NICE decision on ledipasvir/sofosbuvir for chronic HCV

On 25 November, NICE published guidance for the limited use of sofosbuvir/ledipasvir for chronic hepatitis C (HCV). [1]

As with the NICE approach to other new direct acting antivirals DAAs), the recommendation are categorised both by genotype and treatment experience, see Table 1.

NHS treatment with ledipasvir/sofosbuvir should be available within three months of this decision.

The coformulation of ledipasvir.sofosbuvir is manufacture by Gilead Sciences and marketed under the tradename Harvoni.

Table 1: Summary of NICE recommendation for ledipasvir/sofosbuvir
HCV treatment-naive patients
G1 without cirrhosis	8 weeks treatment
G1 or G4 with cirrhosis	12 weeks treatment
HCV treatment-experienced patients
G1 or G4 without cirrhosis	12 weeks treatment
G1 or G4 with cirrhosis	12 weeks treatment, but only if there is a low risk of disease progression

Table 1: Summary of NICE recommendation for ledipasvir/sofosbuvir

HCV treatment-naive patients

G1 without cirrhosis

8 weeks treatment

G1 or G4 with cirrhosis

12 weeks treatment

HCV treatment-experienced patients

G1 or G4 without cirrhosis

12 weeks treatment

G1 or G4 with cirrhosis

12 weeks treatment, but only if there is a low risk of disease progression

Comment

A price for ledipasvir/sofosbuvir is approximately £26,000 for 8-weeks and £38,000 for 12-weeks of treatment, both excluding VAT.

The guidance notes that a nationally available price reduction for ledipasvir/sofosbuvir has been agreed with the Commercial Medicines Unit, but also that this was not considered as part of the submission. No details of the reduced price have been published.

NICE. Ledipasvir–sofosbuvir for treating chronic hepatitis C. NICE technology appraisals [TA363]. (25 November 2015)
http://www.nice.org.uk/guidance/ta363