RanibizumabLucentis
Not recommended OphthalmologyAuthority RequiredFirst-line line 💬 consumer voice
Initial and continuing treatment of proliferative diabetic retinopathy (PDR) without diabetic macular oedema (DMO) in adult patients. Treatment via intravitreal injection administered monthly until maximum visual acuity is achieved and/or there are no signs of disease activity.
14
Submissions
8 resub
2007–25
On the record
$15k–75k
ICER range
7 sourced ICERs · 2007–2013
—
Cost basis
Decisions on record
- Meeting May 2026 Not recommended Neovascular age-related macular degeneration no PSD
- Meeting May 2025 Recommended Proliferative diabetic retinopathy with or without diabetic macular oedema
- Meeting Nov 2022 Noted Neovascular (wet) age-related macular degeneration no PSD
- Meeting Mar 2022 Deferred Neovascular (wet) age-related macular degeneration no PSD
- Meeting Mar 2018 Recommended Visual impairment due choroidal neovascularisation (CNV)
- Meeting Mar 2018 Recommended Visual impairment due to choroidal neovascularisation (CNV)
- Meeting Nov 2014 Recommended 2.3 mg/0.23 mL, 1 x 0.23 mL vial, 1.65 mg/0.165 mL, pre-filled syringe, Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Change to listing (Minor submission) Neovascular age-related macular degeneration To request ranibizumab pre-filled syringe and vial presentations be “a” flagged.
- Meeting Jul 2014 Recommended 2.3 mg/0.23 mL injection, 1 x 0.23 mL vial Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Change to listing (Major submission) Diabetic macular oedema (DME) Authority required listing for treatment of patients with visual impairment due to DME who meet certain criteria. On the basis of the RES
8 earlier decisions
- Jul 2014 Recommended 2.3 mg/0.23 mL injection, 1 x 0.23 mL vial Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Change to listing (Major submission) Macular oedema secondary to retinal vein occlusion (RVO) Authority required listing for treatment of patients with visual impairment due to macular oedema secondary to
- Mar 2014 Recommended Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Neovascular age-related macular degeneration To request a General Schedule Authority Required listing for a new presentation of ranibizumab for the treatment of neovascular age-related macular degeneration.
- Mar 2014 Deferred Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Visual impairment due to diabetic macular oedema and macular oedema secondary to retinal vein occlusion. Resubmission addressing concerns raised by the PBAC at its November 2013 meeting for the treatment of visual impairment due to diabetic macula
- Nov 2013 Deferred 2.3 mg/0.23 mL, injection, vial Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Major submission Visual impairment due to diabetic macular oedema (DME). Resubmission to request an Authority Required listing for the treatment, by an ophthalmologist, of visual impairment due to diabetic macular o
- Nov 2013 Deferred 2.3 mg/0.23 mL, injection, vial Lucentis® Novartis Pharmaceuticals Australia Pty Ltd Major submission Visual impairment due to macular oedema secondary to retinal vein occlusion (RVO). Resubmission to request an Authority Required listing for the treatment, by an ophthalmologist, of visual impairmen
- Nov 2012 Not recommended Vision loss
- Mar 2009 Recommended Antineovascularisation agent no PSD
- Nov 2007 Recommended Macular degeneration no PSD
Access path
- TGA registered · Lucentis
TGA label narrower than the PBS population
- Mar 2007Recommended · restricted
vs photodynamic therapy with verteporfin (PDT-V) for…
- Mar 2007Recommended · restricted
- Nov 2012Recommended · restricted
Comparator changed: Photodynamic therapy with verteporfin (PDT-V) for predominantly…
- Nov 2012Recommended · restricted
Comparator changed: Photodynamic therapy with verteporfin (PDT-V) for predominantly…
- Mar 2013Not recommended
uncertainty about the ICER, uncertainty about comparative long-term safety, lack of clarity in the extent of benefit…
- Nov 2013Deferred
- Nov 2013Deferred
- Mar 2014Deferred
Comparator changed: laser photocoagulation (BRVO) and observation (CRVO); bevacizumab…
- Jul 2014Recommended · restricted
Comparator changed: Laser photocoagulation (DME and branch RVO), best supportive care…
- Jul 2014Recommended · restricted
Comparator changed: Laser photocoagulation (DME and branch RVO), best supportive care…
- Nov 2014Recommended · restricted
Evidence: RCT → Cost-minimisation
- Mar 2018Recommended · restricted
Evidence: Cost-minimisation → RCT
- Mar 2018Recommended · restricted
Evidence: Cost-minimisation → RCT
- May 2025Recommended · restricted
Comparator changed: sham injection (no treatment) → panretinal laser photocoagulation…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the PBS listing of ranibizumab for the treatment of proliferative diabetic retinopathy (PDR) with or without diabetic macular oedema (DMO). The PBAC expanded the requested population, originally requested for patients without DMO, based on unmet clinical need and to ensure continuous treatment for patients with PDR that progress to DMO and who have not developed serious vision impairment.PSD · May 2025
OFFICIAL Public Summary Document – May 2025 PBAC Meeting a cost-effectiveness basis to the current treatment option of PRP and at a price equivalent to patients with visual impairment due to DMO.PSD · May 2025
Economic analysis
6.41 The submission presented a cost utility analysis, using a 26-health state Markov model of ranibizumab compared to PRP for the treatment of PDR. ESC considered the CUA was a reasonable approach, given the reduced risk of DMO.PSD · May 2025
6.42 A summary of the model structure and key inputs along with the rationale of economic evaluation are summarised in Table 15. 18 OFFICIALPSD · May 2025
Clinical claim
6.33 The submission described ranibizumab as superior in terms of effectiveness and non- inferior in terms of safety compared to PRP. The proposed superiority claim was based on visual acuity gain and reduction in risk of clinically significant DMO.PSD · May 2025
6.34 The ESC considered the superiority claim for comparative clinical effectiveness was partially supported.PSD · May 2025
Consumer comments
6.2 The PBAC noted and welcomed the input from 4 health professionals working in the area and 1 organisation. The health care professionals described PDR as the most common cause of blindness in working-age individuals in Australia. The input noted that current therapy with PRP may result in loss of peripheral vision and is not suitable for those presenting with vitreous haemorrhage and advanced cataracts.PSD · May 2025
Financial management – risk sharing
6.60 The sponsor proposed that ranibizumab usage in rare CNV should be listed at the same published and effective prices as the AMD population and should be incorporated into the RSA negotiated to cover that population.PSD · Mar 2018
Cost-effectiveness
ICER not stated in the public text. Document references PBAC's July 2014 consideration of ranibizumab for DMO which accepted ICERs between $15,000 and $45,000/QALY, but no specific ICER for this PDR submission is provided.
Although the application of VA transition probabilities based on the treated eye and transformations based on the overall patient (both eyes) remains, it was considered that the adjustments to the model structure through the application of a weighted scenario analysis may partially resolve the misalignment in the economic model. PBAC · 2014
ICER uncertain ×4Economic model disputed ×5Price cut / RSA neededSurrogate endpointCost-effectiveness accepted ×2
Decision context
PopulationAdult patients with proliferative diabetic retinopathy without clinically significant diabetic macular oedema, diagnosed by fluorescein angiography, treated by ophthalmologists or accredited ophthalmology registrars.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Recommended · restricted | panretinal laser photocoagulation (PRP) | — | RCT · Visual acuity improvement and prevention of clinically significant DMO |
| Mar 2018 | Recommended · restricted | sham treatment | — | RCT · Best corrected visual acuity (BCVA) change from baseline to Month 2 |
| Mar 2018 | Recommended · restricted | sham injection (no treatment) | — | RCT · BCVA |
| Nov 2014 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2014 | Recommended · restricted | laser photocoagulation | — | RCT · BCVA |
| Jul 2014 | Recommended · restricted | laser photocoagulation (BRVO) and observation (CRVO) | — | RCT · BCVA |
| Mar 2014 | Deferred | Laser photocoagulation (DME and branch RVO), best supportive care with observation (RVO), and compounded bevacizumab | — | RCT |
| Nov 2013 | Deferred | laser photocoagulation | $15k–45k | RCT · BCVA (best corrected visual acuity, measured in ETDRS letters) |
| Nov 2013 | Deferred | laser photocoagulation (BRVO) and observation (CRVO); bevacizumab considered as likely actual comparator | $15k–75k | RCT · BCVA |
| Mar 2013 | Not recommended | laser photocoagulation | $15k–45k | RCT · BCVA (best-corrected visual acuity) |
| Nov 2012 | Recommended · restricted | laser photocoagulation and observation | $15k–45k | RCT · BCVA |
| Nov 2012 | Recommended · restricted | laser photocoagulation (for BRVO) and observation (for CRVO); bevacizumab noted as widely used but not TGA-approved for | $15k–45k | RCT · BCVA |
| Mar 2007 | Recommended · restricted | photodynamic therapy with verteporfin (PDT-V) for predominantly classic lesions; placebo/standard care for minimally cla | $15k–45k | RCT · QoL |
| Mar 2007 | Recommended · restricted | Photodynamic therapy with verteporfin (PDT-V) for predominantly classic lesions; placebo/standard care for minimally cla | $15k–45k | RCT · Visual acuity preservation |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| RESTORE | Ph 3 | 345 | Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study … | completed |
| RIDE | Ph 3 | 382 | Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA… | completed |
| RISE | Ph 3 | 377 | Percentage of Patients Who Gained ≥ 15 Letters in Their Best Corrected Visual Acuity (BCVA… | completed |
| READ-2 | Ph 2 | 126 | Mean Change in Best Corrected Visual Acuity (BCVA) at Month 6 | completed |
| REVEAL | Ph 3 | 396 | Average Change From Baseline of Best-Corrected Visual Acuity (BCVA) Over 12 Months (From M… | completed |
| BRAVO | Ph 2 | 40 | Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity) | unknown |
Consumer voice
Four health professionals and one organisation (MDFA) provided input highlighting that ranibizumab improves visual outcomes compared to current PRP therapy, is less invasive than vitrectomy surgery, and addresses equity issues in treatment access, though noting a time and cost burden to monthly treatment that becomes less onerous once disease is controlled.
PDR as the most common cause of blindness in working-age individuals in Australia. Consumer comments · PSD
unmet needaccess barrierstreatment burdenside effects of alternative treatmentsequity in regional settingsquality of life
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to PDR without DMO; TGA label includes PDR regardless of DMO status.