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 name:
- sofosbuvir / velpatasvir (Epclusa)
- SMC ID:
- 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
- Submission type
- Date advice published
- 09 April 2018