PD66 Real-World Evidence In Healthcare - Macro-Management: Judicial Access To Pembrolizumab-Axitinib For Advanced Kidney Cancer In Uruguay (2020 to 2022) - Results and Conclusions Summary

Q: What patient population was included in the Uruguay study?

Patients with advanced clear cell renal carcinoma who received pembrolizumab-axitinib through favorable judicial claims against Uruguay’s National Resources Fund between 2020 and 2022 were included.

Q: How was survival measured?

Global survival was estimated using the Kaplan-Meier method, with confidence intervals reported for multiple time points.

Q: What key conclusion supports policy relevance?

The study reports promising real-world effectiveness results and emphasizes that real-world evidence can help inform healthcare policy decisions, including incorporation into a comprehensive health care plan.

Sep 29, 2026

Uploaded by Theodore

Judicial claims in Uruguay increasingly seek pembrolizumab-axitinib for advanced kidney cancer, making it important to characterize patients receiving therapy through rulings and to assess real-world effectiveness. The study describes sociodemographic and clinical profiles of patients with advanced clear cell renal carcinoma treated via favorable judicial decisions between 2020 and 2022. Survival was estimated with Kaplan-Meier methods, showing global survival of 84.8% at 12 months, 78.3% at 24 months, and 67.1% at 36 months.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages1

Reading Time3 min

AccessFree to download

Introduction

Methods

Results

Conclusions

PD66 Real-World Evidence In Healthcare Macro-Management: Judicial Access To Pembrolizumab-Axitinib For Advanced Kidney Cancer In Uruguay (2020 to 2022) Krizia Osterkamp ([kosterkamp@fnr.gub.uy](kosterkamp@fnr.gub.uy)), Daniel Pedrosa, Abayubá Perna and Eliana Lanzani Introduction: In recent years, there has been an increase in judicial claims in Uruguay seeking pembrolizumab-axitinib for the treatment of advanced kidney cancer. Understanding the characteristics and clinical evolution of patients accessing this medication through judicial rulings is essential to support health policies based on real-world evidence (RWE) . Methods: This study aimed to describe the sociodemographic and clinical characteristics, as well as global survival, of patients diagnosed with advanced clear cell renal carcinoma who received pembrolizumab-axitinib through judicial claims against the National Resources Fund (Fondo Nacional de Recursos) in Uruguay between 2020 and 2022 . Patients with a favorable judicial ruling during the study period who received at least one dose of the combination therapy were included. Descriptive analyses of sociodemographic and clinical characteristics were conducted, and survival was estimated using the Kaplan-Meier method. Results: Between2020and2022,46patients received pembrolizumabaxitinib treatment through judicial claims for advanced clear cell renal carcinoma. The average age of the patients, who were predominantly male, was 55.6 years. Most patients were from the private healthcare sector, with a similar distribution between the capital and the interior of the country. The survival analysis showed a global survival rate of 84.8 percent at 12 months (95% confidence interval [CI]: 70.7, 92.4), 78.3 percent at 24 months (95% CI: 61.8, 88.3), and 67.1 percent at 36 months (95% CI: 38.8, 84.5) . Conclusions: This real-world study provided promising results regarding the effectiveness of pembrolizumab-axitinib treatment in the Uruguayan healthcare context. The findings favored the opportunity to incorporate this therapy for advanced kidney cancer into the Comprehensive Health Care Plan. Additionally, it highlighted the importance of RWE in supporting healthcare policy decisions. PD67 Subsidy Of Monoclonal Antibodies In Brazil: What Criteria Influence Decisions by the National Committee for Health Technology Incorporation (CONITEC)? André Motta-Santos, Daniel Reis, Júlia Tupinambás, Lélia Carvalho, Karina Zocrato, Marcela Freitas, Marcus Borin, Maria Horta, Clarice Petramale, Silvana Kelles ([silvanakelles@gmail.com](silvanakelles@gmail.com)) and Sergio Bersan Introduction: Over the years many researchers have sought to understand the decision-making process ofCONITEC, the Brazilian health technology assessment(HTA) agency. The emergence ofhighcost technologies, such as monoclonal antibodies(mAbs), has heightened the importance of delineating the decision-making criteria. This study aimed to elucidate the criteria employed by CONITEC for the incorporation of mAbs in Brazil. Methods: All CONITEC reports published between 2019 and 2024 on mAbs were included. Descriptive statistics were utilized to summarize the data. The statistical significance between outcomes and covariates was assessed using the Kruskal-Wallis test for continuous variables and the chi-square test for categorical variables. Logistic regressions were produced to evaluate the impact of each covariable on the recommendations. Results with ap-value ofless than0.10were considered statistically significant due to the small sample size. All analyses were conducted using R software. Results: After cleaning the database,53reports were included, encompassing 37 mAbs evaluated for 45 indications. Sixteen submissions (30.1%) received a positive recommendation. Efficacy (p=0.009) and the preliminary decisions (p<0.001) were significantly associated with the final recommendation. Further analysis showed that an incremental cost-effectiveness

FAQs

What patient population was included in the Uruguay study?

Patients with advanced clear cell renal carcinoma who received pembrolizumab-axitinib through favorable judicial claims against Uruguay’s National Resources Fund between 2020 and 2022 were included.

How was survival measured?

Global survival was estimated using the Kaplan-Meier method, with confidence intervals reported for multiple time points.

What key conclusion supports policy relevance?

The study reports promising real-world effectiveness results and emphasizes that real-world evidence can help inform healthcare policy decisions, including incorporation into a comprehensive health care plan.

Sep 29, 2026

Uploaded by Theodore