PBAC's latest decision on Ingenol mebutate: Not recommended (2014). Considered for Treatment of solar (actinic) keratoses on the face and scalp as field therapy in adults.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
3
first 2012
Submissions
3
2012 → 2014
Eligible population
Adults with solar keratoses on the face or scalp treated as field therapy for three days only.
Base case ICER; sensitivity analysis reduces to less than $15,000/QALY but PBAC did not consider the utility values reliable.
Risk sharing
Risk-sharing arrangement in place — Risk share agreement proposed in the form of a price-volume agreement, but PBAC considered the nominated thresholds insufficient as most risk would be borne by the Commonwealth.
Why PBAC said no
Reasons cited in the latest PSD: uncertain and unreliable quality of life benefit, utility estimates not reliable or informative, no demonstrable improvement in quality of life outcomes from SK clearance, cosmetic nature of benefit without tangible health benefit
Submission history
Nov 2012: Not recommended
Nov 2013: Not recommended · Restricted
Jul 2014: Not recommended · Restricted — ICER $45k/QALY