=C3=A7= as raras dificilmente ser=C3=A3o custo-efetivo quando comparados aos medicamentos em= geral, em raz=C3=A3o do mercado restrito, por isso a avalia=C3=A7=C3=A3o deve obse= rvar a natureza da doen=C3=A7a em tela, que =C3=A9 a particularidade que fundamenta a flexibil= iza=C3=A7=C3=A3o dos crit=C3=A9rios para o deferimento.

J=C3=A1 em rela=C3=A7=C3=A3o aos ob= st=C3=A1culos relacionados =C3=A0s incerteza= s, caracter=C3=ADsticas dos medicamentos voltados =C3=A0s doen=C3=A7as raras, = houve a recomenda=C3=A7=C3=A3o da incorpora=C3=A7=C3=A3o mediante o acordo de geren= ciamento de riscos, como o Jap=C3=A3o (Market Expansion Repricing System), a It=C3=A1lia (Payment-by-Result), o Reino= Unido (Patient Access Schemes with a Stopping Rule), e a Fran=C3=A7a (Accord Prix-Volume/= M=C3=A9dicament d'exception) (Jap=C3=A3o, 2015; It=C3=A1lia, 2024; R= eino Unido, 2016; Fran=C3=A7a, 2016).

Al=C3=A9m disso, as ag=C3=AAncias, = tais como a do Reino Unido, da Austr=C3=A1lia, do Canad=C3=A1, da Esc=C3=B3cia ou da Alema= nha atribu=C3=ADram relev=C3=A2ncia no momento da decis=C3=A3o =C3=A0 gravidade da doen=C3=A7a = (Severity Modifie/End-of-Life Criteria= ) e =C3=A0 falta de alternativas para decidirem pela recomenda=C3=A7=C3=A3o (Au= str=C3=A1lia, 2016; Canad=C3=A1, 2016; Esc=C3=B3cia, 2015; Alemanha, 2015).

Portanto, nota-se que v=C3=A1rias ag=C3=AAncias sopesaram a raridade/gravidade da doe= n=C3=A7a para aprovarem o medicamento diante da aus=C3=AAncia de outros tratamentos. Entr= etanto, segue-se que as decis=C3=B5es que negam o fornecimento do medicamento usam = como fundamento o baixo n=C3=ADvel de evid=C3=AAncia cient=C3=ADfica, sem levar = em considera=C3=A7=C3=A3o que os medicamentos voltados =C3=A0s doen=C3=A7as raras na maioria dos casos n= =C3=A3o alcan=C3=A7am a alta evid=C3=AAncia cient=C3=ADfica pela sua pr=C3=B3pria natureza, pois ex= iste a dificuldade na realiza=C3=A7=C3=A3o de ensaios cl=C3=ADnicos em larga escala devido =C3= =A0 popula=C3=A7=C3=A3o pequena.

Assim sendo= , a l=C3=B3gica que permitiu a concess=C3=A3o nos pa=C3=ADses estrangeiros, con= forme Federhen et al. (2014), teve em mente que a realiza=C3=A7=C3=A3o de ensaios cl=C3=ADnicos com a dura=C3=A7=C3=A3o e o n= =C3=BAmero suficientes de pacientes no mesmo padr=C3=A3o das doen=C3=A7as de preval=C3=AAncia maior = =C3=A9 impratic=C3=A1vel nas doen=C3=A7as raras. Ademais, na maioria das vezes, n=C3=A3o existe outro me= dicamento similar para fins de compara=C3=A7=C3=A3o, sem contar que os custos dos med= icamentos s=C3=A3o altos quando comparados com os medicamentos convencionais, pois os gastos s= =C3=A3o dilu=C3=ADdos entre uma popula=C3=A7=C3=A3o menor, por isso =C3=A9 pouco pr= ov=C3=A1vel que o medicamento para doen=C3=A7as raras seja custo-efetivo.

Desse modo,= a an=C3=A1lise das decis=C3=B5es estrangeiras na implementa=C3=A7=C3=A3o da p= ol=C3=ADtica de distribui=C3=A7=C3=A3o da tecnologia mostra que o entrave inicial do custo do medicamento foi romp= ido mediante acordos comerciais. J=C3=A1 o empecilho decorrente das incertezas, inerentes ao tratamento de doen=C3=A7as raras, foi minimizado mediante acor= do de gerenciamento de riscos e, principalmente, foram levadas em considera=C3=A7= =C3=A3o a gravidade da doen=C3=A7a e a falta de alternativas, o que assinala os esfor= =C3=A7os dos Estados estrangeiros no intuito de integrar o medicamento =C3=A0s respectiv= as pol=C3=ADticas.

O ministro Gilmar Mendes julgou pela proced=C3=AAncia do pedido do medicamento Zolgensma para a faixa et=C3=A1ria diferente da recom= endada pela CONITEC, ao fundamentar que:

&nbs= p;

[...] Dev= ido =C3=A0 raridade e complexidade dessas condi=C3=A7=C3=B5es, na maioria das vezes h= =C3=A1 escassez de tratamentos dispon=C3=ADveis e cada op=C3=A7=C3=A3o terap=C3=AAutica repres= enta uma esperan=C3=A7a significativa para os pacientes e suas fam=C3=ADlias. Estudos cient=C3=ADfi= cos de alto n=C3=ADvel de evid=C3=AAncia devem ser sazonalmente re= visitados pelo =C3=B3rg=C3=A3o de recomenda=C3=A7=C3=A3o, sob pena de engessamento e obsol= =C3=AAncia administrativos e descasamento do tratamento na rede p=C3=BAblica e privada de sa=C3=BAdes, t= razendo desrespeito ao direito fundamental =C3=A0 sa=C3=BAde. (Brasil, 2025b, p. 20)

=  

No mesmo sentido, a situa=C3=A7=C3=A3o do medicamento sob exame apresenta bases sufi= cientes para a revis=C3=A3o, pois a decis=C3=A3o exarada no Relat=C3=B3rio n=C2=BA 419/201= 8, de n=C3=A3o recomenda=C3=A7=C3=A3o, indica que a ag=C3=AAncia brasileira deixou de acompanhar os avan=C3=A7os d= as diversas ag=C3=AAncias cong=C3=AAneres. Ademais, cabe a reflex=C3=A3o sobre se a pos= i=C3=A7=C3=A3o do Estado brasileiro =C3=A9 ainda razo=C3=A1vel, sustent=C3=A1vel e aceit=C3=A1vel ao= negligenciar a revis=C3=A3o do relat=C3=B3rio emitido em 2018, frente aos fundamentos e =C3=A0s estrat= =C3=A9gicas adotadas, que levaram v=C3=A1rias ag=C3=AAncias estrangeiras a recomendarem= a concess=C3=A3o.

Por fim, cumpre lembrar que = a Portaria n=C2=BA 86, de 24 de dezembro = de 2018, que tornou p=C3=BAblica a decis=C3=A3o de n=C3=A3o incorporar o OFEV (Nintedanibe) para o tratamento da FPI no =C3=A2mbito do Sistema =C3=9Anico de Sa=C3=BAde= =E2=80=93 SUS, no seu artigo 3=C2=BA disp=C3=B5e que: =E2=80=9CA mat=C3=A9ria poder=C3=A1 ser sub= metida a novo processo de avalia=C3=A7=C3=A3o pela CONITEC caso sejam apresentados fatos novos que po= ssam alterar o resultado da an=C3=A1lise efetuada=E2=80=9D (Brasil, 2= 018c).

 

CONSIDERA=C3=87=C3=95ES FINAIS

 

O pr=C3=B3p= rio Relat=C3=B3rio n=C2=BA 419/2018 informa que n=C3=A3o existe medicamento vol= tado ao tratamento da FPI incorporado =C3=A0 lista do RENAME. Assim sendo, n=C3=A3o restam d= =C3=BAvidas de que esses pacientes est=C3=A3o exclu=C3=ADdos do Sistema =C3=9Anico de Sa=C3=BA= de (SUS).

A pesquisa mostrou que, entre 2015, 2016 e 2017, o medicamento em quest=C3=A3o j=C3=A1= havia sido recomendado por diversas Ag=C3=AAncias de Tecnologia em Sa=C3=BAde no estra= ngeiro, e, desde ent=C3=A3o, o oferecimento do tratamento vem sendo ampliado, seja para alcan=C3=A7ar outras faixas de portadores da doen=C3=A7a em quest=C3=A3o, a= exemplo do Reino Unido e da Esc=C3=B3cia em 2023, seja para englobar, entre 2021 e 2022, out= ras doen=C3=A7as pulmonares.

Entretanto,= no Brasil, desde a elabora=C3=A7=C3=A3o do primeiro Relat=C3=B3rio em 2018, n= =C3=A3o houve a revis=C3=A3o do processo de incorpora=C3=A7=C3=A3o do medicamento OFEV (Nintedabine).=C2=A0 Por isso verifica-se que o Estado = brasileiro n=C3=A3o acompanhou a din=C3=A2mica de expans=C3=A3o das recomenda=C3=A7=C3= =B5es ocorridas em v=C3=A1rios pa=C3=ADses, inclusive naqueles que s=C3=A3o utilizados como refer=C3=AAnci= a para fundamentar diversos relat=C3=B3rios.

Como result= ado, verifica-se que, uma vez preenchidos os demais requisitos, existem fundamen= tos suficientes para o fornecimento judicial de medicamento no caso em quest=C3= =A3o, =C3=A0 luz da decis=C3=A3o do Supremo Tribunal Federal, devido =C3=A0 omiss=C3=A3o= da ag=C3=AAncia respons=C3=A1vel, que adota uma postura est=C3=A1tica, mesmo diante da posi= =C3=A7=C3=A3o contr=C3=A1ria do Estado Brasileiro frente =C3=A0s diversas Ag=C3=AAncias de Tecnologia em= Sa=C3=BAde estrangeiras.

 

REFER=C3=8ANCIAS

 

ALEMANHA. Gemeinsamer Bundesausschuss (G-BA). Beschluss =C3=BCber die =C3= =84nderung der Arzneimittel-Richtlinie: Anlage XII - Nutzenbewertung von = Nintedanib (Nutzenbewertungsverfahren: Idiopathische Lungenfibrose). Berlin: G-BA, 2015. Dispon=C3= =ADvel em: https://www.g-ba.de/downloads/39-261-2322/2015-09-03_AM-RL-XII_Nintedanib_n= AWG_2015-03-15-D-156_BAnz.pdf. Acesso em: 30 dez. 2025.

 

ALEMANHA. Gemeinsamer Bundesausschuss (G-BA). Nutzenbewertungsverfahren zum Wirkstoff Nintedanib (Neues Anwendungsgebiet: Chronische= progredient fibrosierende= interstitielle Lungenerkrankunge= n). Berlim: G-BA, 2021. Dispon=C3=ADvel em: https://www.g-ba.de/bewertungsverfahren/nutzenbewertung/578/. Acesso em: 30 dez. 2025.

 

AMARAL, Alexandre Franco; COLARES, Philippe de Figueiredo Braga; KAIRALLA, Ronaldo Adib. Idiopathic pulmonary fibrosis: current diagnosis and treatment. Jornal Brasileiro de Pneumologia,= [s. l.], v. 49, n. 4, p. 1-14, 2023. Dispon=C3=ADvel em: https://www.jornaldepneumologia.com.br/Content/imagebank/pdf/2023_49_4_3847= _english.pdf. Acesso em: 5 jan. 2026.

 

AUSTR=C3=81= LIA. Department of Health. Pharmaceutical Benefits Advisory Committee. Public Summary Document: nintedanib, capsule, 100 mg and 150 m= g (as esilate), Ofev=C2=AE - Ma= rch 2016 PBAC Meeting. Canberra: Australian Government, 2016. Dispon=C3=ADvel em: https://www.pbs.gov.au/industry/pbac/psd/2016/03/= nintedanib-psd-march-2016. Acesso em: 27 dez. 2025.

 =

AUSTR=C3=81= LIA. The Pharmaceutical Benefits Scheme (PBS). Improving access to medicines =E2=80=93 New medicines added to the Pharmaceutical Ben= efits Scheme. Canberra: Australian Government, 2022.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 Dispon=C3=ADvel=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0 em: https://www.health.gov.au/sites/default/files/documents/2022/03/budget-2022= -23-new-medicines-added-to-the-pharmaceutical-benefits-scheme.pdf

. Acesso em: 27 dez. 2025.

 

=C3=81USTRIA. Hauptverband d= er =C3=B6sterreichischen Sozialvers= icherungstr=C3=A4ger. Amtliche Verlautbar= ung Nr. 174/2015: 132. =C3=84nderung des Erstattungskodex (EKO). Wien: Rec= htsinformationssystem des Bundes (RIS), 2015. p. 6. = Dispon=C3=ADvel em: https://ris.bka.gv.at/Dokumente/Avsv/AVSV_2015_0174/AVSV_2015_0174.pdf. Acesso em: 29 dez. 2025.

 

B=C3=89LGICA. Rijksinstituut= voor Ziekte- en Invaliditeitsverzekering (RIZIV/INAMI). Vergoeding van geneesmidde= len: nintedanib (Ofev). Bruxelas: RIZIV, 2016. Dispon=C3=ADvel em: https://www.riziv.fgov.be. Acess= o em: 30 dez. 2025.

 

= BRASIL. C=C3=A2mara dos Deputados. Congresso Nacional se ilumina de azul po= r sa=C3=BAde pulmonar. Assessoria de Imprensa, Bras=C3=ADlia, DF, 12 set. 2025a. Dispon=C3=ADvel em: https://www.camara.leg.br/assessoria-de-imprensa/1199681-congresso-nacional= -se-ilumina-de-azul-por-saude-pulmonar/. Acesso em: 21 abr. 2026.

 

BRASIL. Conselho Nacional De Justi=C3=A7a. NatJus: N=C3=BAcleos de Ap= oio T=C3=A9cnico do Judici=C3=A1rio. Dispon=C3=ADvel em: www.cnj.jus.br. Acesso em: 26 fev. = 2026.

 

BRASIL. Minist=C3=A9rio da Sa=C3=BAde. Portaria n=C2=BA 199, de 30 de janeiro de 2014. Institui a Pol= =C3=ADtica Nacional de Aten=C3=A7=C3=A3o Integral =C3=A0s Pessoas com Doen=C3=A7as Rar= as, aprova as Diretrizes para Aten=C3=A7=C3=A3o Integral =C3=A0s Pessoas com Doen=C3=A7as Raras no = =C3=A2mbito do Sistema =C3=9Anico de Sa=C3=BAde (SUS) e institui incentivos financeiros de custeio. Di=C3= =A1rio Oficial da Uni=C3=A3o: se=C3=A7=C3=A3o 1, Bras=C3=ADlia, DF, n. 22, p. 44-54, 3= 1 jan. 2014.

 

BRASIL. Minist=C3=A9rio da Sa=C3=BAde. Comiss=C3=A3o Nac= ional de Incorpora=C3=A7=C3=A3o de Tecnologias no Sistema =C3=9Anico de Sa=C3=BAde (= CONITEC). Esilato de nintedanibe<= /span> para o tratamento de fibrose pulmonar idiop=C3=A1tica. Relat=C3=B3rio d= e Recomenda=C3=A7=C3=A3o n=C2=BA 419. Bras=C3=ADlia: Minist=C3=A9rio da Sa=C3=BAde, 2018a. Dispon=C3=ADvel em: https://www.gov.br/conitec/pt-br/midias/relatorios/2018/relatorio_nintedani= befpi.pdf/@@display-file/file. Acesso em: 30 dez. 2025.

 

BRASIL. Minist=C3=A9rio da Sa=C3=BAde. Comiss=C3=A3o Nac= ional de Incorpora=C3=A7=C3=A3o de Tecnologias no Sistema =C3=9Anico de Sa=C3=BAde (= CONITEC). Pirfenidona para o tratamento de fibr= ose pulmonar idiop=C3=A1tica (FPI). Relat=C3=B3rio de Recomenda=C3=A7=C3=A3= o n=C2=BA 420. Bras=C3=ADlia: Minist=C3=A9rio da Sa=C3=BAde,=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 2018b. Dispon=C3=ADvel em: https://www.gov.br/conitec/pt-br/midias/relatorios/2018/relatorio_pirfenido= nafpi.pdf/@@display-file/file. Acesso em: 2 jan. 2026.

 

BRASIL. Minist=C3=A9rio da S= a=C3=BAde. Secretaria de Ci=C3=AAncia, Tecnologia e Insumos Estrat=C3=A9gicos. Portaria n=C2=BA 86, de 24 de dezembro = de 2018. Torna p=C3=BAblica a decis=C3=A3o de n=C3=A3o incorporar o nintedanibe para o tratamento da fibrose pulmonar idiop=C3=A1tica no =C3=A2mbito do Sis= tema =C3=9Anico de Sa=C3=BAde - SUS. Di=C3=A1rio Oficial da Uni=C3=A3o: se=C3=A7=C3=A3o= 1, Bras=C3=ADlia, DF, n. 248, p. 119, 26 dez. 2018c. Dispon=C3=ADvel em: https://www.gov.br/conitec/pt-br/midias/relatorios/portaria/2018/portariass= ctie_86a88_2018.pdf/@@display-file/file. Acesso em: 27 jan. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5003166-34.2022.4.03.6314<= /b>. Relator: Des. Monica Autran Machado Nobre, julgado em 27 jun. 2023. Dispon=C3=ADvel em: h= ttps://web.trf3.jus.br/jurisprudencia/Home/ListaColecao/9?np=3D4. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5018147-65.2021.4.03.6100<= /b>. Relator: Des. Marli Marques Ferreira, julgado em 29 nov. 2022. Dispon=C3=ADvel em: https://web.= trf3.jus.br/jurisprudencia/Home/ListaColecao/9?np=3D3. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5007966-24.2020.4.03.6105<= /b>. Relator: Des. Andre Nabarrete Neto, jul= gado em 13 set. 2022. Dispon=C3=ADvel em: https://web.trf3.jus.br/jurisprudencia/Ho= me/ListaColecao/9?np=3D1. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3=A1ria n=C2=BA 5001983-80.20= 21.4.03.6114. Relator: Des. Marli Marques Ferreira, julgado em 7 jan. 2022. Dispon=C3=ADv= el em: https://web.trf3.jus.br/jurisprudencia/Home/ListaColecao/9?np=3D1. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Reexame Necess=C3=A1rio n=C2=BA 5003120-51.20= 17.4.03.6110. Relator: Des. Marcelo Mesquita Saraiva, julgado em 3 fev. 2020. Dispon=C3= =ADvel em: https://web.trf3.jus.br/jurisprudencia/Home/ListaColecao/9?np=3D= 1. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3=A1ria n=C2=BA 5004489-28.20= 22.4.03.6103. Relator: Des. Luiz Alberto De Souza Ribeiro, julgado em 14 ago. 2023. Dispo= n=C3=ADvel em: https://web.trf3.jus.br/jurisprudencia/Home/ListaColecao/9?np=3D2. Aces= so em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma).=C2=A0 Agravo De Instrumento n=C2=BA 5002240-75.2025.4.03.0000. Relato= r:=C2=A0 Desembargador Federal Wilson Zauhy Filho, julgado em 27 out. 2025. Dispon=C3=ADvel= em: https://web.trf3.jus.br/acordaos/Acordao/BuscarDocumentoPje/340688219. Aces= so em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o= (6=C2=AA= Turma). Apela=C3=A7=C3=A3o C=C3=ADvel n=C2= =BA 5073516-97.2016.4.04.7100/RS. Relator: Alexandre Gon=C3=A7alves Lippel, julgado em 13 fev. 2019. Dispon=C3=ADvel em: = < https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao= =3Djurisprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudenci= a=3D41731548350738449936516382395&termosPesquisados=3DZmlicm9zZXxwdWxtb= 25hcnxpZGlvcGF0aWNh>. Acesso em: Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o= (6=C2=AA= Turma). Apela=C3=A7=C3=A3o/Remessa Necess= =C3=A1ria n=C2=BA 5003491-29.2016.4.04.7110/RS. Relatora: Ta=C3=ADs Schilling Ferraz, jul= gado em 15 abr. 2019. Dispon=C3=ADvel em: < https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 731529706307359884505841219&termosPesquisados=3Db2ZldnxmaWJyb3NlfHB1bG1= vbmFyfGlkaW9wYXRpY2F8Zmlicm9zZXxwdWxtb25hcnxpZGlvcGF0aWNh>. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal 4=C2=AA Regi=C3=A3o (9= =C2=AA Turma). Agravo de Instrumento n=C2= =BA 5045523-68.2018.4.04.0000. Relator: Des. Federal Paulo Afonso Brum Vaz,= julgado em 5 jun. 2019. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 731520529954874593272980749&termosPesquisados=3Db2ZldnxmaWJyb3NlfHB1bG1= vbmFyfGlkaW9wYXRpY2E=3D. Acesso em: Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o= (9=C2=AA Turma). Agravo de Instrumento n=C2= =BA 5022507-51.2019.4.04.0000. Relator: Celso Kipper, julgado em 18 set. 2019. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 731465354731134900395315537&termosPesquisados=3Db2ZldnxwdWxtb25hcnxmaWJ= yb3NlfGlkaW9wYXRpY2F8Zmlicm9zZXxwdWxtb25hcnxpZGlvcGF0aWNh. Acesso em: Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o= (5=C2=AA Turma). Agravo de Instrumento n=C2= =BA 5034712-15.2019.4.04.0000. Relatora: Gisele Lemke, julgado em 17 dez. 2= 019. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 731465354731134908848639642&termosPesquisados=3Db2ZldnxwdWxtb25hcnxmaWJ= yb3NlfGlkaW9wYXRpY2F8b2Zldg=3D=3D Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o= (9=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3=AD= vel n=C2=BA 5009440-72.2018.4.04.7204/SC. Relator: Sebasti=C3=A3o Og=C3=AA Muniz, julgado em 20 jul. 2020. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 731030732641494292446674235&termosPesquisados=3DZmlicm9zZXxpZGlvcGF0aWN= hfG9mZXZ8Zmlicm9zZXxpZGlvcGF0aWNh. Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o= (5=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3=AD= vel n=C2=BA 5004237-42.2021.4.04.7102/RS. Relatora: Adriane Battisti, julgado em 19 set. 2023. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 731030732641494292446674235&termosPesquisados=3DZmlicm9zZXxpZGlvcGF0aWN= hfG9mZXZ8Zmlicm9zZXxpZGlvcGF0aWNh. Acesso em: Acesso em: 23 dez. 2025.

 

BRASIL. Tribunal Regional Federal da 4=C2= =AA Regi=C3=A3o (12=C2=AA Turma). =C2=A0A=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 500= 4703-82.2020.4.04.7001. Relatora: Gisele Lemke, julgado em 13 jul. 2026a. Dispon=C3= =ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 784143981559991271075363001&termosPesquisados=3Db2ZldnxmaWJyb3NlfHB1bG1= vbmFyfGlkaW9wYXRpY2E=3D. Acesso em:=C2=A0 10 out. 2026.=

&nbs= p;

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (6=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3= =A1ria n=C2=BA 5005703-20.2023.4.03.6103. Relator. Juiz Federal Samuel De Castro Barbo= sa Melo, julgado em 20 jul. 2026b. Dispon=C3=ADvel= em: https://web.trf3.jus.br/acordaos/Acordao/BuscarDocumentoPje/387155498. Aces= so em: 10 out. 2026.

 

BRASIL. = Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (4=C2=AA Turma). A=C3=A7=C3=A3o C=C3=ADvel = n=C2=BA 5009776-08.2020.4.04.7107. Relator: Marcos Roberto Araujo Dos Santos, julgado em 22 jul. 2026c. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 784767368302076576441049696&termosPesquisados=3Db2ZldnxmaWJyb3NlfHB1bG1= vbmFyfGZpYnJvc2V8cHVsbW9uYXI=3D. Acesso em: 10 out. 2026.

 

BRASIL. = Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa N= ecess=C3=A1ria n=C2=BA 5005677-64.2021.4.04.7105. Relator: Carlos Eduardo Thompson Flores Lenz= , julgado em 5 ago. 2026d. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 785956434406686851495895018&termosPesquisados=3DZmlicm9zZXxwdWxtb25hcnx= vZmV2fGZpYnJvc2V8cHVsbW9uYXI=3D. Acesso em: 10 out. 2026.

 

BRASIL. = Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa N= ecess=C3=A1ria n=C2=BA 5000753-42.2023.4.04.7104. Relator: Lu=C3=ADs Alberto D Azevedo Aurvalle, julgado em 5 ago. 2026= e. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/download_inteiro_teor&id_jurisprudencia=3D41= 785950806474288541235914556&termosPesquisados=3DZmlicm9zZXxwdWxtb25hcnx= vZmV2fGZpYnJvc2V8cHVsbW9uYXI=3D. Acesso em: 10 out. 2026.

 

BRASIL. = Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (11=C2=AA Turma). A=C3=A7=C3=A3o C= =C3=ADvel n=C2=BA 5006628-40.2021.4.04.7208. Relator: S=C3=A9rgio Renato Tejada Garcia, j= ulgado em 13 ago. 2026f. Dispon=C3=ADvel em: https://eproc-jur.trf4.jus.br/eproc2trf4/externo_controlador.php?acao=3Djur= isprudencia@jurisprudencia/listar_resultados. Acesso em: 10 out. 2026.

 

BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= . (Turma Regional de Mato Grosso do Sul). A= pela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5001417-17.2023.4.03.6000. Relator: Desembargador Fe= deral Jean Marcos Ferreira, julgado em 07 out. 2026g. Disp= on=C3=ADvel em: https://web.trf3.jus.br/acordaos/Acordao/BuscarDocumentoPj= e/402762467. Acesso em: 10 out. 2026.

 

BRASIL. Supremo Tribunal Federal. Recurso Extraordin=C3=A1rio n=C2=BA 566.471/RN. Tema 6 da Rep= ercuss=C3=A3o Geral. Relator: Min. Marco Aur=C3=A9lio. Fixa=C3=A7=C3=A3o da tese: 20 set.= 2024. Dispon=C3=ADvel em: https://portal.stf.jus.br/processos/detalhe.asp?incidente=3D2565078. Ac= esso em: 30 dez. 2025.

 

BRASIL. Supremo Tribunal Federal. Reclama=C3=A7=C3=A3o 75.188 Distrito Federal. Reclamante: Uni= =C3=A3o. Reclamado: Juiz Federal da 21=C2=AA Vara Federal C=C3=ADvel da Se=C3=A7=C3=A3o Judici= =C3=A1ria do Distrito Federal. Benefici=C3=A1rio: C. C. N. Relator: Min. Gilmar Mendes, julgado em 31 jan.= 2025b. Dispon=C3=ADvel em: https://portal.stf.jus.br/processos/detalhe.asp?incidente=3D7142125. Acesso= em: 2 jan. 2026.

 

CANAD=C3=81. Cana= dian Agency for Drugs and Technologies in Health (CADTH). Canadian Drug Expert Committee Final Recommendation. Nintedanib (SR0426). Ottawa: CADTH, September 16, 2015. = Dispon=C3=ADvel em: https://www.cda-amc.ca/sites/default/files/cdr/complete/SR0654%20Ofev%2= 0-%20Final%20CDEC%20Recommendation%20February%2026%2C%202021For%20Posting.p= df. Acesso em: 27 dez. 2025.=

 

CANAD=C3=81. Pan-Canadian Pharmaceutical Alliance. Pan-= Canadian Pharmaceutical Alliance: Completed Negotiations as of September 30, 2016. <= /span>= [S. l.]: pCPA, 2016. Dispon=C3=ADvel em: https://canadaspremiers.ca/wp-content/uploads/2014/11/pcpa_completed_negoti= ations_sept30_2016.pdf. Acesso em: 27 dez. 2025.

 

CANAD=C3=81. Canadian Agency for Drugs and Technologies in Health (CADTH). Drug Reimbursement= Recommendation Nintedanib<= /span> (Ofev). Ottawa: CADTH, 20 January 2021. Dispon=C3=ADvel=C2=A0 em:=C2= =A0=C2=A0=C2=A0 https://www.cda-amc.ca/sites/default/files/cdr/c= omplete/SR0654%20Ofev%20-%20Final%20CDEC%20Recommendation%20February%2026%2= C%202021For%20Posting.pdf. Acesso em: 27 dez. 2025.

 

CANAD=C3=81= . Institut National D'excellence en Sant=C3=A9 et en Servi= ces Sociaux. = OFEV MC =E2=80=93 Fibrose pulmonaire idiopathique. Qu=C3=A9bec: INESSS, Mars 2017. Dispon=C3=ADvel em: https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_= au_ministre/Juin_2017/Ofev_Modification_critere_2017_06.pdf. Acesso em: 27 dez. 2025.

=C2=A0

CHUA, Felix= et al. Pharmacoeconomic Inequity in Accessing Antifibrotic Treatment for Interstitial Lung Diseases. Tuberculosis and Respiratory Diseases= , [s. l.], v. 88, n. 1, p. 12-21, 2025. Dispon=C3=ADvel em: https://pmc.ncbi.nlm.nih.gov/articles/PMC12488351/. Acesso em: 1 jun. 2026.=

 

CRO=C3=81CIA. Hrvatski zavod za zdravstveno osiguranje (HZZO). Osnovna lista lijekova: nintedanib (Ofev). Zagreb: HZZO, 2016. Dispon=C3=AD= vel em: https://hzzo.hr/poslovni-subjekti/zdravstvena-zastita/lijeko= vi/objavljene-liste-lijekova/arhiva-liste-lijekova. Acesso em: 26 fev. 2026.

 

DINAMARCA. Medicinr=C3=A5det. Behandlingsvejledning og anbefaling vedr=C3=B8rende l=C3=A6gemidler<= /span> til idiopatisk pulmonal fibro= se (IPF). Copenhagen: Medicinr=C3=A5det, 2023. Dispon=C3= =ADvel em: https://www.regioner.dk/media/1576/ofev-mini-mtv-1.pdf. Acesso em: 25 fev. 2024.

 

DISTRITO FEDERAL (Territ=C3=B3rio). Tribunal de Justi=C3= =A7a do Distrito Federal e dos Territ=C3=B3rios. N=C3=BAcleo de Apoio T=C3=A9cnico = do Poder Judici=C3=A1rio. Nota T=C3=A9cnica= n=C2=BA 3090: medicamento esilato de nin= tedanibe (Ofev) para fibrose pulmonar idiop=C3=A1tica. B= ras=C3=ADlia: TJDFT, [2024]. Dispon=C3=ADvel em: tjdft.jus.br. Acesso em: 1 jun. 2026.

 

ESC=C3=93CI= A. Scottish Medicines Consortium (SMC). Nintedanib (Ofev) SMC 1076/15. Edinburgh: Scottish Medicines Consortium, 2015. = Dispon=C3=ADvel em: https://scottishmedicines.org.uk/media/2044/nintedanib__ofev__final_sep= tember_2015_amended_061015_for_website.pdf. Acesso em: 27 dez. 2025.

 

ESC=C3=93CIA. Scottish Medicines Consortium (SMC). Medicine: ninted= anib (brand name: Ofev= =C2=AE). Edinburgh: Scottish Medicines Consortium, jun. 2021. Dispon=C3=ADvel em: https://scottishmedicines.org.uk/media/6033/nintedanib-ofev.pdf. Acesso em:= 27 dez. 2025.

 

ESC=C3=93CI= A. Scottish Medicines Consortium (SMC). Nintedanib (Ofev) SMC2513. Edinburgh, Scottish=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0 Medicines=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 Consortium,=C2=A0 mar.=C2=A0=C2=A0=C2=A0=C2=A0 2023. Dispon=C3=ADvel=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 em: https://scottishmedicines.org.uk/media/7449/nintedanib-ofev-resub-final-feb= -2023-for- website.pdf. Acesso em: 27 dez. 2025.

 

ESPANHA. Agencia Espa=C3=B1ola de Medicamentos y = Productos Sanitarios (AEMPS). Informe de Posicionamiento Terap=C3=A9utico de nintedanib (Ofev =C2=AE) para el tratamiento de la Fibrosis Pulmonar Idiop=C3=A1tica. Madrid: AEMPS,= 2015. Dispon=C3=ADvel em: https://www.vademecum.es/lista-IPT-46. Acesso em: 27 de= z. 2025.

 

FEDERHEN, A. et al. Pesquisa cl=C3=ADnica e doe= n=C3=A7as raras: a situa=C3=A7=C3=A3o no Brasil. Jornal Brasileiro de Economia da Sa=C3=BAde, [s.l.], v. 6, supl. 1, p. 17-23, dez. 2014. Dispon=C3=ADvel em: https: https://www.jbes.com.br/index.php/jbes/article/view/363/330. Acesso em: 20 jan. 2026.

 

FINL=C3=82NDIA. L=C3=A4=C3=A4kkeide= n hintalautakunta (Hila). <= span class=3DSpellE>P=C3=A4=C3=A4t=C3= =B6s nintedanibin (Ofev) korvattavuudesta ja tukkuhinnasta. Hel= sinki: Hila, 2015. Dispon=C3=ADvel em: https://www.hila.fi/o= fev-ja-ikervis-valmisteet-erityiskorvattaviksi/#:~:text=3DOfev%2Dvalmisteel= le,viitearvosta. Acesso em: 26 fev. 2024.

 

FRAN=C3=87A. Haute Autorit=C3=A9 de Sant=C3=A9 (HAS). Arr=C3= =AAt=C3=A9 du 13 janvier 2016 modifiant la liste des sp=C3=A9cialit=C3=A9s pharmaceutiques remboursab= les aux assur=C3=A9s sociaux. Saint-Denis La Plaine: HAS=C2=A0=C2=A0=C2=A0 19 janvier=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 2016.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 Dispon=C3=ADvel=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 em: h= ttps://www.legifrance.gouv.fr/jorf/id/JORFTEXT000031854168. Acesso em: 30 dez. 2025.

 

GR=C3=89CIA. Minist=C3=A9rio da Sa=C3=BAde. Decis=C3=A3o Ministerial de Inclus=C3=A3o na Lista Positiva de Med= icamentos Reembols=C3=A1veis (Ato n=C2= =BA =CE=935/=CE=BF=CE=B9=CE=BA.13547= ). Atenas: EOPYY/SFEE, fev. 2016. Dispon=C3=ADvel em: https://www.sfee.gr/wp-content/uploads/2016/02/fek416v19022016_thetikos-kat= alogos.pdf. Acesso em: 26 fev. 2026.

 

HOLANDA. Zorginstituut Nederland (ZIN). Nintedanib (Ofev) bij idiopathische pulmonale fibrose. Bet= reft GVS rapport 15/11: ninteda= nib (Ofev=C2=AE). Diemen: Zorginstituut Nederland, = aug. 2015. Dispon=C3=ADvel em: =C2=A0https://www.zorginstituutnederland.= nl/documenten/2015/06/22/nintedanib-ofev-bij-idiopathische-pulmonale-fibros= e. Acesso em: 27 dez. 2025.

 

HUNGRIA. Orsz=C3=A1gos Gy=C3=B3gyszer=C3=A9szeti =C3=A9s =C3=89lelmez=C3=A9s-eg=C3=A9szs=C3=A9g=C3=BCgyi Int=C3=A9zet (OGY=C3=89I). HTA nyilv=C3=A1nos =C3=B6sszef= oglal=C3=B3: Nintedan= ib (Ofev). Budapeste: OGY=C3=89I, 2016. Dispon=C3=ADvel em: https://ogyei.gov.hu/kiseroirat/hta/163_20_Ofev_150mg_SSc-ILD_nyilvanos%20o= sszefoglalo.pdf. Acesso em: 26 fev. 2026.

 

IRLANDA. National Centre for Pharmacoeconomics. Nintedanib (Ofev=C2=AE). HTA ID: 20034. Dubli= n: NCPE, 2016. Dispon=C3=ADvel em: https://www.ncpe.ie/nintedanib-ofev/#:~:text=3DNCPE%20Nintedanib% 20(Ofev%C= 2%AE)%20Assessment%20%7C%20National%20Centre%20for%20Pha= rmacoeconomics. Acesso em: 30 dez. 2025.

 

IRLANDA. National Centre for Pharmacoeconomics (NCPE). Nintedanib (Ofev). Dublin: NCPE, 2017. Dispon=C3=ADvel em: https://www.ncpe.ie/nintedanib-ofev= /. Acesso em: 3 jun. 2026.

 

IT=C3=81LIA. Agenzia Italian= a del Farmaco (AIFA). Determina n. 405/2016: Regime di rimborsabilit=C3=A0 e = prezzo del medicinale per uso umano =C2=ABOfev (nintedanib)=C2=BB. Roma: Gazzetta Ufficiale della Repubblica Italiana, n. 81, 7 abr. 2016. Dispon=C3=ADvel em: https://www.aifa.gov.it/-/pubblicazione-schede-di-monitoraggio-registro-ofe= v-11-04-2016-. Acesso em: 27 dez. 2025.

 

IT=C3=81LIA. Agenzia Italian= a del Farmaco (AIFA). Determina 10 ott= obre 2024, n. 570/2024: Rinegoziazione del medicinale per uso umano =C2=ABOfev=C2=BB, <= span class=3DGramE>ai sensi dell'articolo= 8, comma 10, della legge 24 dicembre 1993, n= . 537. (24A05766). Gazzetta Ufficiale della Repubblica Italiana, n. 259, 5 nov. 2024. Dispo= n=C3=ADvel em: https://gazzettaufficiale.biz/atti/2024/20240259/24A05766.htm. Acesso e= m: 2 jun. 2026.

 

JAP=C3=83O. Pharmaceuticals and Medical Devices Agency (PMDA). Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau Ministry of Health, Labour and Welfare. = T=C3=B3quio: PMDA, jun. 2015. Dispon=C3=ADvel em: https://www.pmda.go.jp/files/000214531= .pdf. Acesso em: Acesso em: 27 dez. 2025.

 

LUXEMBURGO. Caisse Nationale de Sant=C3=A9 (CNS). Liste positive des m=C3=A9dicaments: nintedanib (Ofev). Luxemburgo: CNS, 2026. Dispon=C3=ADvel em: https://cns.public.lu/fr/assure/= publications/legislations/textes-coordonnes/liste-positive.html. Acesso em: 04 out. 2026.

 

NORUEGA. Norwegian Medical Products Agency (DMP). Health technology assessment: nintedanib (Ofev). <= /span>= Oslo: DMP, [2016-2023]. Dispon=C3=ADvel em: https://www.nyemetoder.no/metoder/nintedanib-ofev-indikasjon-iii. Acesso em: 29 dez. 2025.

 =

NOVA ZEL=C3= =82NDIA. Pharmacology and Therapeutics Advisory Committee (PTAC). Respiratory Subcommittee of the Pharmacology and Therapeutics Advis= ory Committee (PTAC) Meeting held on 4 August 2017. = Wellington: Pharmac, 2021. Dispon=C3=ADvel em: https://www.pharmac.govt.nz/assets/ptac-respiratory-subcommittee-= minutes-2017-08.pdf. Acesso em: 27 dez. 2025.

 

PORTUGAL. Autoridade Nacional do Medicamento e Produtos = de Sa=C3=BAde (INFARMED). M-APH-003/6= 1 / 3 Relat=C3=B3rio de avalia=C3=A7=C3=A3o pr=C3=A9via do medicamento para uso h= umano em meio hospitalar. Lisboa: INFARMED, 2017a. Dispon=C3=ADvel em: ht= tps://www.infarmed.pt/web/infarmed/infarmed?p_p_id=3D101&p_p_lifecycle= =3D0&p_p_state=3Dmaximized&p_p_mode=3Dview&_101_struts_action= =3D%2Fasset_publisher%2Fview_content&_101_returnToFullPageURL=3Dhttps%3= A%2F%2Fwww.infarmed.pt%2Fweb%2Finfarmed%2Finfarmed%3Fp_auth%3DMjp0WGhQ%26p_= p_id%3D3%26p_p_lifecycle%3D1%26p_p_state%3Dnormal%26p_p_state_rcv%3D1&_= 101_assetEntryId=3D2010379&_101_type=3Ddocument&inheritRedirect=3Df= alse&redirect=3Dhttps%3A%2F%2Fwww.infarmed.pt%2Fweb%2Finfarmed%2Finfarm= ed%3Fp_p_id%3D3%26p_p_lifecycle%3D0%26p_p_state%3Dmaximized%26p_p_mode%3Dvi= ew%26_3_modifieddayTo%3D4%26_3_cur%3D1%26_3_modifiedyearTo%3D2026%26_3_entr= yClassName%3Dcom.liferay.portlet.documentlibrary.model.DLFileEntry%26_3_key= words%3Dofev%2B%2528nintedanib%2529%26_3_formDate%3D1791083303962%26_3_modi= fieddayFrom%3D3%26_3_format%3D%26_3_modifiedyearFrom%3D2026%26_3_modifiedfr= om%3D03%252F10%252F2026%26_3_documentsSearchContainerPrimaryKeys%3D20_PORTL= ET_2010376%252C15_PORTLET_2010536%252C20_PORTLET_8680948%252C20_PORTLET_123= 42948%252C20_PORTLET_8680922%252C20_PORTLET_2648571%252C15_PORTLET_1235837%= 252C20_PORTLET_2416747%252C20_PORTLET_2176886%252C20_PORTLET_2112257%252C20= _PORTLET_4481866%252C20_PORTLET_1235824%252C20_PORTLET_2761646%252C20_PORTL= ET_13473836%252C20_PORTLET_12592131%252C20_PORTLET_9887252%252C20_PORTLET_9= 887304%252C20_PORTLET_12584636%252C20_PORTLET_13184038%252C20_PORTLET_13474= 978%26_3_assetCategoryIds%3D%26_3_modifiedselection%3D0%26_3_assetTagNames%= 3D%26_3_modifiedmonthTo%3D9%26_3_modified%3D%26_3_modifiedmonthFrom%3D9%26_= 3_modifiedto%3D04%252F10%252F2026%26_3_struts_action%3D%252Fsearch%252Fsear= ch. Acesso em: 27 dez. 2025.

 

PORTUGAL. Autoridade Nacional do Medicamento e Produtos = de Sa=C3=BAde (INFARMED). Processos de Comparticipa=C3=A7=C3=A3o e de Avalia=C3=A7=C3=A3o Pr=C3=A9via. Lisboa:= INFARMED, 2017b. Dispon=C3=ADvel em: https://www.infarmed.pt/documents/15786/2112249/Processos_Comparticipacao_e= _Av aliacao_previa_1_trimestre/d25accf6-f933-4d1a-b15e-ae818e3da88f?%20Verso=3D1.0.

Acesso em: 27 dez. 2025.

 

PORTUGAL. Autoridade Nacional do Medicamento e Produtos = de Sa=C3=BAde (INFARMED). Relat=C3=B3= rio p=C3=BAblico de avalia=C3=A7=C3=A3o: Ofev (Nintedanib). =C2=A0Lisboa: INFARMED, 2022. Dispo= n=C3=ADvel em: https://www.infarmed.pt/documents/15786/3368817/Relat%C3%B3rio+de+avalia%C3= %A7%C3%A3o+de+financiamento+p%C3%BAblico+de+Ofev+%28nintedanib%291/ae0f5203= -a87d-4c3c-30de-a80873ccc065?version=3D1.0. Acesso em: 27 dez. 2025.

 =

REINO UNIDO. National Institute for Health and Care Excellence (NICE). Nintedanib for treating idiopathic pulmonary fibrosis (NICE guideli= ne TA379). London: NICE, jan. 2016. Dispon=C3=ADvel em: https://www.nice.org.uk/guidance/ta379/resources/nintedanib-for-treating-id= iopathic- pulmonary-fibrosis-pdf-82602797638597. Acesso <= span class=3DSpellE>em: 27 dez. 2025.

=C2=A0

REINO UNIDO. National Institute for Health and Care Excellence (NICE). Nintedanib for treating progressive fibrosing interstitial lung diseases (NICE guideline TA747). London: NICE, nov. 2021. Dispon=C3=ADvel em: https://www.nice.org.uk/guidance/ta379/resources/ninted= anib-for treatingidiopathic- pulmonary-fibrosis-pdf-826027976385= 97. Acesso em: 27 dez. 2025.

 

REINO UNIDO. National Institute for Health and Care Excellence (NICE). Nintedanib for treating idiopathic pulmonary fibrosis when forced v= ital capacity is above 80% predicted (NICE guideline TA864). = London: NICE, fev. 2023. Dispon=C3=ADvel em: https://www.nice.org.uk/guidance/ta379/resources/nintedanib-for-treatingidi= opathic- pulmonary-fibrosis-= pdf-82602797638597. Acesso em: 27 dez. 2025.

 

ROM=C3=8ANIA. Agen=C8=9Bia <= span class=3DSpellE>Na=C8=9Bional=C4=83 a Medicament= ului =C8=99i a Dispozitivelor = Medicale din Rom=C3=A2nia= (ANMDMR). Raport de evaluare a tehnologiilor medicale: <= span class=3DSpellE>nintedanib (Ofev). Bu= careste: ANMDMR, 2016. Dispon=C3=ADvel em: https://www.anm.ro/_/EVALUARE%20TEHNOLOGII%20MEDICALE/3791_Nintedanibum.pdf. Acesso em: 26 fev. 2026.

 

SU=C3=89CIA. Tandv=C3=A5rds-= och l=C3=A4kemedelsf=C3=B6rm=C3= =A5nsverket (TLV). Beslut om subvention av Ofev (nintedanib). Estocolmo: TLV, 2016. Dispon=C3=ADv= el em: https://www.tlv.se/beslut/beslut-lakemedel/generell-subventi= on/arkiv/2015-05-27-ofev-ingar-i-hogkostnadsskyddet.html. Acesso em: 29 dez. 2025.

 

SU=C3=8D=C3=87A. Bundesamt f=C3=BCr Gesundheit (BAG). Spec= ialities list (SL): Nintedanib (Ofev). Berna: BAG, 2015. Dispon=C3=ADvel e= m: https://www.bag.admin.ch/dam/it/sd-web/5fKseD86YEX5/ofev-neu= aufnahme-01.09.2015. Acesso em: 29 dez. 2025.

=  

 


* Doutora em Direito Internacional pela Universidade de S=C3=A3o Paulo (USP) e Mestre= em Direito Negocial pela Universidade Estadual de Londrina (UEL).

[1]= Ver: BRA= SIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o (4=C2=AA Turma). = Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5003166-34.2022.4.03.6314. Relator: Des. Monica Autr= an Machado Nobre, julgado em 27 jun. 2023; BRASIL. Tribunal Regional Federal da 3=C2= =AA Regi=C3=A3o (4=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3= =ADvel n=C2=BA 5018147-65.2021.4.03.6100. Relator: Des. Marli Marques Ferreira, julgad= o em 29 nov. 2022; BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o (4=C2=AA Turma). Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 500796= 6-24.2020.4.03.6105. Relator: Des. Andre Nabarr= ete Neto, julgado em 13 set. 2022; BRASIL. Tribunal Regional Federal da 3=C2=AA= Regi=C3=A3o (4. Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3=A1ria n=C2=BA 5001983-8= 0.2021.4.03.6114. Relator: Des. Marli Marques Ferreira, julgado em 07 jan. 2022; BRASIL. Trib= unal Regional Federal da 3=C2=AA Regi=C3=A3o (4=C2=AA Turma). = Apela=C3=A7=C3=A3o/Reexame Necess=C3=A1rio n=C2=BA 5003120-51.2017.4.03.6110. Relator: Des. Marcel= o Mesquita Saraiva, julgado em 03 fev. 2020; BRASIL. Tribunal Regional Federal da 3=C2= =AA Regi=C3=A3o (4. Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3=A1ria n=C2= =BA 5004489-28.2022.4.03.6103. Relator: Des. Luiz Alberto De Souza Ribeiro, julgado em 14 ago. 2023; BRASI= L. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (6=C2=AA Turma). = Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5073516-97.2016.4.04.7100/RS. Relator: Alexandre Gon=C3=A7alves Lippel. Julgado em: 13 fev. 2019; BRASIL. Tribunal Re= gional Federal da 4=C2=AA Regi=C3=A3o (6= =C2=AA Turma). = Apela=C3=A7=C3=A3o/Remessa Necess=C3= =A1ria n=C2=BA 5003491-29.2016.4.04.7110/RS. Relatora: Ta=C3=ADs Schilling Ferraz. Jul= gado em: 15 abr. 2019; BRASIL. Tribunal Regional Federal 4=C2=AA Regi=C3=A3o (9 Turm= a). Agravo de Instrumento n=C2=BA 5045523-68.2018.4.04.0000. Relator: Des. Federal Paulo Afonso Brum Vaz. Julgado em 5 jun. 2019; BRASIL. Tribunal Regional Federal da 4=C2=AA Regi= =C3=A3o (9=C2=AA Turma). Agravo= de Instrumento n=C2=BA 5022507-51.2019.4.04.0000. Relator: Celso Kipper. Julgado em: 18 set. 2019; BRASIL. Tribunal Re= gional Federal da 4=C2=AA Regi=C3=A3o (5= =C2=AA Turma). = Agravo de Instrumento n=C2=BA 5034712-15.2019.4.04.0000. Relatora: Gisele Lemke. Julgado em: 17 dez. 2019; BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (5=C2=AA Turma). Apela= =C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5004237-42.2021.4.04.7102/RS. Relatora: Adriane Batt= isti. Julgado em: 19 set. 2023; BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o = (6=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3= =A1ria n=C2=BA 5005703-20.2023.4.03.6103. Relator: Juiz Federal Samuel De Castro Barbo= sa Melo, julgado em 20 jul. 2026; BRASIL. Tribunal Regional Federal da 3=C2=AA= Regi=C3=A3o (Turma Regional de Mato Grosso do Sul). Apela=C3=A7=C3=A3o C=C3=ADvel n=C2=BA 5001417-17.2023.4.03.6000. Relator: Desembargador Fe= deral Jean Marcos Ferreira, julgado em 07 out. 2026.

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[2] Ver: BRASIL. Tribunal Regional Federal da 3=C2=AA Regi=C3=A3o= (4=C2=AA Turma). Agravo De Instrumento n=C2=BA 5002240-75.2025.4.03.0000. Relator: Desembargador Federal Wilson Zauhy Filho, julgado em 27 out. 2025;= BRASIL. Tribunal Regional Federal da 4=C2= =AA Regi=C3=A3o (12=C2=AA Turma). A=C3=A7=C3=A3o C=C3=ADvel= n=C2=BA 5004703-82.2020.4.04.7001. Relatora: Gisele Lemke, julgado em 13 jul. 2= 026; BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (11=C2=AA Turma). A=C3=A7=C3=A3o C=C3=ADvel = n=C2=BA 5006628-40.2021.4.04.7208. Relator: S=C3=A9rgio Renato Tejada Garcia, j= ulgado em 13 ago. 2026; BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o<= span style=3D'font-size:10.0pt'> (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3=A1ria n=C2=BA 5005677-64.2021.4.04.7105. Relator Carlos Eduar= do Thompson Flores Lenz. Julgado em 05/08/2026; BRASIL. Tribunal Regional Federal da 4=C2= =AA Regi=C3=A3o (4=C2=AA Turma). Apela=C3=A7=C3=A3o/Remessa Necess=C3=A1ria n=C2=BA 5000753-42.2023.4.04.7104. Relator: Lu=C3=ADs A= lberto D Azevedo Aurvalle. Julgado em 05/08/2026; BRASIL. Tribunal Regional Federal da 4=C2=AA Regi=C3=A3o (4=C2=AA Turma). A=C3=A7=C3=A3o C=C3=ADvel n=C2=BA = 5009776-08.2020.4.04.7107. Relator: Marcos Roberto Araujo Dos Santos, julgado em 22/07/2026.=

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Erika Maeoka

A judicializa=C3=A7=C3= =A3o do pedido de concess=C3=A3o do medicamento OFEV (Nintedabine= )

=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0 Direito em Movimento, ISSN: 2238-7110, Rio de Ja= neiro, v. 24, exxx, p. 1-x, 2026.=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 16

 

=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0 Direito em Movimento, ISSN: 2238-7110, Rio de Janeiro, v. 24, = e705, p. 1-22, 2026.=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0 <= /span>20

 

 

DOI: 10.70622/2238-7110.2026.705

 

Submiss=C3=A3o em: 04/03/2026 | Apr= ova=C3=A7=C3=A3o em: 04/09/2026

Editora: Cristina Tereza Gaulia

 

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