The Pharmaceutical Benefits Advisory Committee (PBAC) has recommended Lucentis (ranibizumab) be listed on the Pharmaceutical Benefits Schedule (PBS) for the treatment of proliferative diabetic retinopathy (PDR).
Lucentis is currently approved by the Therapeutic Goods Administration (TGA) for PDR. The PBAC recommendation represents an important milestone in improving access to this treatment for eligible patients.
A potential PBS listing for Lucentis in PDR would represent the seventh listing for Lucentis. It would also be the first anti-VEGF listed on the PBS for PDR.
PBAC has recommended Lucentis (ranibizumab) be listed on the Pharmaceutical Benefits Schedule (PBS) for the treatment of proliferative diabetic retinopathy
Potential Advantages
Lucentis offers an effective alternative to panretinal photocoagulation (PRP) laser therapy with potential advantages for patients:
Proven efficacy, and well-established safety. The Protocol S trial demonstrated Lucentis is non-inferior to PRP laser in preserving central vision in PDR.1 Ocular and non-ocular events observed were consistent with what would be expected in a diabetic patient population with diabetic retinopathy or have been reported with a frequency and severity similar to those seen in previous clinical trials with Lucentis.2
Improves Diabetic Retinopathy Severity Scale (DRSS). At year one, 41.8% of eyes experienced a ≥2-step improvement in the DRSS when treated with Lucentis compared to 14.6% of eyes treated with PRP, (difference, 27.4% 95% CI: [18.9, 35.9]).2
Reduces risk of diabetic macular oedema (DME). Anti-VEGF therapy lowers the chance of developing DME compared to PRP. DME development in the PRP group was more frequent 28% vs 9% (difference, 19%; 95% CI, 10%-28%; P < .001) vs the ranibizumab group.1
Preserves night and peripheral vision. PRP laser can cause loss of peripheral vision and diminished night vision.¹ Lucentis treats PDR without this impact on vision.1
Listing Awaited
While Lucentis is yet to be listed on the PBS for PDR, patients may incur out of pocket costs. In a statement Novartis said the company is actively collaborating with the health department to expedite the inclusion of Lucentis on the PBS.
Administered by intravitreal injection, appropriate patient selection, adherence to the injection schedule, and monitoring for injection-related risks are essential, in accordance with the product information.2
PBS Information
Use of this medicinal product in paediatric ROP patients is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.
For Lucentis PBS information, please click here (pre-filled syringe) or here (vial for injection)
For Lucentis Product Information, click here
References
- Gross, J.G et al. 2015. Panretinal photocoagulation vs intravitreous ranibizumab for proliferative diabetic retinopathy: a randomized clinical trial. Jama, 314(20), pp.2137-2146.
- LUCENTIS (ranibizumab) Approved Product Information.
