[Judicialization of high priced medications in Argentina: quali-quantitative study].

INTRODUCTION

The economic consequences of mandatory coverage, through judicial means, of high-priced medications constitutes a growing problem, which merits knowing its local characteristics to provide possible solutions.

OBJECTIVE

To identify medications, diseases involved, economic impact and contextual factors of the judicialization of high-priced medications in the Argentine Health System(MEP).

METHODS

Quali-quantitative descriptive study that retrospectively analyzed legal protection resources by MEP from three national and provincial databases from January 2017 to December 2020, evaluating the existing relationship between lawsuits with regulatory approval, inclusion in benefit packages and relationship with journalistic articles for the three most frequently prosecuted drugs.

RESULTS

405 lawsuits were included, mainly from the Ministry of National Health. The three most prosecuted medications were nusinersen (21.7%), palbociclib (5.9%) and agalsidase-alfa (4.7%). Only 69.4% of medications were approved for marketing in Argentina at the time of the protection; 45.7% were incorporated into the Single Reimbursement System, and 16.8% had a report from the National Commission for the Evaluation of Health Technologies and Clinical Excellence (CONETEC), which was negative in 87.1% of cases. The average time from request to provision of the medication was 150 days. A temporal correlation was observed between the appearance of the MEP in the national graphic press and the appeals occurrence.

CONCLUSIONS

Judicialization focused on very highpriced medications for rare or oncological diseases. The rulings were mostly in favor of the plaintiff, and access times to the medication took a long time. The mass media anticipated the judicial processes.