DexamethasoneDBL Dexamethasone Sodium Phosphate
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.
Decisions on record
- Meeting Mar 2018 Recommended Macular oedema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
- Meeting Nov 2017 Recommended Non-infectious uveitis (inflammatory disease of the eye)
- Meeting Nov 2016 Noted Indication not stated no PSD
- Meeting Mar 2016 Recommended Diabetic macular oedema
- Meeting Mar 2015 Not recommended Diabetic macular oedema
Access path
- TGA registered · DBL Dexamethasone Sodium Phosphate
TGA label narrower than the PBS population
- Mar 2015Not recommended
vs ranibizumab (primary); bevacizumab (secondary)
- ↻ resubmittedMar 2016Recommended · restricted
Comparator changed: ranibizumab (primary); bevacizumab (secondary) → ranibizumab and…
- Nov 2017Recommended · restricted
Comparator changed: ranibizumab and aflibercept → placebo (sham); secondary comparators:…
- Mar 2018Recommended · restricted
Comparator changed: placebo (sham); secondary comparators: intravitreal triamcinolone…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended extending the listing of dexamethasone intravitreal injection 700 micrograms as an Authority required benefit for patients with CRVO or BRVO who have failed or are contraindicated to VEGF inhibitors. This recommendation was based on clinical need, acceptable clinical effectiveness compared to placebo, and the broader context of the existing listing of dexamethasone for DMO.PSD · Mar 2018
The clinical need for an alternative therapy for patients who may respond to a VEGF inhibitor, but for whom monthly injections may be difficult, was not adequately supported to make available a sub-optimal therapy for a generally short-term condition.PSD · Mar 2018
6.44 Based on the pragmatic approach adopted by the PBAC for the dexamethasone DMO submission, the submission requested that PBAC consider whether the lower cost of dexamethasone versus comparators represents a sufficient discount to account for the worse efficacy and safety of dexamethasone implants compared to VEGF inhibitors in RVO patients.PSD · Mar 2018
6.45 The submission only presented a limited economic analysis for dexamethasone compared with VEGF inhibitors, relevant for the population who could use a VEGF inhibitor, but for whom such treatment is not preferred or unsuitable. No economic analysis was presented for the comparison of dexamethasone implant versus no active treatment in patients in whom VEGF inhibitors are contraindicated or have failed or are otherwise unsuitable.PSD · Mar 2018
6.41 The submission described dexamethasone implant as superior in terms of effectiveness compared with placebo (sham), and inferior in terms of safety. The ESC considered that these claims were reasonable, although the benefits were modest and the duration of therapy needed to be considered. Dexamethasone implant was superior in terms of efficacy to placebo at 2 and 3 months after administration, but not at 6 months. The PBAC agreed with the ESC advice.PSD · Mar 2018
6.42 The submission described dexamethasone implant as inferior in terms of effectiveness compared with ranibizumab, and inferior in terms of safety. The ESC considered that these claims were reasonable. The PBAC agreed with the ESC advice.PSD · Mar 2018
6.2 The PBAC noted and welcomed the input from health care professionals (5) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described treatment with dexamethasone implant as a desirable alternative for patients who respond poorly or are contraindicated to the current first line agents with the potential advantage of requiring less frequent injections, thus reducing treatment burden for patients and decreasing …PSD · Mar 2018
6.67 The PBAC noted the pre-PBAC response offered to address the potential financial issues by entering a risk share arrangement ''''''''''''''' '''''''''''''''''''''''' ''''' '''''''''''''''''''''''''''' ''''''''''''''' ''''''''''' '''''''' ''''' '''''''''''''''''''' '''' '''''''' ''''''' '''''' ''''''''''''''''''''''''' ''''''' '''''' ''''''''''''' '''''''''''''''''''''' '''''''' '''''''''''''''' '''' '''''' ''''''''''''''' ''''''''''' '''' …PSD · Mar 2018
Cost-effectiveness
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.
The submission only presented a limited economic analysis for dexamethasone compared with VEGF inhibitors, relevant for the population who could use a VEGF inhibitor, but for whom such treatment is not preferred or unsuitable. PSD · 2018
Decision context
PopulationAdults 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)
Why it was knocked back
- 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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended · restricted | VEGF inhibitors (ranibizumab and aflibercept); sham injection as proxy for no active treatment in contraindicated/failed | — | RCT · BCVA (best corrected visual acuity); reduction of macular oedema (central retinal thickness); QoL |
| Nov 2017 | Recommended · restricted | placebo (sham); secondary comparators: intravitreal triamcinolone acetonide and adalimumab | — | RCT · Vitreous haze score of 0 at week 8 |
| Mar 2016 | Recommended · restricted | ranibizumab and aflibercept | — | RCT · Visual acuity |
| Mar 2015 | Not recommended | ranibizumab (primary); bevacizumab (secondary) | — | RCT · BCVA |
Consumer voice
Healthcare professionals and organisations submitted comments describing dexamethasone implant as a desirable alternative for patients who respond poorly or are contraindicated to current first-line agents, highlighting reduced treatment burden from less frequent injections and benefits to hospital clinics.
treatment with dexamethasone implant as a desirable alternative for patients who respond poorly or are contraindicated to the current first line agents with the potential advantage of requiring less frequent injections, thus reducing treatment burden for patients and decreasing cost Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line use after VEGF inhibitor failure/contraindication, whereas TGA label permits first-line use.