Wet AMD: Does Cost Matter?

One of our employees recently lost vision in one eye and was found to have neovascular (wet) age-related macular degeneration. He has been receiving injections in the affected eye, and he says that his vision is improving. Wet AMD is caused by rapid growth of leaky blood vessels into the subretinal space. Intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors slow the process and can restore lost vision.

Three VEGF inhibitors have been approved by the FDA for this indication. The newest of the three, aflibercept (Eylea), costs nearly $2000 for a single-use vial. That is the wholesale cost. We reviewed aflibercept in The Medical Letter issue of February 6, 2012. We concluded then that it appeared to be as effective as the previous standard VEGF inhibitor, ranibizumab (Lucentis), which also costs about $2000 wholesale for a single-use vial. Someone (the patient, his insurance company, Medicare) has to pay for this. You can’t let people go blind because of money in the richest country on earth.

Well, actually, there is an alternative. Bevacizumab (Avastin), a VEGF inhibitor derived from the same antibody as ranibizumab, is approved by the FDA for treatment of various malignancies in much larger doses than are injected into the eye. It is not approved for intravitreal injection in wet AMD, but it has been widely used off-label for that purpose, at a cost 20-100 times less than the FDA-approved drugs. In an NIH-sponsored trial comparing it with ranibizumab, bevacizumab had equivalent effects on visual acuity. Repackaging of the drug into small aliquots for ophthalmic use can be done by compounding pharmacies, which recently have taken some hits, reputation-wise, but in the NIH-sponsored trial, endophthalmitis, the chief concern, occurred after only 0.07% of injections with bevacizumab, compared to 0.04% of injections with ranibizumab.

This situation should engender some interesting choices. Will the manufacturer of Avastin bring out an ophthalmic formulation and then claim it needs to raise the price 50- or 100-fold per unit volume for the smaller packages? Will Medicare and Medicaid decide to pay only for off-label use of the less expensive VEGF inhibitor when FDA-approved alternatives are available? Probably not. One thing is clear: For the soon-to-be-few uninsured, the off-label drug should be a vision-saver. We will keep following this.

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