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Opinions on drugs - Posted on Jul 30 2013

Reason for request

Inclusion on the list of medicines refundable by National Health Insurance (B/14, B/28 and B/42 for the 15 mg/tablet dosage and B/14 and B/28 for the 20 mg/tablet dosage) and approved for hospital use (B/10 and B/100 for both dosages) in the extension of indication: “Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack”.

Atrial fibrillation (AF) is the most common cardiac arrhythmia, and it increases with age. It is the primary cause of cerebral embolism of cardiac origin, and it is responsible for about 50 % of cases of ischaemic stroke. AF may be immediately life-threatening to the patient or following complications; stroke, which is a complication of AF, is characterised by its severity and greatly affects the quality of life.

The efficacy/adverse effects ratio of rivaroxaban is high.

Public health benefit

The public health burden represented by stroke and systemic embolism is substantial, because of their frequency and/or the often disabling sequelae that follow.

The availability of a preventive treatment for these events, particularly in at-risk subjects, is a public health need and is included in national stroke plan 2010-2014.

On the basis of the available data, a supplementary impact of rivaroxaban (XARELTO) on morbidity and mortality of treated patients is not expected in comparison with current therapy. The impact on the quality of life is not documented. An impact on the organisation of healthcare is expected, particularly because there is no need for specific monitoring of the blood values, in contrast to VKA, but this impact has not been documented.

There is no guarantee that the trial data can be carried over into actual practice, particularly because of the following factors: the demonstration of efficacy is based on a randomised, double-blind study versus warfarin, which is not the most commonly used comparator in France (where fluindione is the most frequently prescribed), the number of French patients enrolled into this study is small and the persistence of this treatment over the medium and long term is not assured.

Consequently, rivaroxaban (XARELTO) offers a supplementary, partial response to an identified public health need.

Overall, a benefit to public health is not expected for rivaroxaban (XARELTO) in the prophylaxis of stroke and systemic embolism in adult patients with nonvalvular AF and presenting with one or several risk factors.

XARELTO is a first line or second line (in the case of poor control of the INR with VKA) prophylactic treatment in patients at moderate to high risk of thromboembolism as defined in the indications in the Marketing Authorisation.

Alternative medicinal products exist to the prescription of rivaroxaban : vitamin K antagonist oral anticoagulants and dabigatran etexilate (PRADAXA).

In conclusion, the actual benefit of XARELTO is substantial.

Clinical Benefit


the actual benefit of XARELTO is substantial.

Clinical Added Value

no clinical added value
Only the non-inferiority of rivaroxaban with respect to warfarin was demonstrated : The absence of the possibility for routine monitoring of haemostasis with rivaroxaban must not lead to it consistently being prescribed in preference to VKA, particularly to very elderly patients (above 75-80 years old) and/or those at increased risk of bleeding (renal impairment, concomitant treatment with aspirin or clopidogrel for coronary artery disease).
However, these patients make up a substantial portion of those eligible for anticoagulant treatment for the prevention of stroke and systemic embolism in adult patients with atrial fibrillation.
Consequently, the Committee is of the opinion that XARELTO offers no improvement in actual benefit (IAB V) compared to vitamin K antagonist anticoagulants.

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