MARKET ACCESS INTELLIGENCE • Weekly Digest • February 28, 2026

Market Access Intelligence — February 28, 2026
MARKET ACCESS INTELLIGENCE • Weekly Digest • February 28, 2026
The FTC’s landmark settlement with Express Scripts on February 4 dismantles the rebate-linked PBM business model that Drug Channels has spent two decades chronicling—requiring net-price benefit designs, cost-plus pharmacy reimbursement, and reshoring of the Ascent GPO from Switzerland. Coming just one day after the CAA 2026 was signed into law, the combined legislative-enforcement pincer compresses the timeline for PBM business model transformation from years to months. Meanwhile, the Trump administration escalated its Most Favored Nation pricing campaign with enforcement letters to 17 manufacturers, and a first-of-its-kind Minnesota report revealed that 340B hospitals collected $1.34 billion in program revenue in 2024—with the largest institutions capturing 80% of the total.

TOP STORIES

Policy FTC settlement with Express Scripts requires structural overhaul of PBM model—Caremark and Optum settlements expected to follow

The Federal Trade Commission announced on February 4 that Express Scripts agreed to fundamental changes to its rebate practices, benefit design, and pharmacy reimbursement structure. The settlement, which resolves the FTC’s September 2024 lawsuit alleging that ESI artificially inflated insulin list prices through anticompetitive rebating, extends well beyond insulin to cover all pharmaceutical products and biologics. Key terms include: ESI must stop preferring high list-price drugs on standard formularies when cheaper equivalents exist; compensation must be delinked from manufacturer rebates and negotiated savings; pharmacy reimbursement must shift to a cost-plus model; and the Ascent GPO must be reshored from Switzerland to the United States, bringing over $750 billion in purchasing activity back onshore. The FTC projects the settlement will reduce patient out-of-pocket costs by up to $7 billion over ten years.

Express Scripts avoided financial penalties and did not admit wrongdoing, but the structural concessions are far more consequential than any fine. The settlement imposes a three-year compliance monitor and a ten-year consent order—meaning ESI’s business practices will be under federal oversight through 2036. The critical detail is that plan sponsors retain the ability to opt out of certain provisions (Section XI of the order), which creates a potential loophole for large self-insured employers who prefer the status quo. Market access teams should monitor whether employers exercise this opt-out or whether competitive pressure from the settlement’s transparency provisions makes the old model untenable. CVS Health has indicated it is negotiating in good faith with FTC staff on a similar settlement, and Optum Rx is expected to follow. If all three Big Three PBMs settle on comparable terms, the net-price drug channel that Adam Fein has been forecasting becomes the default industry architecture.

Competitive implications: Express Scripts / Cigna was already migrating clients to its rebate-free Evernorth model announced in October 2025, blunting the settlement’s near-term disruption. CVS Caremark faces the most acute pressure: its Cordavis private-label biosimilar business depends on formulary steering that the settlement’s net-price provisions would constrain. Optum Rx / UnitedHealth must reconcile Nuvaila’s preferred positioning with new formulary transparency requirements. Community pharmacies gain directly from the cost-plus reimbursement mandate, reversing years of below-acquisition-cost dispensing that has driven independent pharmacy closures.

Key risks: As Goodwin analysis highlights, the settlement does not address mail-order pharmacies or PBM-affiliated specialty pharmacy steering—two channels where ESI, Caremark, and Optum retain substantial dispensing margins. If Caremark and Optum settle on materially different terms, the resulting inconsistent pricing requirements across PBMs would create contract complexity for manufacturers negotiating across all three.

Pricing Post-CAA 2026 analysis: the drug pricing spotlight swings back to manufacturers as PBM reform enters implementation

With the CAA 2026 signed and the FTC settlement in hand, the policy narrative is rapidly shifting from PBM reform to manufacturer pricing scrutiny. PharmaVoice reported on February 27 that restructuring PBM contracts is the immediate operational priority for drugmakers—any fees tethered to list prices or percentages will be prohibited once the new rules take effect, requiring manufacturers to renegotiate formulary placement, administrative, and data fees on a flat-rate basis. PCMA (the PBM trade association) wasted no time pivoting the narrative, publishing a memo arguing that manufacturers deserve scrutiny for patent abuse, shadow pricing, and pay-for-delay tactics that the PBM reform debate has obscured. Meanwhile, AJMC reported that Johns Hopkins researcher Ge Bai cautioned that patients may not see near-term savings because cost-sharing continues to be based on list prices rather than net prices—the rebate pass-through benefits plan sponsors, not patients directly.

The Bai critique is the most important structural observation about the CAA 2026 that market access professionals need to internalize: 100% rebate pass-through to plan sponsors does not automatically translate into lower patient cost-sharing. As long as benefit designs base copays and coinsurance on list prices, the list-to-net price gap persists as a cost burden on patients even if PBMs no longer retain the spread. This creates an opening for manufacturers who can demonstrate patient-facing affordability—copay assistance, direct-to-patient programs, and low list-price launches will gain strategic importance as the differentiator between drugs that technically have net-price parity but produce very different out-of-pocket experiences. The manufacturers who proactively redesign their pricing architecture around patient cost-sharing, rather than waiting for payers to do it for them, will secure the strongest formulary positions in 2028 and beyond.

340B Minnesota publishes first state-level 340B revenue data: $1.34 billion to hospitals, with 80% concentrated in the largest systems

STAT News reported on February 27 that Minnesota’s second annual 340B transparency report revealed that the state’s participating hospitals and clinics received $3.045 billion in discounted medicines under the program in 2024, paying $1.53 billion in acquisition costs plus $165 million in administration fees, yielding net revenue of approximately $1.34 billion. The largest hospitals captured more than $1 billion of that total—representing 80% of statewide 340B revenue. Minnesota remains the only state to collect and publish this level of 340B financial data. Separately, HRSA extended the comment period on its Request for Information regarding the 340B Rebate Model Pilot Program by an additional 30 days, following the February 10 federal court ruling that vacated the original pilot.

The Minnesota data is the strongest empirical evidence yet for the manufacturer argument that 340B revenue concentration in large health systems does not align with the program’s statutory purpose of helping safety-net providers stretch scarce resources. The 80/20 distribution pattern—where the largest hospitals capture four-fifths of the financial benefit—mirrors national estimates from Drug Channels and BRG, and will be cited extensively in the HRSA RFI comment period and in congressional markup of any 340B reform legislation. For covered entities, the counterargument is that these large systems provide the most complex, high-cost care in underserved communities and that 340B revenue funds service lines that would otherwise close. Market access teams at manufacturers should incorporate state-level transparency data into their 340B policy positions and monitor whether other states follow Minnesota’s model.

Competitive implications: Large health systems (Mayo Clinic, Allina Health, Essentia, Hennepin Healthcare in Minnesota specifically) now face public accountability for how 340B revenue is deployed. PhRMA gains a powerful data point for its rebate model advocacy. FQHCs and rural hospitals—which the America’s Essential Hospitals fact sheet argues are the program’s true intended beneficiaries—may find their case for program preservation strengthened by demonstrating that their share of 340B revenue is proportionally small relative to the safety-net care they deliver.

Biosimilar CVS Caremark extends biosimilar-first formulary strategy to osteoporosis, replacing Prolia and Forteo effective April 1

CVS Health announced on February 5 that Caremark will add denosumab biosimilars Ospomyv (Cordavis/CVS’s private-label subsidiary) and Stoboclo (Celltrion) to major national commercial template formularies effective April 1, replacing reference brand Prolia. Generic teriparatide, Bonsity, and Tymlos will replace Forteo. Caremark estimates the biosimilar formulary approach is over 50% lower in cost per prescription than the branded originator. The move extends the playbook Caremark deployed with Humira, where it excluded the reference brand in favor of low list-price biosimilars—transitioning 96% of its Humira patients to biosimilars and generating $1.5 billion in cumulative gross savings. Separately, the 2026 Cardinal Health Biosimilars Report published February 24 found that biosimilars have generated $56 billion in cumulative US savings since 2015 but warned of a potential $232 billion in missed savings over the next decade if development and adoption do not accelerate.

The Prolia/Forteo formulary shift is strategically significant for two reasons. First, it extends the private-label biosimilar model into a new therapeutic category: Ospomyv is a Cordavis product, manufactured by Sandoz but marketed under CVS Health’s subsidiary. This deepens the vertical integration pattern where each Big Three PBM steers volume to its affiliated biosimilar brand. Second, denosumab is a heavily government-payer population product—Medicare and Medicaid account for a large share of osteoporosis treatment, as Mayo Clinic’s Chelsee Jensen noted in a recent AJMC interview. That means copay assistance programs have limited utility for switching incentives, making formulary position the dominant access lever. For Amgen (Prolia/Xgeva originator), the formulary losses accelerate a revenue headwind that biosimilar competition has been building since mid-2025, when six denosumab biosimilars launched within a three-month window.

Pricing Trump administration escalates MFN enforcement with CEO letters and TrumpRx launch—September 29 deadline looms for 17 manufacturers

The Trump administration’s Most Favored Nation pricing initiative reached a new phase of intensity this month. Following the May 2025 executive order and July 2025 CEO letters to 17 manufacturers, the administration has now secured 16 voluntary manufacturer agreements, including the blockbuster GLP-1 deals with Novo Nordisk and Eli Lilly pricing injectable Ozempic, Mounjaro, Wegovy, and Zepbound at $245/month for Medicare. TrumpRx.gov launched on January 15 with 40 drugs from five initial manufacturers (AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk, Pfizer), offering cash prices aligned with the lowest OECD reference price. Manufacturers that have not reached agreements face a September 29, 2025 deadline, after which the administration has threatened rulemaking to impose MFN pricing, expanded drug importation, enforcement actions, and potential revocation of drug approvals.

The MFN initiative creates a three-tier pricing landscape that market access teams must now navigate simultaneously: IRA-negotiated Medicare prices (for the 10 initial drugs), MFN voluntary agreement prices (for drugs covered by the 16 manufacturer deals), and traditional PBM-negotiated net prices (for everything else). The key unresolved question, as AMCP analysis notes, is whether the administration has legal authority to compel MFN pricing without congressional action. The voluntary agreements have been structured as bilateral deals offering tariff exemptions in exchange for pricing concessions—a carrot-and-stick model that works for large multinationals but may not scale to the broader market. Additionally, TrumpRx purchases are cash-only transactions that do not count toward insurance deductibles for most plan designs, limiting uptake among commercially insured patients. Manufacturers should model the revenue impact of participating versus not participating in MFN deals as the September deadline approaches.

QUICK TAKES

  • Policy PCMA publishes post-reform PBM value defense. PCMA released a February 26 analysis from Phoenix Center economist George Ford arguing PBMs reduce drug costs by 17% to 47%, and that net prices rose only 60% from 2007-2018 versus 159% list price growth thanks to PBM-negotiated rebates. The timing is defensive—an attempt to prevent further regulatory action now that the initial reform wave is complete.
  • Biosimilar Cardinal Health reports $232 billion in potential missed biosimilar savings. The 2026 Cardinal Health report found that while biosimilars now account for 23% of the US biologics market, only 10% of the 110+ biologics losing patent protection over the next decade have biosimilars currently in development. Nearly 25 new biosimilars are expected to receive FDA approval between 2026-2027 across oncology, immunology, and ophthalmology.
  • 340B Virginia advances state-level 340B workgroup legislation. SB 278 by Sen. Srinivasan (D-Loudoun) was amended from mandating contract pharmacy protections to establishing a workgroup studying 340B operations in Virginia—a scaled-back approach reflecting the difficulty of state-level action on a federally authorized program.
  • Policy AAM ACCESS! 2026 conference underscores PBM-biosimilar tension. The generics and biosimilars industry conference in Miami this week featured sharp criticism of PBM private-label biosimilar strategies, with multiple speakers arguing that rebate models and affiliated formulary steering prevent independent biosimilar manufacturers from competing on price alone.
  • Pricing CBO scores CAA 2026 PBM provisions at $2.12 billion deficit reduction over 10 years. KFF analysis notes the largest savings component ($1.865 billion) comes from increased oversight of PBMs working with employer health plans, reflecting CBO’s assumption that transparency leads to lower premiums rather than direct drug price reductions.

WHAT TO WATCH NEXT

Caremark and Optum Rx FTC settlement negotiations

With Express Scripts settled, the remaining two Big Three PBMs are under pressure to reach comparable terms with the FTC. CVS Health publicly stated it is negotiating in good faith, and legal analysts at Managed Healthcare Executive expect both to settle rather than litigate. The critical variable is whether their settlements mirror ESI’s terms or diverge on key provisions such as the plan-sponsor opt-out clause, mail-order pharmacy exemption, or specialty pharmacy steering restrictions. Divergent terms would create a fragmented regulatory landscape that complicates manufacturer contracting. Market access teams should prepare for a scenario in which all three PBMs operate under net-price, cost-plus models by 2028—and a second scenario where Caremark and Optum negotiate more lenient terms that preserve margin flexibility.

MFN compliance deadline: September 29, 2026

The administration’s deadline for manufacturers to demonstrate compliance with MFN pricing demands is less than seven months away. Manufacturers who have not signed voluntary agreements face escalating enforcement threats, but the legal authority for compulsory MFN pricing remains contested. The Congressional Research Service analysis identifies CMMI demonstration authority as the most plausible statutory pathway but notes significant legal challenges. Market access teams should track whether additional manufacturers sign voluntary deals in Q2 2026, and model the portfolio-level revenue impact of extending MFN pricing from Medicaid-only to Medicare and commercial payers. The interaction between MFN prices and IRA-negotiated prices for drugs subject to both programs remains undefined and presents compliance risk.

340B RFI comment deadline: now extended to May 2026

HRSA’s 30-day extension of the RFI comment period gives stakeholders additional time to respond to the central question: whether a rebate-based model can legally replace upfront 340B discounts under existing statutory authority. The Minnesota revenue data adds urgency to the debate by quantifying the concentration of 340B financial benefits among large hospital systems. Congressional interest in 340B reform legislation is rising, with the AHA and Essential Hospitals mobilizing to preserve the upfront discount model while PhRMA and individual manufacturers continue pushing for structural accountability measures. The parallel D.C. Circuit litigation on manufacturer rebate authority could produce a ruling that either reinforces or undermines HRSA’s regulatory options before any new pilot program takes effect.

DATA SNAPSHOT

  • FTC settlement projected savings: $7 billion in patient out-of-pocket cost reductions over 10 years from Express Scripts settlement alone. Cost-plus pharmacy reimbursement expected to generate millions in new annual revenue for community pharmacies (FTC)
  • Minnesota 340B revenue (2024): $3.045 billion in discounted drug purchases, $1.53 billion in acquisition costs, $165 million in admin fees = $1.34 billion net revenue. Top hospitals captured 80% of total (STAT News / Minnesota Dept. of Health)
  • Biosimilar market size: 23% of total US biologics market; $56 billion in cumulative savings since 2015; $232 billion in projected missed savings over next decade at current development pace; ~25 new biosimilar approvals expected 2026-2027 (Cardinal Health 2026 Report)
  • CVS biosimilar formulary impact: 96% of Caremark Humira patients transitioned to biosimilars; $1.5 billion in cumulative gross savings; Prolia/Forteo biosimilar switch effective April 1 with >50% cost reduction per prescription (CVS Health)
  • MFN/TrumpRx scope: 16 manufacturer voluntary agreements; 40 drugs on TrumpRx.gov at launch; GLP-1 Medicare price: $245/month (vs. Ozempic list $1,028, Wegovy list $1,349); CBO scored CAA 2026 PBM provisions at $2.12 billion deficit reduction over 10 years (KFF)

MARKET ACCESS POSITIONING HEATMAP

Winners this week:

  • Community pharmacies — FTC settlement mandates cost-plus reimbursement from Express Scripts, reversing below-acquisition-cost dispensing; similar terms expected from Caremark and Optum settlements
  • Cordavis / CVS Health — Private-label biosimilar model expands into osteoporosis with Ospomyv (denosumab) on Caremark formulary; 96% Humira transition rate demonstrates execution capability
  • Celltrion (Stoboclo) — One of only two denosumab biosimilars on Caremark’s new template formulary alongside CVS’s own Cordavis product; rare formulary parity with a PBM-affiliated competitor
  • PhRMA / manufacturer pricing advocates — Minnesota 340B data validates core argument about program revenue concentration; expect heavy citation in HRSA RFI comments and congressional testimony

Under pressure this week:

  • Amgen (Prolia / Xgeva) — CVS Caremark formulary exclusion of Prolia effective April 1 follows mid-2025 denosumab biosimilar wave; revenue erosion accelerates across all major PBM formularies
  • Manufacturers without MFN agreements — September 29 deadline approaching with administration threatening rulemaking, importation, and approval revocations; holdout strategy carries escalating political risk
  • Large 340B hospital systems — Minnesota transparency report creates accountability pressure; other states may adopt similar reporting requirements, narrowing the information advantage that has shielded revenue practices
  • Independent biosimilar manufacturers — AAM ACCESS! conference highlighted persistent formulary barriers; private-label biosimilar dominance by Cordavis, Quallent, and Nuvaila leaves non-affiliated manufacturers with limited formulary access despite lower pricing

Neutral but pivotal:

  • CVS Caremark / Optum Rx — FTC settlement negotiations will determine whether the Big Three operate under uniform or divergent consent orders; uniform terms simplify industry transition, divergent terms create competitive asymmetries
  • Plan sponsors / large employers — Section XI opt-out clause in ESI settlement allows preservation of existing rebate arrangements; employer response will determine whether net-price transition is universal or selective
  • TrumpRx platform — 40 drugs launched at MFN prices, but cash-only structure that doesn’t count toward insurance deductibles limits uptake among commercially insured patients; integration with PBM benefit designs remains undefined

Market Access Intelligence • Weekly Digest • February 28, 2026

This digest synthesizes data from FTC, AJMC, Drug Channels Institute, KFF, PharmaVoice, STAT News, CVS Health, Center for Biosimilars, AMCP, Goodwin, and primary sources (CMS, HRSA, White House, company filings). Supported entirely by subscriber revenue. No sponsored content, no consulting relationships, no manufacturer funding.