Patient access to new oncology medicines in the Spanish hospital setting: exploring explanatory factors through a Cox regression model

ABSTRACT Introduction: Most new antineoplastic agents (NAAs) must undergo a complex and subject-to-uncertainty selection process before they are included in Hospital Formularies. The aim of this study is to quantify the temporal differences for NAA inclusion across Spanish hospitals and to identify the potential predictive factors for actual access times. Methods: A panel of NAAs approved by the Spanish Drug and Sanitary Products Agency from 2000 to 2010 was studied. A Cox regression model was performed in order to detect the potential predictors of time to NAA inclusion across hospitals. Results: Disparities in time to NAA access were identified. Several factors were found to be associated with faster access, the most important hospital participation in clinical trials. Orphan product designation, among others, was related to delayed access.