Pradaxa Prior Authorization Removal

March 15, 2012

The prior authorization requirement for Pradaxa (dabigatran etexilate) was removed in March 2012.

Pradaxa is a blood thinner that is used to prevent clot formation in patients at risk for stroke or other heart conditions. The intent of the prior authorization program was to address safety concerns, appropriate patient selection, and dosing.

Upon review of the cases received through February 2012, it has been determined that use of Pradaxa is consistent with clinical treatment and safety guidelines. In many cases, patients were started on Pradaxa treatment in the hospital and were monitored for potential adverse events and stabilized prior to discharge. Due to the above findings, the decision was to remove the prior authorization review and end the denial at point of sale for review for appropriate patient selection.

A quantity limit will be maintained at point-of-sales claims processing to ensure that dosing is within FDA-approved labeling for Pradaxa. If a claim for Pradaxa is submitted with dosing above the maximum FDA-approved dose, it will deny for review.