Paritaprevir With Ritonavir And Ombitasvir
Treatment of patients infected with genotype 4 chronic hepatitis C virus infection, irrespective of previous treatment history, in combination with ribavirin.
Decision on record
- Meeting Nov 2021 Withdrawn Hepatitis C no PSD
Access path
- Nov 2016Recommended · restricted
vs grazoprevir-elbasvir ± ribavirin
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required General Schedule and Section 100 listing of paritaprevir with ritonavir and ombitasvir, in combination with ribavirin for treatment naïve and treatment experienced genotype 4 CHC infection on a cost- minimisation basis with grazoprevir with elbasvir with or without RBV, in accordance with the treatment recommendations in the approved Australian Product Information for each product.PSD · Nov 2016
7.2 The PBAC recommended that the cost of a course of treatment for paritaprevir with ritonavir and ombitasvir + RBV should be the same as the cost of a course of treatment with GZR-EBR ± RBV for patients with GT4 CHC.PSD · Nov 2016
6.32 Although an economic analysis was presented (a modelled cost-utility analysis versus ‘no treatment’), the submission indicated that the sponsor was willing to accept a price for Technivie® based on a cost-minimisation analysis versus GZR- EBR ± RBV. 13PSD · Nov 2016
6.27 Table 5 summarises the clinical claims made in the submission on the comparative efficacy and safety of Technivie® + RBV for 12 weeks versus the nominatedPSD · Nov 2016
6.2 The PBAC noted and welcomed the input from individuals (3) and organisations (10) via the Consumer Comments facility on the PBS website. The comments described how this [class of] drug will improve cure rates, reduce treatment duration and offer simpler administration with fewer side effects. The comments also noted that increased treatment of hepatitis C infection will reduce the risk of transmission within the community.PSD · Nov 2016
6.40 None proposed, but the submission proposed an effective DPMQ price for Technivie® of $''''''''''''''''''''''' per pack. This is approximately ''''''% of its published price.PSD · Nov 2016
6.41 The PBAC recommended that Technivie® enter the Risk Sharing Arrangement (RSA) currently in place for other drugs used for the treatment of CHC, and be subject to the same Subsidisation Caps and rebate arrangements.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis conducted against grazoprevir-elbasvir ± ribavirin; no ICER calculated as per cost-minimisation approach
Decision context
PopulationAdults aged 18 years or older with genotype 4 chronic hepatitis C infection, treatment-naïve or treatment-experienced, with or without cirrhosis, treated for 12 weeks in combination with ribavirin
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended · restricted | grazoprevir-elbasvir ± ribavirin | — | Single-arm · Surrogate |
Consumer voice
Consumer input from 3 individuals and 10 organisations highlighted that this drug class will improve hepatitis C cure rates, reduce treatment duration, simplify administration with fewer side effects, and increase community treatment to reduce transmission. Organisations emphasised the importance of GP prescribing access, interferon-free treatment for all people with hepatitis C, and simplified he
The comments described how this [class of] drug will improve cure rates, reduce treatment duration and offer simpler administration with fewer side effects. Consumer comments · PSD