dabigatran etexilate (Pradaxa)
following a full submission:
dabigatran etexilate (Pradaxa®) is accepted for use within NHS Scotland.
Indication under review: treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Dabigatran etexilate was non-inferior to a vitamin K antagonist for recurrent symptomatic venous thromboembolism events (VTE) and death related to VTE in three phase III studies (two in the treatment of DVT/PE and one in the prevention of recurrent DVT/PE).
The economic case was based on evidence relating to a maximum of 18 months treatment so the cost-effectiveness of longer term use is uncertain.
|Drug Name:||dabigatran etexilate (Pradaxa)|
|SMC Drug ID:||995/14|
|Manufacturer:||Boehringer Ingelheim Ltd|
|Indication:||For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.|
|Sub Category:||2.8 Anticoagulants and protamine|
|Submission Type:||Full submission|
|Date Advice Published:||13 October 2014|