PimecrolimusElidel
Extension of PBS listing to include treatment of facial or eyelid atopic dermatitis in patients aged at least 3 months (including adults over 18 years) who are contraindicated for or unresponsive to topical corticosteroids.
Access path
- TGA registered · Elidel
TGA label narrower than the PBS population
- Jul 2006Recommended · restricted
Comparator changed: topical corticosteroids (TCS) or vehicle → topical corticosteroids…
- Jul 2006Recommended · restricted
Comparator changed: topical corticosteroids (TCS) or vehicle → topical corticosteroids…
- PBS listing · Authority Required
Cost-effectiveness
The base case modelled incremental discounted cost per extra discounted QALY estimated by this model is < $15,000 for listing 1 (adult patients contraindicated for TCS) and < $15,000 for listing 2 vehicle comparison (adult patients unresponsive to or needing respite from TCS). PBAC · 2006
Decision context
PopulationPatients aged at least 3 months with facial or eyelid atopic dermatitis who are contraindicated for topical corticosteroids or who have failed to achieve satisfactory disease control with intermittent topical corticosteroid therapy.
Risk sharingSponsor committed to maintaining the risk-sharing threshold at its current level based on listing in children and adolescents only; PBS budget impact subsumed within existing commitment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2006 | Recommended · restricted | topical corticosteroids (TCS) or vehicle | $15k | RCT · QoL | ORR |
| Jul 2006 | Recommended · restricted | topical corticosteroids and vehicle cream | $15k | RCT · EASI-60 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to facial/eyelid sites and adds criteria: contraindications to corticosteroids or failure on intermittent corticosteroid therapy.