OBJECTIVES. Since the year of 2013, evaluations of new medicines, or new indications for the products that are already in the market, are being published as Therapeutic Positioning Reports (TPR) by the Spanish Agency for Medicines and Health Products (AEMPS). In this analysis, factors that may influence positive decisions were studied.

METHODS. All publicly available TPRs which were published from 2013 until February 15^th of 2019 for oncology products were evaluated for each approved line. Logistic regression analysis was conducted using R version 3.5.2. Variables included were: approved line of treatment, year of publication, status of mutation or biomarker, consideration of health economic analysis and consideration of prognostic variables (Overall Survival-OS, Progression Free Survival-PFS and Response Rate).

RESULTS. A total of 91 results were evaluated for each approved line of treatment out of 71 TPRs. While 57 product-line (62.6%) were recommended, 34 (37.4%) were rejected. Inclusion of PFS (Odds ratio [OR], 10.42; 95% confidence interval [CI]: 1.60-114.05, p = 0.03), health economics analysis consideration (OR, 5.43; 95% CI: 1.72-21.04, p = 0.007) and mutation/biomarker status (OR, 11.73; 95% CI: 2.96-79.88, p = 0.02) were the variables that were found to be affecting the recommendation status of products.

CONCLUSIONS. This analysis identified that TPRs for oncology products that are for usage in a specific subgroup of patients who have mutations, those that take into consideration the PFS and those that consider health economics analysis, were likely to be recommended by AEMPS. Sample size and unbalanced proportion of recommended and rejected products were limitations of study.