SIXMO implant (buprénorphine)

Key points

Favourable opinion for reimbursement in substitution treatment for opioid dependence within a framework of medical, social and psychological treatment. Treatment is reserved for clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine.

What therapeutic improvement?

No clinical added value in the management of opioid dependence.

Role in the care pathway?

Opioid substitution therapy should be part of an overall process of support, medical, psychological, social and educational follow-up and rehabilitation of the dependent person, aspects that require networking and a collaborative approach between facilities. The success of medicinal treatments depends largely on the quality of the psychotherapeutic and social support provided.

Three sublingual or oral medicinal products with an MA in the treatment of opioid dependence are currently prescribed:

• high-dose sublingual buprenorphine (HDB) alone or in combination (HDB/naloxone), included in list I with prescribing and dispensing rules for narcotics, which may be prescribed by any physician
• Daily dosing. After a satisfactory stabilisation has been achieved the frequency of dosing may be decreased to every other day at twice the patient’s daily dose. In some patients, this frequency of dosing may be decreased to 3 times a week.
• subcutaneous buprenorphine, included in list I with prescribing and dispensing rules for narcotics, for which prescription is reserved for hospital physicians or for physicians practising in an addiction prevention and support and treatment centre (CSAPA).
• Weekly or monthly dosing, in a hospital or CSAPA.
• methadone, classed as a narcotic, for which initial prescription is reserved for physicians practising in addiction prevention and support and treatment centres (CSAPA), in a hospital department or in a prison healthcare unit.
• Daily dosing.

Role of the medicinal product in the care pathway

SIXMO (buprenorphine) subcutaneous implant is an additional therapeutic option in the medicinal treatment of opioid dependence in adults. The indication for this opioid dependence substitution therapy is restricted to a selected population of patients clinically stabilised under sublingual buprenorphine at a dosage of no more than 8 mg/day.

The prescription of SIXMO is reserved for physicians practising in an addiction prevention and support and treatment centre (CSAPA), or for hospital physicians. The six-monthly administration of the implants, performed in a healthcare facility, must be performed by a physician trained in implant insertion and removal procedures. This medicinal product requires special monitoring during treatment.

The role of SIXMO in the care pathway remains to be specified. It will depend, in particular, on patients’ acceptance of the constraints inherent to the treatment and any adverse effects related to the implantable formulation.