PBAC's latest decision on Cobicistat: Not recommended (2013). Considered for Treatment of HIV-infected patients as a pharmacokinetic enhancer of atazanavir.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
HIV-infected patients as a pharmacokinetic enhancer of atazanavir, proposed without restriction on treatment experience.
Therapy area
Infectious disease
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Virological response (HIV-1 RNA < 50 copies/mL at Week 48)
Pivotal trial size
85 patients
Key trials
GS-0105, GS-0114
Comparator
ritonavir
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented; no ICER calculated as submission was based on non-inferiority claim.
Why PBAC said no
Reasons cited in the latest PSD: Unclear clinical need for cobicistat as a single-ingredient product, inadequate evidence to support non-inferior comparative effectiveness and safety claim, no current place in published treatment guidelines outside of combination product Stribild, trial population not consistent with proposed PBS population (all treatment-naïve), small trial size, limited duration (48 weeks), partial support for safety non-inferiority claim, viral load as sole outcome not appropriate for a pharmacokinetic enhancer with no intrinsic antiretroviral activity