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CHICAGO -- Availability of a bevacizumab biosimilar for ophthalmic use could eliminate a lower-cost treatment option for a wide variety of off-label indications and add hundreds of millions of dollars in healthcare costs, according to a study reported here.

Bevacizumab-vikg for ophthalmic use has been submitted for FDA approval. A positive decision from the agency would trigger a provision of the (DQSA) prohibiting repackaging of the oncologic formulation of bevacizumab (Avastin) for off-label use. Eliminating the low-cost option for the vast majority of non-FDA-approved indications not only would leave thousands of patients without a low-cost treatment option but no anti-VEGF treatment option at all in many cases.

Additionally, prohibiting repackaging of bevacizumab would add almost half a billion dollars annually to Medicare costs and increase patient costs by more than $100 million, reported Ravi Parikh, MD, of NYU Grossman School of Medicine in New York City, and colleagues in a poster presentation at the American Academy of Ophthalmology (AAO) meeting.

"You need a low-cost option for a lot of these non-FDA-approved indications," Parikh told 番茄社区. "We're not talking about macular degeneration or retinal vein occlusion [RVO] or diabetic retinopathy, but people with sickle-cell retinopathy and radiation retinopathy, for example. It wouldn't be practical to try to get FDA approval for all of these indications."

Repackaged (or compounded) bevacizumab has been widely used for more than a decade as a low-cost off-label treatment for neovascular age-related macular degeneration (nAMD), RVO, diabetic macular edema (DME), and multiple other ophthalmic conditions. Standard 4 mL vials of bevacizumab for cancer treatment have been repackaged into 0.05 mL doses for intravitreal administration at a substantially lower cost than other anti-VEGF therapies.

Parikh and colleagues assessed the potential impact of FDA approval of a bevacizumab biosimilar for ophthalmic use on anti-VEGF treatment of non-FDA-approved ophthalmic indications.

They queried the to identify patients who received anti-VEGF injections for both FDA-approved and off-label indications from 2016 through 2021. To determine the number of off-label bevacizumab injections that would have been prohibited with FDA approval of bevacizumab-vikg, investigators excluded diagnoses that would fall within FDA-approved anti-VEGF indications or bevacizumab-vikg indications (nAMD, diabetic retinopathy, RVO, DME, and myopic choroidal neovascular membranes).

The search identified 1,987,906 patients and 2,661,610 eyes treated with anti-VEGF injections over the 6-year period. Non-approved indications accounted for 429,140 (21.6%) of patients and 511,223 (19.2%) of eyes. Repackaged bevacizumab accounted for about half of all the anti-VEGF injections.

The analysis showed that 279,513 (65.13%) patients and 327,064 (63.98%) eyes received off-label bevacizumab injections that would be excluded with approval of a bevacizumab biosimilar. The numbers constituted 19.9% of all bevacizumab injections during the study period but 65.1% of eyes with conditions that would be excluded by the DQSA prohibition on repackaging. The single most common excluded diagnosis was retinal neovascularization (38,473 eyes, 11.8%). Diagnoses with prevalence less than 1% accounted for 202,861 eyes (62.0%) that would be excluded.

The investigators performed a cost analysis using a "conservative estimate" of $500 per injection of a bevacizumab biosimilar and Medicare cost allowances for other anti-VEGF therapies: bevacizumab 1.25 mg ($78), aflibercept (Eylea) 2 mg ($1,856), and ranibizumab (Lucentis) 0.3 mg ($752) and 0.5 mg ($1,856). The analysis showed an estimated $457 million increase in Medicare costs and $117 million in patient costs annually with approval of a bevacizumab biosimilar for ophthalmic use.

The study is a follow-up to an analysis Parikh reported last year at the American Society of Retina Specialists meeting, suggesting Medicare would pay 15-30% more for anti-VEGF injections with approval of bevacizumab biosimilars, assuming a cost range of $500 to $900. With those estimates, Medicare costs for anti-VEGF therapy would increase by $500-$900 million annually.

The investigators also of the potential impact of FDA approval of a bevacizumab biosimilar for ophthalmic use and the DQSA.

"Even when biosimilars come out, the prices will still be high, even though, obviously, it's hard to speculate about the future," said Parikh. "We've seen in other places that the prices go down only when there's something like three or more biosimilars."

"It's highly unlikely that in the near future, any biosimilar would price lower than the current cost of repackaged bevacizumab, which is currently less than 10% of the prices of current ranibizumab biosimilars that are available in the United States," he continued. "You need multiple biosimilars, and then you have to hope the price comes down."

The FDA could make an exception to the DQSA and continue to allow repackaging of bevacizumab for ophthalmic use, but that remains to be seen, said Parikh.

A spokesperson for the AAO told 番茄社区 the organization has not taken a position on the issue of repackaged bevacizumab.

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