Daclatasvir
Treatment of chronic hepatitis C infection (CHC) across all genotypes (1-6), irrespective of previous treatment history or cirrhosis status, in patients with compensated liver disease.
Decisions on record
- Meeting Nov 2015 Recommended Combination with sofosbuvir for chronic hepatitis C
- Meeting Mar 2015 Recommended Hepatitis C virus (HCV) infection
Access path
- Mar 2015Recommended · restricted
vs no treatment (for IFN-free context); protease inhibitor…
- Nov 2015Recommended · restricted
Comparator changed: no treatment (for IFN-free context); protease inhibitor plus…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended to expand the Authority Required listing of daclatasvir in combination with sofosbuvir for the treatment of all patients with Genotype 1 and Genotype 3 chronic hepatitis C (CHC).PSD · Nov 2015
7.2 In making this recommendation, the PBAC recalled that daclatasvir in combination with sofosbuvir was recommended for Genotype 1 treatment naïve non-cirrhotic and Genotype 3 chronic hepatitis C patients at its March 2015 PBAC meeting. The PBAC ** Bruggmann P, Berg T, et al. Historical epidemiology of hepatitis C virus (HCV) in selected countries. Journal of viral hepatitis. 2014;21 Suppl 1:5-33. 12PSD · Nov 2015
6.23 The re-submission did not present any economic analysis.PSD · Nov 2015
6.19 The re-submission claimed that the efficacy and safety of DCV+SOF was consistent across genotypes and hard-to-treat patient groups. The clinical evidence supported the claim that DCV+SOF (±RBV) was effective across HCV genotypes 1-4 and traditionally hard-to-treat patient groups, including treatment experienced patients and patients with cirrhosis: There was sufficient evidence to support the claim that: o DCV+SOF12 was highly effective in …PSD · Nov 2015
Submitted evidence for DCV12 + SOF12 + RBV 12 was insufficient to support a claim of: o non-inferiority against LDV/SOF24 for treatment experienced GT1 CHC patients with cirrhosis o non-inferiority against RBV12+SOF12 for GT2 CHC patients with cirrhosis o high effectiveness compared to no treatment against GT4-6 CHC patients with cirrhosis Submitted evidence for DCV24 + SOF24 was insufficient to support a claim of: o non-inferiority against LDV/SOF24 …PSD · Nov 2015
6.2 The PBAC noted and welcomed the input from individuals (172), health care professionals (16) and organisations (18) via the Consumer Comments facility on the PBS website. The PBAC noted the correspondence from the Gastroenterological Society of Australia (GESA) on use of DAAs in the treatment of patients with liver cirrhosis and severe portal hypertension, decompensated liver disease, or patients post liver transplant.PSD · Mar 2015
6.3 Representatives of the PBAC met with Hepatitis Australia, Hepatitis NSW, the Australian Injecting and the Illicit Drug User’s League prior to the PBAC meeting, and reported the following key points to the PBAC in relation to the agenda items for the treatment of Hepatitis C:PSD · Mar 2015
6.57 If daclatasvir is listed for use in combination with both asunaprevir and sofosbuvir, the submission proposed that daclatasvir would be listed at a published DPMQ of $'''''''''''''''''''''''', with a rebate applied to the proportion of daclatasvir dispensed for use in combination with asunaprevir to reduce the effective DPMQ to $'''''''''''''''''''''.PSD · Mar 2015
Cost-effectiveness
Re-submission did not present Sections A, C, D or E (economic evaluation sections). Only new clinical evidence was presented. No ICER was calculated or provided in this re-submission.
Decision context
PopulationAdults aged ≥18 years with chronic hepatitis C infection (all genotypes 1-6), including treatment naïve and treatment experienced patients, with or without cirrhosis, and patients co-infected with HIV, requiring compensated liver disease.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended · restricted | For genotype 1: ledipasvir/sofosbuvir (LDV/SOF); for genotype 2: sofosbuvir plus ribavirin; for genotypes 4-6: no treatm | — | Single-arm · SVR12 |
| Mar 2015 | Recommended · restricted | no treatment (for IFN-free context); protease inhibitor plus peginterferon alfa and ribavirin (for genotype 1); peginter | — | Single-arm · SVR |
Clinical evidence
Consumer voice
Consumer input from 172 individuals, 16 healthcare professionals, and 18 organisations highlighted the need for curative hepatitis C treatments with shorter durations, improved quality of life outcomes, and avoided side effects from current therapies. Consumer groups emphasised the need for broad access to treatments rather than restrictions based on disease severity, and expressed concern about '
The large number of comments highlighted the benefit of the availability of a curative treatment that should be made available for all infected individuals and the improved quality of life as well as the side effects associated with the current treatments that would be avoided. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify chronic hepatitis C in adults with compensated liver disease; PBAC adds genotype/treatment history details but does not narrow the eligible population.