The approval of an ophthalmic bevacizumab biosimilar might mean the end of low-cost, repackaged Avastin as an anti-VEGF treatment for retinal diseases, with the unintended consequence of adding $457 million to Medicare B spending.
The approval of an ophthalmic bevacizumab biosimilar might mean the end of low-cost, repackaged Avastin as an anti-VEGF treatment for retinal diseases, with the unintended consequence of adding $457 million to Medicare B spending, says Ravi Parikh, M.D., M.P.H., a retinal specialist in New York.
Biosimilars are supposed to act as a counterweight to the high prices of the biologics.
But if a biosimilar to ophthalmic bevacizumab is approved, the effect may be just opposite, according to Ravi Parikh, M.D., M.P.H.
Parikh, a retina specialist in New York and director of healthcare delivery research for the Department of Ophthalmology at NYU Grossman School of Medicine, spoke about this apparent paradox today at the American Society of Retina Specialists (ASRS) annual scientific meeting in Seattle.
If the ophthalmic bevacizumab biosimilar is approved and then priced at $500 per 1.25 mg dose, Parikh and his colleagues have calculated that costs to Medicare B would increase by $457 million, from $3.01 billion to $3.47 billion, and that cost burden on patient would increase by $117 million, from $768 million to $884 million,
In an interview with Managed Healthcare Executive that was recorded before the ASRS meeting, Parikh explained that the 2013 Drug Quality and Security Act prohibits compounding an approved drug. As a result, were Outlook Therapeutics’ Lytenava (bevacizumab-vikg) to be approved and put on the market, then that prohibition would presumably apply to the Avastin (bevacizumab) that is being repackaged from larger doses for cancer treatment into smaller doses for the eye.
“Our research hopes to highlight the need for an exemption (to the Drug Quality and Security Act) so patients don’t lose access to a low-cost option,” he said. Parikh said he couldn’t speak for ASRS but he knows many members who are concerned about low-cost, repackaged Avastin no longer being available as an unintended consequence of the biosimilar approval.
Parikh said that even in the unlikely event all the patients treated with Lucentis (ranibizumab) and Eylea (aflibercept) were switched to less expensive biosimilars, that would offset only 30% of the cost increases associated with the cost hike from low-cost, repackaged Avastin no longer being available.
It Flopped on Primary Endpoint, But Succeeded on Visual Acuity | ASRS 2023
July 31st 2023AXNOO7, an investigational agent for geographic atrophy, did not affect geographic atrophy lesions but showed positive effects of tests of visual acuity. A novel, neuroprotective mechanism of action may be why.
Read More
Endophthalmitis After Anti-VEGF Injections: A Rare But Real Risk | ASRS 2023
July 30th 2023Researchers used the American Academy of Ophthalmology's IRIS database to quantify the risk of endophthalmitis — inflammation of intraocular fluids — after injections with anti-VEGF drugs. They found that post-injection endophthalmitis occurs, on average, once every 3,500 injections.
Read More
Eylea Biosimilar Produces Favorable Results in a Switching Study | ASRS 2023
July 30th 2023Samsung Bioepsis' SB15 was comparable to Eylea (aflibercept) in a 56-week randomized clinical trial that included a rerandomization at 32 weeks. The rerandomization resulted in 111 study volunteers switching from Eylea to the biosimilar for the last part of the study.
Read More
The Long and Short (Interval Switch) of the PULSAR Trial | ASRS 2023
July 29th 2023About 20% of patients in the trial of a high-dose, longer-interval regimen of Eylea (aflibercept )switched to shorter intervals, according to data presented today at the American Society of Retinal Specialists annual scientific meeting, which is being held in Seattle. Researchers didn't find any clues as to why in their baseline characteristics.
Read More
Geographic Atrophy Presents Significant Burden to Patients and Caregivers | ASRS 2023
July 29th 2023Patients with geographic atrophy and their caregivers would benefit from support and accommodations related to managing daily life activities and social activities, as well as their mental health, Sophie J. Bakri, M.D., said during her presentation
Read More