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https://doi.org/10.17566/ciads.v8i3.571Cómo citar
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Objetivos: el registro sanitario garantiza mínimamente la seguridad de las instrucciones de etiquetado. Con la sentencia de Apelación Extraordinaria (RE) No. 657,718 / 2019, este asunto no se pacifica. El objetivo de este estudio es comparar las indicaciones aprobadas por las agencias de salud estadounidenses, europeas y brasileñas y analizar datos sobre la indicación de medicamentos de inmunoterapia para el tratamiento del cáncer, en demandas contra el Departamento de Salud del Estado de São Paulo (SES / SP). Métodos: se realizó una investigación documental en los prospectos de seis medicamentos inmunoterapéuticos, disponibles en julio de 2019, en los sitios web de las agencias de salud elegibles para el estudio. documentos escaneados disponibles en el sistema S-Codes. Resultados: todos los medicamentos tienen un historial médico para al menos una indicación de etiqueta en las tres agencias de salud, pero con diferencias en las indicaciones aprobadas, muchas de ellas son aprobaciones aceleradas. El tiempo promedio entre la aprobación de la Food and Drug Administration (FDA) y la Agencia de Vigilancia de la Salud (Anvisa) fue de 464.5 ± 170.8 días; y 278 (98%) de las demandas ocurrieron después de registrarse con Anvisa. Hay poca información disponible en los documentos escaneados, pero fue posible identificar situaciones que implican indicaciones de drogas, así como resultados de pruebas genéticas. Discusión y conclusión: el análisis muestra que la FDA tiende a ser menos rigurosa en la aprobación de nuevas indicaciones, y que la mayoría de las demandas no se ajustan a los criterios de RE 657.718/2019. A pesar del progreso, es necesario discutir el uso fuera de etiqueta de estos medicamentos y su especificidad.Referencias
Brasil. Supremo Tribunal Federal. RE 657718 [Internet]. 2019 [Acesso em 30 julho 2019]. Disponível em: https://portal.stf.jus.br/processos/detalhe.asp?incidente=4143144
Gronde T van der, Uyl-de Groot CA, Pieters T. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks. PLoS One [Internet]. 2017;12(8):e0182613. Disponível em: http://www.ncbi.nlm.nih.gov/pubmed/28813502
U.S. Food and Drug Administration. Understanding Unapproved Use of Approved Drugs “Off-Label” [Internet]. Disponível em: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label [Acesso em 28 julho 2019].
Wittich CM, Burkle CM, Lanier WL. Ten Common Questions (and Their Answers) About Off-label Drug Use. Mayo Clin Proc [Internet]. 2012 Oct;87(10):982–90.
Brasil. Agência Nacional de Vigilância Sanitária. Resolução RDC no 111, de 6 de Setembro de 2016 [Internet]. 2016. Disponível em: http://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/23530126/do1-2016-09-08-resolucao-rdc-n-111-de-6-de-setembro-de-2016-23530036 [Acesso em 17 julho 2019].
Shea MB, Stewart M, Van Dyke H, Ostermann L, Allen J, Sigal E. Outdated Prescription Drug Labeling. Ther Innov Regul Sci. 2018 Nov 5;52(6):771–7.
Yan L, Zhang W. Precision medicine becomes reality-tumor type-agnostic therapy. Cancer Commun (London, England) . 2018;38(1):6.
Lacombe D, Burock S, Bogaerts J, Schoeffski P, Golfinopoulos V, Stupp R. The dream and reality of histology agnostic cancer clinical trials. Mol Oncol. 2014 Sep 12;8(6):1057–63.
Iriart JAB. Medicina de precisão/medicina personalizada: análise crítica dos movimentos de transformação da biomedicina no início do século XXI. Cad Saude Publica. 2019 Mar 25;35(3).
Senado Notícias. Especialistas defendem testes genéticos para tratamento do câncer no SUS [Internet]. 2018 [Acesso em 28 julho 2019]. Disponível em: https://www12.senado.leg.br/noticias/materias/2018/11/06/especialistas-defendem-testes-geneticos-para-tratamento-do-cancer-no-sus
Chang MT, Bhattarai TS, Schram AM, Bielski CM, Donoghue MTA, Jonsson P, et al. Accelerating Discovery of Functional Mutant Alleles in Cancer. Cancer Discov. 2018 Feb;8(2):174–83. Disponível em: http://cancerdiscovery.aacrjournals.org/lookup/doi/10.1158/2159-8290.CD-17-0321
Buljan M, Blattmann P, Aebersold R, Boutros M. Systematic characterization of pan‐cancer mutation clusters. Mol Syst Biol. 2018 Mar 23;14(3):e7974.
Bartels S, Schipper E, Hasemeier B, Kreipe H, Lehmann U. Hotspot mutations in cancer genes may be missed in routine diagnostics due to neighbouring sequence variants. Exp Mol Pathol. 2018 Aug;105(1):37–40.
Chang MT, Asthana S, Gao SP, Lee BH, Chapman JS, Kandoth C, et al. Identifying recurrent mutations in cancer reveals widespread lineage diversity and mutational specificity. Nat Biotechnol. 2016 Feb;34(2):155–63.
Marquart J, Chen EY, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Benefit From Genome-Driven Oncology. JAMA Oncol. 2018 Aug 1;4(8):1093.
Haslam A, Prasad V. Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs. JAMA Netw open. 2019 May 3;2(5):e192535.
U.S. Food and Drug Administration. Fast Track [Internet]. [Acesso em 23 julho 2019]. Disponível em: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
US Government Accountability Office. New drug approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints.
Healio Immuno-Oncology Resource Center. Phase 3 trial of pembrolizumab for advanced HCC fails to meet primary endpoints [Internet]. [Acesso em 02 Agosto 2019]. Disponível em: https://www.healio.com/hematology-oncology/gastrointestinal-cancer/news/online/%7Ba1a112d0-3f4c-425b-bb25-0823c56e56e6%7D/phase-3-trial-of-pembrolizumab-for-advanced-hcc-fails-to-meet-primary-endpoints
Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ . 2017 Oct 4;j4530.
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 3;j1680.
Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival. JAMA Intern Med. 2015 Dec 1;175(12):1992. Disponível em: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2015.5868
Cohen D. Cancer drugs: high price, uncertain value. BMJ. 2017 Oct 4;j4543.
Dusetzina SB. Drug Pricing Trends for Orally Administered Anticancer Medications Reimbursed by Commercial Health Plans, 2000-2014. JAMA Oncol. 2016 Jul 1;2(7):960–1.
Dolgin E. Bringing down the cost of cancer treatment. Nature. 2018 Mar 8;555(7695):S26–9.
Le Tourneau C, Kamal M, Bièche I. Precision medicine in oncology: what is it exactly and where are we? Per Med. 2018 Sep;15(5):351–3.
Le Tourneau C, Borcoman E, Kamal M. Molecular profiling in precision medicine oncology. Nat Med. 2019;25(5):711–2.
Rodrigues‐Soares F, Suarez‐Kurtz G. Pharmacogenomics research and clinical implementation in Brazil. Basic Clin Pharmacol Toxicol. 2019 May 24;124(5):538–49.
McCarthy JJ, McLeod HL, Ginsburg GS. Genomic medicine: a decade of successes, challenges, and opportunities. Sci Transl Med. 2013 Jun 12;5(189):189sr4.
Klein ME, Parvez MM, Shin J-G. Clinical Implementation of Pharmacogenomics for Personalized Precision Medicine: Barriers and Solutions. J Pharm Sci. 2017 Sep;106(9):2368–79.
Owusu Obeng A, Fei K, Levy K, Elsey A, Pollin T, Ramirez A, et al. Physician-Reported Benefits and Barriers to Clinical Implementation of Genomic Medicine: A Multi-Site IGNITE-Network Survey. J Pers Med. 2018 Jul 24;8(3):24.
Albassam A, Alshammari S, Ouda G, Koshy S, Awad A. Knowledge, perceptions and confidence of physicians and pharmacists towards pharmacogenetics practice in Kuwait. Rovers J, editor. PLoS One . 2018 Sep 5;13(9):e0203033.
Stanek EJ, Sanders CL, Taber KAJ, Khalid M, Patel A, Verbrugge RR, et al. Adoption of Pharmacogenomic Testing by US Physicians: Results of a Nationwide Survey. Clin Pharmacol Ther. 2012 Mar 25;91(3):450–8.
Nickola TJ, Green JS, Harralson AF, O’Brien TJ. The current and future state of pharmacogenomics medical education in the USA. Pharmacogenomics. 2012 Sep;13(12):1419–25.
Daly AK. Is There a Need to Teach Pharmacogenetics? Clin Pharmacol Ther. 2014 Mar;95(3):245–7.
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