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THERASOLV (urokinase)

Antithrombotic agent
Opinions on drugs - Posted on Feb 21 2020

Reason for request

First assessment

  • Key points

Favourable opinion for reimbursement for the lysis of blood clots in the following conditions:

  • thrombosed intravascular catheters and cannulae,
  • acute occlusive peripheral arterial disease with limb-threatening ischemia.

Unfavourable opinion for reimbursement for the lysis of blood clots in the following conditions:

  • extensive acute proximal deep vein thrombosis,
  • acute massive pulmonary embolism.
  • What therapeutic improvement?

No clinical added value in the treatment of thrombosed intravascular catheters and cannulae or acute occlusive peripheral arterial disease with limb-threatening ischemia.

  • Role in the care pathway?

Thrombosed intravascular catheters and cannulae

THERASOLV (urokinase) is a first-line treatment, in the event of thrombosed intravascular catheters and cannulae, in the same way as the other thrombolytic agents currently available in this indication.

Acute occlusive peripheral arterial disease with limb-threatening ischemia

THERASOLV (urokinase) is a first-line treatment in acute occlusive peripheral arterial disease with limb-threatening ischemia only in the absence of neurological deficit. In accordance with the SPC and current recommendations, THERASOLV (urokinase) should be administered locally via a catheter. The intravenous route must not be used.

Extensive acute proximal deep vein thrombosis and acute massive pulmonary embolism

THERASOLV (urokinase) has no role in the care pathway.

 

 


Clinical Benefit

Substantial

Thrombosed intravascular catheters and cannulae : the clinical benefit of THERASOLV is substantial in this marketing authorisation indication.

 

Low

Acute occlusive peripheral arterial disease with limb-threatening ischemia : the clinical benefit of THERASOLV is low in this marketing authorisation indication.

 

Insufficient

Extensive acute proximal deep vein thrombosis and Acute massive pulmonary embolism : the clinical benefit of THERASOLV is insufficient in the marketing authorisation indication to justify its funding by the French national health insurance system.


Clinical Added Value

no clinical added value

In the absence of a study demonstrating a clinical benefit of thrombolysis using urokinase compared to the available alternatives, and in view of the met medical need in this indication, the Committee considers that THERASOLV (urokinase) provides no clinical added value (CAV V) in the care pathway for thrombosed intravascular catheters and cannulae. In the absence of a study demonstrating a clinical benefit of thrombolysis using urokinase compared to the available alternatives, and considering the bleeding risk associated with the use of thrombolytic agents, the Committee considers that THERASOLV (urokinase) provides no clinical added value (CAV V) in the care pathway for acute occlusive peripheral arterial disease with limb-threatening ischemia.

 


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