AAO speaks out on untested biosimilar use in eyes during Avastin supply disruption
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The American Academy of Ophthalmology has asked CMS and HHS to prohibit Medicare Advantage and exchange plans from suggesting biosimilar alternatives to Avastin, according to a press release.
Avastin (bevacizumab, Genentech) is an anti-VEGF therapy used off label to treat age-related macular degeneration and other vision-threatening diseases, “supported by years of published research validating its effectiveness and safety for use in the eye,” the release said.
A production process overhaul has disrupted the Avastin supply chain, and in the vacuum, some insurance companies, including Aetna, CareFirst, United Healthcare, Humana, Horizon Blue Cross Blue Shield of New Jersey, AmeriHealth and Health Assurance Pennsylvania, have recommended Zirabev (bevacizumab-bvzr, Pfizer) and Mvasi (bevacizumab-awwb, Amgen) as alternatives, the release said.
However, the biosimilars have not been tested in eyes and are currently approved for intravenous injection. Their labels do not include treatment of eye disease, and the companies have not recommended their use 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,” the release said.
Additionally, Zirabev is prepared with edetate disodium dihydrate, an agent that “has demonstrated toxicity to corneal and conjunctival epithelial cells” and that has not been evaluated for potential retinal toxicity, the release said.
“The American Academy of Ophthalmology is asking the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services to prohibit these policies for Medicare Advantage and exchange plans,” the release said. “We’ve also informed the insurers that their pursuit of the bottom line is a danger to patient safety.”
AAO told the agencies that “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.”
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