Ophthalmologists Face Insurance Issues when Using Biosimilars

While ophthalmologists are familiar with biosimilars, they don’t always prescribe them, according to a new survey by Cardinal Health. In fact, while 61% of ophthalmologists surveyed said that biosimilars can contribute to improving patient care, almost half have concerns about the long-term data on biosimilars and 40% said they lack confidence in biosimilars’ safety and efficacy.

Fran Gregory, Pharm.D.

“This highlighted to me that we need to continue to educate and provide resources to our healthcare providers so that when biosimilar options are available, they're very knowledgeable, and they can pass that confidence on to their patients,“ Fran Gregory, Pharm.D., MBA, vice president of Emerging Therapies at Cardinal Health, said in an interview.

Cardinal Health surveyed providers in ophthalmology in the fall of 2023 to obtain perspectives that may influence adoption while highlighting continued obstacles to wider use of biosimilars. The survey suggest a positive impact on healthcare system sustainability, with 75% of participants agreeing that biosimilars can improve healthcare system sustainability.

In the retinal space, two biosimilars are available that are interchangeable with Genentech’s Lucentis (ranibizumab): Byooviz and Cimerli. Byooviz (ranibizumab-nuna), which was developed by Samsung Bioepis and is marketed in the United States by Biogen, is indicated to treat neovascular (wet) age-related macular degeneration, macular edema, and myopic choroidal neovascularization. When it launched in 2022, Byooviz had a list price of $1,130 per single use vial to administer 0.5 mg via intravitreal injection. For 2023, Biogen reported worldwide revenue of Byooviz of $9.2 million.

Cimerli (ranibizumab-eqrn), which was developed by Coherus BioSciences, is available in both 0.3 mg and 0.5 mg dosages and is interchangeable for all of Lucentis’s indications, including neovascular age-related macular degeneration, macular edema, diabetic retinopathy, and myopic choroidal neovascularization. Cimerli launched in 2022 with a list price of $1,360 and $816 per single-dose vial for the 0.5 mg and 0.3 mg dosages respectively.

This year, Sandoz has acquired the Cimerli business for $170 million. The acquisition includes the Cimerli biologics license application, ophthalmology sales and select field reimbursement teams, and access to proprietary commercial software. Coherus officials indicated they are concentrating on their oncology pipeline and the launch of Loqtorzi to treat patients with nasopharyngeal carcinoma

The Cardinal Health survey found that 82% of retina specialists said they would be very or somewhat more likely to prescribe biosimilars if they became a payer’s preferred drug. They also indicated that securing prior authorization for biosimilars is more challenging than for reference products.

“The reference product is still often on the formulary and remains at parity, which means at about the same level of reimbursement,” Gregory said. “The prescriber really doesn’t have that incentive to use a biosimilar.”

Of those surveyed by Cardinal Health, 75% said safety of compounded products for retinal use was their biggest concern. Avastin (bevacizumab), for example, is used off-label to treat patients with wet age-related macular degeneration, but must be compounded for retinal use. Several biosimilars are available, including Mvasi, Zirabev, Alymsys, and Vegzelma. These products are approved to treat patients with several cancers, including colorectal, lung, glioblastoma, kidney, cervical and ovarian cancer.

Avastin is an anti-vascular endothelial growth factors (VEGFs), which block the protein that leads to abnormal growth of blood vessels in the eye. This can lead to symptoms and retinal damage.

An ophthalmic formulation of bevacizumab to treat patients with wet age-related macular degeneration failed to fill FDA approval. In Augusts 2023, the FDA issued a complete response letter (CRL) for Outlook Therapeutics’ biologics license application for Lytenava (bevacizumab-vikg), which had been under review to treat patients with wet age-related macular degeneration.

The survey found that using the Avastin biosimilars off-label for retinal conditions presented insurance issues; ophthalmologists surveyed said lack of data was also a barrier.

Regeneron’s Eylea (aflibercept) is another anti-VEGF therapy that is approved to treat several eye diseases, including age-related macular degeneration, diabetic retinopathy and diabetic macular edema. Several biosimilars are in development, and Gregory said there could be eight Eylea biosimilars approved this year. For example, Biocon Biologics has a biosimilar to Eylea that it acquired from Viatris. Applications for its biosimilar of aflibercept are being reviewed by regulatory authorities in the United States, the European Union, the UK and Japan.

But few of the ophthalmologists surveyed were aware of the coming biosimilars for Eylea. However, 80% of the ophthalmologists said they would consider using these biosimilars for existing patients stable on Avastin. They would be more likely to use Eylea biosimilars if launched at a 40% discount off of Eylea price of $2,625 per single-use vial.