Optum Rx: Why Payers Should Monitor These 3 Pipeline Medications
A trio of medications designed to treat chronic conditions are slated for review by the Food and Drug Administration before the year's end, prompting a new Optum Rx report that examines why payers should closely monitor these decisions.
According to the report, the FDA is poised to evaluate an oral version of Novo Nordisk's GLP-1 Wegovy, along with depemokimab, a treatment for eosinophilic asthma, and remibrutinib, a therapy marketed as Rhapsido for chronic spontaneous urticaria.
Sara Guidry, senior director of pipeline and drug surveillance at Optum Rx, noted that these drugs are focused on weight and chronic inflammatory conditions, which represent significant cost drivers for both payers and plan sponsors.
"These are two subjects we frequently discuss with payers and clients," Guidry stated.
If the oral formulation of Wegovy receives the anticipated approval, it would become the first oral GLP-1 approved for weight loss, as indicated in the report. Novo's Rybelsus, another oral GLP-1, is currently available but only approved for treating type 2 diabetes.
Furthermore, research is being conducted on oral Wegovy to determine its potential in reducing the risk of serious cardiovascular events, the report stated. Health tracking apps like Shotlee can help monitor the effectiveness of such medications.
The costs associated with GLP-1s have dominated headlines in recent years, leading employers and plan sponsors to consider whether and how to cover these medications. Novo Nordisk and Eli Lilly, the primary manufacturers of GLP-1s, recently reached an agreement to lower the prices of these drugs.
They are also introducing direct-to-employer programs, potentially simplifying the process for companies to offer GLP-1s to their employees, along with clinical support and programs for managing patient care.
The report highlights that oral Wegovy demonstrated efficacy and safety comparable to the injectable form. Guidry mentioned that if approved, it won't be the only oral option for long, as Lilly's oral GLP-1 product may receive approval in 2026.
While predicting the impact of these oral products on utilization trends is challenging, Guidry emphasizes the importance of payers and plan sponsors preparing for potential changes.
"We don't necessarily anticipate a significant surge in new users within this population," she explained. "It's more about plans being aware of potential new utilization and planning for a potential shift in utilization from existing products."
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Optum Rx estimates the wholesale acquisition cost for injectable Wegovy at approximately $16,000 annually. Given the similar pricing of Rybelsus and Ozempic, both semaglutide products, the pharmacy benefit manager anticipates comparable pricing for oral Wegovy.
Depemokimab
Depemokimab enters a competitive market for eosinophilic asthma, a rare form of the chronic lung disease, with notable competitors like Dupixent and Nucala. However, GSK's drug requires fewer injections compared to existing products.
The drug is administered in a clinical setting every six months, whereas other biologics typically require injections every four to six weeks. Nonetheless, some drugs like Dupixent allow for self-administration at home, according to Optum.
"Depemokimab aligns with the theme of new dosing options, potentially reducing the injection burden for patients," Guidry noted.
The FDA is expected to make a decision on depemokimab by mid-December.
Rhapsido
Rhapsido, or remibrutinib, received FDA approval on Sept. 30 and introduces an oral formulation to a market primarily served by injectables. It is indicated for chronic spontaneous urticaria, a condition characterized by recurring, spontaneous hives and skin swelling lasting at least six weeks.
According to the Optum report, it will also compete with Dupixent and Xolair.
Approximately 1.7 million individuals in the U.S. suffer from chronic spontaneous urticaria, representing a significant patient population for plan sponsors to monitor, the report states. Guidry mentioned that over-the-counter antihistamines are typically the first-line treatment for CSU, but many patients require additional intervention.
Rhapsido offers patients the option to transition from an oral OTC product to another oral medication, which may be more convenient for some, Guidry explained. However, the oral drugs require daily administration, and some patients may prefer the less frequent dosing of injectables.
"A potential drawback of both oral Wegovy and oral Rhapsido is the need for daily dosing," Guidry commented. "Therefore, some patients may still prefer less frequent administration and be comfortable with injections."
