dolutegravir (Tivicay)

following a full submission

dolutegravir (Tivicay®) is accepted for use within NHS Scotland.

Indication under review: in combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age.

In phase III clinical studies, dolutegravir has demonstrated non-inferiority or superiority to three comparator antiretroviral medicines in treatment-naïve adults with HIV, and superiority to an alternative integrase inhibitor in treatment-experienced adults.  (All study patients also received two nucleoside reverse-transcriptase inhibitors).

This SMC advice takes account of the benefits of a patient access scheme (PAS) that improves the cost-effectiveness of dolutegravir.  This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.