By Beckie Fenrick, PharmD, MBA and Jason Peterson, RPh
The FDA’s Q3 2025 approvals mark a pivotal quarter, with new therapies for HIV prevention, liver disease, RSV, and chronic hand eczema—plus the first at-home flu vaccine and generics entering at steep discounts. These updates are already influencing benefit design, formulary strategy, and pharmacy budgets. Here’s what plan sponsors need to know to stay ahead.
Wegovy (semaglutide): Newly Approved for MASH Treatment
The FDA approved Wegovy to treat adults with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (F2–F3). Originally launched for weight loss, Wegovy’s new approval could open access to MASH patients regardless of BMI. Access will vary by PBM and their specific prior auth criteria. The 2025 American Diabetes Association (ADA) guidelines now support GLP-1 use in MASH, citing evidence that these agents reduce liver enzyme levels and excess fat.
Plan Sponsor Considerations:
- Utilization Management: Prior authorization with renewal criteria based on therapy response.
- Cost Impact: $1,349 WAC for 4 once-weekly doses.
- Clinical Considerations: Expanded indication increases the eligible population, with ADA guidelines supporting GLP-1 use in some patients with liver disease.
Yeztugo (lenacapavir): Long-Acting Injectable HIV PrEP
The long-acting injectable Yeztugo is now FDA-approved for pre-exposure prophylaxis (PrEP) in adults and adolescents at risk of HIV-1. Administered subcutaneously every six months, Yeztugo demonstrated greater effectiveness in preventing HIV than Truvada, a widely used oral PrEP. It is only the second FDA-approved injectable PrEP on the market and allows a ±2-week dosing window from the previous injection date.
Plan Sponsor Considerations:
- Utilization Management: Prior authorization and quantity limits recommended.
- Cost Impact: $28,218 annually (two injections); currently the most expensive PrEP therapy.
- Clinical Considerations: Six-month injections may improve adherence but require provider administration and documented HIV-negative status; high annual cost demands careful value assessment.
Enflonsia (clesrovimab): RSV Prevention in Infants
Enflonsia, a monoclonal antibody, is now approved to prevent lower respiratory tract illness caused by RSV in neonates and infants born during or shortly before RSV season whose mother’s did not receive the RSV vaccination during their pregnancy. RSV is a common cause of respiratory illness in the U.S., circulating in fall, winter, and spring, and is a leading cause of hospitalization among infants under one year.
Offering protection for about five months—the length of a typical RSV season—Enflonsia provides a simpler dosing option than competitor Beyfortus, requiring only a single injection regardless of weight. Unlike Enflonsia, Beyfortus is also approved for RSV prevention in high-risk toddlers during their second RSV season.
Plan Sponsor Considerations:
- Utilization Management: Align with ACIP guidance for infants under 8 months without maternal vaccination.
- Cost Impact: $556 WAC per injection, priced the same as Beyfortus.
- Clinical Considerations: Flat-dose injection simplifies use compared to Beyfortus, though limited to first RSV season for infants born just before or during the RSV season, and whose mother did not receive the RSV vaccine during the pregnancy. Enflonsia is not approved for high-risk toddlers.
Anzupgo (delgocitinib): First FDA-Approved Therapy for Chronic Hand Eczema
The FDA approved Anzupgo for adults with moderate to severe chronic hand eczema (CHE) who do not respond adequately to corticosteroids—the first therapy specifically approved specifically for CHE. CHE is a persistent, relapsing inflammatory disorder affecting roughly 4.7% of adults annually and up to 14.5% over a lifetime. Classified within the atopic dermatitis (AD) spectrum, CHE has been managed primarily with topical corticosteroids or calcineurin inhibitors. Use of corticosteroids is often limited by side effects such as skin atrophy, highlighting the need for new non-steroidal options.
Plan Sponsor Considerations:
- Utilization Management: Require prior authorization with documentation of corticosteroid and/or calcineurin inhibitor trial; renewals based on therapy response.
- Cost Impact: $1,986 WAC per 30-gram tube; costlier than alternatives such as Opzelura ($34.90 per gram)
- Clinical Considerations: First therapy specifically for chronic hand eczema; higher per-gram cost than other topical JAK inhibitors raises payer scrutiny.
Generic and Biosimilar Launches: Cost-Saving Opportunities
Q3 2025 included multiple generic and biosimilar launches, with some entering at steep discounts:
| Brand Name | Generic Name | Generic WAC | Discount to Brand WAC | Launch Date | Comments |
| Entresto (tablets) | sacubitril-valsartan | $1.37/tab | 88% | 7/23/2025 | Twelve generic competitors launched with 6 additional manufacturers expected to enter the market. |
| Dificid (tablet) | fidaxomicin | $224.86/tab | 14% | 7/15/2025 | Only 1 generic competitor launched with 1 additional manufacturer expected to enter the market. |
| Eprontia | topiramate | $1.32/ml | 19% | 7/7/2025 | Only 1 generic competitor and no additional manufacturers are expected to enter the market. |
| Xarelto (oral susp) | rivaroxaban | $2.44/ml | 37% | 7/2/2025 | Only 1 generic launched with 6 additional manufacturers expected to enter the market. |
| Fycompa (tablets) | perampanel | $35.34/tab | 14% | 5/29/2025 | Only 1 generic of each strength launched with 3 additional manufacturers expected to enter the market. |
| Complera | emtricitabine- rilpivirine- tenofovir disoproxil fumarate | $116.64/tab | 9% | 5/27/2025 | Only 1 generic competitor launched with 1 additional manufacturer expected to enter the market. |
| Saxenda | liraglutide injection | $1,166/15 ml | 14% | 8/28/2025 | Only 1 generic competitor launched with 5 additional manufacturers expected to enter the market. |
| Novolog | insulin aspart-xjhz | $69.57/10ml | 4% | 9/15/2025 | Biosimilar trade name is Kirsty |
| Arnuity Ellipta | fluticasone furoate | $135.52/unit | 35% | 7/21/2025 | By Prasco, Authorized Brand Alternative |
In addition, Tradjenta (a DPP-4 inhibitor) is anticipated to face generic competition starting in November 2025. Up to 13 manufacturers could introduce generics over the following year, with initial launches from up to 6 companies generating moderate savings. Significant price reductions are expected as more competitors enter the market.
FluMist Home: The First At-Home Flu Vaccine
FluMist Home introduces the first-ever self-administered flu vaccine. The prescription-only nasal spray is available for patients ages 2–49 and shipped through flu-mist.com in 34 states. Due to pharmacy laws, it is not available for home delivery in the following states: AL, AR, DE, HI, ID, LA, MD, MA, MI, MT, NV, NJ, NM, NY, ND, OH.
With commercial insurance, patients will pay a $8.99 processing fee plus any applicable copayment. The home delivery program is not available to uninsured patients or those with government-issued coverage such as Medicare or Medicaid. Patients ineligible for home delivery can still receive FluMist directly at a pharmacy or doctor’s office.
Plan Sponsor Considerations:
- Access: Innovative home delivery option could improve uptake, though some states prohibit this option.
- In addition to normal copayments for the vaccine, patients opting for home delivery will be charged an additional processing fee of $8.99.
Key Takeaways for Plan Sponsors
- Specialty drug approvals like Wegovy, Yeztugo, and Anzupgo will drive increased utilization and spend.
- Generics and biosimilars continue to expand savings opportunities across major therapeutic categories.
- Innovative access models, such as at-home vaccines, could change how members ireceive preventive care.
The Q3 2025 pipeline reflects both the promise of innovation and the pressure of rising costs. From generics entering at steep discounts to novel therapies with premium pricing, plan sponsors must balance access and affordability.
At Navion, we deliver precision pharmacy benefit navigation—tailored strategies that ensure clinical value while managing spend responsibly. Reach out today to prepare your plan for what’s next.
