PBAC's latest decision on Clindamycin phosphate with benzoyl peroxide, gel: Not recommended (2009). Considered for Treatment of moderate acne vulgaris with inflammatory lesions in patients with an inadequate response to a minimum of two over-the-counter products.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
$75k/QALY
Range: $45k/QALY–$75k/QALY
Submissions
1
first 2009
Submissions
1
2009 → 2009
Eligible population
patients with moderate acne vulgaris with inflammatory lesions who have an inadequate response to at least two over-the-counter medications
Therapy area
Dermatology
Evidence base
RCT
Primary endpoint
QOL, global improvement in acne vulgaris of the face
Key trials
Langner A randomized, single-blind comparison of topical clindamycin + benzoyl peroxide and adapalene in the treatment of mild to moderate facial acne vulgaris. Lookingbill D.P. Treatment of acne with a combination clindamycin/benzoyl peroxide gel compared with clindamycin gel, benzoyl peroxide gel and vehicle. Study 150
Comparator
no treatment (placebo)
Economic model
CUA
ICER note
Base case submitted as less than $15,000 per QALY, but PBAC recalculation with corrected utility values yields ICER in range $45,000–$75,000 per QALY. Further sensitivity analyses would produce higher values.
Why PBAC said no
Reasons cited in the latest PSD: Unacceptably high and uncertain cost effectiveness; considerable uncertainty in QALY modelling approach (psoriasis-based mapping algorithm, Korean population QOL generalisability, utility assumptions); uncertainty regarding clinical place and potential for long-term use; unclear definition of mild to moderate acne; concern regarding development of antibiotic resistance and increase in community acquired MRSA resistance