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New HTA Decisions in Scotland
June 2020
Drug name
ZYCLARA® (imiquimod)
Company
Meda Pharmaceuticals Ltd
Decision date
11/11/2019
Therapeutic area
Skin conditions
Therapeutic sub area
Skin conditions: general and other
Decision
Recommended with restrictions
Indication
For the topical treatment of clinically typical, nonhyperkertotic, nonhypertrohpic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.
Decision Detail
For the treatment of large field actinic keratosis (>25cm²).
Summary
In two randomised, double-blind, phase III studies (GW01-0702 and GW01-0704), a greater proportion of adults with actinic keratosis affecting an area >25cm² on the face or balding scalp achieved complete clearance when treated with imiquimod 3.75% cream compared with vehicle. The submitting company presented a cost-utility analysis evaluating imiquimod 3.75% for the topical treatment of clinically typical, non-hyperkeratotic, nonhypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate. The submitting company applied an additional restriction, positioning imiquimod 3.75% for the treatment of large field actinic keratosis (>25cm²). Comparisons were provided against diclofenac 3% (Solaraze®), fluorouracil 5% cream (Efudix®), and methyl-amino levulinate plus photodynamic therapy (MAL + PDT). Imiquimod 5% cream (Aldara®) and ingenol mebutate (Picato® 0.015% or 0.05%) were excluded. The main limitations of the analysis are as follows: - The use of a naïve unadjusted comparison results in uncertain estimates of relative effectiveness. The submitting company was initially reluctant to undertake alternative comparisons, but did submit a network meta-analysis and corresponding economic analysis (CUA and CMA) to support the base case analysis. - Changes to a number of assumptions in the estimation of clinical effectiveness (complete clearance rates, recurrence rates) result in a change from a small ICER for imiquimod 3.75%, to being dominated by fluorouracil and MAL-PDT. This is driven by very small incremental differences in health outcomes between the treatments. - The dose of imiquimod 3.75% and each comparator is assumed consistent with the Summary of Product Characteristics rather than data observed within the clinical trials supporting efficacy estimates. In the case of imiquimod 3.75%, this may underestimate the number of sachets (and therefore cost) required to achieve the clinical outcomes reported in the clinical trial. The results show extremely small QALY differences between treatments and given the concerns about various methods of the estimation of treatment differences, a cost-minimisation analysis was requested to test the influence of these estimates. This approach suggested that despite the uncertainties regarding relative effectiveness, imiquimod 3.75% has the potential to be cost-saving against the comparators. As such, the economic case was considered demonstrated.