script.reportAU
Hepatology

Grazoprevir / elbasvir

Brand: Zepatier

PBAC's latest decision on Grazoprevir / elbasvir: Recommended with restriction (2016). Considered for Treatment of chronic hepatitis C infection in patients infected with genotypes 1, 4 or 6 (irrespective of previous treatment history) and genotype 3 treatment-naïve patients.

PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016

Eligible population

Adults (≥18 years) with chronic hepatitis C infection: genotypes 1, 4, or 6 (treatment-naïve and treatment-experienced); genotype 3 treatment-naïve patients.

Therapy area
Hepatology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
SVR
Key trials
C-EDGE TN, C-EDGE TE, C-SWIFT, C-WORTHY, C-SALVAGE, C-SCAPE, ION-1, ION-2, ION-3, LONESTAR, VALENCE, NEUTRINO
Comparator
ledipasvir/sofosbuvir (genotype 1), sofosbuvir + ribavirin (genotype 3), sofosbuvir + peginterferon + ribavirin (genotypes 4 and 6), no treatment (genotypes 4 and 6 treatment-experienced)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design. Pricing commercially sensitive and redacted throughout document.

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