Blog Big Molecule Watch August 19, 2021

American Academy of Ophthalmology Pushes Back Against Bevacizumab Biosimilar Use in Treating Ophthalmic Conditions

On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases.  The statement alleges that certain large healthcare insurers—including Aetna, CareFirst, UnitedHealthcare, Humana, Horizon Blue Cross Blue Shield of New Jersey, AmeriHealth and Health Assurance Pennsylvania—have recommended Zirabev (bevacizumab-bvzr) from Pfizer and Mvasi (bevacizumab-awwb) from Amgen as alternatives to Avastin for treatment of retinal diseases.  At least one insurer—Horizon Blue Cross Blue Shield of New Jersey—disputes its inclusion on this list, stating it does not require biosimilar use in ophthalmic settings.  Aetna, on the other hand, considers bevacizumab biosimilars to be viable treatments for ophthalmic conditions.

The AAO’s statement was released against the backdrop of CMS’s Trump era reversal of a policy resulting in Medicare Advantage plans being able to use step therapy for Part B drugs—those that are administered in a doctor’s office.  Step therapy helps “achieve the goal of lower drug prices” by allowing payors to require the use of less costly therapeutics before patients are prescribed costlier medications.  Further compounding the issue is a supply chain disruption of Optum, one of Avastin’s largest suppliers, due to an overhaul of its production process to enhance safety, causing ophthalmologists to experience difficulty in obtaining Avastin for patients.

While the AAO explained that it “does not oppose the use of biosimilars or the use of drugs off-label in general”, it noted that Avastin, an anti-VEGF medication, is used to treat “serious eye conditions and is supported by years of published research validating its effectiveness and safety for use in the eye.”  On the other hand, the AAO statement explains that Zirabev and Mvasi “have never been tested in the eye,” and that their labels “do not include treatment of eye disease.”  The AAO also expressed concern over Zirabev being prepared with edetate disodium dihydrate (EDTA), an ingredient for which potential retinal toxicity has not been studied.

On August 17, 2021 the AAO released another statement commending UnitedHealthcare’s removal of Mvasi and Zirabev from its maximum dosing and anti-VEGF commercial policies where UnitedHealthcare stated that it revised the “list of applicable vascular endothelial growth factor (VEGF) inhibitors; remov[ing Myvasi and Zirabev],” and “[r]emoved language indicating ‘Bevacizumab’ will be used to refer to Avastin, Mvasi, and Zirabev.”

According to the AAO, while Avastin is currently being used off-label to treat ophthalmic conditions, its use is supported by clinical experience and cost advantage as compared to the four FDA approved anti-VEGF ophthalmic medications, “which cost substantially more than Avastin.”  As we have previously reported, Outlook Therapeutics is currently developing a bevacizumab formulation for which it is seeking approval specifically for use in ophthalmic conditions.

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