0162/2017 - The lawsuits to antineoplastic drugs: the tip of an iceberg?
Demandas judiciais por medicamentos antineoplásicos: a ponta de um iceberg?
Author:
• Thaís Jeronimo Vidal - Vidal, Thaís Jeronimo - Instituto Nacional de Cancer - <thaisjvidal@gmail.com>Co-author(s):
• Mario Jorge Sobreira da Silva - Sobreira, M.J. - Rio de Janeiro, - Instituto Nacional de Câncer - <mario.silva@inca.gov.br>ORCID: https://orcid.org/0000-0002-0477-8595
• Maely Peçanha Favero Retto - Retto, Maely Peçanha Favero - Instituto Nacional de Cancer - <maely@globo.com>
• Elaine Lazzaroni - Lazzaroni, Elaine - UERJ, Instituto de Medicina Social /PPAS - <elaza@ig.com.br>
Thematic Area:
Não CategorizadoAbstract:
The lawsuits with antineoplastic drugs generate high costs for governments and require careful analysis to ensure efficient and adequate health results. This study analyzed cases conducted by federal entities to a reference institute for the treatment of cancer for technical opinion. Data were collectedcopies of the cases examinedJuly 1 to December 31, 2013. It was analyzed: therapeutic subgroups, presence in essential drug list, drug registry, off-label use, indications of clinical practice guidelines, drug incorporation in Brazilian Health System and estimated value of court cases. 158 cases were examined, with a total of 164 requests of 35 antineoplastic drugs. Most of the medications were tyrosine kinase inhibitors (31.4%), ten (28.6%) were included in the essential drugs list, three did not contain sanitary registration, ten had indication of off-label use, 56.7% were described in clinical practice guidelines and four drugs were recommended for incorporation.The total estimated amount of the court cases was R$ 18,110,504.89. It was identified that the technical and sanitary instruments currently available to support the decisions seem to be insufficient and that there is need to establish strategies to minimize inconsistencies that compromise the comprehensiveness of care.