乌鸦传媒

SEATTLE -- Availability of a bevacizumab (Avastin) biosimilar for ophthalmic use could have the unintended consequence of driving up the cost of treating retinal disease with angiogenesis inhibitors, according to an economic study reported here.

An economic model that assumed a cost range of $500 to $900 per 1.25-mg dose for the biosimilar projected a 15% to 30% increase in Medicare expenditures for anti-vascular endothelial growth factor (VEGF) treatment of eye disease, approximately $500 to $900 million annually. Patient out-of-pocket expenses also would increase. Medicare currently pays about $85/1.25 mg for off-label compounded bevacizumab for ophthalmic use.

Switching from ranibizumab (Lucentis) and aflibercept (Eylea) to biosimilars would offset only 30% of the increase resulting from the higher cost of the bevacizumab biosimilar, reported Ravi Parikh, MD, of the NYU Grossman School of Medicine and Manhattan Retina and Eye Consultants in New York City, at the American Society of Retina Specialists (ASRS) meeting.

"There is a concern that low-cost, repackaged bevacizumab will no longer be available due to the looming FDA approval of an on-label-for-ophthalmic-use bevacizumab biosimilar," said Parikh. "Why would this occur? The [DQSA] states that compounding pharmacies cannot compound one or more approved drugs. Pharmacies will no longer be able to do compounding and repackaging."

A bevacizumab biosimilar for ophthalmic use currently is pending FDA approval (bevacizumab-vikg). Additionally, a precedent already exists in ziv-aflibercept (Zaltrap) -- like bevacizumab, an oncologic drug available in the U.S. A compounded, repackaged formulation of aflibercept for ophthalmic use is not available in the U.S. but is used in other countries. A compounded ophthalmic formulation of aflibercept would cost less than compounded bevacizumab, said Parikh.

"So both the letter of the law and this precedent in the same space of an oncologic drug would likely prohibit the use of low-cost, repackaged bevacizumab once the FDA approves a retinal indication for the bevacizumab biosimilar," he added.

To examine the potential economic impact of the still-theoretical scenario, Parikh and colleagues performed an economic analysis using average sales prices for ranibizumab, aflibercept, and bevacizumab, based on Medicare allowable payments.

The analysis showed that an FDA-approved bevacizumab biosimilar ophthalmic use priced at $500/1.25 mg would increase Medicare costs by $457 million annually. Patient out-of-pocket payments would increase by about 15%. If the biosimilar were priced at $900, Medicare outlays would increase by $897 million annually and the patient's share of the cost by almost 30%.

The per-dose cost of ranibizumab and aflibercept would have to decrease by 15.7% to offset the higher price of the bevacizumab biosimilar.

"The purpose of our study is to create formal evidence for [ophthalmology organizations] and to encourage you to reach out to your local representatives about this issue," said Parikh. "Advocacy efforts and data are going to be very important to make sure patients have access to low-cost medications, as we all know that when cost goes up, access will decrease."

The DQSA afforded protections to pharmaceutical companies and their investment in therapies, but Congress, albeit currently dysfunctional, could change the course, said John Thompson, MD, of Retina Specialists in Towson, Maryland.

"The DQSA was created during the Obama administration, and if Congress feels this is as much of an issue, potentially it could be changed if Republicans and Democrats can get together," he said during a discussion that followed Parikh's presentation.

Parikh agreed and encouraged ASRS members to contact their congressional representatives about the issue.

"[The Biden administration] has made a big point about drug costs," he said. "If a low-cost option is going to be off the table, for what's essentially the same drug, I think that it's even more important for people to reach out to their representatives and at least get this on their radar, because it could be an easy win."

In response to a question from the audience, Parikh noted that the implications extend beyond age-related macular degeneration as the bevacizumab biosimilar also is being evaluated in diabetic macular edema and retinal vein occlusion.

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