Imiquimod, Cream
treatment of solar (actinic) keratosis in the face and the scalp, primary treatment of confirmed superficial basal cell carcinoma where surgery is considered inappropriate, and the treatment of external genital and peri-anal warts (Condyloma acuminata) in adults
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
- Nov 2005Not recommended
inappropriate and imprecise restriction criteria allowing substantial usage beyond intent, inadequate patient…
- ↻ resubmittedJul 2006Recommended · restricted
Comparator changed: current usual care, including cryotherapy, curettage and cautery…
- Mar 2009Recommended
Comparator changed: placebo (non-intervention monitoring) and photodynamic therapy with…
- PBS listing
Cost-effectiveness
Cost-minimisation analysis determined appropriate; ICER not calculated. Cost-minimisation analysis found imiquimod significantly more expensive than comparators.
The trial-based incremental cost per extra initial cure gained at 12 weeks was < $15,000. The modelled economic evaluation was presented to represent the value that imiquimod offers patients over a two year time frame. The base case modelled incremental cost per extra discounted disease free year was < $15,000. PBAC · 2006
Decision context
Populationadults with solar (actinic) keratosis on the face or scalp in a patient with normal immune function who has multiple clinically evident solar keratosis lesions and requires topical drug treatment as field therapy
Why it was knocked back
- Lack of data to support value in treating solar keratosis, no reliable evidence of superiority over comparators (5-flurouracil and cryotherapy), lack of safety data for treatment surface areas exceeding 25 cm², imiquimod more expensive than comparators on cost-minimisation analysis, absence of data on QALY outcomes, no reliable data on duration of treatment effect after 16 months, inadequate demonstration of superiority over comparator therapies
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2009 | Recommended | 5-flurouracil and cryotherapy | — | RCT | Other |
| Jul 2006 | Recommended · restricted | placebo (non-intervention monitoring) and photodynamic therapy with methyl aminolevulinate (MAL-PDT) | — | RCT · initial cure rate and recurrence rate |
| Nov 2005 | Not recommended | current usual care, including cryotherapy, curettage and cautery, surgical excision, and photodynamic therapy with methy | — | RCT, Single-arm, Registry · complete and histological clearance of sBCCs |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts actinic keratosis treatment to patients with normal immune function and multiple lesions requiring field therapy.