Efalizumab
Recommended DermatologyRestrictedNot applicable line
Extension of initial treatment phase from 12 to 24 weeks for chronic plaque psoriasis in patients who achieve a PASI over 50 and less than 75 at 12 weeks.
4
Submissions
3 resub
2005–08
On the record
$15k–75k
ICER range
4 sourced ICERs · 2005–2008
ICER stated
Cost basis
Decisions on record
- Meeting Nov 2008 Recommended Psoriasis
- Meeting Jul 2007 Recommended Plaque psoriasis no PSD
Access path
- Jul 2005Not recommended
unacceptable cost-effectiveness, high base case cost-effectiveness ratio
- ↻ resubmittedNov 2005Recommended · restricted
Listing: Not applicable → Authority Required
- Nov 2005Recommended · restricted
Listing: Not applicable → Authority Required
- Nov 2008Recommended · restricted
ICER dropped $75,000 → $45,000 (-40%)
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
The PBAC considered that the incremental cost per extra QALY gained was still high but acceptable, and that treatment would now be targeted to a more severely affected patient group. PBAC · 2005
ICER uncertainICER / price too highCost-effectiveness accepted
Decision context
PopulationPatients with severe refractory chronic plaque psoriasis who achieve a PASI over 50 and less than 75 at 12 weeks of efalizumab treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Recommended · restricted | efalizumab using a 12-week initial treatment period | $15k–45k | RCT · PASI ≥ 75% response |
| Nov 2005 | Recommended · restricted | placebo | $45k–75k | RCT · PASI 75% improvement |
| Nov 2005 | Recommended · restricted | placebo | $45k–75k | RCT · PASI-75 |
| Jul 2005 | Not recommended | placebo | $45k–75k | RCT · PASI-50 |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients achieving specific PASI response (>50 and <75) at 12 weeks; TGA label has no response criteria requirement.