As we enter 2026, the pharmacy benefits landscape continues its rapid transformation. Building on the momentum from 2025, Q4 brought pivotal developments in GLP-1 therapies, continued PBM scrutiny, biosimilar expansions and persistent issues with pharmacy access. These shifts underscore the need for employers and consultants to prioritize agility, transparency and member-centric strategies. From regulatory actions to market innovations, here’s a recap of key events from late 2025 and their implications for the year ahead.
GLP-1 Medications: Oral Advances and Expanded Access
GLP-1s remained a focal point in Q4 2025, with breakthroughs in oral delivery methods and indications driving utilization and cost discussions. The introduction of non injectable options, alongside resolved supply constraints, signaled a shift toward broader and more sustained access.
Breakthrough for Oral GLP-1 Receptor
The FDA approved the first oral GLP-1 receptor agonist, semaglutide (Wegovy pill), for chronic weight management in December 2025, providing a non-injectable option that could improve adherence and expand patient reach.
New Indications and Resolution
Semaglutide gained approval earlier in 2025 for slowing kidney disease progression in type 2 diabetes patients, while the FDA officially resolved the semaglutide injection shortage by phasing out compounded versions.
Pricing Comparison for DTC Options
DTC platforms have made GLP-1s more accessible, with competitive cash-pay pricing direct from manufacturers. Below is a summary of key options as of January 2026:
| Drug | Form | DTC Platform | Starting Price/Month | Notes |
| Oral Wegovy (semaglutide) | Pill (1.5 mg/4 mg) | NovoCare | $149 | 4 mg rises to $199 after April 15, 2026; higher doses (9 mg/25 mg) at $299. Eligible self-pay patients with valid prescription; limited-time offer. |
| Injectable Wegovy (semaglutide) | Injection (0.25 mg/0.5 mg) | NovoCare | $350 | List price ~$1,349; savings card reduces costs for self-pay to ~$350-$500 depending on dose and eligibility; offers vary. |
| Zepbound (tirzepatide) | Vial (2.5 mg) | NovoCare | $299 | 5 mg at $399; higher doses (7.5 mg-15 mg) at $449; for self-pay patients with valid prescription; vial format for flexibility. |
Looking Ahead
With oral options now available and next-gen therapies like CagriSema advancing in pipelines, expect broader indications (e.g., peripheral artery disease) and heightened focus on utilization management in 2026.
PBM Reform: Intensified Oversight and Legal Actions
Pharmacy benefit manager (PBM) scrutiny continued through 2025, with federal and state actions targeting transparency and pricing practices.
Regulatory investigations and legal challenges highlighted concerns around spread pricing, rebate structures and PBM market concentration, even as broader reform efforts advanced unevenly at the legislative level. Together, these dynamics kept PBM oversight and accountability at the forefront of pharmacy benefits discussions heading into 2026.
FTC Reports and Lawsuits
The FTC released its second interim report in January 2025, highlighting significant markups by PBMs on specialty generics for cancer and HIV, and filed lawsuits against major PBMs, including Caremark, Express Scripts and OptumRx, for anticompetitive behavior. There was one filed in 2024 about insulin, but that is paused indefinitely due to the change in administration and a complete turnover of the FTC. Nothing advanced in 2025 that I could find. PBMs’ motions to dismiss FTC cases were ongoing by Q4, emphasizing debates over fiduciary roles and rebate structures.
Legislative Progress
Bills like the PBM Reform Act of 2025 advanced, banning spread pricing and mandating rebate disclosures (though it did not pass and remains in committee), while states implemented pass-through pricing models effective July 2025.
Biosimilars and Generics: Accelerated Adoption and Competition
Biosimilars saw robust growth in 2025, with Q4 launches intensifying competition and savings across several high cost therapeutic categories. New options for drugs like Stelara and Humira began to influence PBM formulary decisions and payer steering strategies. These early shifts set the stage for how biosimilars were positioned, preferred or excluded across plans.
- Stelara Biosimilars: Eight Stelara biosimilars launched starting January 2025, including Wezlana and Selarsdi, creating U.S. competition for the first time and driving down costs.
- Humira Updates: While 10+ Humira biosimilars were available, major PBMs excluded many from 2025 formularies, favoring preferred options like Cyltezo.
- Insulin and Others: New insulin biosimilars expanded options, alongside generics for drugs like Victoza.
2026 Outlook
More interchangeable biosimilars for Humira and Stelara are expected, with patent expirations for Trulicity on the horizon. As competition increases, PBMs and plan sponsors face more choice in how these products are positioned on formularies. Continued focus on member education will be necessary to maximize adoption and savings.
Pharmacy Deserts and Access Challenges
The wave of pharmacy closures in 2025 deepened the crisis of pharmacy deserts, where residents face significant barriers to obtaining medications. Nearly 50 million Americans – about 1 in 7 – now reside in these areas, with disproportionate effects on low-income, rural and urban underserved populations.
- Extent of Closures: Over 29% of pharmacies shuttered nationwide, driven by corporate restructuring, slim margin and slim consumer behaviors.
- Health Consequences: Limited access contributes to poorer management of chronic illnesses, heightened disparities and avoidable health complications.
- Mitigation Efforts: Plan sponsors are adopting alternatives like enhanced mail-order services, virtual pharmacy consultations and integrated wellness initiatives; meanwhile, states such as Massachusetts are using mapping tools to guide targeted interventions.
Next Steps
Bills like the PBM Reform Act of 2025 advanced, banning spread pricing. Employing data analytics tied to employee demographics can help identify high-risk areas and provide customized benefits. This includes incentives for digital and mail-based pharmacy solutions to help reduce access gaps. Together, these approaches support more equitable healthcare delivery while maintaining care.
Trade Policy and Drug Pricing
Tariffs and trade tensions in 2025 disrupted supply chains, raising concerns for 2026. Proposed and enacted trade actions heightened uncertainty around the availability and cost of generic drugs and active pharmaceutical ingredients, many of which rely on global manufacturing networks. In response, manufacturers and policymakers began reassessing sourcing strategies and domestic production capacity to reduce future volatility.
- Tariff Impacts: Proposed tariffs under the Trump administration increased drug costs and deepened shortages for generics, prompting reshoring efforts.
- Supply Chain Shifts: Pharma invested in domestic manufacturing to mitigate volatility, though costs rose moderately.
Monitoring Ahead
Employers should closely monitor ongoing trade and policy changes that could affect drug pricing and supply reliability. Planning ahead for disruption may include identifying high-risk generics and expanding mail-order or alternative pharmacy options.
Digital Health and Direct-to-Consumer Pharmacy
DTC models expanded rapidly in 2025, blending telehealth and pharmacy. While these platforms can improve convenience and reach, particularly for GLP-1s, they also introduce new challenges.
- Key Platforms: LillyDirect (launched 2024) and PfizerForAll grew, offering telehealth, prescriptions and education for GLP-1s and beyond.
- Challenges and Benefits: These platforms enhance access but complicate utilization management and integration with traditional benefits.
Plan Design Consideration
As DTC models continue to evolve the conversation often centers on how these options fit within existing benefits and how access and prescribing are managed. Consultants can help guide plan designs to incorporate DTC safely by ensuring alignment with safety protocols and cost controls.
Looking Ahead to the Rest of 2026
Q1 2026 sets the stage for continued evolution in pharmacy benefits, balancing innovation with affordability. Key trends emerging at the end of 2025 are likely to influence strategy moving forward. Expect:
- FDA Approvals: Surge in specialty drugs and gene therapies, with 55+ approvals in 2025 paving the way; watch for decisions on new therapies in Q1 2026.
- PBM Shifts: Greater disaggregation of PBM services, transparency mandates and cost trends rising 4-7%.
- Market Disruptors: DTC expansion and biosimilar competition are reshaping access.
- Medicare Drug Price Negotiations: Implementation of negotiated maximum fair prices under the Inflation Reduction Act for the first selected drugs, potentially lowering costs for Medicare beneficiaries and influencing broader payer strategies.
Final Thoughts
Late 2025 reinforced the need for proactive strategies in pharmacy benefits. The path forward will depend on continuing to advocate for transparent, equitable models that deliver value. Collaboration and insight will be key to navigating 2026’s challenges and opportunities.
Sources
- FDA. “Novel Drug Approvals for 2025,” FDA, 2025.
- FTC. “Second Interim Staff Report on Prescription Drug Middlemen,” FTC, 2025.
- FTC. “Specialty Generic Drugs: A Growing Profit Center for Vertically Integrated Pharmacy Benefit Managers,” FTC, 2025.
- Eli Lilly. “LillyDirect Updates,” Eli Lilly, 2025.
- CMS. “Negotiated Prices for Initial Price Applicability Year 2026,” CMS, 2024.
- Novo Nordisk. “Wegovy Pill Launch and Pricing,” Novo Nordisk, 2026.