Sofosbuvir With Velpatasvir And VoxilaprevirVosevi
Treatment of adult patients with chronic hepatitis C who have received prior treatment with an NS5A-based treatment regimen and not achieved sustained virological response (SVR).
Access path
- TGA registered · Vosevi
TGA label narrower than the PBS population
- Mar 2018Recommended · restricted
vs standard medical management (supportive care only, no…
- PBS listing · Restricted
From the public summary
7.1 The PBAC deferred making a recommendation on the listing of sofosbuvir with velpatasvir and voxilaprevir without discussion, to allow further consideration of the issues raised within the sponsor’s pre-PBAC response. The PBAC also considered that further consultation was required on the proposed changes to the HCV treatment matrix given the introduction of new DAA treatments since the general statement was developed.PSD · Mar 2018
7.2 The PBAC noted that this submission is not eligible for an Independent Review as it was deferred. Outcome: DeferredPSD · Mar 2018
6.25 The submission presented a cost-utility model based on the claim of superior efficacy and tolerable safety in comparison to standard management (no active treatment).PSD · Mar 2018
Given that ESC considered glecaprevir with pibrentasvir is likely to be a more appropriate comparator than standard management should it be PBS-listed according to the recommendations of the PBAC, a cost-utility model against standard management may no longer be relevant. Should a claim of non-inferiority to glecaprevir with pibrentasvir be accepted, a cost-minimisation analysis would be appropriate.PSD · Mar 2018
6.23 The submission described sofosbuvir with velpatasvir and voxilaprevir as superior in terms of effectiveness compared with standard medical management and having an acceptable safety profile compared with standard medical management. This claim was reasonable.PSD · Mar 2018
6.24 However, given the positive PBAC recommendation for glecaprevir with pibrentasvir in patients with chronic hepatitis C (CHC) that have failed prior treatment with the use of an NS5A inhibitor (Glecaprevir with pibrentasvir, PBAC web outcome; November 2017), upon PBS-listing, glecaprevir with pibrentasvir would be the appropriate comparator and an explicit clinical claim in comparison to glecaprevir with pibrentasvir was warranted.PSD · Mar 2018
6.2 The PBAC noted and welcomed the input from organisations (1) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with sofosbuvir with velpatasvir and voxilaprevir including the addition of a pan-genotypic treatment option for patients with HCV, particularly in patients who have previously failed treatment with NS5A–based direct acting antiviral treatment regimen, as well as the high SVR rates …PSD · Mar 2018
Cost-effectiveness
ICER values are redacted (shown as '****') in the pricing table; document does not provide numeric ICER in public text.
Decision context
PopulationAdult patients with chronic hepatitis C who have received prior treatment with an NS5A-based treatment regimen and not achieved sustained virological response.
Risk sharingSponsor noted that if recommended for listing, sofosbuvir with velpatasvir and voxilaprevir would likely join the existing Risk Sharing Arrangement (RSA) for other drugs for the treatment of HCV as per the glecaprevir with pibrentasvir recommendation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended · restricted | standard medical management (supportive care only, no active treatment); glecaprevir with pibrentasvir upon PBS listing | — | RCT · SVR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| POLARIS-1 | Ph 3 | 416 | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Disconti… | completed |
Consumer voice
Hepatitis Australia welcomed sofosbuvir with velpatasvir and voxilaprevir as a pan-genotypic treatment option, particularly for patients who previously failed NS5A-based direct acting antivirals, and advocated for streamlined access through both General Schedule and S100 Schedule to enable treatment in community settings via general practitioners or nurse practitioners.
The comments described a range of benefits of treatment with sofosbuvir with velpatasvir and voxilaprevir including the addition of a pan-genotypic treatment option for patients with HCV, particularly in patients who have previously failed treatment with NS5A–based direct acting antiviral treatment regimen, as well as the high SVR rates achieved in patients without cirrhosis or with compensated cirrhosis. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to prior NS5A-based treatment failure; TGA label permits all prior DAA treatment failures.