Bevacizumab Biosimilar Approval Could Eliminate Low-Cost AMD Therapy Access
核心洞察
FDA approval of bevacizumab-vikg could trigger a Drug Quality and Security Act provision, prohibiting the repackaging of bevacizumab for off-label ophthalmic uses.
A study at the AAO meeting found that prohibiting repackaging could eliminate a low-cost option for many patients, especially those with non-FDA-approved indications like sickle-cell retinopathy (搜索).
The analysis estimates that this prohibition could increase Medicare costs by $457 million annually and patient costs by over $100 million.
A potential FDA approval of a bevacizumab biosimilar for ophthalmic use could eliminate a lower-cost treatment option for various off-label indications, potentially adding hundreds of millions of dollars in healthcare costs, according to a study presented at the American Academy of Ophthalmology (AAO) meeting.
Bevacizumab-vikg is currently under FDA review for ophthalmic use. Approval would invoke the Drug Quality and Security Act (DQSA), which prohibits the repackaging of the oncologic formulation of bevacizumab (Avastin) for off-label applications. This change would affect numerous patients who rely on the lower-cost, repackaged bevacizumab for conditions lacking FDA-approved alternatives.
Ravi Parikh, MD, of NYU Grossman School of Medicine, and colleagues estimate that prohibiting bevacizumab repackaging would increase Medicare costs by approximately $457 million annually and patient costs by over $100 million. "You need a low-cost option for a lot of these non-FDA-approved indications," Parikh told MedPage Today. He noted the impracticality of securing FDA approval for each specific indication, such as sickle-cell retinopathy (搜索) and radiation retinopathy.
Current Bevacizumab Use
Repackaged bevacizumab has been a cost-effective off-label treatment for neovascular age-related macular degeneration (nAMD), retinal vein occlusion (搜索) (RVO), diabetic macular edema (搜索) (DME), and other ophthalmic conditions for over a decade. The standard 4 mL vials of bevacizumab, originally intended for cancer treatment, are repackaged into 0.05 mL doses for intravitreal administration, significantly reducing costs compared to other anti-VEGF therapies.
Study Details and Findings
Parikh's team analyzed the potential impact of a bevacizumab biosimilar approval on anti-VEGF treatment for non-FDA-approved ophthalmic indications using data from the AAO IRIS Registry from 2016 to 2021. They identified patients receiving anti-VEGF injections for both FDA-approved and off-label uses, excluding diagnoses covered by existing FDA approvals (nAMD, diabetic retinopathy, RVO, DME, and myopic choroidal neovascular membranes).
The study encompassed 1,987,906 patients and 2,661,610 eyes treated with anti-VEGF injections. Non-approved indications accounted for 429,140 (21.6%) of patients and 511,223 (19.2%) of eyes. Repackaged bevacizumab constituted approximately half of all anti-VEGF injections.
The analysis revealed that 279,513 (65.13%) patients and 327,064 (63.98%) eyes received off-label bevacizumab injections that would be prohibited upon biosimilar approval. These figures represent 19.9% of all bevacizumab injections during the study period and 65.1% of eyes with conditions excluded by the DQSA. Retinal neovascularization was the most common excluded diagnosis, affecting 38,473 eyes (11.8%).
Cost Analysis
The researchers conducted a cost analysis, estimating $500 per injection of a bevacizumab biosimilar and using Medicare cost allowances for existing 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 projected an estimated $457 million increase in Medicare costs and $117 million in patient costs annually if a bevacizumab biosimilar is approved for ophthalmic use.
Implications and Possible Solutions
Parikh noted that even with biosimilars, prices are unlikely to fall below the current cost of repackaged bevacizumab, which is less than 10% of the prices of available ranibizumab biosimilars. He suggested that the FDA could create an exception to the DQSA to allow continued repackaging of bevacizumab for ophthalmic use.