raltegravir (Isentress)

following an abbreviated submission:

raltegravir 600mg film-coated tablets (Isentress®) are accepted for restricted use within NHS Scotland.

Indication under review: in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in adults and paediatric patients weighing at least 40kg.

SMC restriction: patients who are intolerant or resistant to non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) or when these options are compromised due to drug-drug interactions.

The 600mg tablet allows once daily dosing (1200mg once daily) at no additional cost compared with raltegravir 400mg tablets administered twice daily. Raltegravir 400mg tablets should not be used to administer the 1200mg once daily regimen.

SMC has previously accepted raltegravir 400mg film-coated tablets for restricted use in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infection in adolescents and children aged 2 to 17 years and in adult patients. In the original full submission the health economic case was made for a sub-population of patients within the licensed indication.