Ledipasvir/Sofosbuvir
Treatment of patients infected with genotype 1 chronic hepatitis C (CHC), irrespective of previous treatment history.
Access path
- Mar 2015Recommended · restricted
vs no treatment
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required listing of ledipasvir/Sofosbuvir for the treatment of Genotype 1 chronic hepatitis C (CHC) on the basis of cost- effectiveness of the treatment over no treatment.PSD · Mar 2015
7.2 The PBAC reiterated that the Committee recognised that new treatments of HCV resulted in high rates of sustained virological response, where the HCV virus could not be detected in the blood of patients 12 weeks after treatment commenced.PSD · Mar 2015
6.19 The submission presented a modelled economic evaluation based on an unadjusted comparison of results from single arms of different studies. The evaluation is 16PSD · Mar 2015
Summary of model structure and rationale Time horizon 30 years. This is consistent with PBAC Advice (Para 7.10, Item 5.17 Sofosbuvir Public Summary Document, July 2014 PBAC meeting).PSD · Mar 2015
• superior in terms of efficacy and safety to the nominated comparator of a protease inhibitor +PR; andPSD · Mar 2015
• superior in terms of efficacy and with an acceptable safety profile compared with no treatment.PSD · Mar 2015
6.2 The PBAC noted and welcomed the input from individuals (231), health care professionals (14) 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 the 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
Cost-effectiveness
ICER values not stated in the public summary document; listing was sought on the basis of cost-effectiveness but specific ICER figures are not provided.
Listing was sought on the basis that LDV/SOF is cost-effective compared with PR plus protease inhibitors or no treatment. PSD · 2015
Decision context
PopulationAdults aged 18 years or older with chronic genotype 1 hepatitis C infection, stratified by cirrhosis status and prior treatment history (treatment-naïve without cirrhosis, treatment-naïve with cirrhosis, treatment-experienced).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended · restricted | no treatment | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ION-2 | Ph 3 | 441 | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Disconti… | completed |
Consumer voice
Consumer input emphasized the benefits of highly effective DAA treatments for hepatitis C, including improved quality of life, avoidance of side effects from current treatments, and patient preference for shorter treatment durations.
the benefit of the availability of a highly effective treatment that should be made available for all infected individuals Consumer comments · PSD