POST-CAA 2026: PRICING SPOTLIGHT SHIFTS TO MANUFACTURERS
Policy PBM reform is done—now manufacturers face the scrutiny they deflected for a decade
PharmaVoice reported (Feb. 27) that the CAA 2026 PBM provisions are already reshaping the political dynamic around drug pricing. Jesse Dresser, a partner at Frier Levitt heading the firm's pharmacy practice group, warned that manufacturers must begin restructuring PBM contracts immediately: any fees tethered to list prices or percentage-based structures will be prohibited once the delink provisions take effect by August 2028. The PCMA published a memo (Feb. 3) arguing that with PBM reform complete, Congress should now direct its attention to manufacturer practices including patent abuse, shadow pricing, and pay-for-delay tactics. AJMC's analysis (March 2) identified five distinct policy goals driving PBM reform implementation: transparency mandates, compensation delinking, rebate pass-through requirements, pharmacy access protections, and scrutiny of vertical integration—with civil penalties of up to $10,000 per day for noncompliance with transparency reporting requirements.
KFF's updated PBM reform brief (Feb. 9) provides the definitive summary of the enacted provisions. CBO estimates the reforms will reduce the federal deficit by $2.12 billion over 10 years, with $1.865 billion coming from increased oversight of PBMs working with employer health plans—signaling that CBO expects the largest fiscal impact in the commercial market, not Medicare. The $444 million scored for Part D delinking and transparency is relatively modest, suggesting that the commercial-market reporting requirements are where the real behavioral change is expected to occur.
TRUMPRX & MFN PRICING
Pricing TrumpRx falls short of promises one month after launch as Trump pushes Congress to codify MFN
STAT News reported (March 5) that one month after its Feb. 5 launch, TrumpRx is underperforming the administration's claims. Few drugs have been added beyond the initial ~43, usage data remains undisclosed, and deals with several manufacturers are still being finalized. Pfizer, which the White House said would offer "virtually all" of its drugs at a discount, has listed only 30 of its hundreds of marketed products. Several companies—including Sanofi and Boehringer Ingelheim—have not yet added any drugs to the platform despite signing MFN agreements. The cash-only purchases do not count toward insurance deductibles or out-of-pocket maximums, and KFF's Juliette Cubanski noted that for most insured patients, existing plan co-pays are already lower than TrumpRx prices.
PhRMA's response to the State of the Union codification call was telling: the industry lobby urged PBM and 340B reform instead of MFN legislation, according to 340B Report. But that deflection strategy is weakened now that PBM reform is already law. PhRMA's remaining legislative target—340B reform—faces bipartisan support for the program in Congress and an active state-level contract pharmacy access movement.
VERTICAL INTEGRATION & 340B
340B Cigna quietly completes CarepathRx acquisition, gaining access to hospital pharmacy dispensing at ~10% of US hospitals
STAT News broke (Feb. 26) that Cigna's Evernorth health services division has completed its acquisition of CarepathRx, a hospital pharmacy that dispenses drugs to nearly 10% of U.S. hospitals. The transaction was not formally announced—STAT discovered it in financial filings. Fierce Healthcare confirmed the deal, noting that Oregon regulators determined it would not materially increase Evernorth's market concentration. Evernorth already controls Express Scripts (one of the Big Three PBMs) and Accredo (a major specialty pharmacy). CarepathRx supports hundreds of hospitals with specialty, infusion, and 340B pharmacy services, giving Cigna indirect access to 340B economics—including discounted drug acquisition costs and revenue-sharing with hospital partners.
Separately, STAT's Pharmalot reported (Feb. 27) that the Department of Justice filed a brief supporting AbbVie's challenge to Colorado's 340B contract pharmacy access law, marking the first time the Trump DOJ has directly intervened on the manufacturer side in state 340B litigation. PhRMA has also sued New Mexico's contract pharmacy access law and AstraZeneca has sued Vermont. Combined with the administration's budget proposal to move 340B from HRSA to CMS, the pattern is clear: coordinated federal pressure to centralize control over 340B economics while state legislatures continue expanding contract pharmacy protections.
FORMULARY & BIOSIMILARS
Biosimilar PBM private-label biosimilar strategies face new scrutiny as Net Pricing Drug Channel emerges
Drug Channels Institute's analysis of the Big Three PBMs' 2026 formulary exclusions documented an accelerating trend: Express Scripts has removed brand Stelara in favor of three ustekinumab products—two deeply discounted biosimilars from Teva and Biocon, plus a higher-priced PBM-affiliated private-label version from Cigna's Quallent Pharmaceuticals. CVS Health has blocked all reporting of its Cordavis biosimilar sales data since January 2025, creating a transparency gap in the market's largest private-label biosimilar program. The Stelara market now includes 12 biosimilars plus an unbranded biologic from J&J, with list price discounts ranging from 5% to 90%. Separately, the Center for Biosimilars reported that a budget impact analysis found omalizumab (Xolair) biosimilar entry could generate significant payer savings while expanding patient access.
QUICK TAKES
- Policy CAA 2026 implementation timeline — The law mandates 100% rebate pass-through to plan sponsors by August 2028, with PBM compensation limited to flat, bona fide service fees. HHS estimates mandatory point-of-sale rebate pass-throughs will save seniors an average of $125 per year in direct out-of-pocket costs. Market access teams should begin modeling flat-fee PBM contracting structures for all 2027+ launches.
- 340B Washington state advances 340B contract pharmacy bill with provider and manufacturer reporting requirements, becoming the latest state to combine contract pharmacy protections with transparency mandates. Five states now require some form of 340B provider reporting: Minnesota, Colorado, Hawaii, Vermont, and (pending) Washington. The reporting requirements give manufacturers data to argue against program expansion, but also create a public record that safety-net advocates can use to demonstrate community benefit.
- Pricing Health Affairs study found that list price reductions among brand-name ICS-LABA inhalers in 2024 were associated with increased generic uptake—providing empirical evidence that manufacturer list-price cuts in advance of IRA negotiation can accelerate competitive entry rather than protect market share, a counterintuitive finding with implications for the 15 drugs in IRA Cycle 2 negotiation for 2027 price applicability.
- Policy State PBM reform continues accelerating alongside the federal law. Arkansas' ban on PBMs owning retail or mail-order pharmacies faces a federal preliminary injunction on Commerce Clause grounds. Idaho, Utah, West Virginia, and Alabama have all enacted rebate pass-through or spread pricing bans effective 2025–2026, with Texas, Florida, and California expected to advance additional bills this session. Multi-state employers face an increasingly fragmented compliance landscape.
- 340B 340B covered entities preparing for IRA-driven margin compression — As IRA Maximum Fair Prices take effect for the first 10 negotiated drugs, 340B ceiling prices for those products may increase (because lower manufacturer best prices reduce the inflation penalty component), compressing pharmacy margins. VytlOne's analysis urges covered entities to monitor MFP rebate denials, examine formularies for lowest-cost therapies, and prepare for the possibility that the 340B Rebate Pilot re-emerges under new regulatory authority.
WHAT TO WATCH NEXT
GLOBE and GUARD CMS Innovation Center models—mandatory reference pricing pilot
The CMS Innovation Center has proposed two models—GLOBE (Part D) and GUARD (Part B)—that would apply mandatory international reference pricing to approximately 25% of Medicare beneficiaries in randomly selected geographic areas. Crowell & Moring's analysis notes that GLOBE's five-year performance period would begin October 1, 2026, with GUARD starting January 1, 2027. The public comment period for both models closed February 23, 2026. Unlike MFN codification, these models operate under existing CMS Innovation Center authority and do not require congressional action. If finalized, they represent the first mandatory government reference pricing applied to commercial-market-relevant drugs outside the IRA negotiation framework. Market access teams should model portfolio exposure to both models, particularly for high-spend Part B biologics and Part D specialty drugs where US-to-OECD price differentials are largest.
Drug Channels Leadership Forum 2026—March 16–18, Miami
DCI's invite-only annual gathering of senior drug channel leaders takes place March 16–18 at Turnberry Resort in Miami, with agenda items covering the NPDC transition, PBM reform implementation, 340B dynamics, and biosimilar market restructuring. The forum historically produces the sharpest public statements from PBM, manufacturer, and wholesaler executives about strategic direction. Watch for signals on how the Big Three PBMs plan to restructure compensation models ahead of the August 2028 delink deadline, and whether wholesalers announce further vertical integration into biosimilar manufacturing and physician practice ownership.
State 340B litigation trajectory—DOJ intervention signals
The Trump DOJ's brief supporting AbbVie against Colorado's 340B contract pharmacy law marks a potential inflection point. If the federal government continues siding with manufacturers in state contract pharmacy cases while simultaneously pursuing the HRSA-to-CMS transfer, the combined effect could preempt the state-level 340B access framework that covered entities have been building through legislation. The 5th Circuit's unanimous 2025 decision upholding Louisiana's law provides a strong counterweight, and several additional state cases (Vermont, Tennessee, Rhode Island) will produce rulings in 2026 that collectively determine whether state contract pharmacy protections survive federal challenge.
DATA SNAPSHOT
- CAA 2026 PBM reform: CBO scored at $2.12 billion deficit reduction over 10 years; $1.865B from commercial-market PBM oversight, $444M from Part D delinking (KFF). Civil penalties up to $10,000/day for transparency noncompliance. 100% rebate pass-through required by August 2028
- TrumpRx (1 month post-launch): ~43 drugs listed from 5 manufacturers (AstraZeneca, Eli Lilly, EMD Serono, Novo Nordisk, Pfizer). Pfizer listing 30 of hundreds of marketed drugs. Discounts range 33%–93% off list price, cash-only. GLP-1s at $149–$299/month (STAT News)
- Stelara biosimilar market: 12 biosimilars + 1 unbranded biologic. List price discounts 5%–90%. CVS blocking Cordavis sales data reporting since Jan 2025. Express Scripts 2026 formulary: brand removed, 3 ustekinumab products preferred (Drug Channels)
- MFN/GLOBE/GUARD: 16 voluntary MFN agreements signed. GLOBE (Part D) performance period begins Oct 1, 2026; GUARD (Part B) begins Jan 1, 2027. Both mandatory for eligible manufacturers, applied to ~25% of beneficiaries in randomized geographies (Crowell & Moring)
- 340B program (2024): $81.4 billion in discounted purchases (+23% YoY), accounting for nearly one-fifth of the $356B total gross-to-net bubble. 87% of purchases by hospitals. IRA provisions expected to begin compressing 340B margins in 2026 (Drug Channels Institute)
MARKET ACCESS POSITIONING HEATMAP
Winners this week:
- Plan sponsors / self-insured employers — CAA 2026 commercial-market reporting requirements (the $1.865B CBO score) give plan sponsors unprecedented visibility into PBM economics; smart employers will use 2026–2027 to renegotiate contracts before mandatory compliance
- Independent / transparent PBMs (Navitus, Capital Rx) — Already operating at or near flat-fee models; CAA 2026 levels the competitive playing field against Big Three PBMs that relied on rebate retention
- Community pharmacies — CAA 2026 pharmacy access protections and state-level anti-steering laws (Idaho, Arkansas) reduce PBM ability to funnel patients to vertically integrated pharmacies
- State attorneys general advancing 340B protections — 5th Circuit Louisiana precedent provides strong legal foundation despite DOJ intervention in Colorado; momentum continues with Washington, Rhode Island bills
Under pressure this week:
- High list-price / high-rebate manufacturers — PharmaVoice/Frier Levitt analysis makes clear: list-price-linked PBM fees are prohibited under CAA 2026; contract restructuring must begin now, not in 2028
- Cigna/Evernorth — CarepathRx acquisition deepens vertical integration precisely as Congress and the public demand transparency; the "quiet" disclosure strategy signals awareness of the optics
- TrumpRx / MFN initiative — One-month reality check reveals slow rollout, limited drug inventory, unfinished deals, and cash-only limitation that excludes insured patients; political utility may exceed practical impact
- 340B covered entities in states facing DOJ intervention — Trump DOJ siding with AbbVie in Colorado creates new legal risk for state-level contract pharmacy access frameworks
Neutral but pivotal:
- CMS Innovation Center (GLOBE/GUARD) — If finalized, these models apply mandatory international reference pricing without congressional action; comment period closed Feb 23, final rule expected mid-2026
- Manufacturers in IRA Cycle 2 negotiation — Health Affairs inhaler study suggests list-price cuts can accelerate generic/biosimilar uptake rather than protect share; 15 drugs in negotiation for 2027 MFP must weigh proactive price action against negotiation leverage
- PhRMA — Deflection strategy weakened now that PBM reform is law; 340B reform remains the sole active legislative target, but bipartisan congressional support for the program limits legislative pathway