What is Zaltrap, and how is it used in retinal diseases?
A printable pdf copy of this leaflet is available here.
Regarding intravitreal injections with anti-vascular endothelial growth factors (anti-VEGF), there is a choice of therapeutic agents depending on cost and availability. In New Zealand, bevacizumab (Avastin) is the first-line therapy in both public and private sectors as it is both the cheapest and is funded by Pharmac. In many patients, Avastin is adequate to control the disease process and stabilise vision.
Aflibercept (Eylea) is a newer anti-VEGF agent. Eylea appears to be stronger (i.e., better at eliminating subretinal and intraretinal fluid) and lasts longer in the eye than Avastin without any additional risks. In many countries, such as the UK, Eylea is the first-line anti-VEGF treatment. The issue with Eylea is cost, as it is around $1400 per injection, compared to $100 per injection with Avastin. Given these injections are ongoing and recurrent, the difference in cost makes Eylea unfeasible as a treatment agent unless funded by Pharmac.
Indeed, Pharmac has narrow funding criteria for Eylea. Essentially Eylea will be funded for patients with neovascular AMD or diabetic macular oedema if they fail a course of Avastin injections and meet reasonable visual acuity criteria.
How about Zaltrap?
Many patients will benefit from Eylea therapy but do not qualify based on the Pharmac criteria. One major group is patients with retinal vein occlusion who do not respond to Avastin. Otherwise, patients with neovascular AMD or diabetic maculopathy who are on frequent Avastin injections and wish to have less frequent injections will also benefit from Eylea but are not funded.
The generic name of Zaltrap is ziv-aflibercept. It is the active ingredient of Eylea (i.e. aflibercept) in a different buffer. It is available as a large vial for intravenous use for oncology patients, but in New Zealand, it is repackaged into individual syringes for intravitreal injections by compounding pharmacies.
Is Zaltrap safe?
Given Zaltrap is not explicitly formulated for the eye, there can be concerns about if this medication is safe for intravitreal use. The short answer is YES. It is safe to use Zaltrap in the eye.
The safety of Zaltrap has been demonstrated in a large series of 5914 patients, published in the British Journal of Ophthalmology, with no increased risks compared to other anti-VEGF injections. Other studies supporting its safety are found here, here, and here.
As Zaltrap is a repackaged drug using a compounding pharmacy, additional contamination risks can occur during the compounding process. This study shows that it is possible to re-compound Zaltrap safely. However, it is essential that the compounding pharmacy is reputable and adheres to a high standard.
Is Zaltrap as effective as Eylea?
I do not expect Zaltrap to be any less effective than Eylea in treating retinal diseases, as the active ingredient is the same. No large studies address this question (as large randomised controlled trials are expensive, and there is no financial incentive for a drug company to sponsor such a trial). Smaller trials on AMD and diabetic macular oedema suggest Zaltrap as an effective treatment for these conditions.
How much is Zaltrap?
In New Zealand, Zaltrap is available at roughly the same price as Avastin (around $100).
Is Zaltrap available in the public sector?
Currently, Zaltrap is unavailable in the public sector, as Pharmac does not fund ziv-aflibercept.
Is Zaltrap suitable for me or for my patient?
If Avastin does not adequately control the disease process, Zaltrap is a reasonable second-line option if Eylea is not funded. However, one should always use Eylea ahead of Zaltrap, as Eylea is designed explicitly for intravitreal use, and there is a wealth of evidence behind its safety and efficacy. In New Zealand, one should always start with Avastin therapy for diabetic macular oedema and neovascular AMD, the Pharmac prerequisite for Eylea funding.
On the other hand, despite Zaltrap being a section 29 drug, it appears that Zaltrap is both safe and effective for intravitreal use in patients requiring anti-VEGF therapy.
About Dr Leo Sheck
Dr Sheck is a RANZCO-qualified, internationally trained ophthalmologist. He combined his initial training in New Zealand with a two-year advanced fellowship in Moorfield Eye Hospital, London. He also holds a Doctorate in Ocular Genetics from the University of Auckland and a Master of Business Administration from the University of Cambridge. He specialises in medical retina diseases (injection therapy), cataract surgery, ocular genetics, uveitis and electrodiagnostics.
Patient information on intravitreal injections with Dr Sheck and further details on intravitreal injection techniques can be found here. Click here to refer a patient to Dr Sheck for consideration of an intravitreal Zaltrap injection.
