Glecaprevir With PibrentasvirMaviret
Treatment of chronic hepatitis C (CHC) infection in patients who are treatment-naïve with compensated cirrhosis, genotypes 1-6, with a shortened 8-week treatment duration.
Decision on record
- Meeting Nov 2017 Recommended Chronic hepatitis C virus (HCV) infection
Access path
- TGA registered · Maviret
TGA label narrower than the PBS population
- Jul 2017Deferred
vs sofosbuvir/velpatasvir
- Nov 2017Recommended · restricted
Comparator changed: sofosbuvir/velpatasvir → no treatment (for NS5A experienced…
- Dec 2020Recommended
Comparator changed: no treatment (for NS5A experienced patients); sofosbuvir/velpatasvir…
- PBS listing · Restricted
From the public summary
6.1 The PBAC was of a mind to recommend the listing of an 8-week treatment option of glecaprevir with pibrentasvir (GLE/PIB) for the treatment of chronic hepatitis C (CHC) infection in patients who are treatment-naïve with compensated cirrhosis (TN/CC), however deferred making a recommendation to amend the General Statement for Drugs for the Treatment of Hepatitis C (the General Statement) pending finalisation of 7PSD · Dec 2020
6.2 The PBAC was of a mind to retain the 12-week regimen option if it remains part of the TGA registration. The Committee advised that this regimen should be included as a footnote to the General Statement for simplicity and reaffirmed that any change to treatment options within the General Statement that achieve the same health outcomes must be at no increase in the average cost to the Government.PSD · Dec 2020
5.14 The minor submission requested the same cost for the 8-week course as the current cost of the 12-week course by application of the existing Special Pricing Arrangement (SPA), and no changes to the risk sharing arrangements.PSD · Dec 2020
5.11 The submission claimed non-inferior comparative effectiveness and safety of GLE/PIB for the 8-week treatment course compared to the 12-week course.PSD · Dec 2020
5.12 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Dec 2020
6.2 The PBAC noted and welcomed the input received from professional organisations representing people living with hepatitis (4) via the consumer comments facility on the PBS website. The comments described a range of benefits of treatment with glecaprevir/pibrentasvir including the addition of another pan-genotypic treatment choice for patients with HCV; and that it appears to be efficacious for people with severe chronic kidney disease and compensated …PSD · Nov 2017
6.46 The PBAC recommended that glecaprevir/pibrentasvir 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 · Jul 2017
Cost-effectiveness
This was a minor submission requesting amendment of treatment duration; no economic evaluation with ICER was required. The submission was based on cost minimisation principles with no change to cost per treatment course.
The submission was based on a cost-minimisation analysis of glecaprevir/pibrentasvir in comparison with a FDC of sofosbuvir and velpatasvir. PSD · 2017
Decision context
PopulationAdults with chronic hepatitis C genotypes 1-6 who are treatment-naïve with compensated cirrhosis
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2020 | Recommended | 12-week treatment course of glecaprevir with pibrentasvir (current PBS listed regimen); alternative pan-genotypic treatm | — | Single-arm · SVR12 |
| Nov 2017 | Recommended · restricted | no treatment (for NS5A experienced patients); sofosbuvir/velpatasvir (for non-NS5A experienced patients) | — | RCT · SVR12 |
| Jul 2017 | Deferred | sofosbuvir/velpatasvir | — | Single-arm · SVR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ENDURANCE-1 | Ph 3 | 703 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR1… | completed |
| ENDURANCE-3 | Ph 3 | 506 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR1… | completed |
| EXPEDITION-1 | Ph 3 | 146 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR1… | completed |
| EXPEDITION-4 | Ph 3 | 104 | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR1… | completed |
Consumer voice
Professional organisations representing people living with hepatitis provided input highlighting the benefits of glecaprevir/pibrentasvir as another pan-genotypic treatment option, particularly for patients with severe chronic kidney disease, compensated cirrhosis, and those with prior antiviral treatment experience.
the addition of another pan-genotypic treatment choice for patients with HCV Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naïve patients with compensated cirrhosis; TGA label includes treatment-experienced and non-cirrhotic patients.