SOTALEX

Key points

Unfavourable opinion for maintenance of reimbursement in the prevention of recurrences of supraventricular tachycardias and ventricular rhythm disorders (for more details, see MA).

Clinical benefit now insufficient to justify public funding cover (previously it was substantial) in the indications of the MA.

Role in the care pathway ?

1. Supraventricular tachycardias

- Prevention of recurrences of atrial fibrillation

Antiarrhythmic treatment may be considered as long-term therapy to maintain sinus rhythm in the event of symptomatic recurrent paroxysmal or persistent AF. It is not generally initiated from the first episode of AF. Long-term antiarrhythmic treatment is aimed at improving symptoms and preventing recurrences of symptomatic AF. It falls within the scope of specialised management with a cardiological opinion and at least annual ECG monitoring. Catheter ablation may be a first-line therapeutic alternative in specific situations or a second-line alternative in the event of failure of medicinal treatment. It requires oral anticoagulant therapy and is reserved for cardiac rhythm specialists.

Role of the medicinal product in the care pathway :

In patients with paroxysmal or persistent atrial fibrillation, the Committee considers that sotalol no longer has a role in the care pathway for the prevention of recurrences of atrial fibrillation, in view of the available alternatives, given its risk of excess mortality demonstrated in the prevention of recurrences of atrial fibrillation and its low effect size in the prevention of recurrences of atrial fibrillation compared to the control group (placebo or the absence of treatment).

In patients with permanent atrial fibrillation, the Committee reiterates that oral antiarrhythmic drugs no longer have a role in the prevention of recurrences.

- Prevention of recurrences of other supraventricular tachycardias

The therapeutic strategy for the prevention of recurrences of supraventricular rhythm disorders apart from atrial fibrillation (focal atrial tachycardias, common atrial flutter, atrioventricular nodal re-entry tachycardia (AVNRT), atrioventricular re-entry tachycardia (AVRT)) is based on catheter ablation as a first-line approach. Medicinal treatment with beta-blockers or non bradycardia-inducing calcium channel blockers is recommended pending or following refusal or failure of ablation. The use of oral antiarrhythmic drugs has become marginal.

Role of the medicinal product in the care pathway :

SOTALEX (sotalol) proprietary medicinal products no longer have a role in the care pathway for the prevention of recurrences of other supraventricular tachycardias.

1. Prevention of recurrences of ventricular rhythm disorders

With the exception of certain specific cardiac diseases, the prevention of recurrences of ventricular arrhythmias is based on an implantable cardioverter defibrillator (ICD) and, more rarely, on antiarrhythmic drugs. The decision to implant an ICD requires the opinion of a cardiac rhythm specialist. Implantation is only considered in authorised centres in patients in whom the reasonable expectancy of survival with a satisfactory functional status is more than 1 to 2 years and in patients over 30 years of age.

Beta-blockers (excluding sotalol) are recommended as first-line treatment in patients with ventricular arrhythmia.

In the event of failure of or contraindication to beta-blockers, the European guidelines indicate antiarrhythmics. Antiarrhythmic drugs are often used as an adjuvant therapy in the treatment of patients with ventricular arrhythmias. The choice of antiarrhythmic drug must take into account the causal disease and/or the associated heart condition.

Furthermore, interventional procedures are alternatives :

-    The ablation of arrhythmogenic foci is considered as a second-line treatment of recurrent idiopathic ventricular tachycardias, following the failure of pharmacotherapy.

-    Ablation is generally performed percutaneously (percutaneous catheter ablation), by the subepicardial route in rare cases and, in exceptional cases, surgically.

-   Finally, other invasive or surgical treatments, such as myocardial revascularisation, ventricular aneurysm resection, sympathetic denervation, short-term mechanical circulatory support, heart transplant, the use of a total artificial heart device or anaesthetic sedation, represent special situations, with implementation decided upon on a case-by-case basis following a specialised opinion.

Role of the medicinal product in the care pathway :

SOTALEX (sotalol) proprietary medicinal products no longer have a role in this strategy insofar as a potential risk of excess mortality compared to placebo was identified in the SWORD study (with d-sotalol) as well as a meta-analysis conducted in the prevention of atrial fibrillation. The Committee considers that there would therefore be a potential loss of opportunity for patients in view of the alternatives, although this medicinal product is still cited in the European guidelines (ESC 2016).

Special recommendations

The Committee reiterates that if it is necessary to change treatment, any overlapping of prescriptions of antiarrhythmic drugs should be avoided, since this could exacerbate their toxicity.

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