Q1 2026 PBM Formulary Exclusion Analysis
Contents
Executive Summary
The 2026 formulary cycle marks a structural inflection point for pharmaceutical market access. Express Scripts added nearly 130 new exclusions — roughly 7x its 2025 count — while CVS Caremark and Optum Rx held closer to prior-year levels. The driving force is not incremental formulary optimization but a fundamental shift in how the Big Three PBMs generate revenue: private-label biosimilar subsidiaries (Cordavis, Quallent, Nuvaila) now dominate preferred formulary placement for both adalimumab and ustekinumab, while excluding most manufacturer-marketed biosimilars alongside the reference products.
Simultaneously, three external forces are compressing the traditional PBM business model: the FTC’s February 2026 settlement with Express Scripts requiring net-price-based benefit designs, the CAA 2026 PBM delink effective 2028, and IRA Maximum Fair Prices for 10 Part D drugs. The combined effect is a market access environment where the assumptions underlying manufacturer payer contracting — high list price, high rebate, broad formulary access — are weakening across both commercial and government channels.
This report analyzes the 2026 exclusion data, maps PBM-by-PBM formulary strategy, evaluates the private-label biosimilar model’s implications for future biologic launches, and provides scenario analysis for how formulary economics will evolve through 2028.
2 Key Metrics: 2026 vs. 2025
The asymmetry between Express Scripts and its competitors is the defining feature of the 2026 cycle. Express Scripts expanded exclusions across multiple therapeutic categories, including specialty biologics, diabetes supplies, oncology agents, and antipsychotics. In contrast, CVS Caremark and Optum Rx took more measured approaches, with CVS notably retaining brand Stelara on formulary alongside biosimilars — a departure from its aggressive Humira strategy.
Express Scripts’ aggressive exclusion posture may be partially driven by the FTC settlement pressure. By pre-emptively shifting formularies toward lower net-cost alternatives, Express Scripts can demonstrate compliance with the settlement’s requirements while simultaneously expanding the role of its Quallent private-label subsidiary.
3 Big Three PBM Exclusion Comparison
Adalimumab (Humira) Biosimilar Formulary Placement
| Product | Manufacturer | List Price Discount | CVS Caremark | Express Scripts | Optum Rx |
|---|---|---|---|---|---|
| Humira (reference) | AbbVie | — | Excluded | Excluded | Tier 3 / PA (Select Std only) |
| Hyrimoz (Cordavis) | Sandoz / Cordavis | ~85% | Preferred | — | — |
| Cyltezo / adalimumab-adbm (Quallent) | BI / Quallent | ~46% | — | Preferred | — |
| Amjevita (Nuvaila) | Amgen / Nuvaila | Low-list-price version | — | — | Preferred |
| Other manufacturer biosimilars | Various | Varies | Mostly excluded | Mostly excluded | Mostly excluded |
Source: Drug Channels Institute, PSG Consults, PHSL, PBM formulary documents. Formulary status as of January 2026.
The pattern is now unmistakable: each of the Big Three PBMs preferentially places its own private-label biosimilar or a product from its affiliated subsidiary, while excluding most competing manufacturer-branded biosimilars. As of April 2025, the six adalimumab biosimilar manufacturers without a PBM private-label arrangement held just 3% combined market share, according to a peer-reviewed analysis published in the Journal of Managed Care & Specialty Pharmacy. This raises fundamental questions about whether non-affiliated biosimilar manufacturers can achieve commercially viable market access in the current PBM structure.
Ustekinumab (Stelara) Biosimilar Formulary Placement
| Product | Private-Label Affiliate | List Price Discount | CVS Caremark | Express Scripts | Optum Rx |
|---|---|---|---|---|---|
| Stelara (reference) | — | — | On formulary (parity) | Phased removal (IV 1/1; SC all 7/1) | Tier 3 / PA |
| Pyzchiva (Cordavis) | CVS / Cordavis | ~86-90% | Preferred | — | — |
| ustekinumab-ttwe (Quallent) | Cigna / Quallent | ~46% | — | Preferred | — |
| Wezlana (Nuvaila) | UHG / Nuvaila | High + low list-price versions | — | — | Preferred |
| Yesintek | — | ~90% | On formulary | Preferred | Preferred |
| Selarsdi | — | ~85% | — | Preferred | — |
Source: Drug Channels Institute, PSG Consults, PBM formulary documents. Stelara MFP: 66% below 2023 list price (IRA negotiation). Nine biosimilars now marketed.
The Stelara biosimilar rollout is proceeding faster than the Humira precedent. Express Scripts is phasing out brand Stelara by July 2026 for all users — roughly 18 months after biosimilar entry, compared to ~30 months for Humira. CVS Caremark’s decision to retain brand Stelara alongside biosimilars is a notable outlier, which CVS attributes to “supply chain instability” concerns and ongoing litigation. However, this approach may cost CVS Caremark clients early access to biosimilar savings that Express Scripts and Optum Rx clients are already capturing.
Quallent’s ustekinumab biosimilar launched with a list price only 46% below Stelara, despite Evernorth’s earlier announcement of a 90% discount. Drug Channels has been unable to determine why the actual discount was reduced, and Cigna’s PR team declined to comment. This pricing opacity — combined with exclusive formulary placement — means plan sponsors cannot independently verify whether Quallent’s pricing is competitive relative to alternatives that PBMs have excluded.
4 Private-Label Biosimilar Dominance
The private-label biosimilar model has consolidated faster than most industry observers anticipated. Each Big Three PBM now operates a subsidiary that co-produces or distributes biosimilars manufactured by partnered companies, then grants those products preferred or exclusive formulary placement. The economic structure involves revenue sharing between the PBM subsidiary and the manufacturing partner, with the PBM capturing margin at both the formulary negotiation layer and the distribution layer.
| PBM Parent | Private-Label Subsidiary | Manufacturing Partners | Products on Formulary |
|---|---|---|---|
| CVS Health | Cordavis | Sandoz, Samsung Bioepis | Hyrimoz (adalimumab), Pyzchiva (ustekinumab) |
| Cigna / Evernorth | Quallent Pharmaceuticals | Boehringer Ingelheim, Alvotech/Teva | Cyltezo/Simlandi (adalimumab), ustekinumab-ttwe |
| UnitedHealth Group | Nuvaila | Amgen | Amjevita (adalimumab), Wezlana (ustekinumab) |
Source: Drug Channels Institute, MMIT, Ipsos, JMCP peer-reviewed analysis (2025).
The consequences for the broader biosimilar market are becoming visible. CVS Health has blocked all reporting of Cordavis sales data since early 2025, eliminating independent market share tracking for its private-label products. The JMCP analysis found that non-affiliated manufacturers hold just 3% combined adalimumab market share — a figure that raises questions about the commercial viability of developing biosimilars without a PBM private-label partnership. As Dr. Benjamin Rome of Brigham and Women’s Hospital has noted, this model creates “short-term gains” in biosimilar uptake but raises “long-term concerns about the biosimilar marketplace” by discouraging future development investment.
Manufacturers planning biosimilar programs for the next wave of patent expirations — including Keytruda (pembrolizumab), Eylea (aflibercept), and Dupixent (dupilumab) — must now treat PBM private-label partnerships as a prerequisite for commercial market access, not an optional distribution channel. The window for independent biosimilar commercialization at the Big Three PBMs has effectively closed.
5 IRA Maximum Fair Prices: Commercial Formulary Impact
The first 10 Medicare Drug Price Negotiation Program Maximum Fair Prices took effect January 1, 2026. A key question for market access teams was whether commercial formularies would respond by excluding or deprioritizing MFP drugs. Early evidence suggests minimal commercial formulary disruption from MFP status alone. Drug Channels found little evidence that MFP drugs have been broadly excluded from commercial formularies, particularly for brand-name drugs where manufacturers have reduced list prices to align with negotiated levels. The coverage changes that did occur were driven by generic or biosimilar competition — normal formulary dynamics unrelated to MFP status.
However, the downstream effects are still developing. Some plans are introducing new step therapy requirements or prior authorization hurdles for MFP drugs in 2026, potentially offsetting the list price reductions with tighter utilization management. Stelara presents a unique case: its MFP of 66% below the 2023 list price coexists with an active biosimilar market where private-label products offer 46-90% discounts. CMS has stated it will monitor whether “meaningful competition continues to exist” before implementing certain MFP provisions — and PBM private-label activity likely qualifies as competition under this framework.
6 FTC Settlement: Structural Implications
The FTC’s February 2026 settlement with Express Scripts requires structural changes to commercial formulary economics. The settlement mandates that Express Scripts end formulary practices favoring higher list-price drugs over lower net-cost alternatives, offer benefit designs where member cost-sharing reflects net drug prices, expand transparency reporting to plan sponsors, and reduce compensation structures tied to rebates and list pricing. The settlement also requires Express Scripts to integrate TrumpRx-style direct-to-consumer pricing within standard offerings where legally permissible.
Combined with the CAA 2026 PBM delink (effective 2028 for Part D), Express Scripts now faces simultaneous commercial and government pressure to restructure its economic model. The practical effect is that high list-price / high-rebate formulary positioning — the dominant launch strategy for specialty drugs over the past decade — will face increasing friction at the nation’s second-largest PBM.
FTC has signaled interest in PBM private-label biosimilar arrangements. Congressional lawmakers have also called on the FTC to investigate whether the Big Three PBMs’ vertical integration with private-label subsidiaries constitutes anticompetitive behavior. If the FTC opens a formal investigation, the private-label model could face structural constraints — which would reopen formulary access for independent biosimilar manufacturers.
7 Scenario Analysis: 2027-2028 Formulary Trajectory
8 Strategic Recommendations
For Pharmaceutical Manufacturers (Market Access Teams)
Biosimilar developers should treat PBM private-label partnerships as essential infrastructure, not optional distribution channels. The data is unambiguous: non-affiliated manufacturers hold 3% combined market share in the adalimumab category. Early engagement with Cordavis, Quallent, or Nuvaila before biosimilar launch is now a prerequisite for viable commercial market access at the Big Three.
Innovator manufacturers should model dual-track contracting assumptions for 2027-2028 launches. Part D economics under the CAA 2026 delink will diverge from commercial economics, creating a two-tier system where the same product may require fundamentally different pricing and contracting strategies across government and commercial channels. Market access teams should develop parallel payer value dossiers that account for this divergence.
Net price positioning is emerging as a viable commercial strategy. AbbVie’s experience with Humira list price reductions, Novo Nordisk’s insulin pricing restructuring, and Boehringer Ingelheim’s $35 inhaler cap are all signals that manufacturers can use low-list-price positioning to maintain formulary access without relying on rebate-driven economics. This approach aligns with both the FTC settlement requirements and the broader market trajectory toward net price transparency.
For Health Plans and PBM Clients
During 2026 renewals, require PBMs to disclose net-cost comparisons between preferred private-label biosimilars and excluded manufacturer alternatives. The Quallent pricing discrepancy (46% discount vs. announced 90%) illustrates why plan sponsors need independent verification of biosimilar economics. The FTC settlement provides additional leverage for this request.
Evaluate pass-through PBMs as a competitive check. Navitus, MedImpact, and other transparent-model PBMs are structurally advantaged in an environment where the FTC and Congress are scrutinizing vertical integration. Including a pass-through PBM in RFP processes can reveal whether Big Three pricing is truly competitive after private-label economics are accounted for.
9 Competitive Positioning Map
10 Sources
Drug Channels Institute, “The Big Three PBMs’ 2026 Formulary Exclusions” (Jan 2026) · Drug Channels Institute, “The Stelara Biosimilar Price War” (rerun Oct 2025) · PSG Consults, “2026 Formulary Changes: Express Scripts” (Dec 2025) · PSG Consults, “2026 Formulary Changes: CVS Caremark” (Dec 2025) · PHSL, “2026 Formulary Exclusions Lists: A Review” (Jan 2026) · JMCP, “Will the emerging private-label market access channel help or hinder biosimilar market access?” (Aug 2025) · Ipsos, “U.S. Biosimilars: Greater Access and New Commercial Models” (Aug 2025) · MMIT, “How PBMs Are Reshaping Biosimilar Market Access” (Aug 2025) · Sequoia Consulting, “What TrumpRx and the FTC Settlement with Express Scripts Means” (Feb 2026) · Milliman, “Prescribing a Part D formulary for the new IRA world” (2025) · Medscape, “PBM Private Labeling Boosts Biosimilar Adoption, Raises Anticompetitive Concerns” (Apr 2025) · AIS Health / MMIT, “2025 Formularies: Humira Is Out, White-Label Biosimilars Are In” (Feb 2025) · Vizient, “Biosimilars” therapeutic insights (Nov 2025) · Samsung Bioepis US Biosimilar Market Report (2025)