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Hepatology

Sofosbuvir with velpatasvir and voxilaprevir

Brand: VOSEVI

PBAC's latest decision on Sofosbuvir with velpatasvir and voxilaprevir: Recommended with restriction (2018). Considered for 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).

PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
1
first 2018
Submissions
1
2018 → 2018

Eligible population

Adult patients with chronic hepatitis C who have received prior treatment with an NS5A-based treatment regimen and not achieved sustained virological response.

Therapy area
Hepatology
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
SVR
Pivotal trial size
416 patients
Key trials
POLARIS-1, GS-US-367-1168, TRILOGY-3, MAGELLAN-1 (Part 2)
Comparator
standard medical management (supportive care only, no active treatment); glecaprevir with pibrentasvir upon PBS listing
Economic model
CEA
ICER note
ICER values are redacted (shown as '****') in the pricing table; document does not provide numeric ICER in public text.
Risk sharing
Risk-sharing arrangement in place — Sponsor 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.

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