Comportamiento de los registros sanitarios para tratamiento oncológico en Colombia según la modalidad y estado regulatorio

Abstract

The sanitary registration is the document issued by the Colombian regulatory body, INVIMA, so that a drug can be marketed, whether it is a drug manufactured in Colombia or abroad. The database published by INVIMA is used with the list of these registrations since its creation until March 2021 and selecting those of ATC classification; L and V03AF, corresponding to oncological treatment drugs, since the treating disease is considered a public health problem and where the effectiveness of the treatment can be affected by the access and availability of the same, therefore it is sought to establish the behavior of the sanitary registrations of these drugs in terms of their regulatory status and the modality under which the registration is requested. In addition to the descriptive analysis, Machine learning methods were used to expose the association of the variables, the use of classification trees was not effective in the variables handled, however, in the logarithmic model and Linear Discriminant Analysis predictive models with a good classification higher than 80% are obtained. The sanitary registrations of these drugs are mostly imported, not because of INVIMA's decision, but because there are fewer requests for local manufacture, in addition, less than half of these drugs are not included in the Health Benefits Plan (PBS), therefore, their acquisition is an out-of-pocket expense for the patient, being this a high-cost disease, there is an opportunity for improvement in national manufacture and inclusion in the PBS.