PBAC's latest decision on Dexamethasone: Not recommended (2018). Considered for Macular oedema secondary to central or branch retinal vein occlusion in patients contraindicated to, unsuitable for, or who have failed prior treatment with VEGF inhibitors.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
4
first 2015
Submissions
4
2015 → 2018
Eligible population
Adults with macular oedema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) who are contraindicated to, unsuitable for, or have failed prior treatment with VEGF inhibitors (ranibizumab and aflibercept), with documented visual impairment defined as BCVA score between 73 and 20 letters (BRVO) or 73 and 24 letters (CRVO)
Therapy area
Ophthalmology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
BCVA (best corrected visual acuity); reduction of macular oedema (central retinal thickness); QoL
Comparator
VEGF inhibitors (ranibizumab and aflibercept); sham injection as proxy for no active treatment in contraindicated/failed populations
Economic model
Cost-minimisation
ICER note
No ICER stated. The submission presented only limited economic analysis comparing dexamethasone with VEGF inhibitors for the 'unsuitable' population, and no economic analysis for contraindicated/failed populations.
Why PBAC said no
Reasons cited in the latest PSD: Unmet clinical need not adequately justified; inferior efficacy and safety compared to VEGF inhibitors; limited clinical place in treatment-failure population; unclear clinical rationale for 'unsuitable' population (patient preference/logistical reasons); insufficient evidence for contraindicated population; increased risk of cataract formation and elevated intraocular pressure; RVO does not require prolonged treatment unlike DMO, making pragmatic cost-based approach inapplicable; no unequivocal evidence dexamethasone effective in VEGF inhibitor-resistant patients
Submission history
Mar 2015: Recommended with restriction · Authority Required
Mar 2016: Recommended with restriction · Authority Required
Nov 2017: Recommended with restriction · Authority Required