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Ophthalmology Group Opposes Payer Recommendations for Bevacizumab Biosimilars

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A supply chain shortage of Avastin (bevacizumab) is prompting policies for use of bevacizumab biosimilars instead, which the American Academy of Ophthalmology says could lead to problems.

The American Academy of Ophthalmology (AAO) is protesting payer policies that recommend biosimilars be used for the treatment of certain ophthalmologic diseases, on grounds that more clinical testing is needed and one of the biosimilars in question may be toxic to the retina.

The originator drug Avastin (bevacizumab) is used off label currently for treatment of wet age-related macular degeneration (AMD) and involves an injection into the eye, and it is currently the price-competitive alternative for ranibizumab (Lucentis) and aflibercept (Eylea).

In the United States there are no biosimilars for ranibizumab or aflibercept available, 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 eye, essentially making patients who depend on this commonly used drug unwitting subjects in a clinical experiment,” the AAO said in a statement.

Biosimilars are approved by the FDA as being highly similar in terms of safety and efficacy, with no clinically meaningful differences, to originator drugs. Although the FDA has not specifically indicated Avastin for ophthalmologic disease, the AAO says there is sufficient clinical evidence that Avastin is safe and effective in the treatment of AMD, macular edema, and neovascular glaucoma, among other diseases.

The group contends there ought to be separate testing of biosimilar bevacizumabs to verify that they work equally 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 harm vision.

A supply shortage of Avastin, caused by a production line overhaul, has pushed this issue to the forefront, the AAO says. Commercial payers, it says, are unwisely recommending that providers use the 2 available bevacizumab biosimilars on the market: Zirabev (Pfizer) and Mvasi (Amgen).

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.

“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,” the group said.

One of those biosimilars, Zirabev, is manufactured with edetate disodium dihydrate (EDTA), a buffering agent that the AAO says has shown to be toxic to corneal and conjunctival epithelial cells. “Potential retinal toxicity of EDTA has not been studied,” it notes.

Aetna is among the payers that are recommending bevacizumab biosimilars in place of more costly VEGF inhibitors.

“There is a lack of reliable evidence that Lucentis and Eylea are superior to the lower cost VEGF inhibitors,” Aetna says in a policy statement updated June 3, 2021. Aetna names Avastin, Mvasi, and Zirabev as equivalent treatments for 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 that are supporting the use of biosimilars for ophthalmologic conditions.

“The [AAO] 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,” the group’s statement said.

The experience in oncology 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 of being biosimilars wouldn’t be logical, he said.

“Whether it’s indicated or not, we know that bevacizumab works in macular degeneration,” he said. “The trepidation for using biosimilars in ophthalmology is similar to what we felt in oncology, but there haven’t been any issues.”

For an informative Cardinal Health column on the biosimilar pipeline in ophthalmology, click here.

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