UnitedHealthcare (UHC) backs away from its biosimilar inclusion policy after the American Academy of Ophthalmology (AAO) raises concerns about safety and lack of clinical evidence.
UnitedHealthcare (UHC) has changed its policy to indicate that the bevacizumab biosimilars Mvasi and Zirabev will not be covered in the treatment of certain ophthalmic conditions or considered ophthalmically equivalent to Avastin, the reference product.
The policy change drew a statement of relief from the American Academy of Ophthalmology (AAO), which has sought to emphasize that its membership has more confidence in Avastin, given the weight of clinical evidence supporting its use for ophthalmic conditions vs the relative scarcity or outright lack of evidence supporting the use of bevacizumab biosimilars for these particular conditions.
AAO is concerned that bevacizumab biosimilars have not yet been qualified as being as safe and efficacious in ophthalmology. The group, which represents 32,000 eye physicians and surgeons, is opposing decisions by many payers to treat the bevacizumab biosimilars as equivalent to Avastin in ophthalmology.
Originally indicated and FDA-approved for the treatment of certain cancers, Avastin is not indicated for ophthalmic conditions such as age-related macular degeneration, macular edema, neovascular glaucoma and others, but it has long been used for treatment of these diseases. The difference is the weight of clinical studies that have specifically evaluated Avastin for these uses, the AAO states.
“The academy commends UnitedHealthcare for acting quickly to clarify its policy regarding the use of 2 biosimilars untested for ophthalmic/intravitreal use as alternatives to the sight-saving drug Avastin,” the AAO said.
Biosimilars are often extrapolated for use in conditions they are not directly indicated for, and this extrapolation is typically for conditions for which the reference drugs got FDA clearance. The use of bevacizumab in ophthalmology is an exception because Genentech, Avastin’s maker, has never sought FDA approval for ophthalmic conditions. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor that retards growth of blood vessels; excess growth can cause blindness and other vision problems.
In ophthalmic uses, the drug is administered intravitreally, or via injection in the eye; and the drug must be sent to compounding pharmacies to be specially prepared for this type of dosage, which raises additional concerns about safety and purity, the AAO has stated.
UHC changed its policy recently after meeting with the AAO to discuss the issue. “Anti-VEGFs are critically important treatment options for patients facing vision-threatening diseases....We appreciate the insurer’s willingness to listen to our position and to clarify policy language to protect patients,” the AAO stated.
In a policy update Tuesday, August 17, 2021, UHC said it had revised its list of covered VEGF inhibitors to exclude Mvasi and Zirabev, which are Amgen and Pfizer products, respectively.
For an interview about this issue with George Williams, MD, clinical spokesman for the AAO, click here.
For an article about payer responses and related issues, click here.