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Reason for request
Inclusion of the 110 mg capsules on the list of products refundable by National Health Insurance and approved for hospital use in the extension of the indication “prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors”. Inclusion of the 150 mg capsules on the list of products refundable by National Health Insurance and approved for hospital use in “prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors”, the only indication for this dose.
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Clinical Benefit
| Substantial |
The actual benefit of PRADAXA is substantial. |
Clinical Added Value
| no clinical added value |
The Committee is of the opinion that PRADAXA offers no improvement in actual benefit (IAB V) compared with vitamin K antagonists anticoagulants. |
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