1 Recommendations

1 Recommendations

1.1 Sofosbuvir–velpatasvir–voxilaprevir is recommended as an option for treating chronic hepatitis C in adults, only if it is used as specified in table 1 and the company provides the drug at the same price or lower than that agreed with the Commercial Medicines Unit.

Table 1 Sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C

Treatment history

Hepatitis C virus genotype

Liver disease stage

Recommendation

Previous direct-acting antivirals

1–6

With or without compensated cirrhosis

Recommended for 12 weeks

No direct-acting antivirals

3

Recommended for 8 weeks

1.2 It is recommended that the decision to treat and prescribing decisions are made by multidisciplinary teams in the operational delivery networks put in place by NHS England, to prioritise treatment for people with the highest unmet clinical need.

1.3 These recommendations are not intended to affect treatment with sofosbuvir–velpatasvir–voxilaprevir that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

Treatment options for chronic hepatitis C depend on the genotype of the virus and the person's cirrhosis status and treatment history. They include direct-acting antivirals (DAA) and interferon-containing treatments. There are currently no treatments with a marketing authorisation available for people who have had unsuccessful treatment with DAA.

Clinical trials show that sofosbuvir–velpatasvir–voxilaprevir is effective for treating all genotypes of chronic hepatitis C, irrespective of the person's cirrhosis status and treatment history.

The company's economic evidence is limited to people who have had DAA (genotypes 1–6) and people with genotype 3 hepatitis C who have not had DAA before. This reflects the groups with the highest unmet clinical need. Cost-effectiveness estimates for sofosbuvir–velpatasvir–voxilaprevir are within what NICE usually considers acceptable. Therefore sofosbuvir–velpatasvir–voxilaprevir can be recommended for these groups for treating chronic hepatitis C, as specified in table 1.

  • National Institute for Health and Care Excellence (NICE)