buprenorphine oral lyophilisate (Espranor)

following an abbreviated submission:

buprenorphine oral lyophilisate (Espranor®) is accepted for restricted use within NHS Scotland.

Indication under review: Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Treatment with buprenorphine oral lyophilisate is intended for use in adults and adolescents aged 15 years or over who have agreed to be treated for addiction.

SMC restriction: to patients in whom methadone is not suitable. 

In patients who require supervised consumption of buprenorphine, the oral lyophilisate formulation has the advantage of a faster dissolution time compared to other available buprenorphine preparations.

Prescribers should be aware that buprenorphine preparations are not interchangeable.

Generic buprenorphine sublingual tablets are available at lower cost.

This SMC advice takes account of the benefit of a Patient Access Scheme (PAS) that improves the cost effectiveness of buprenorphine oral lyophilisate.  This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.