ImiquimodAldara
Solar (actinic) keratosis on the face or scalp as field therapy in patients with multiple lesions and normal immune function.
Decisions on record
- Meeting Nov 2012 Recommended Skin cancer no PSD
- Meeting Jul 2009 Not recommended Skin cancers Genital warts no PSD
- Meeting Jul 2008 Not recommended Skin cancer
- Meeting Nov 2007 Recommended Skin cancer no PSD
Access path
- TGA registered · Aldara
TGA label narrower than the PBS population
- Nov 2005Not recommended
Inappropriate restriction with wide and imprecise patient eligibility criteria, trials not representative of target…
- ↻ resubmittedJul 2008Recommended
Comparator changed: cryotherapy, curettage and cautery, surgical excision, photodynamic…
- Jul 2008Recommended
Comparator changed: cryotherapy, curettage and cautery, surgical excision, photodynamic…
- PBS listing
Cost-effectiveness
ICER expressed as cost per recurrence-free year (not per QALY or LY). Two-way sensitivity analysis yielded upper bound of $1,846 per recurrence-free year.
the economic model presented utilises the same structure as the model previously presented for basal cell carcinoma (BCC) and the PBAC considered this inappropriate in the context of SK, a disease which has a much longer course. PBAC · 2008
Decision context
PopulationImmunocompetent patients with multiple clinically evident solar keratosis lesions on the face or scalp requiring topical field therapy.
Why it was knocked back
- uncertain evidence of effectiveness and safety over the comparator, safety concerns regarding use over large skin areas (greater than 25 cm²), inadequate safety data for sequential use on different patches, inappropriate economic model structure for solar keratosis, uncertain cost-effectiveness
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2008 | Recommended | topical 5-fluorouracil (Efudix®) | — | RCT, Single-arm · QoL |
| Jul 2008 | Recommended | 5-fluorouracil (5-FU) and cryotherapy | $0k–2k | RCT |
| Nov 2005 | Not recommended | cryotherapy, curettage and cautery, surgical excision, photodynamic therapy with methyl-5-aminolevulinate (MAL-PDT), and | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with normal immune function requiring field therapy for multiple lesions; TGA label includes all solar keratosis patients.