NICE approves daclatasvir to treat adult HCV
1 February 2016. Related: Hepatitis coinfection.
On 25 November, NICE published guidance for the limited use of daclatasvir to treat adult with hepatitis C genotype 1, 3 or 4. [1]
A summary of recommendations is included below in Table 2, but please refer to the full NICE document for details.
This is dependent on the company providing these drugs at the same price or lower than that agreed with the Commercial Medicines Unit.
Daclatasvir has the brand name Daklinza and is manufactured by BMS.
| Type of hepatitis C | Treatment recommended by NICE | Length of treatment |
|---|---|---|
| If hepatitis C has not been treated before | ||
| 1, without cirrhosis | Daclatasvir plus sofosbuvir only for people with significant fibrosis | 12 weeks |
| 4 | Daclatasvir plus peginterferon alfa and ribavirin only for people with significant fibrosis or cirrhosis | 24 weeks |
| If hepatitis C has been treated before | ||
| 1 or 4 without cirrhosis | Daclatasvir plus sofosbuvir only for people with significant fibrosis | 12 weeks |
| 4 | Daclatasvir plus peginterferon alfa and ribavirin only for people with significant fibrosis or cirrhosis | 24 weeks |
| If interferon cannot be used | ||
| 1, 3 or 4 without cirrhosis | Daclatasvir plus sofosbuvir only for people with significant fibrosis | 12 weeks |
| 1 or 4 with cirrhosis | Daclatasvir plus sofosbuvir, with or without ribavirin | 24 weeks |
| 3, with cirrhosis | Daclatasvir plus sofosbuvir and ribavirin | 24 weeks |
Abbreviation: HCV, hepatitis C virus. Treated – the person’s hepatitis C has not adequately responded to interferon-based treatment.
Comment
A price for daclatasvir alone is approximately £24,500 for 12 weeks and £49,000 for 24 weeks of treatment, both excluding VAT.
The average cost of daclatasvir plus sofosbuvir is £59,501 for a 12-week course and £119,002 for a 24-week course; when ribavirin is added these costs increase to £60,304 and £120,608 respectively. The average cost of a course of treatment with daclatasvir in combination with peginterferon alfa and ribavirin ranges from £53,628 to £58,221 (depending on whether peginterferon alfa and ribavirin are taken for 24 or 48 weeks; daclatasvir may only be taken for 24 weeks).
The guidance notes that a nationally available price reduction for daclatasvir 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.
Treatment should be available on the NHS within 3 months of the guidance being issued.
Reference:
NICE guidance. Daclatasvir for treating chronic hepatitis C (TA364). NICE technology appraisal guidance [TA364] (November 2015).
http://www.nice.org.uk/guidance/ta364