AfliberceptAfqlir
Recommended OphthalmologyAuthority Required 💬 consumer voice
Treatment of subfoveal choroidal neovascularisation (CNV) due to pathologic myopia (PM) in adults.
16
Submissions
6 resub
2012–25
On the record
$45k–75k
ICER range
3 sourced ICERs · 2013–2014
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2025 Recommended Subfoveal choroidal neovascularisation due to pathologic myopia
- Meeting Jul 2025 Recommended Macular oedema secondary to RVO, DMO, CNV secondary to AMD
- Meeting Nov 2024 Recommended Diabetic macular oedema
- Meeting Nov 2024 Recommended Subfoveal choroidal neovascularisation secondary to age-related macular degeneration
- Meeting May 2024 Recommended Visual impairment due to diabetic macular oedema
- Meeting May 2024 Recommended Visual impairment caused by CNV secondary to nAMD
- Meeting Mar 2024 Noted Diabetic macular oedema (DMO) no PSD
- Meeting Mar 2024 Noted Subfoveal choroidal neovascularisation secondary to age-related macular degeneration no PSD
9 earlier decisions
- Jul 2019 Recommended Subfoveal choroidal neovascularisation (CNV)
- Nov 2015 Recommended Branch retinal vein occlusion (BRVO)
- Mar 2015 Recommended Wet age-related macular degeneration, central retinal vein occlusion, and diabetic macular oedema.
- Nov 2014 Recommended 4 mg/0.1 mL injection, 1 x 0.1 mL vial 4 mg/0.1 mL injection, 1 x 0.90 mL syringe Eylea® Bayer Australia Ltd Change to listing (Major submission) Diabetic Macular Oedema Authority Required listing for the treatment of diabetic macular oedema. On the basis of direct evidence presented by the submissi
- Nov 2014 Recommended 4 mg/0.1 mL injection, 1 x 0.1 mL vial 4 mg/0.1 mL injection, 1 x 0.90 mL syringe Eylea® Bayer Australia Ltd Change to listing (Major submission) Macular Oedema secondary to central retinal vein occlusion Authority Required listing for the treatment of central retinal vein occlusion. On the basis of
- Mar 2014 Not recommended Eylea® Bayer Australia Ltd Indicated in adults for treatment of: - neovascular (wet) age-related macular degeneration (wet AMD) and - visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO) Subfoveal choroidal neovascularisation (CNV) due to age-related macular deg
- Jul 2013 Not recommended Vision loss
- Jul 2013 Not recommended Bowel cancer
- Mar 2012 Recommended Age-related macular degeneration
Access path
- TGA registered · Afqlir
TGA label narrower than the PBS population
- Mar 2012Recommended · restricted
vs ranibizumab
- Mar 2012Recommended · restricted
- Jul 2013Recommended
Comparator changed: ranibizumab → FOLFIRI (K-RAS mutant); cetuximab (WT K-RAS)
- Jul 2013Not recommended
concerns over long-term efficacy and deterioration of treatment effect after initial 24 weeks when dosing switched to…
- Mar 2014Not recommended
Comparator changed: placebo/sham injection (as proxy for best supportive care) →…
- ↻ resubmittedNov 2014Recommended · restricted
Comparator changed: placebo/sham injection (best supportive care); bevacizumab and…
- Nov 2014Recommended · restricted
Comparator changed: placebo/sham injection (best supportive care); bevacizumab and…
- Mar 2015Recommended
Evidence: RCT → Cost-minimisation
- Nov 2015Recommended · restricted
Evidence: Cost-minimisation → RCT
- Jul 2019Recommended · restricted
Listing: Authority Required → Restricted
- May 2024Recommended · restricted
Comparator changed: ranibizumab → aflibercept 2 mg
- May 2024Recommended · restricted
Comparator changed: ranibizumab → aflibercept 2 mg
- Nov 2024Recommended · restricted
- Nov 2024Recommended · restricted
- Jul 2025Recommended · restricted
Comparator changed: aflibercept 2 mg → Eylea (reference biologic aflibercept)
- Nov 2025Recommended
Evidence: Other → Cost-minimisation
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the General Schedule Authority Required listings of a new aflibercept biosimilar (Eydenzelt®) for the treatment of subfoveal choroidal neovascularisation (CNV) due to pathologic myopia (PM) on a cost-minimisation basis and under the same conditions as its reference biologic (Eylea®).PSD · Nov 2025
5.2 The PBAC advised the equi-effective doses to be 1 mg Eydenzelt = 1 mg Eylea.PSD · Nov 2025
Economic analysis
6.39 The submission presented a CMA, comparing aflibercept 8 mg PFS to aflibercept 2 mg, as presented in the submission for the 8 mg vial. The key assumptions and components of the CMA are presented in Table 11 and were unchanged from the initial CMA proposed in May 2024 other than updating the MBS scheduled fee for the IVT injection.PSD · Nov 2024
Table 11: Key assumptions and components of the cost-minimisation approach Component Claim or assumption Therapeutic claim: Based on evidence presented in Section 2 of the submission, aflibercept 8 mg PFS is non- effectiveness inferior in effectiveness to aflibercept 2 mg Therapeutic claim: Based on evidence presented in Section 2 of the submission, aflibercept 8 mg PFS is non- safety inferior in safety to aflibercept 2 mg Evidence base Direct randomised …PSD · Nov 2024
Clinical claim
6.34 The submission described aflibercept 8 mg PFS as non-inferior in effectiveness compared to aflibercept 2 mg. This claim has previously been accepted by the PBAC.PSD · Nov 2024
6.35 The submission described aflibercept 8 mg PFS as non-inferior in terms of safety compared to aflibercept 2 mg, with a reduced injection burden. The claim of non- 16PSD · Nov 2024
Consumer comments
4.3 As per the Product Information, the TGA has confirmed that “Eydenzelt (for 2 mg dosing) is a biosimilar medicine to the reference product Eylea (aflibercept) (for 2 mg dosing). The evidence for comparability supports the use of Eydenzelt for the listed indication.”PSD · Nov 2025
Financial management – risk sharing
6.44 The submission stated that the sponsor is willing to work with the Department to ensure that there was an equivalent Commonwealth cost for aflibercept when compared to ranibizumab in mCNV.PSD · Jul 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Eydenzelt is a biosimilar with no expected net cost to PBS as it substitutes for Eylea.
The PBAC considered that the listing of Eydenzelt would not result in a net cost to the PBS as it would likely substitute for Eylea and not increase the overall market utilisation. PBAC · 2025
ICER uncertain ×5ICER / price too highEconomic model disputed ×3Price cut / RSA needed ×2Immature survival dataCost-effectiveness accepted ×4
Decision context
PopulationAdults with subfoveal choroidal neovascularisation due to pathologic myopia.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | Eylea (reference biologic aflibercept) | — | Cost-minimisation · Cost-minimisation |
| Jul 2025 | Recommended · restricted | Eylea (reference biologic aflibercept) | — | Other · Cost-minimisation |
| Nov 2024 | Recommended · restricted | aflibercept 2 mg | — | RCT · BCVA |
| Nov 2024 | Recommended · restricted | aflibercept 2 mg | — | RCT · BCVA |
| May 2024 | Recommended · restricted | aflibercept 2 mg | — | RCT · Change in best corrected visual acuity (BCVA) |
| May 2024 | Recommended · restricted | aflibercept 2 mg | — | RCT · BCVA (best corrected visual acuity) |
| Jul 2019 | Recommended · restricted | ranibizumab | — | RCT · BCVA |
| Nov 2015 | Recommended · restricted | ranibizumab | — | RCT · Proportion of subjects who gained ≥15 letters in BCVA |
| Mar 2015 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Recommended · restricted | ranibizumab; laser photocoagulation | — | RCT · BCVA |
| Nov 2014 | Recommended · restricted | best supportive care (primary); ranibizumab and bevacizumab (secondary) | — | RCT · BCVA gain ≥15 letters |
| Mar 2014 | Not recommended | placebo/sham injection (best supportive care); bevacizumab and ranibizumab also considered | $45k–75k | RCT · Proportion of patients with ≥15 letter gain in BCVA at 24 weeks |
| Jul 2013 | Recommended | FOLFIRI (K-RAS mutant); cetuximab (WT K-RAS) | $45k–70k | RCT · OS |
| Jul 2013 | Not recommended | placebo/sham injection (as proxy for best supportive care) | $45k–75k | RCT · BCVA-gain-15 |
| Mar 2012 | Recommended · restricted | ranibizumab | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
| Mar 2012 | Recommended · restricted | ranibizumab | — | RCT · ETDRS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PULSAR | Ph 3 | 1,011 | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 | completed |
| CANDELA | Ph 2 | 106 | Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | completed |
| GALILEO | Ph 3 | 177 | Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Let… | completed |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to subfoveal CNV location; TGA label covers all myopic CNV locations without anatomical specification.