Advice

following a resubmission:

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 1 or 4 HCV infection.

Sofosbuvir-velpatasvir was associated with high rates of sustained virologic suppression in adults with genotype 1 and 4 chronic HCV infection, including those with decompensated cirrhosis.

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.
SMC has issued separate advice accepting the use of sofosbuvir-velpatasvir for the treatment of patients with genotype 3 (SMC No.1195/16) and for the treatment of patients with genotypes 2, 5 and 6 chronic HCV infection and for those patients with decompensated cirrhosis, irrespective of chronic HCV genotype (SMC No. 1271/17).

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Medicine details

Medicine name:
sofosbuvir / velpatasvir (Epclusa)
SMC ID:
1271/17
Indication:
The licensed indication for SOF/VEL covers chronic HCV infection of any genotype (GT1-6) in patients without cirrhosis, those with compensated cirrhosis and those with decompensated cirrhosis. The current submission covers genotypes 1 and 4 patients without or with compensated cirrhosis. SOF/VEL has received prior approval from the SMC for the treatment of CHC GT2, 3, 5 and 6 patients without or with compensated cirrhosis as well as patients with decompensated cirrhosis irrespective of CHC genotype (2, 3).
Pharmaceutical company
Gilead Sciences Ltd
BNF chapter
Infections
Submission type
Resubmission
Status
Restricted
Date advice published:
09 April 2018