On The Radar – 5th Edition
By
The FDA is cracking down on pharmaceutical advertising that downplays risks or omits boxed warnings. Companies cited include Novo Nordisk, Eli Lilly, and Hims, signaling a more proactive enforcement stance.
➡ Why it matters: With the U.S. one of only two countries allowing DTC drug ads, closer oversight could reshape how medications are marketed—and demanded—by patients.
Health insurance costs for state and local governments are projected to rise nearly 10% in 2026—the sharpest increase in 15+ years. GLP-1 drugs and potential pharma tariffs are major drivers, with unions limiting cost-sharing flexibility.
➡ Why it matters: Public sector plans are particularly exposed, but all employers must prepare for higher pharmacy-driven costs.
PBMs, once designed to reduce spend, are now criticized for “high price/high rebate” practices that inflate costs. Reform proposals include pass-through rebate models and direct-to-employer or direct-to-patient strategies.
➡ Why it matters: Transparent PBMs and alternative contracting models are gaining traction as employers demand better alignment.
Manufacturers are restricting use of contract pharmacies in the 340B program, citing duplicate discounts. States are fighting back with “pharmacy access” laws, leading to ongoing court battles and mixed rulings.
➡ Why it matters: 340B disputes could affect safety-net providers and patient access to discounted drugs.
PhRMA is pushing back against Medicare negotiation under the IRA, warning about impacts on small-molecule R&D. The group also calls for reform of the 340B program and tighter PBM regulation, while opposing federal and state price-setting.
➡ Why it matters: Expect pharma lobbying to intensify as industry braces for new pricing controls.
A new survey shows employees prioritize wellness, family support, and financial services over formal policies alone. Manager behavior and culture play a bigger role in retention than written benefits policies.
➡ Why it matters: Holistic support is becoming a competitive advantage in recruiting and retention.
Use of transparent PBMs more than doubled from 2024 to 2025, with employers reporting lower premiums and greater confidence when they had access to claims data.
➡ Why it matters: Employers are recognizing that transparency and data access drive both confidence and cost control..
Employers Turn to Preventive Drug Lists
PDLs reduce or eliminate out-of-pocket costs for drugs treating chronic conditions, improving adherence and lowering long-term spend.
➡ Why it matters: PDLs are a practical way for self-funded employers to drive both cost control and member health.
Specialty pharmacies provide high-touch support, improve adherence, and connect patients with financial assistance. Leaders in the field argue they play a central role in managing both outcomes and costs for complex conditions.
➡ Why it matters: Specialty pharmacy integration can reduce downstream costs like ER visits and hospitalizations.
The MFN model aims to align U.S. drug costs with the lowest global prices. Advocates argue it corrects extreme disparities; critics say only value-based pricing can sustainably balance cost and access.
➡ Why it matters: Employers should prepare for potential disruptions in pricing models that directly affect plan spend.
Premiums for employer-sponsored plans are expected to rise 6.5%, while ACA marketplace plans may see 18% increases. Specialty drugs and chronic condition prevalence remain key drivers.
➡ Why it matters: Escalating costs will pressure employers to adopt cost-containment strategies and explore innovative models.
Final Thoughts
From FDA enforcement to PBM reform and record-setting premium hikes, the cost of care is rising on all fronts. Employers and brokers who embrace transparency, alternative pharmacy strategies, and holistic employee support will be best positioned to navigate what’s ahead.
We’ll be back in two weeks with more news you need to know. If you’d like a custom analysis or want to explore SHARx program options for your clients, contact us!
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