Three drugs treating chronic conditions are set for Food and Drug Administration review by the end of the year, and a new report from Optum Rx digs into why payers should be watching these decisions.
According to the report, the FDA is set to review an oral formulation of Novo Nordisk's GLP-1 Wegovy as well as depemokimab, a drug that treats eosinophilic asthma, and remibrutinib, a therapy for chronic spontaneous urticaria under the brand name Rhapsido.
Sara Guidry, senior director of pipeline and drug surveillance at Optum Rx, told Fierce Healthcare in an interview that these drugs target weight and chronic inflammatory conditions, both segments that are significant cost drivers for payers and plan sponsors.
"They are two topics we are consistently discussing with payers and clients," Guidry said.
If the oral formulation of Wegovy secures the expected approval, it would be the first oral GLP-1 that is approved for weight loss, according to the report. Another oral GLP-1, Novo's Rybelsus, is on the market, but it has been approved only for the treatment of type 2 diabetes.
Oral Wegovy is also being studied for its potential to reduce the risk of serious cardiac health events, according to the report.
GLP-1s and their associated cost have been a major headline for the past several years, with employers and plan sponsors weighing whether, and how, to cover these products. Novo Nordisk and Eli Lilly, which manufacture the most prominent GLP-1s on the market, recently reached a deal with the Trump administration to reduce the price of these drugs.
In addition, they are rolling out direct-to-employer programs that may make it easier for these firms to offer GLP-1s to their workforces, paired with clinical supports and programs to assist in managing the member's care.
The report notes that oral Wegovy showed similar efficacy and safety to the injectable version of the drug. Guidry said that should the drug secure approval, it won't stay alone on the market for long, as Lilly's own oral GLP-1 product could be approved in 2026.
It's hard to predict whether these oral products will drive a significant shift in utilization trends, but Guidry notes that it's important for payers and plan sponsors to prepare for the potential.
"We don't necessarily expect that within this population that there's going to be a big surge in new utilizers," she said. "It's more about how plans should be aware that there is potential new utilization, but they should also plan for the potential shift in utilization from those existing products."
Optum Rx notes that the wholesale acquisition cost for injectable Wegovy is about $16,000 each year. Pricing is similar for Rybelsus and Ozempic, as well as semaglutide products, so the pharmacy benefit manager expects pricing to be in line with that figure for the oral Wegovy.
Depemokimab, meanwhile, enters a market for eosinophilic asthma, a rare subtype of the chronic lung disease, where there are several notable competitors, including Dupixent and Nucala. However, the drug, which is manufactured by GSK, requires fewer injections than the products currently on the market.
The drug is administered in clinic every six months, while other biologics typically require injections every four to six weeks. However, drugs like Dupixent can be self-administered at home, Optum said.
"That's where depemokimab goes back to that theme of the new dosing option, so it could reduce injection burden for patients," Guidry said.
An FDA decision on depemokimab is expected in mid-December.
Rhapsido, or remibrutinib, secured FDA approval on Sept. 30 and similarly brings an oral formulation to a segment dominated by injectables. It treats chronic spontaneous urticaria, a condition where the patient experiences repeated, spontaneous hives and swelling of the skin, with outbreaks lasting at least six weeks.
It will also compete with Dupixent as well as Xolair, according to the Optum report.
About 1.7 million people in the U.S. have chronic spontaneous urticaria, representing a fairly significant patient population for plan sponsors to monitor, the report said. Guidry said that over-the-counter antihistamines are generally the frontline treatment for patients with CSU, but many require additional intervention.
For patients, Rhapsido would allow them to move from an oral OTC product to another oral drug, which may be easier for some, Guidry said. However, the oral drugs must be taken daily, and other patients may prefer the lower frequency of injectables.
"The potential disadvantage for both the oral Wegovy and the oral Rhapsido is that you then do go to daily dosing," Guidry said. "So there could still be patients who prefer less frequent administration, and they're okay with an injection."