← The record

Clindamycin Phosphate With Benzoyl Peroxide, Gel

Not recommended DermatologyRestricted

Treatment of moderate acne vulgaris with inflammatory lesions in patients with an inadequate response to a minimum of two over-the-counter products.

1
Submissions
2009–09
On the record
$45k–75k
ICER range
1 sourced ICER · 2009
ICER stated
Cost basis

Decision on record

1 decision
  • Meeting Mar 2009 Not recommended Acne treatment

Cost-effectiveness

1 sourced ICER · 2009

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.

ICER uncertainICER / price too highEconomic model disputed

Decision context

Populationpatients with moderate acne vulgaris with inflammatory lesions who have an inadequate response to at least two over-the-counter medications

Why it was knocked back

  • 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

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2009 Not recommended no treatment (placebo) $45k–75k RCT · QOL, global improvement in acne vulgaris of the face

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to moderate acne with inflammatory lesions and prior inadequate response to ≥2 OTC products; TGA label includes all comedo, papular, and pustular acne.