Prerakkumar Parikh, PharmD, and Sneha Sharma, PharmD, from Magellan Rx Management, tackle some of the biggest concerns ophthalmologists have regarding emerging biosimilars for ophthalmic conditions, including interchangeability as well as lack of real-world evidence and education.
Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, and Sneha Sharma, PharmD, director of specialty clinical solutions at Magellan Rx Management discuss some of the major topics of concerns surrounding the use of ophthalmology biosimilars.
So far, there are 2 ophthalmology biosimilars on the US market, both of which are ranibizumab products and vascular endothelial growth factor inhibitors (anti-VEGF). Biosimilars for ophthalic indications are new globally and the biggest challenge facing this sector of the industry is how to get patients and providers to trust that biosimilars are as safe and effective as their originators.
This interview is part 3 of a multimedia series on ophthalmology biosimiars in the United States expanding on the discussion from our LinkedIn Live event “In Sight: The Future of Biosimilars in Ophthalmology Care.” Click here to part 1, a written Q&A Kyung-Ah Kim, executive vice president of Samsung Bioepis. Click here for part 2, a podcast episode of Not So Different featuring Sarah Yim, MD, director of the FDA’s Office of Therapeutic and Biologics and Biosimilars.
How have payers responded to the influx of ophthalmology biosimilars so far and are they preferring interchangeable biosimilars?
Sharma: The ophthalmology biosimilars came onto the market late last year. So the influx has been dependent on a few factors [and] we haven't seen much uptake yet. Avastin [reference bevacizumab] is the most cost-effective product in this category. So there's still some uncertainty as to how the biosimilars will be preferenced in this category.
Some experts are concerned about anti-VEGF biosimilars having an interchangeability designation because the label does not impact biosimilars dispensed through the medical benefit, potentially causing confusion over what the label means. How do payers view interchangeability generally and how will these views shape the biosimilars space?
Parikh: Yeah, I feel the interchangeability designation certainly allows for better access to biosimilars. Especially with the automatic substitution piece, I feel that the payers are thinking ahead of the game in thinking these might be easier to preference, because they have that automatic substitution piece, especially in the pharmacy benefit, where they won't really need a new prescription to substitute an interchangeable biosimilar for a reference product. So definitely has some impacts there.
For the medical benefit, I feel like the impacts are still unknown because Cimerli [reference ranibizumab] just came out as the first medical benefit interchangeable biosimilar. All the other ones were on the pharmacy side. So the impacts for medical benefit are unknown, but I feel like this will only create more flexibility and confidence in the provider community to prescribe biosimilars for this category.
So far, ophthalmologists are very concerned about the safety of ophthalmology biosimilars, particularly because all the FDA-approved ophthalmology biosimilars so far are administered via an injection in the eye. How might payer preferences for ophthalmology biosimilars impact physician confidence in these products?
Sharma: Sure, it's a valid concern—you are injecting a drug into the eye. But the reference product for these ophthalmology biosimilars has little to minimal interocular inflammation or adverse events. So, a biosimilar should behave similar to their reference product. As we've seen in other categories where biosimilars have been introduced, they've been used safely and efficaciously. And our clients, payers, health plans, [almost] everyone is pretty much familiar with step therapy, so providers should be familiar with that if preferencing does occur for the biosimilars.
The FDA has said that it granted Cimerli, a ranibizumab biosimilar, interchangeability without a switching study data because the company asked for it and because the administration route did not require additional testing. How do you think this decision will impact the overall view of interchangeability designations and the safety of ranibizumab biosimilars?
Parikh: Right, you're correct. The second ranibizumab biosimilar, which is Cimerli, did get an interchangeable designation without a switching study. Now, when we look at the data, [the manufacturer] did supply strong clinical data and robust analytical data, which led the FDA to believe that there is no risk in switching between the biosimilar and the reference product. And that is why they granted this approval. So, in my opinion—having that approval in place [without] having like the switching study—if there is strong data as compared to switching study and as long as there is no risk for FDA, that approval is okay and should not really create any confusion in terms of interchangeability.
How do you think the Inflation Reduction Act [IRA] will impact the accessibility and affordability of biosimilars?
Parikh: The IRA is still very, very new and all of us in the managed care community are trying to find out what is going to be the impact with biosimilars. So one thing that comes to mind is that some of the select biosimilars are going to have a little bit of extra payment from Medicare, and that is going to be temporary for 5 years, but still it is an incentive. So, I feel like that particular thing will certainly boost the biosimilar prescribing and make biosimilars more flexible since Medicare is going to be raising a little bit of payment rates on them.
Usually, when the United States is introduced to biosimilars in a new disease state, it can look to the European Union’s real-world evidence to boost physician and patient confidence. However, the ophthalmology biosimilar space is very new globally. How do you respond to ophthalmologists, payers, and patients when they express concerns over the lack of real-world data?
Sharma: As with anything, education and experience are the best teachers and there is lack of real-world data. But at the same time, as I mentioned, we've seen biosimilars be used safely and efficaciously in other disease states. And we do have safeguards in the US. If there are adverse events that need to be reported, the FDA does intervene. But we should expect the biosimilars to behave similarly and the studies that have been conducted are also a standard in the US, so we shouldn't see any issues.
What actions can clinics take to better advocate for ophthalmology biosimilars and instill greater confidence in the safety of these products?
Sharma: Sure, so clinics can educate the patients and the staff on what studies have been conducted, how biosimilars have been safely used in other disease states, intervene with pharmacist Lunch and Learn education. Again, education is key. And you can arm yourself by being comfortable with using the products, similar to how Avastin came about in this market [and] other drugs. We [originally] weren't sure how they would behave post market. So there is a lot of opportunity to just educate the patient.