2025 Formulary Changes: Optum Rx

The following is an analysis of the Optum Rx 2025 formulary changes for the Premium Formulary (PF), effective January 1, 2025. PSG’s clinical team evaluated the changes, including an impact analysis based on our book of business dataset, to provide an overview of the most important considerations. Twelve drugs will be excluded, and 9 drugs will have tier changes on the PF, with 3 drugs moving to a higher tier and 6 drugs to a lower tier. Seven specialty drugs will be impacted by the exclusions, the majority of which are related to the Humira biosimilar strategy update. Optum also announced updates to formulary coverage and utilization management of Wegovy, a weight loss GLP-1 receptor agonist. 

Notable Observations 

• The quantity and impact of Optum’s 2025 formulary exclusions are less than what was observed in past years.
• Optum plans to leverage the interchangeability of biosimilars for both Humira and Stelara to potentially help drive utilization to the lower-cost biosimilars.
• Optum will add Wegovy to the PF, requiring plans to cover the drug for cardiovascular risk reduction in a select population, which will most likely increase plan spend.

Velphoro Chewable Tablets

Optum will exclude Velphoro (sucroferric oxyhydroxide) from the PF effective 1/1/25 and prefer a lower-cost generic, lanthanum carbonate. These drugs are phosphate binders and are used to control phosphorus levels in people with chronic kidney disease. Both Velphoro and lanthanum carbonate are available as chewable tablets, administered three times daily with meals and dosed based on phosphorus levels.  While these drugs are similar, preference for the taste of the chewable tablet and the overall pill burden, or the number of tablets chewed per dose, may cause some disruption among members.

Emflaza Tablet and Suspension

Emflaza (deflazacort) is a corticosteroid approved for the treatment of a specific type of muscular dystrophy – Duchenne muscular dystrophy (DMD), a rare condition estimated to affect 2 in 10,000 people in the U.S., most under the age of 20. Optum will exclude Emflaza from the PF and prefer prednisone, another corticosteroid. Although prednisone is not FDA-approved for this indication, there is support for its use in managing patients with DMD.  Variability in patient’s response to therapy and side effects may cause some member disruption, albeit small, due to lower utilization of this drug.

Alzheimer’s Disease – Kisunla

Kisunla (donanemab) was approved for the treatment of early symptomatic Alzheimer’s disease. Consistent with Optum’s prior formulary decision for other Alzheimer’s drugs (i.e. Leqembi), Kisunla will be excluded from coverage. The use of these drugs to treat Alzheimer’s disease has sparked controversy due to the uncertainty surrounding long-term treatment benefits, potential side effects, and high monitoring burden. To date, the market uptake of these drugs has been slow; however, with more competition, the utilization may begin to accelerate. Since Kisunla is physician-administered and may be covered under the medical benefit, patients may seek coverage through this benefit channel.

Biosimilar Strategy Update – Humira and Stelara

The first Humira biosimilar was launched almost 2 years ago, and although several biosimilars were added to the PF soon after the launch, the uptake was low. Humira remained preferred and continued to be the market leader. As the biosimilar market matured, Optum, like many PBMs, is reevaluating and updating its strategies. Effective 1/1/2025, Optum will consolidate the preferred Humira biosimilars on the PF into one product. Amjevita, including the Nuvaila white-label product and the Amgen biosimilar, will be the preferred biosimilars. Members currently on Humira can continue therapy until Amjevita receives its interchangeable designation, which Optum expects to occur in early 2025. At that time, the market share of Amjevita should increase as pharmacists will be able to switch Humira to the biosimilar without requiring a new prescription. Optum’s decision to prefer two different versions of the same biosimilar could pose a risk if there is a market shortage of the product.

Biosimilars to Stelara, another biologic to treat inflammatory conditions, are expected to launch in January 2025. Upon market launch, Optum will add Wezlana (white-labeled version from Nuvaila), an interchangeable biosimilar, to the PF. Like Stelara, Wezlana will be available in both intravenous and subcutaneous formulations. Although Stelara will remain on the formulary, the interchangeability status of Wezlana could make it easier to shift from the brand to the biosimilar driving cost savings. Members will also benefit as Optum will offer the biosimilar at a zero-dollar copay.

Wegovy  – GLP-1 Agonists

On March 8, 2024, the FDA approved a new indication for Wegovy to reduce the risk of major cardiovascular events in people with obesity or overweight and established cardiovascular disease. As a result, Optum will add Wegovy to the PF requiring plans that do not cover the drug for weight loss to cover the GLP-1 agonist for this indication. Identifying the reason for a Wegovy prescription at the pharmacy can be challenging since diagnoses are not required or included on prescriptions. Therefore, patients will need to disclose their reason for use. If the prescription is for CV risk reduction, it will proceed to the PA process; if it is for weight loss, it will be denied. To date, other PBMs have not taken this approach and have maintained coverage of Wegovy for weight loss only, as there are other FDA-approved drugs for cardiovascular risk reduction. Despite a prior authorization being used to help manage utilization, plans can still expect an increase in costs. Clients have the option of selecting from two different PA criteria – a stricter version that aligns with the population in the clinical trial and another version based on the current labeled indication. Optum estimated that up to 10% of obese and overweight members will seek treatment for this new indication; however, the popularity of these weight loss drugs may lead to an even higher percentage.

Specialty Drug Reclassification

Effective January 1, 2025, Optum will reclassify three specialty drug classes to non-specialty status. The non-specialty designation will help members gain better access to retail and mail pharmacies, allow for 90-day supplies, and potentially reduce their cost-sharing. Clients may also benefit from improved plan discounts as drugs move from a specialty classification to retail or home delivery discounts. Any utilization management will continue to apply to the drugs despite this change.

Optum will also reclassify two other drug classes from non-specialty to specialty status, requiring dispensing from specialty pharmacies.

Filsuvez is a topical gel used to treat wounds associated with two types of epidermolysis bullosa, a rare debilitating inherited skin disorder that causes fragile skin. Filsuvez is the only FDA-approved drug for this condition and helps wounds heal. Given the drug’s attributes, including its high cost, specialty classification is appropriate.

The specialty classification of Leukeran, a lower-utilized oral cancer drug, is consistent with the classification of other similar drugs.

Drug Classes Moving from Specialty to Non-Specialty

Drug Classes Moving from Non-Specialty to Specialty

Unlike in previous years, the member and financial impact of Optum’s formulary exclusions on January 1, 2025, will be minimal. Only twelve drugs with limited utilization are being excluded. Updates to Optum’s biosimilar strategy, which will prefer interchangeable biosimilars, are expected to provide some cost savings for plans. However, other formulary changes, such as the addition of Wegovy for cardiovascular risk reduction, will likely lead to increased spending.

Need help navigating 2025 formulary changes? PSG has the unbiased clinical and market expertise you need. Contact us today to learn more.