Lawsuits against the Brazilian Unified Health System regarding Bladder/Ureteral Cancer

Abstract

Objective To evaluate the technical notes (TNs) issued by the Center for Technical Support of the Judiciary (Núcleo de Apoio Técnico do Poder Judiciário, NAT-Jus, in Portuguese) of the Brazilian Ministry of Justice regarding lawsuits against the Brazilian Unified Health System (Sistema Único de Saúde, SUS, in Portuguese) concerning bladder/ureteral cancer, in order to better advise the formulation of public policies regarding oncologic care.

Materials and Methods A cross-sectional study on the TNs issued by NAT-Jus regarding lawsuits from patients against SUS from 2019 to 2023 concerning bladder or ureteral cancer.

Results A total of 137 TNs were issued. Most plaintiffs were male patients (70.8%), with a mean age of 69.1 ± 17.6 years. The lawsuits were filed in an attempt to obtain medications (67%), medical care or procedures (26%), or other health products (7%).

The most common medications requested were immuno-oncology (IO) therapeutic agents, in 66 cases (pembrolizumab, avelumab, nivolumab, and atezolizumab), followed by the Bacillus Calmette-Guerin (BCG) vaccine (n = 13), chemotherapeutic agents in 5 cases, erdafitinib in 2 cases, and enfortumab vedotin in 1 case.

Pembrolizumab was the medication most frequently requested by patients undergoing treatment for bladder or ureteral cancer. Out of more than 50 thousand TNs, there were 1,349 requests for this medication. Bladder or ureteral cancer was responsible for 3.4% of all the demands for pembrolizumab.

It is also notable that lawsuits were more common in the Southern (n = 47), followed by the Southeastern (n = 26), Northeastern (n = 20), and Midwestern (n = 6) regions. The lawsuits in the South were more often related to expensive medications. In the Northeast and Midwest, there were proportionally more lawsuits demanding medical procedures. The Brazilian Federal Government lost the lawsuits, representing expenses of BRL 42.1 million with these novel medications within the period evaluated.

Conclusion Bladder cancer treatment within SUS faces obstacles and shortages of essential medications. Moreover, advanced and costly therapies are not widely available, straining the public healthcare system and resulting in increasing legal costs. Collaboration among the government, the scientific community, and patient advocacy organizations is crucial to ensure the sustainability of SUS in the face of these challenges.

Keywords

ureteral neoplasms - judicial role - Brazil - urinary bladder neoplasms

Author's Contribution

FK: conception and design, data analysis and interpretation, final approval of the manuscript, and writing of the manuscript; MAS: collection and assembly of data and data analysis and interpretation; FT: collection and assembly of data and conception and design; and CP, VDT, LHCB, and SG: conception and design.

Publication History

Received: 09 April 2024

Accepted: 22 May 2024

Article published online:
15 July 2024

• References

• 1 Vidal TJ, Moraes EL, Retto MPF, Silva MJSD. Demandas judiciais por medicamentos antineoplásicos: a ponta de um iceberg?. Cien Saude Colet 2017; 22 (08) 2539-2548 https://www.scielo.br/j/csc/a/6JtXgc6w4TTg57ZCGptCLCS/?lang=pt cited 2023 Dec 2
• 2 Judiciário vai avaliar impacto das notas técnicas de saúde nas decisões judiciais* – Portal TRF2 [Internet]. [cited 2023 Dec 2]. Available from: https://www10.trf2.jus.br/portal/judiciario-vai-avaliar-impacto-das-notas-tecnicas-de-saude-nas-decisoes-judiciais/
• 3 Korkes F, Timóteo F, Martins S. et al. Dramatic Impact of Centralization and a Multidisciplinary Bladder Cancer Program in Reducing Mortality: The CABEM Project. JCO Glob Oncol 2021; 7 (07) 1547-1555 https://pubmed.ncbi.nlm.nih.gov/34767463/ cited 2023 Dec 2
• 4 Korkes F, Palou J. High mortality rates after radical cystectomy: we must have acceptable protocols and consider the rationale of cutaneous ureterostomy for high-risk patients. Int Braz J Urol 2019; 45 (06) 1090-1093
• 5 Korkes F, Timóteo F, Ferrari KL, Reis LO. Bacillus Calmette-Guérin (BCG) Brazilian Backstage in Bladder Cancer. Int Braz J Urol 2021; 47 (02) 232-236 https://pubmed.ncbi.nlm.nih.gov/33284531/ cited 2023 Dec 2
• 6 Catto JWF, Khetrapal P, Ricciardi F. et al; iROC Study Team. Effect of Robot-Assisted Radical Cystectomy With Intracorporeal Urinary Diversion vs Open Radical Cystectomy on 90-Day Morbidity and Mortality Among Patients With Bladder Cancer: A Randomized Clinical Trial. JAMA 2022; 327 (21) 2092-2103 https://pubmed.ncbi.nlm.nih.gov/35569079/ cited 2023 Dec 2
• 7 Powles T, Park SH, Voog E. et al. Maintenance avelumab + best supportive care (BSC) versus BSC alone after platinum-based first-line (1L) chemotherapy in advanced urothelial carcinoma (UC): JAVELIN Bladder 100 phase III interim analysis. J Clin Oncol 2020; 38 (18_suppl): LBA1-LBA1
• 8 Powles T, Park SH, Caserta C. et al. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up. J Clin Oncol 2023; 41 (19) 3486-3492 https://pubmed.ncbi.nlm.nih.gov/37071838/ cited 2023 Dec 2
• 9 Suzman DL, Agrawal S, Ning YM. et al. FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy. Oncologist 2019; 24 (04) 563-569
• 10 Loriot Y, Matsubara N, Park SH. et al; THOR Cohort 1 Investigators. Erdafitinib or Chemotherapy in Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2023; 389 (21) 1961-1971 https://pubmed.ncbi.nlm.nih.gov/37870920/ cited 2023 Dec 2
• 11 Loriot Y, Necchi A, Park SH. et al; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med 2019; 381 (04) 338-348 https://pubmed.ncbi.nlm.nih.gov/31340094/ cited 2020 Dec 22
• 12 Approves Padcev FDA. (Enfortumab vedotin-ejfv) for Bladder Cancer [Internet]. [cited 2020 Jul 1]. Available from: https://www.cancer.org/latest-news/fda-approves-padcev-enfortumab-vedotin-ejfv-for-bladder-cancer.html
• 13 Korkes F, Maluf F. Increasing costs from bladder cancer in the Brazilian Health System: the role of establishing public health policies. Int Braz J Urol 2021; 47 (02) 443-447
• 14 Korkes F, Timóteo F, Soledade LCB. et al. Stage-Related Cost of Treatment of Bladder Cancer in Brazil. PharmacoEconom Open 2022; 6 (03) 461-468
• 15 Capa CMED—Agência Nacional de Vigilância Sanitária - Anvisa [Internet]. [cited 2023 Dec 3]. Available from: https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/cmed
• 16 Timoteo F, Korkes F, Baccaglini W, Glina S. Bladder cancer trends and mortality in the brazilian public health system. Int Braz J Urol 2020; 46 (02) 224-233 https://pubmed.ncbi.nlm.nih.gov/32022511/ cited 2023 Dec 2
• 17 Sievert KD, Amend B, Nagele U. et al. Economic aspects of bladder cancer: what are the benefits and costs?. World J Urol 2009; 27 (03) 295-300 Available from: http://pmc/articles/PMC2694315/?report=abstract
• 18 Coelho TL, Ferré F, Campos Neto OH, Acurcio Fde A, Cherchiglia ML, Andrade EIG. Legal and health variations in drug litigation injunctions granted in Minas Gerais. Rev Saude Publica 2014; 48 (05) 808-816 https://www.scielo.br/j/rsp/a/dqCy4ZjSB7CTfFB9KPDXhmt/?lang=en cited 2023 Dec 5
• 19 Pichon-Riviere A, Drummond M, Palacios A, Garcia-Marti S, Augustovski F. Determining the efficiency path to universal health coverage: cost-effectiveness thresholds for 174 countries based on growth in life expectancy and health expenditures. Lancet Glob Health 2023; 11 (06) e833-e842 www.thelancet.com/lancetgh cited 2023 Dec 2
• 20 Conitec aprova proposta de uso de limiares de custo-efetividade (LCE) nas decisões em saúde—Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde - CONITEC [Internet]. [cited 2023 Dec 2]. Available from: https://www.gov.br/conitec/pt-br/assuntos/noticias/2022/setembro/conitec-aprova-proposta-de-uso-de-limiares-de-custo-efetividade-lce-nas-decisoes-em-saude
• 21 Lista de Alto Risco da Administração Pública [Internet]. [cited 2023 Dec 2]. Available from: https://sites.tcu.gov.br/listadealtorisco/sistema_unico_de_saude_acesso_e_sustentabilidade.html
• 22 Impactos da judicialização da saúde são debatidos no I Congresso do Fonajus - Portal CNJ [Internet]. [cited 2023 Dec 2]. Available from: https://www.cnj.jus.br/impactos-da-judicializacao-da-saude-sao-debatidos-no-i-congresso-do-fonajus/
• 23 Juízes e juízas podem acessar notas técnicas sobre saúde - Ejef [Internet]. [cited 2023 Dec 5]. Available from: https://ejef.tjmg.jus.br/e-natjus-disponibiliza-novas-funcionalidades/
• 24 Justiça leva em média um ano para dar resposta a processos de saúde | Agência Brasil [Internet]. [cited 2023 Dec 5]. Available from: https://agenciabrasil.ebc.com.br/saude/noticia/2023-05/justi%C3%A7a-leva-em-m%C3%A9dia-um-ano-para-dar-resposta-a-processos-de-sa%C3%BAde
• 25 CNJ promove evento para debater as demandas da saúde no Judiciário [Internet]. [cited 2023 Dec 5]. Available from: https://www.conjur.com.br/2022-nov-17/cnj-promove-evento-debater-demandas-saude-judiciario/
• 26 TCU e Estados apontam aumento dos gastos com a judicialização da saúde - Portal CNJ [Internet]. [cited 2023 Dec 5]. Available from: https://www.cnj.jus.br/tcu-e-estados-apontam-aumento-dos-gastos-com-a-judicializacao-da-saude/
• 27 Powles TB, Perez Valderrama B, Gupta S. et al. LBA6 EV-302/KEYNOTE-A39: Open-label, randomized phase III study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (Chemo) in previously untreated locally advanced metastatic urothelial carcinoma (la/mUC). Ann Oncol 2023; 34: S1340 Available from http://www.annalsofoncology.org/article/S0923753423042709/fulltext cited 2023 Dec 2