SELINCRO (nalmefene)

Key points

Maintenance of the favourable opinion for reimbursement, in conjunction with continuous psychosocial support, in the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification.

Role in the care pathway?

The therapeutic methods used in the treatment of primary alcohol dependence are multidisciplinary and include, in particular, psychotherapy or support groups for former drinkers, medicinal products and hospitalisation. Used simultaneously or consecutively in variable proportions, these methods are proposed to treat a polymorphous problem.

Psychosocial support of patients is essential throughout medicinal treatment and forms the foundation for the management of any individual with alcohol problems. The French Alcohology Society (SFA) indicates in its various recommendations that “the prescription of medicinal treatment - particularly in addictive behaviours - should always be part of a holistic care approach and medicinal treatment cannot be the only therapy for addiction”.

At the current time, six medicinal products have an MA in the treatment of alcohol dependence in the following two indications:

-    three medicinal products are indicated in the maintenance of abstinence after detoxification: AOTAL 333 mg and its generics (acamprosate), generics of REVIA 50 mg (naltrexone, with REVIA no longer marketed), and ESPERAL 500 mg (disulfiram);

-    three medicinal products indicated in the reduction of alcohol consumption in high-risk patients:

•   SELINCRO (nalmefene);
•  two baclofen-based medicinal products only indicated following the failure of the other medicinal treatments available:   BACLOCUR (baclofen) and BACLOFENE ZENTIVA (baclofen).

Role of SELINCRO (nalmefene) in the care pathway:

The management of alcohol dependence is based on multidisciplinary treatment methods (psychotherapy, support groups for former drinkers, medicinal products, hospitalisation, psychosocial support, etc.). When a medicinal treatment is envisaged in the context of the holistic care of alcohol dependence, SELINCRO (nalmefene), in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption, remains the first-line medicinal product for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. The potential benefit of the treatment is dictated by the patient’s compliance.

The choice of SELINCRO from the various medicinal and non-medicinal supportive methods available is based on shared decision-making between the physician and the patient, after providing the patient with honest information on the various therapeutic options that exist and their characteristics, in particular, the risks of dissociation reported in clinical studies with SELINCRO.

In the French observational study initiated at the request of the Committee following the assessment on 4 December 2013, a profile of patients included on the basis of a broader drinking risk level than that validated by the MA for SELINCRO (nalmefene) was identified. Consequently, the Committee highlights that, with the aim of ensuring good practice, SELINCRO (nalmefene) should be reserved purely for patients with a high DRL (alcohol consumption >60 g/day for men and >40 g/day for women according to the WHO DRLs of alcohol consumption). In addition, patients must not present physical withdrawal symptoms or require immediate detoxification, in accordance with the MA indication.