MARKET ACCESS INTELLIGENCE • Weekly Digest • May 1, 2026

340B DOJ tells federal judge Washington's 340B contract pharmacy law is unconstitutional—federal government now intervening against state protections in three states

340B Report reported that the Justice Department filed a brief in the Novartis v. Brown lawsuit arguing that Washington state's SB 5981 is preempted by federal law. Law360 confirmed the filing, noting DOJ argued that federal law preempts the state statute that expands discounts manufacturers must provide under 340B. Washington's law, signed by Governor Ferguson on March 12, prohibits manufacturers from restricting contract pharmacy access and bars them from conditioning drug deliveries on claims data submissions. It carries penalties of up to $5,000 per day per violation and was set to take effect June 10, 2026. The law faces four separate lawsuits: from Novartis, AbbVie, PhRMA, and a manufacturer coalition. AbbVie's filing estimated the law would cost it tens of millions in unrecoverable discounts, with 340B discounts running around 60% of market value.

Policy PCMA: CAA 2026 delink is "Big Pharma's big win"—PBM lobby reframes the reform it fought against as a manufacturer giveaway

PCMA published an analysis arguing that the most consequential provision in the CAA 2026 PBM reform was not transparency or rebate pass-through—which PCMA claims PBMs were already implementing voluntarily—but the delink requirement itself. PCMA frames delinking as a victory for pharmaceutical manufacturers because it eliminates PBMs' ability to use rebate-driven formulary competition to drive down net drug costs. The blog argues that without percentage-based rebate incentives, PBMs lose their primary tool for pressuring manufacturers on price, effectively removing the competitive mechanism that produced the gross-to-net bubble but also generated significant savings for plan sponsors. PCMA's analysis implicitly concedes that PBMs passed through nearly 100% of rebates to employers, while arguing the real value was in the negotiating leverage that rebate-based compensation created.

340B Bipartisan House bill would exempt smaller covered entities from 340B rebates—first legislative acknowledgment that one-size-fits-all doesn't work

340B Report reported that Representatives Bergman (R) and Ruiz (D) plan to introduce bipartisan legislation exempting a range of covered entities—but notably not major hospitals—from the 340B rebate model. The bill would preserve upfront discounts for FQHCs, rural hospitals, and other smaller safety-net providers while allowing the rebate model to proceed for larger hospital systems. This represents the first Congressional acknowledgment that HRSA's rebate pilot cannot be applied uniformly across the 340B program's diverse provider landscape. The bill's bipartisan sponsorship suggests genuine legislative viability rather than messaging positioning.

FORMULARY & BIOSIMILARS

• 340B Stemline Therapeutics becomes 41st drugmaker to impose 340B contract pharmacy restrictions — The New York-based oncology company's restrictions on a breast cancer treatment bring the total number of manufacturers with active 340B contract pharmacy limitations to 41. The steady accumulation of restrictions—now spanning oncology, immunology, rare disease, and metabolic therapeutics—means covered entities must manage different access rules, data requirements, and attestation formats across an increasingly fragmented manufacturer landscape.
• Biosimilar Amgen: Repatha sales up 34% to $876M as Prolia biosimilar erosion hits Q1 (FiercePharma) — Amgen's Q1 2026 results show the two-speed biosimilar economy in action. Repatha (cholesterol) surged 34% to $876M on expanded cardiovascular indications and formulary wins. Prolia (osteoporosis) faced biosimilar competition including CVS/Cordavis's private-label denosumab, with Amgen relying on newer products to offset LOE erosion. The divergence illustrates how biosimilar impact varies dramatically by therapeutic class, payer mix, and manufacturer response strategy.
• Formulary Drug Channels: Beyond formulary access—building manufacturer DTC and employer commercial platforms — GoodRx's Chief Commercial Officer argues that manufacturers must move beyond payer-centric models toward integrated direct-to-consumer and employer channel strategies. The analysis reflects a broader structural shift: as PBM reform eliminates rebate-driven formulary placement, manufacturers need commercial platforms that reach patients and employers directly rather than through the PBM intermediary. This accelerates the DTC pharmacy trend that Amazon, Mark Cuban Cost Plus, and Walmart have driven since 2023.
• ICER AMCP launches CHROME cardiometabolic research initiative — The multisite initiative evaluates real-world outcomes for comprehensive cardiometabolic care models, reflecting payer interest in building the evidence base for GLP-1 coverage decisions beyond obesity and diabetes. With GLP-1 drugs driving 60% of retail pharmacy revenue growth over five years, managed care organizations need outcomes data to justify formulary expansion into cardiovascular risk reduction.

PRICING & REIMBURSEMENT

• Pricing Drug Channels: Where gross-to-net pressure actually lives after launch — ConnectiveRx's analysis documents that many gross-to-net exposures now occur at the claim level, where evolving payer tactics, pharmacy benefit design changes, and channel-specific rebate dynamics create unpredictable margin compression. The analysis is particularly relevant post-CAA 2026, as delinking PBM compensation from drug prices will shift where in the supply chain GTN pressure concentrates—potentially moving it from rebate negotiations upstream to claim-level adjustments downstream.
• Policy AstraZeneca CEO: "conservative" MFN model excludes reference markets from forecast (FiercePharma) — Pascal Soriot revealed that AstraZeneca is modeling MFN impact by removing the eight reference countries from its revenue forecast entirely—a conservative assumption that assumes full MFN-linked price cuts in those markets. This is the first public disclosure of how a major manufacturer is quantifying MFN exposure at the enterprise level, and it confirms that MFN is driving material changes in global revenue planning, not just U.S. pricing strategy.
• Pricing CMS issues status update on BRIDGE demo and BALANCE model in Part D for CY 2027 (AMCP) — CMS's update on the Part D demonstration models signals continued experimentation with benefit design and cost-sharing structures ahead of the full CAA 2026 implementation. Market access teams should monitor whether BRIDGE and BALANCE models create differential formulary incentives that advantage or disadvantage specific therapeutic classes in 2027 plan year designs.

POLICY & REGULATORY

• Policy Cigna will exit ACA individual markets in 2027, affecting 369,000 enrollees (STAT News, April 30) — Cigna's exit follows the Congressional failure to extend enhanced ACA premium subsidies, which had been driving enrollment growth. ACA membership is declining as affordability erodes, and Cigna's departure leaves 369,000 people searching for coverage in a shrinking individual market. For drug manufacturers with ACA formulary positioning strategies, Cigna's exit reshuffles the covered-lives denominator and concentrates remaining ACA volume among fewer carriers.
• Policy AHA seeks en banc review of 4th Circuit West Virginia 340B ruling (April 17) — AHA, 340B Health, and ASHP filed an amicus brief arguing the 2-1 panel decision conflicts with the 4th Circuit's own precedent and diverges from the 5th and 8th Circuits. If the full court agrees to rehear, it could narrow the circuit split and delay the path to Supreme Court certiorari. If denied, the split deepens and a cert petition becomes more likely by late 2026.
• Policy PBM lobbyists push back hard on DOL commercial transparency proposal (STAT News, April 20) — Over 500 comment letters on the DOL's proposed per-drug remuneration disclosure rule for self-insured employer plans revealed deep industry fault lines: PBMs and insurers opposed, Mark Cuban Cost Plus and employer advocates supported, and pharma manufacturers selectively cheered PBM scrutiny while opposing their own pricing data disclosure. If DOL finalizes alongside CAA 2026 and reconciliation spread pricing provisions, PBMs face transparency across every market segment simultaneously.
• Pricing AJMC AXS26 experts flag structural contradiction: CAA 2026 delink rules designed for a pricing environment that no longer exists — AJMC's conference coverage documented policy experts warning that MFN pricing, IRA Maximum Fair Prices, and state affordability board upper payment limits all depend on rebate-type pricing arrangements—even as federal reform is designed to discourage rebates. The contradiction means a second round of legislative refinement is likely necessary before the current reforms are fully implemented.

WHAT TO WATCH NEXT

Washington state 340B litigation—four lawsuits, DOJ intervention, June 10 effective date

Washington's SB 5981 faces four separate lawsuits (Novartis, AbbVie, PhRMA, manufacturer coalition) plus a DOJ brief arguing preemption, all before the June 10 effective date. The 9th Circuit has not yet weighed in on 340B contract pharmacy preemption, making Washington the test case for the largest remaining circuit. If the district court grants a preliminary injunction blocking the law before June 10, it joins the 4th Circuit's preemption position. If the court allows enforcement to begin, it aligns with the 5th and 8th Circuits—and the circuit split widens further.

CAA 2026 delink implementation—the structural contradiction deepens

The emerging consensus among policy analysts (AJMC, Pharmaceutical Commerce, Mintz, Groom Law Group) is that the CAA 2026 delink framework cannot coexist with MFN pricing without further legislative adjustment. CMS must issue implementing guidance before the August 2028 compliance deadline, but the structural tension between delinked PBM compensation and government pricing mechanisms that depend on rebate-type arrangements will force either legislative refinement or regulatory workarounds. Monitor CMS rulemaking for signals of how the agency plans to reconcile these conflicting mandates.

Bergman-Ruiz 340B rebate exemption bill—bipartisan path or messaging vehicle?

The bipartisan sponsorship distinguishes this bill from the partisan 340B proposals that have characterized this Congress. If the bill advances through committee, it creates the framework for a two-tier 340B structure that could represent the realistic legislative compromise: upfront discounts preserved for safety-net providers, rebate model applied to larger hospital systems. Watch for co-sponsor accumulation and committee scheduling as indicators of whether this is a serious legislative vehicle or a positioning statement.