The American Academy of Ophthalmology (AAO) protests against payers’ policies that recommend the use of biosimilars for the treatment of certain eye diseases, on the grounds that more clinical trials are needed and that one of the biosimilars in question may be toxic to the retina.
The original drug Avastin (bevacizumab) is currently used off-label for the treatment of wet age-related macular degeneration (AMD) and involves injection into the eye. ).
In the United States, there are no biosimilars for ranibizumab or aflibercept, although there are biosimilar versions of bevacizumab.
“Insurance companies are pushing ophthalmologists to use new biosimilar drugs as alternatives to Avastin that have never been tested in the eyes, essentially making patients who depend on this commonly used drug unwitting subjects in clinical experience. “the AAO said in a statement.
Biosimilars are approved by the FDA to be very similar in terms of safety and efficacy, with no clinically significant differences, to the brand name drugs. Although the FDA has not specifically listed Avastin for eye disease, the AAO says there is sufficient clinical evidence that Avastin is safe and effective in the treatment of AMD, macular edema, and glaucoma. neovascular, among other diseases.
The group argues that there should be separate testing of biosimilar bevacizumabs to verify that they work as well in eye disease. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor, which works by preventing the abnormal growth of blood vessels that can damage the eye or impair vision.
A shortage of Avastin, caused by an overhaul of the production line, has brought this problem to the fore, according to the AAO. Commercial payers, he says, recklessly recommend providers to use the 2 bevacizumab biosimilars available on the market: Zirabev (Pfizer) and Mvasi (Amgen).
“Avastin is also an anti-VEGF drug; however, its use in the eye is supported by clinical evidence. The new biosimilar drugs have never been tested in the eyes, ”the group said.
One of these biosimilars, Zirabev, is made with disodium edetate dihydrate (EDTA), a buffering agent that the AAO says has been shown to be toxic to corneal and conjunctival epithelial cells. “The potential retinal toxicity of EDTA has not been studied,” he notes.
Aetna is among the payers who recommend bevacizumab biosimilars in place of the more expensive VEGF inhibitors.
“There is a lack of reliable evidence that Lucentis and Eylea are superior to lower-cost VEGF inhibitors,” Aetna says in an updated policy statement on June 3, 2021. Aetna names Avastin, Mvasi and Zirabev as equivalent treatments for the macular edema, AMD, and various other eye conditions including diabetic retinopathy and myopic choroidal neovascularization.
The AAO also names CareFirst, United Healthcare, Humana, Horizon Blue Cross Blue Shield of New Jersey, AmeriHealth and Health Assurance Pennsylvania as other payers who support the use of biosimilars for eye conditions.
“The [AAO] told HHS and CMS that it was inappropriate for plans to recommend or mandate the use of these biosimilars for intravitreal injection without prior clinical testing in eye disease and without retinal toxicity testing, ”the statement said. group.
The oncology experience could be instructive for the use of biosimilars in ophthalmology, said Neal Dave, PharmD, executive director of pharmacy for Texas Oncology. Biosimilars have been a positive experience and excluding biosimilars from ophthalmology solely on the basis that they are biosimilars would not make sense, he said.
“Whether it’s indicated or not, we know that bevacizumab works on macular degeneration,” he said. “The fear of using biosimilars in ophthalmology is similar to what we felt in oncology, but there was no problem. “
For an informative Cardinal Health column on the biosimilars pipeline in ophthalmology, click here.