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Updated: Feb 25, 2026

Assessing Specificity of Anticancer Drugs In Vitro
Published on: March 23, 2016
The lawsuits to antineoplastic drugs: the tip of an iceberg?
Thaís Jeronimo Vidal1, Elaine Lazzaroni Moraes1, Maely Peçanha Favero Retto1
1Instituto Nacional de Câncer. R. Marquês de Pombal 125/3º, Centro. 20230-240 Rio de Janeiro RJ Brasil. thaisjvidal@gmail.com.
Abstract:
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 collected from copies of the cases examined from July 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 protein 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.
Insights
Lawsuits for antineoplastic drugs are costly. Analysis revealed issues with drug registration, off-label use, and guideline adherence, indicating a need for better decision-making strategies in cancer care.
Area of Science:
- Oncology
- Health Economics
- Pharmaceutical Policy
Background:
- Litigation involving antineoplastic drugs presents significant financial burdens for governments.
- Ensuring efficient healthcare outcomes and adequate treatment requires thorough analysis of these legal cases.
Purpose of the Study:
- To analyze court cases concerning antineoplastic drugs submitted to a reference cancer treatment institute.
- To evaluate key aspects of these cases, including drug characteristics and alignment with health policies.
Main Methods:
- Retrospective analysis of 158 court cases involving 35 antineoplastic drugs from July 1 to December 31, 2013.
- Data collected included therapeutic subgroups, essential drug list status, drug registration, off-label use, clinical practice guideline indications, Brazilian Health System incorporation, and estimated case values.
Main Results:
- Protein kinase inhibitors were the most frequent (31.4%).
- Ten drugs (28.6%) were on the essential drugs list, three lacked sanitary registration, and ten had off-label use indications.
- 56.7% were supported by clinical practice guidelines, and four drugs were recommended for incorporation.
Conclusions:
- Existing technical and sanitary instruments appear insufficient for informed decision-making in cancer drug litigation.
- Strategies are needed to reduce inconsistencies and ensure comprehensive cancer care, addressing issues like off-label use and registration gaps.
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