The Academy has stepped up to speak out against the use of untested biosimilars in the eyes of patients amid a disruption in the drug supply chain.
The American Academy of Ophthalmology (AAO) has commended UnitedHealthcare (UHC) for acting quickly to clarify its policy regarding the use of two biosimilars untested for ophthalmic/intravitreal use as alternatives to the sight-saving drug Avastin.
According to a statement from AAO, UHC removed the drugs, Mvasi and Zirabev, from the maximum dosing policy and the anti-VEGF commercial policy, effective Aug. 6. AAO supports this action to protect patients and said it hopes other insurers will follow UHC's lead.
The AAO noted that recent supply chain disruption that limited Avastin's availability has led several large healthcare insurers to list the two biosimilars as alternatives.
This development has alarmed ophthalmologists because these drugs have never been tested in the eye. They are not approved for intravitreal injection and their labels do not include treatment of eye disease.
Even the drug's manufacturers, Pfizer and Amgen, have not recommended the use of their biosimilars in the eye, according to AAO.
In a statement, the AAO said it met with officials at UHC to discuss the organization’s concern that the drugs are inappropriate alternatives for patients who need intravitreal anti-VEGF treatment.
“Anti-VEGFs are critically important treatment options for patients facing vision-threatening diseases, such as age-related macular degeneration, macular edema, neovascular glaucoma and others,” AAO said in its statement. “We appreciate the insurer's willingness to listen to our position and to clarify policy language to protect patients.”
The other insurers have yet to announce any change in their policies.
The Academy continues to discuss with the Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services the necessity of prohibiting the drugs for ophthalmic use in policies for Medicare Advantage and exchange plans.