PBAC's latest decision on Cabotegravir: Recommended with restriction (2023). Considered for Pre-exposure prophylaxis (PrEP) for HIV-1 infection in persons in whom tenofovir disoproxil and emtricitabine (TD/FTC) is contraindicated, or persons who are intolerant or have reported suboptimal adherence to TD/FTC.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2023
Submissions
1
2023 → 2023
Eligible population
Persons at risk of HIV infection unable to be treated with TD/FTC due to contraindication, intolerance, or repeated suboptimal adherence; at least 12 years of age and weighing at least 35 kg
Therapy area
Infectious disease
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
HIV infection; safety
Key trials
HPTN-083, HPTN-084
Comparator
Placebo (as proxy for no medical PrEP) in combination with standard of care safer sex practices
ICER note
ICER value not stated in the public text; document appears to be truncated before economic analysis details
Risk sharing
Risk-sharing arrangement in place — Risk Sharing Arrangement proposed by PSCR to address the risk of use in a broader population than the restricted indication