The American Academy of Ophthalmology is asking the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS) to prohibit these policies for Medicare Advantage and exchange plans. We’ve also informed the insurers that their pursuit of the bottom line is a danger to patient safety.
Avastin is a critically important treatment option for patients facing vision-threatening diseases, such as age-related macular degeneration, macular edema, neovascular glaucoma and others. Avastin is a treatment for these serious eye conditions and is supported by years of published research validating its effectiveness and safety for use in the eye.
Optum, one of the largest suppliers of Avastin, is currently unable to ship the drug due to an overhaul of their production process to enhance safety. As a result, some ophthalmologists are experiencing challenges acquiring repackaged Avastin for their patients.
Several large healthcare insurers – including Aetna, CareFirst, United Healthcare, Humana, Horizon Blue Cross Blue Shield of New Jersey, AmeriHealth and Maximus Federal-Health Assurance Pennsylvania – have stepped into this unfortunate supply chain disruption to recommend two biosimilars as alternatives to Avastin: Zirabev (bevacizumab-bvzr) from Pfizer and Mvasi (bevacizumab-awwb) from Amgen.
These two drugs are biosimilars for anti-VEGF medication. Avastin is also an anti-VEGF medication, however, its use in the eye is supported by clinical evidence. The newer biosimilar drugs have never been tested in the eye. They are approved for intravenous injection and their labels do not include treatment of eye disease. Pfizer and Amgen have not recommended the use of their biosimilars in the eye. The Academy does not oppose the use of biosimilars or the use of drugs off-label in general. We are against the use of drugs in the eye that have never been tested for ophthalmic diseases.
Ophthalmologists are also concerned that Pfizer’s Zirabev is prepared with edetate disodium dihydrate (EDTA). This buffering agent has demonstrated toxicity to corneal and conjunctival epithelial cells. Potential retinal toxicity of EDTA has not been studied.
There are only four Food and Drug Administration-approved anti-VEGF medications for ophthalmic indications as an alternative to repackaged Avastin, each of which costs substantially more than Avastin.
The Academy has told HHS and CMS it is inappropriate for plans to recommend or mandate use of these biosimilars for intravitreal injection without a prior clinical trial in eye disease and testing for retinal toxicity.