The 2026 PBM formulary updates from the nation’s three largest pharmacy benefit managers (PBMs)—CVS Caremark, Express Scripts, and Optum Rx—signal a continued shift in how biologic therapies gain market access.
Historically, formulary positioning of high-cost biologics was largely shaped by manufacturer rebates. Today, private-label biosimilars, lower list-price strategies, and net-price competition are reshaping pharmacy benefit coverage.
For independent specialty practices, these shifts have practical implications for therapy access, reimbursement predictability, and purchasing strategy.
What to Know
- The largest PBMs are increasingly excluding reference biologics such as Humira and Stelara from standard commercial formularies.
- PBM-affiliated private-label biosimilars are gaining preferred formulary placement.
- Many competing biosimilars are still excluded despite having lower list prices.
- The traditional rebate-driven formulary system is gradually evolving toward net-price competition.
- Independent specialty practices must closely monitor payer policies to maintain predictable biologic access for patients.
The Rise of PBM-Affiliated Biosimilars
One of the most notable developments in the 2026 formulary cycle is the increasing influence of PBM-affiliated biosimilar manufacturers.
The largest PBMs have introduced private-label biosimilar subsidiaries, including:
- Cordavis (CVS Health / CVS Caremark)
- Nuvaila (UnitedHealth Group / Optum Rx)
- Quallent Pharmaceuticals (Cigna / Express Scripts)
These entities allow PBMs to participate directly in the biosimilar supply chain while also shaping formulary design. As a result, preferred coverage increasingly favors biosimilars distributed through PBM-aligned channels.
For practices, this can mean a narrower range of covered biosimilars.
Why Lower List Prices Don’t Always Guarantee Access
The expectation when biosimilars entered the U.S. market was straightforward: more competition would produce lower prices and broader access.
However, formulary decisions remain influenced by complex contracting dynamics. Even when multiple biosimilars are available, PBMs often select only a limited subset for preferred coverage. Some lower-priced biosimilars may still be excluded if they do not align with the PBM’s broader pricing or distribution strategy.
For independent practices, this means that clinical equivalence does not necessarily translate to payer acceptance. Coverage policies may vary significantly across insurers, requiring practices to adapt prescribing and prior authorization workflows accordingly.
The Shift Toward Net Pricing
The 2026 formulary updates also reflect a broader industry trend: the gradual shift from rebate-driven pricing toward net-price competition.
Historically, PBMs negotiated rebates from manufacturers in exchange for preferred formulary positioning, creating large gaps between list prices and net prices paid by plans.
As biosimilars enter the market with substantially lower list prices, this rebate-based model becomes less central. The industry is increasingly discussing the emergence of a “net pricing drug channel,” where pricing transparency and lower list prices play a larger role in formulary design.
Although the transition remains incomplete, it signals structural changes in how biologics compete for coverage.
Operational Implications for Independent Specialty Practices
For independent specialty practices, formulary volatility can create additional operational and purchasing challenges.
Key considerations include:
Formulary variability
Preferred biosimilars may differ across PBMs and plan sponsors, requiring ongoing monitoring of payer policies.
Prior authorization adjustments
Coverage restrictions may require updated clinical documentation or therapeutic substitution.
Patient affordability challenges
Coverage changes can affect patient copay structures, especially when patients must transition between therapies.
Inventory and procurement planning
Practices that administer biologics must remain aware of which products are consistently reimbursed and how payer policies influence purchasing strategy.
In short, independent practices that maintain strong payer awareness and operational flexibility are better positioned to navigate these evolving access models.
The Strategic Outlook
Biosimilars are expected to remain a central driver of biologic cost management across pharmacy and medical benefit channels.
However, the 2026 formulary changes illustrate that market access is no longer determined solely by clinical equivalence or list price. Distribution alignment, contracting strategy, and payer economics increasingly influence which therapies patients ultimately receive.
Understanding and adapting to these dynamics is becoming essential for specialty practices seeking to maintain consistent access to biologics and financial sustainability.
FAQ
Why are PBMs excluding reference biologics like Humira and Stelara?
PBMs are excluding reference biologics such as Humira and Stelara to prioritize lower-cost biosimilars and reduce overall drug spending. By placing biosimilars, especially private-label biosimilars, in preferred formulary positions, PBMs aim to increase competition and shift utilization toward lower-priced alternatives.
What are private-label biosimilars?
Private-label biosimilars are products marketed by companies affiliated with pharmacy benefit managers (PBMs). These products often receive preferred formulary placement within the PBM’s commercial plans.
Does a lower-priced biosimilar always gain formulary coverage?
Lower-priced biosimilars do not automatically receive formulary coverage from PBMs. Coverage decisions often depend on contracting arrangements, distribution partnerships, and net-price negotiations rather than list price alone.
How do PBM formulary changes affect independent specialty practices?
PBM formulary changes can alter which biologics independent specialty practices can prescribe or administer with reliable reimbursement. Practices may need to adjust prescribing workflows, prior authorization processes, and payer coordination to ensure patients receive covered therapies.
How can practices stay ahead of formulary changes?
Specialty practices can stay ahead of PBM formulary changes by closely monitoring payer policies and maintaining flexible treatment pathways. Working with organizations that help practices navigate payer dynamics and contracting strategy, such as Remedy GPO, can help maintain consistent patient access.
