OcriplasminJetrea RTU
Vitreomacular traction syndrome (VTS), including when associated with macular hole of diameter ≤400 microns.
Decisions on record
- Meeting Mar 2019 Recommended Vitreomacular traction syndrome (VTS)
- Meeting Mar 2016 Recommended Vitreomacular traction
- Meeting Nov 2014 Not recommended 0.5 mg/0.2 mL injection, 1 x vial Jetrea® Alcon Laboratories (Australia) Pty Ltd New Listing (Major submission) Vitreomacular traction Authority Required listing for the treatment of vitreomacular traction including full-thickness macular hole in patients who meet certain criteria. Sponsor Comment:
Access path
- TGA registered · Jetrea RTU
TGA label narrower than the PBS population
- Nov 2014Not recommended
Uncertain clinical benefit (VMA resolution did not reliably predict avoidance of vitrectomy; no difference in best…
- ↻ resubmittedMar 2016Recommended · restricted
- Mar 2019Recommended · restricted
Evidence: RCT → Cost-minimisation
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the Authority Required listing of the new form of ocriplasmin (0.375 mg in 0.3 mL) for the treatment of vitriomacular traction syndrome, under the same circumstances as the current ocriplasmin listings.PSD · Mar 2019
5.2 The PBAC noted that JETREA RTU contains 0.375 mg of active ingredient instead ofPSD · Mar 2019
4.5 As a minor submission, there was no economic comparison presented.PSD · Mar 2019
6.17 The re-submission described ocriplasmin as superior in terms of comparative effectiveness and inferior in terms of comparative safety over watchful waiting. This claim was adequately supported based on the primary outcome of the trials (non- surgical VMA resolution at day 28; the point where vitrectomy was not offered except if patients did not achieve VMA resolution, or at any point after day 1 if BCVA worsened by >2 lines (or 10 letters)), although …PSD · Mar 2016
6.18 For the purposes of the modelled economic evaluation, which was based solely on the results of the OASIS trial, the re-submission also explicitly claimed (p222 of the 11PSD · Mar 2016
4.2 The PBAC noted that there were no consumer comments for this submission.PSD · Mar 2019
6.52 The PBAC considered that the cost to Government may be underestimated, at the proposed price, due to leakage outside the proposed restriction, for example, into the patient population with ERM or with adhesion diameter >1500 µm, which together may represent 57% of the total VMT population.PSD · Mar 2016
For more detail on PBAC’s view, see section 7 “PBAC outcome”.PSD · Mar 2016
Cost-effectiveness
No economic analysis conducted; minor submission for formulation change only.
As a minor submission, there was no economic comparison presented. PSD · 2019
Decision context
PopulationAdults with visual impairment due to vitreomacular traction (VMT) without or with full thickness macular hole ≤400 micrometres, best corrected visual acuity ≥20/25 or worse, vitreomacular adhesion diameter ≤1500 micrometres, no epiretinal membrane, previously untreated, no prior vitrectomy, and symptomatic.
Risk sharingSpecial Pricing Arrangement (SPA) applies; existing Deed of Agreement between the Commonwealth and Novartis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Recommended · restricted | — | — | Cost-minimisation |
| Mar 2016 | Recommended · restricted | watchful waiting ± vitrectomy | $15k–45k | RCT · Surrogate |
| Nov 2014 | Not recommended | watchful waiting ± vitrectomy | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| TG-MV-006 | Ph 3 | 326 | Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day … | completed |
| TG-MV-007 | Ph 3 | 326 | Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day … | completed |
| OASIS | Ph 3 | 220 | Proportion of Subjects With Pharmacological Vitreomacular Adhesion (VMA) / (Vitreomacular … | completed |
Consumer voice
No consumer comments were received for this submission.
The PBAC noted that there were no consumer comments for this submission. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults with specific visual acuity thresholds, adhesion diameter limits, absence of epiretinal membrane, treatment-naive status, and symptomatic disease.