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Anecortave Acetate

Recommended OphthalmologyAuthority RequiredFirst-line line

Treatment of subfoveal choroidal neovascularisation (CNV) due to exudative age-related macular degeneration (AMD) where the CNV is composed predominantly (>50%) of classic lesions.

4
Submissions
2 resub
2006–06
On the record
$105k–200k
ICER range
2 sourced ICERs · 2006
ICER stated
Cost basis

Decision on record

1 decision
  • Meeting Nov 2006 Recommended Subfoveal choroidal neo- vascularisation (CNV)

Access path

4 submissions · public record
  1. Mar 2006
    Not recommended

    Inadequate evidence that anecortave is no worse than PDT with verteporfin in effectiveness and safety; pre-specified…

  2. Mar 2006
    Not recommended

    inadequate evidence to support non-inferiority claim versus verteporfin; pre-specified non-inferiority criterion (7.0%)…

  3. ↻ resubmitted
    Nov 2006
    Recommended · restricted

    Comparator changed: photodynamic therapy with verteporfin → photodynamic therapy (PDT)…

  4. Nov 2006
    Recommended · restricted

    Comparator changed: photodynamic therapy with verteporfin → photodynamic therapy (PDT)…

  5. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

2 sourced ICERs · 2006
The incremental cost per additional QALY gained from treatment with PDT with verteporfin versus anecortave acetate was estimated to be in the range $105,000 – $200,000. PSD · 2006
Economic model disputedSurrogate endpoint

Decision context

PopulationPatients with subfoveal CNV due to exudative AMD with predominantly (>50%) classic lesions and baseline visual acuity equal to or better than 6/60 (20/200).

Submission history

4 entries
DecidedOutcomeComparatorICEREvidence
Nov 2006 Recommended · restricted photodynamic therapy (PDT) with verteporfin $105k–200k RCT
Nov 2006 Recommended · restricted photodynamic therapy (PDT) with verteporfin $105k–200k RCT
Mar 2006 Not recommended photodynamic therapy with verteporfin RCT, Single-arm · QoL
Mar 2006 Not recommended photodynamic therapy with verteporfin RCT

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to >50% classic lesions, baseline VA ≥6/60, and requires fluorescein angiography confirmation; TGA label only requires classic component presence.