The American Academy of Ophthalmology has accused large health insurers of using a biologic drug shortage as a means to push patients into using biosimilars for a common retina disease, even though the drugs haven't been tested for that use.
The San Francisco-based lobbying group called on seven health insurers to stop recommending the use of two biosimilars for Genentech USA's Avastin, a biologic drug used to treat eye diseases such as age-related macular degeneration and some cancers. The industry group has asked CMS to stop insurers from pressuring patients to take biosimilars Zirabev from Pfizer and Mvasi from Amgen for age-related macular degeneration, which is the leading cause of blindness in individuals over 60 and affects approximately 15 million people in the U.S.
"Insurance companies are pushing ophthalmologists to use new biosimilar drugs as alternatives 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.
Unlike chemically derived generic medicines, biosimilars cannot promise to be exact replicas of their originator biologic drugs. Biologics are grown from living organisms like cell tissue, bacteria or proteins, which means they can mimic the original medicines but not exactly duplicate them.
Biosimilars are seen as a promising way to lower drug costs—a 2019 study from the Pacific Research Institute estimated that biosimilars save commercial insurers $136.8 million annually and, if their reach is expanded to make up 75% of biologic prescriptions, the U.S. healthcare system would save nearly $7 billion each year.
The Food and Drug Administration has approved approximately 30 biosimilars so far, including Zirabev and Mvasi, which the agency cleared as a chemotherapy treatment for five types of cancer. But the federal agency hasn't approved them specifically for macular degeneration.
Neither Pfizer nor Amgen list the biosimilars as treatment options for eye conditions on their websites.
"Even the drugs' manufacturers have advised against injecting the alternative drugs into the eye because there is no scientific proof to support it," the AAO said in a statement, alleging Zirabev may even accelerate the severity of patients' eye disease.
Health insurers are apparently capitalizing on an Avastin shortage caused by UnitedHealth Group's Optum, which is one of the largest suppliers of the biologic. Optum is currently undergoing a safety-related update to its distribution process, leaving it unable to ship the drug, according to the AAO. This has left some ophthalmologists struggling to obtain the originator.
Optum declined to comment on the matter.
AAO claims UnitedHealthcare, Aetna, Humana, CareFirst Blue Cross and Blue Shield, Horizon BCBS of New Jersey, AmeriHealth and HealthAssurance Pennsylvania have started recommending biosimilars Zirabev and Mvasi to patients due to the Avastin shortage.
As of July 1, Minnetonka, Minn.-based UnitedHealthcare limited commercial members' use of Avastin and biosimilars to once a month in each eye for the first year and "fewer injections needed in subsequent years." The updated policy document lists the biosimilars as treatment options for commercial and Medicare Advantage members' age-related macular degeneration. UnitedHealthcare did not respond by deadline to an interview request.
An Aetna spokesperson pointed to a June policy document by the Woonsocket, R.I.-based insurer, which lists the biosimilars as an approved therapy for its commercial and Medicare members' eye conditions.
CareFirst disputed the AAO's claims, saying the Baltimore-based insurer does not support the use of either biosimilar to treat retinal disorders and lists Avastin as the preferred treatment. Newark, N.J.-based Horizon BCBS also said AAO's characterization of its policy was incorrect.
"Horizon's policy concerning the use of an approved biosimilar for Avastin applies only to its use for patients who have certain cancers and who are new to treatment," a Horizon spokesperson wrote in a statement. "As it relates to ophthalmic use for treatment of eye disease, the academy got it wrong—there is no policy requiring the use of a biosimilar for Avastin for any Horizon member."
Louisville, Ky.-based Humana, Cranbury, N.J.-based AmeriHealth and North Bethesda, Maryland-based HealthAssurance Pennsylvania did not respond to interview requests.
AAO's report comes as health insurers increasingly crack down on members' use of high-cost biologic drugs, with UnitedHealthcare, Aetna and Cigna unveiling policies this year that force patients to switch to biosimilars or restrict the drug dosage an individual can receive. Bloomfield, Conn.-based Cigna offered patients a $500 prepaid gift card for switching, a practice the American Medical Association's House of Delegates voted to oppose shortly after the formulary change was announced.