On The Radar – 8th Edition
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With over 1,250 PBM-related bills introduced nationwide this year, reform is accelerating faster than ever. Employers are urged to proactively review PBM contracts for rebate transparency, audit rights, and pass-through clarity before new state mandates take effect.
➡ Why it matters: Waiting for legislation could put employers at risk. Plans need to ensure their PBMs are compliant, flexible, and aligned with fiduciary standards now.
The FDA plans to cut biosimilar approval timelines in half, easing requirements like switching studies to speed market entry. Biosimilars already saved Americans $20 billion last year, and the new approach could double those savings by 2030.
➡ Why it matters: Faster biosimilar adoption means more competition and lower costs for employers managing specialty spend.
Employers are looking for strategies to manage rising costs from high-cost claimants and specialty drugs while keeping benefits robust. Many are reevaluating coverage for GLP-1s and investing in population health programs to prevent chronic conditions.
➡ Why it matters: Sustainable cost management depends on proactive care, not just coverage cuts.
As the Trump administration enforces its MFN pricing model, some drugmakers are cutting deals to lower prices and avoid tariffs. Analysts say the industry’s unified resistance is fracturing.
➡ Why it matters: If MFN pricing expands, employers, and Medicaid plans could see meaningful cost reductions across high-volume drugs.
States are passing laws to protect independent pharmacies and limit PBM control, but experts warn the patchwork regulations could raise costs and reduce patient access if not implemented carefully.
➡ Why it matters: Reforming PBMs is essential, but policy design must avoid creating new inefficiencies or cost barriers.
Nearly 70 state laws now target drug pricing transparency, PBM practices, and affordability. Drug Affordability Review Boards in states like Colorado and California are setting price caps and negotiating directly with manufacturers.
➡ Why it matters: State-level leadership on drug pricing is filling gaps in federal reform and could set new precedents for cost controls nationwide.
HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary unveiled reforms that remove expensive comparative studies and streamline interchangeability. These changes aim to align biosimilar pricing with global benchmarks under the MFN framework.
➡ Why it matters: Reducing regulatory friction will accelerate affordable alternatives and intensify pressure on high-cost biologics.
Critics say the DOJ’s aggressive enforcement against pharmacies is creating a chilling effect, making pharmacists hesitant to fill legitimate prescriptions for pain and chronic illness.
➡ Why it matters: Oversight is necessary, but overreach can restrict patient access and worsen care gaps.
As drugs worth $61 billion in annual sales lose exclusivity each year through 2030, major pharmaceutical firms are turning to acquisitions to replace lost revenue. The result is an expensive M&A wave that could drive future price pressures.
➡ Why it matters: Employers may see temporary relief from new generics but should expect continued volatility in specialty pricing.
Experts at AMCP Nexus 2025 debated PBM transparency, spread pricing, and rebate ethics. FTC data show billions in PBM spread margins, while PCMA argues that risk-based pricing protects employers from volatility.
➡ Why it matters: Employers must demand full rebate visibility to ensure savings reach the plan—not the middlemen.
PBMs are reportedly using “rebate aggregators” to retain funds meant for plans and patients, circumventing new pass-through laws. Utah is leading reform with legislation requiring direct rebate distribution.
➡ Why it matters: Real transparency requires constant vigilance. Even well-intentioned reforms can be undermined without ongoing oversight.
Experts argue that meaningful reform requires three key actions: expanding Medicare negotiation power, fixing wasteful reimbursement formulas, and closing loopholes that delay generic competition.
➡ Why it matters: The most effective solutions combine negotiation, transparency, and innovation—not political theater.
Final Thoughts
From accelerated biosimilar approvals and state-level affordability boards to aggressive PBM reform, the movement toward transparency and accountability is gaining momentum. Employers and brokers that act now—by auditing PBM contracts, prioritizing biosimilars, and adopting net pricing models—will be best positioned to control costs and protect members.
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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