Jake Goll, PharmD (jake.goll@theprismhealthgroup.com) serves as the clinical consultant at Prism Health Group, where he provides end-to-end oversight of clinical strategy through in-depth data analysis, proactive consultation, and subject matter expertise. 

Wegovy vs Zepbound: Navigating New Study Results and Updated PBM Strategies

May marked an eventful month in the weight loss GLP-1 space, with new clinical data and diverging PBM strategies reshaping how these therapies may be accessed moving forward.

On May 11, The New England Journal of Medicine published results from SURMOUNT-5, the first head-to-head trial comparing Zepbound (tirzepatide) and Wegovy (semaglutide). Among 751 randomized participants, Zepbound demonstrated superior reductions in both body weight and waist circumference at week 72. Clinically speaking, Zepbound remains the more effective agent for weight management specifically, yet cost dynamics are driving divergent approaches among PBMs.

CVS Caremark

As part of its Q1 earnings release, CVS announced a formulary exclusion of Zepbound effective July 1, 2025 for weight loss indications. Wegovy will be the preferred GLP-1 for plans that cover anti-obesity medications.

Key details:

• The decision is tied to a new strategic partnership with Novo Nordisk, allowing CVS to offer Wegovy at what it describes as a “more affordable price” than Zepbound. Net pricing has not been publicly disclosed.
• This move triggered widespread patient and provider frustration, as Zepbound users will need to switch to Wegovy or discontinue therapy.
• From a clinical standpoint, the decision is controversial, Zepbound is the superior product for weight loss outcomes. However, access and affordability appear to be CVS’s driving priorities.
• Strategically, CVS may be betting on broader uptake of weight loss drugs if lower pricing on Wegovy leads more plans to adopt coverage.

Evernorth (Express Scripts)

Evernorth took a different approach, maintaining coverage of both Wegovy and Zepbound while introducing new financial models under its Encircle program:

Key details:

• Evernorth is offering up to 20% off current net prices, thanks to newly negotiated discounts with both Novo Nordisk and Eli Lilly. Exact net prices have not been disclosed by Evernorth.
• In addition, Encircle now offers a more affordable entry point as an option, which Evernorth states will provide a per unit price that competes with direct-to-consumer prices seen with LillyDirect ® and NovoCare ®. This new offering comes with some trade-offs: These groups must accept less robust utilization management (UM) than the standard Encircle program. In other words, new adopters can’t require lifestyle coaching, engagement metrics, or enhanced UM if they want the deepest discounts. Plans must pay the Encircle PMPM program fee.
• Member costs are capped at $200/month, creating predictability for patients while reducing plan liability.

As demand grows and plan sponsors weigh whether to cover these products, understanding the financial trade-offs, member experience implications, and clinical distinctions between agents is more important than ever. Prism remains available to support clients in evaluating coverage, disruption management, and cost modeling.

FDA Issues New Warning on Cetirizine and Levocetirizine: Post-Discontinuation Itching Identified

On May 16, the FDA announced that cetirizine and levocetirizine (marketed under brand names such as Zyrtec and Xyzal) will carry a new warning regarding a rare but serious side effect: severe itching (pruritus) after stopping the medication.

Key details:

• From April 2017 to July 2023, 209 cases of severe itching were reported to the FDA’s Adverse Event Reporting System following discontinuation of cetirizine or levocetirizine. Many cases involved long-term use, though some occurred after just weeks of treatment.
• Itching typically began within a few days of stopping the medication and was often severe enough to prompt restarting therapy.
• While there are currently no FDA-approved treatments for this type of post-discontinuation itching, symptoms often resolved after restarting the medication or tapering off slowly.

Clinical Implications:

• Prescribers and pharmacists should counsel patients on this potential reaction, particularly those using these antihistamines daily and long-term, or those using OTC versions without clinical oversight.
• Patients should be advised to report severe itching after stopping these medications and to consult a healthcare provider before discontinuing long-term use.

This update underscores the need for proactive patient education, even with medications often perceived as benign, and reminds clinicians to reassess chronic antihistamine use where appropriate.

HHS Clarifies Scope of Most-Favored-Nation Drug Pricing Executive Order

Earlier this month, Prism shared an initial analysis of the Trump administration’s Executive Order titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” issued on May 12th. While the EO signaled a bold stance on drug pricing reform, the original release lacked clarity on key implementation details. While some additional details have emerged, there is still a lot of uncertainty as to how these proposed changes will play out.

On May 20th, HHS issued an update that offers further insight. Three key clarifications were provided:

• MFN pricing will apply only to single-source brand medications, meaning those without generic or biosimilar competition.
• MFN prices will be benchmarked against the lowest price available in any OECD (Organization for Economic Cooperation and Development) country with a GDP per capita of at least 60% of the U.S. GDP per capita. A specific list of affected drugs and prices has not yet been released.
• Notably, the pricing policy is not limited to Medicare or Medicaid. HHS stated that manufacturers would be expected to offer these lower prices “across all markets,” which strongly suggests that commercial plans may also be impacted.

As further guidance emerges, Prism will continue to monitor developments and keep clients informed of how this policy may affect future contracting, formulary design, and pricing strategies across both public and private payers.

Novavax’s Nuvaxovid Receives Limited Approval Amid New FDA Guidance on COVID Vaccines

Last week, the FDA granted limited approval for Novavax’s latest COVID-19 vaccine (Nuvaxovid). The approval is restricted to:

• Adults aged 65 and older, and
• Individuals aged 12 to 64 with at least one underlying medical condition that places them at high risk for severe illness if infected with COVID-19.

As of now, PBM coverage decisions remain unclear given the narrower approval parameters. Plan sponsors should monitor how payers classify this product under preventive or medical benefit policies.

This development comes as the FDA released updated guidance on COVID vaccine approval, published May 20th in the New England Journal of Medicine. Key changes include:

• For High-Risk Populations (65+ or 6 months+ with CDC-defined risk factors): The FDA will permit approval based on immunogenicity data alone, meaning antibody response will be sufficient without requiring clinical outcome data.
• For Healthy Individuals (6 months to 64 years, no risk factors): Future vaccine approvals will require randomized controlled trial (RCT) data demonstrating clinical outcomes (e.g., reduced symptomatic COVID) prior to receiving Biologics License Application (BLA) approval.
• Post marketing Requirements: When approvals are granted based on immunogenicity in high-risk groups, the FDA will strongly encourage post-approval RCTs.

The study argues that U.S. currently has the most aggressive vaccination policy compared to select countries in Europe as well as Canada and Australia. Currently, the United States recommends a one-size-fits all regulatory framework and has granted broad marketing authorization all Americans over the age of 6 months.

As regulatory expectations evolve, Prism will continue to monitor vaccine development pathways and payer policy shifts to guide clients in planning around product access and coverage.