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Processo Judicial Eletrã´Nico:€ Processo Judicial Eletrônico: https://pje.jfce.jus.br/pje/Painel/painel_usuario/documentoHTML.seam... PROCESSO Nº: 0801073-38.2020.4.05.8102 - PROCEDIMENTO COMUM CÍVEL AUTOR: JOEL ALVES DA SILVA e outro ADVOGADO: Francisco Luciano Vieira Filho e outros REU: UNIÃO FEDERAL 16ª VARA FEDERAL - CE (JUIZ FEDERAL SUBSTITUTO) SENTENÇA "Cada cidadão brasileiro faz jus, sem discriminação ou privilégio, ao máximo de justiça em matéria de saúde que o país possa pagar. Não se devem ter ilusões nesta matéria: há limites. Nenhum país do mundo oferece todo o tipo de medicamento e todo o tipo de tratamento a todas as pessoas. Há escolhas trágicas a serem feitas, trágicas, mas inexoráveis. Nessa matéria, como em tudo o mais, o populismo não é solução, mas parte do problema."[1] 1. Relatório Trata-se de ação sob o procedimento comum, com pedido de tutela provisória, ajuizada por URIEL ALVES SANTANA, menor representado por seu genitor (JOEL ALVES DA SILVA), em face da UNIÃO, objetivando provimento jurisdicional que condene a parte ré ao fornecimento imediato do medicamento denominado Zolgensma® (onasemnogene abeparvovec), na forma prescrita no relatório médico subscrito pela Dr.ª Maria Denise Fernandes Carvalho de Andrade (CREMESP 119.296/CREMEC 8141 - RQE 6701). Afirma que foi diagnosticado com Atrofia Muscular Espinhal do Tipo I (AME I) (CID10: G12.0), conforme laudo médico anexado aos autos, necessitando urgentemente do tratamento com a administração do referido fármaco, aprovado recentemente pela Agência Nacional de Vigilância Sanitária (ANVISA). Relatou os seguintes fatos na petição inicial (id. 4058102.18860968): [...] DO BOSQUEJO FÁTICO O autor depois do seu nascimento que ocorrera em 15/05/2020 fora diagnosticado portador de moléstia rara, Atrofia Muscular Espinhal (AME) Tipo 1, uma deficiência neuromuscular de origem genética de caráter progressivo que leva a atrofia dos músculos. Atualmente o peticionário tem 3 (três) meses e 16 (dezesseis) dias de vida e já apresenta os primeiros sinais da progressão da doença, possuindo dificuldade respiratória. Em razão da doença o peticionário possui diminuição de força muscular diafragmática que reduz a capacidade respiratória, que por sua vez implica em redução da saturação sanguínea. Por efeito, futuramente será dependente de ventilação mecânica domiciliar. Outrossim, o peticionário fica suscetível as mais diversas intercorrências em especial as infecções Por ser doença rara, no sentido de informar V.Exa. sobre a AME, seguem informações sobre a doença em questão: [...] Com efeito, a AMIOTROFIA ESPINHAL PROGRESSIVA é doença neurodegenerativa, que promove a perda progressiva de neurônios motores e da medula espinhal. Ainda no primeiro semestre de vida, o paciente apresenta fraqueza muscular progressiva, com a falência da musculatura da deglutição e respiratória, provocando parada cardiorrespiratória e morte. Resta claro que a doença evolui de forma contínua e razoavelmente rápida, com sério risco de morte do paciente ainda na infância. O autor do presente processo é acompanhado pela médica geneticista MD. Maria Denise Fernandes Carvalho, CRM 8141, que recomendou o uso adequado urgente do medicamento ZOLGENSMA®, vez o paciente que apresenta todos os pré-requisitos necessários para uso. O medicamento ZOLGENSMA® (onasemnogeno abeparvoveque) aprovado pela ANVISA neste ano de 2020 consiste em suspensão para infusão intravenosa de uma terapia gênica baseada em um vetor viral adenoassociado. Trata-se de um AAV9 recombinante auto complementar contendo uma codificação transgênica da proteína humana de sobrevivência do neurônio motor (SMN), sob o controle de um promotor híbrido CMV enhancer / beta-actina. Baseados nos estudos resumidamente descritos a seguir: O Estudo CL-304 tratou 14 pacientes com 2 cópias do SMN2 e 15 pacientes com 3 cópias do SMN2. No momento da última visita do estudo antes de 31 de dezembro de 2019, os pacientes tratados com 2 cópias do SMN2 tinham entre 6 meses e 18,6 meses de idade, e estavam no estudo por uma média de 10,5 meses (variação: 5,1 a 18,0 meses), e os 15 pacientes com 3 cópias do SMN2 tinham entre 3,3 e 15,1 meses de idade e estavam no estudo por uma média de 8,74 meses (variação: 2 a 13,9 meses). Todos os pacientes no Estudo CL-304 estavam vivos e livres de ventilação permanente até sua última visita do estudo antes de 31 de dezembro de 2019. No momento de sua última visita antes do corte de dados, 6 dos 14 (42,9%) pacientes com 2 cópias do SMN2 tinham menos de 9,2 meses de idade. Os 8 indivíduos mais velhos conseguiram se sentar antes de sua última visita antes de 31 de dezembro de 2019, em idades que variaram de 6,4 a 11,8 meses, sendo que 7 desses 8 (87,5%) conseguiram se sentar de maneira independente antes dos 9,2 meses de idade, o percentil 99 para o desenvolvimento desse marco. Doze pacientes (85,7%) haviam alcançado pontuações do CHOP-INTEND 60 até o corte de dados de 31 de dezembro de 2019. Dos pacientes com 3 cópias do SMN2, 10 de 15 pacientes foram capazes de se sentar sem suporte por no mínimo 30 segundos, 4 pacientes foram capazes de ficar de pé sozinhos sem suporte por pelo menos 3 segundos e 2 pacientes foram capazes de caminhar pelo menos 5 passos de forma independente. Os pacientes com 3 cópias do SMN2 que ainda não tinham alcançado o marco de desenvolvimento do desfecho primário da Coorte 2 de ficar de pé sozinho sem suporte por no mínimo 3 segundos têm 6,4 a 13,6 meses de idade. Esses pacientes permanecem dentro da janela normal de desenvolvimento da idade para esses marcos e, portanto, espera-se que eles possam desenvolver essas habilidades no futuro, conforme o estudo avança. (Referências Bibliográficas 1. AVXS-101-CL-303 Phase 3 Study in Patients with Type 1 SMA; 2. AVXS-101- CL-101 Phase 1 Study in Patients with Type 1 SMA; 3. AVXS-101-CL-304 Phase 3 Study in Patients with pre-symptomatic SMA) [...] 1 de 15 12/11/2020 13:34 Processo Judicial Eletrônico: https://pje.jfce.jus.br/pje/Painel/painel_usuario/documentoHTML.seam... Juntou procuração e outros documentos, bem como requereu o benefício da justiça gratuita. Atribuiu à causa o valor de R$ 11.000.000,00 (onze milhões de reais). Decisão de id. 4058102.18871071 concedeu ao autor o benefício da justiça gratuita, ante o conteúdo da declaração de id. 4058102.18860975, e determinou a realização de audiência por videoconferência com a finalidade de ouvir a médica geneticista Dr.ª Maria Denise Fernandes Carvalho de Andrade (CREMESP 119.296/CREMEC 8141 - RQE 6701), signatária do relatório que subsidia a petição inicial (id. 4058102.18861056). Ordenou-se também a juntada aos presentes autos das notas técnicas e pareceres já emitidos pelo Sistema e-NatJus, do Conselho Nacional de Justiça (CNJ), acerca do medicamento Zolgensma® (onasemnogeno abeparvoveque), e solicitou-se ao mencionado sistema de consulta a emissão, com urgência, de nota técnica sobre o caso concreto. Em complemento à decisão supra, designou-se audiência por videoconferência para a data de 9 de setembro de 2020, às 9h30min, e determinou-se a citação da UNIÃO para contestar o feito (id. 4058102.18873098). Certidão de id. 4058102.18871250 atesta a juntada aos autos das notas técnicas e pareceres do Sistema e-NatJus, do CNJ, sobre o fármaco requerido na inicial. Certidão de id. 4058102.18879507 noticia a juntada aos autos da Nota Técnica nº 16.309, emitida pelo Sistema e-Natjus, sobre o caso concreto. A UNIÃO no id. 4058102.18903799 acostou aos autos pareceres referentes ao medicamento Zolgensma® (onasemnogene abeparvovec). Audiência por videoconferência realizada em 9 de setembro de 2020 (id. 4058102.18908594), oportunidade em que foram ouvidas a médica Dr.ª Maria Denise Fernandes Carvalho de Andrade (CREMESP 119.296/CREMEC 8141 - RQE 6701) e a Dr.ª Erlane Marques Ribeiro (CRM/CE 6.067), profissional médica do Hospital Albert Sabin, em Fortaleza/CE, onde a parte autora se encontra internada. Os representantes da Secretaria Estadual de Saúde do Ceará presentes à audiência informaram que o autor se encontra internado no Hospital Infantil Albert Sabin (HIAS) (situado em Fortaleza/CE e vinculado à Secretaria de Saúde do Estado do Ceará), desde agosto deste ano, que ainda não havia sido iniciado o tratamento medicamentoso com o Spinraza® (nusinersena), fármaco previsto para a Atrofia Muscular Espinhal do Tipo I (AME I), no âmbito do Sistema Único de Saúde (SUS), e que o medicamento estava previsto para ser entregue ao hospital em 15 de setembro de 2020. Encerrados os depoimentos e após analisar os requerimentos das partes e do MINISTÉRIO PÚBLICO FEDERAL (MPF), este juízo federal ordenou a realização de prova pericial e postergou o exame do pedido de tutela de urgência para o momento posterior à realização da prova técnica. Concedeu-se às partes e ao MPF o prazo de 5 (cinco) dias para apresentarem quesitos e indicarem assistentes técnicos. Determinou-se, por fim, à Dr.ª Erlane Marques Ribeiro (CRM/CE 6.067) que encaminhasse por e-mail, tão logo possível, a este juízo federal cópias dos relatórios e prontuários médicos referentes ao atual estado de saúde do autor. Link com o registro em meio audiovisual da audiência (certidão de id. 4058102.18913454): http://drsweb.jfce.jus.br/DRSWebJFCE/?NumeroProcesso=0801073-38.2020.4.05.8102&DataAudiencia=202009090930&DataAcesso=202009092204& Hash=03a6b6d816fc74254903e636a9a14d55 O MPF, o autor e a UNIÃO aduziram seus quesitos nos ids. 4058102.18915388, 4058102.18952287 e 4058102.18958688, respectivamente. No id. 4058102.18958465, o autor atravessou petição impugnando o quesito nº 2 formulado pela parte ré. Em resposta à solicitação deste juízo federal, o Complexo Hospitalar da Universidade Federal do Ceará (UFC), administrado pela Empresa Brasileira de Serviços Hospitalares (Ebserh), encaminhou o Ofício SEI nº 277/2020/SUPRIN/CH-UFC-EBSERH (id.
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