sofosbuvir/velpatasvir (Epclusa)

following a full submission:

sofosbuvir-velpatasvir (Epclusa®) is accepted for restricted use within NHS Scotland.

Indication under review: Treatment of chronic hepatitis C virus (HCV) infection in adults.

SMC restriction: in patients with 
• genotype 2, 5 or 6 chronic HCV infection
• decompensated cirrhosis, irrespective of chronic HCV genotype

Sofosbuvir-velpatasvir was associated with high rates of sustained virologic suppression in adults with genotype 1, 2, 4, 5 and 6 chronic HCV infection, including those with decompensated cirrhosis. Sofosbuvir-velpatasvir was associated with significantly superior sustained virologic suppression compared with sofosbuvir plus ribavirin in adults with genotype 2 chronic HCV infection.

SMC has issued separate advice accepting the use of sofosbuvir-velpatasvir for the treatment of patients with genotype 3 chronic HCV infection.  
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sofosbuvir-velpatasvir. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.