Paritaprevir / Ritonavir / Ombitasvir / Dasabuvir
Treatment of patients with genotype 1 chronic hepatitis C infection who have compensated liver disease, irrespective of previous treatment history.
Access path
- Jul 2015Recommended · restricted
vs no treatment, ledipasvir/sofosbuvir
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required listing of paritaprevir/ritonavir/ombitasvir plus dasabuvir (Viekira PAK) and paritaprevir/ritonavir/ombitasvir plus dasabuvir with ribavirin (Viekira PAK-RBV) for the treatment of patients with genotype 1 chronic hepatitis C (CHC) infection on the basis of non-inferior efficacy and safety with Ledipasvir/Sofosbuvir (LDV/SOF), recommended in March 2015.PSD · Jul 2015
7.2 The PBAC recommended the price of a course of treatment for Viekira PAK / Viekira PAK-RBV should be the same as the price of a course of treatment with LDV/SOF for treatment naïve, non-cirrhotic genotype 1 patients. 27PSD · Jul 2015
6.25 Given the rapidly changing treatment landscape for genotype 1 (GT1) CHC, the sponsor indicated that they were willing to accept a price on a cost-minimisation basis compared with LDV/SOF, should PBAC recommend LDV/SOF for PBS listing at the March 2015 meeting.PSD · Jul 2015
6.26 The submission presented a modelled cost-utility analysis of Viekira PAK / Viekira PAK-RBV relative to a mixed comparator of no treatment and protease inhibitor plus PR. The evaluation presented a cost-utility analysis of Viekira PAK / Viekira PAK- RBV versus no treatment, consistent with previous considerations by the PBAC.PSD · Jul 2015
6.21 The submission described Viekira PAK / Viekira PAK-RBV as superior in terms of efficacy and inferior in terms of safety compared with no treatment.PSD · Jul 2015
6.22 The submission described Viekira PAK / Viekira PAK-RBV as equivalent in terms of efficacy and safety to LDV/SOF. The submission’s claim appeared reasonable within similar populations, although the magnitude of differences in terms of SVR rates or rates of adverse events was uncertain due to reliance on the single arm trials. There are differences in the safety profile of the drugs as well as the potential for safety issues.PSD · Jul 2015
6.4 The PBAC noted and welcomed the input from individuals (114), health care professionals (14) and organisations (17) via the Consumer Comments facility on the PBS website. The large number of comments and discussion reiterate the comments received during previous considerations of the IFN-free treatments, namely the benefit of the availability of a highly effective treatment that should be made available for all infected individuals, the improved …PSD · Jul 2015
6.57 The submission proposed a risk-sharing arrangement (RSA) to address some of the uncertainties surrounding the uptake rate of the new all-oral interferon-free treatment regimens. The proposed RSA is based on ''''''''''''''''' ''''''''''''''''' ''''''''''''''''''''''''''''''''' ''''''''' '''''''''''.PSD · Jul 2015
Cost-effectiveness
ICER values are redacted/commercially sensitive — the document states pricing information and economic model details are redacted with asterisks throughout
Decision context
PopulationAdults aged 18 years or older with genotype 1 chronic hepatitis C infection and compensated liver disease, treated in accredited treatment centres, with varied eligibility by genotype and prior treatment history.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2015 | Recommended · restricted | no treatment, ledipasvir/sofosbuvir | — | RCT · SVR |
Consumer voice
Consumer input highlighted the benefit of highly effective interferon-free treatments for hepatitis C, emphasizing improved quality of life and avoidance of side effects associated with current treatments. Input was received from individuals, healthcare professionals, and organizations via the PBS website and through discussions with patient advocacy groups.
the benefit of the availability of a highly effective treatment that should be made available for all infected individuals Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted TGA label to patients with compensated liver disease; decompensated cirrhosis excluded from subsidy.