PBAC's latest decision on Elvitegravir: Not recommended (2013). Considered for Continuing treatment of HIV-1 infection in antiretroviral treatment-experienced adults and adolescents in combination with a ritonavir-boosted protease inhibitor and other antiretroviral therapy.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2013
Submissions
1
2013 → 2013
Eligible population
Treatment-experienced adults and adolescents with HIV-1 infection receiving a ritonavir-boosted protease inhibitor and other antiretroviral agents
Therapy area
Infectious disease
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Virological response (HIV-1 RNA <50 copies/mL)
Pivotal trial size
724 patients
Key trials
GS-0145
Comparator
raltegravir
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented; no ICER calculated as the submission claimed non-inferiority and identical pricing to comparator.
Why PBAC said no
Reasons cited in the latest PSD: Absence of final TGA indication at time of consideration preventing identification of clinical place and appropriate PBS restriction; uncertain utilisation estimates based on unsupported assumptions; uncertain long-term safety beyond 96 weeks; unclear whether safety events identified post-marketing are class effects; high discontinuation and loss to follow-up rates in trial