We have some new folks around these parts so quick intro. I’m Jennifer Snow. I’ve spent 25 years inside the U.S. pharmaceutical policy world, not watching it from the outside, but sitting in the meetings, reading the rules, and translating what they actually mean for the people whose drugs are on the line.

I’m not a lobbyist. I’m not going to give you a neutral take on something that isn’t neutral.

IRA negotiations, 340B fights, PBM reform. I take that dense, politically charged stuff and tell you what it means for coverage, access, and your commercial strategy. Not someday. Now.

For most clients, that starts with a monthly Policy Intelligence Briefing: a dedicated session where I translate what’s happening in the policy landscape into what your organization actually needs to do about it. Some want that in a shared format; others need it fully customized to their portfolio. I also get brought it as a deeper strategic partner or a one-time white paper or board briefing.

AMP is WAC is my way of cutting through the noise. You’ve got better things to do.

QALY-fied to Decide? Late last week, an article in AJMC makes an argument that sounds simple but has real policy weight right now: when the U.S. uses foreign health technology assessment (HTA) frameworks to set drug prices, it’s not just borrowing a methodology. It’s importing a set of values that don’t match what American patients actually say they want.

The piece is authored by researchers affiliated with the National Pharmaceutical Council, so yes, there’s an industry viewpoint here. But the argument is worth taking seriously on its merits. Foreign HTA bodies, the UK’s NICE, France’s HAS, Canada’s CADTH, are funded by governments with fixed health budgets. Their job is to allocate within a cap. That structurally forces them to measure value in narrow terms: average clinical benefit, cost per quality-adjusted life-year, net cost to the national system. The QALY, in fact, is a metric that Congress has already prohibited Medicare from using in a way that discriminates against elderly or disabled patients.

When you ask American patients, they point to a much wider set of priorities: treatment autonomy, caregiver burden, the “value of hope” in severe disease, the option value of staying alive long enough to access the next therapy. The research backs this up. Across cancer, rare disease, and chronic conditions, patients consistently rank these priorities well above what HTA bodies typically capture.

Most Favored Nation (MFN) pricing models like GLOBE, GUARD, and GENEROUS, are explicitly designed to tie U.S. prices to what foreign governments pay. The price isn’t the only thing being imported, the value framework (and its priorities) comes with it.

If I had a Billion Dollars…We’ve known for a while that 340B creates winners and losers. Employers lose rebates when drugs are dispensed through 340B channels. State Medicaid programs often can’t capture their share of the discount. Now there’s a number for one more victim category: state employee health plans.

A new IQVIA analysis puts the figure at $1 billion in additional spending attributable to 340B overcharges across state employee health plans. That’s the aggregate, but the more useful part of the analysis is the state-by-state breakdown, which is exactly the kind of data that makes a state budget director anxious. When you can tell a state comptroller what 340B is costing their plan specifically, you’re having a different conversation than when you’re talking in national averages.

Covered entities, hospitals and health systems eligible for 340B discounts, acquire drugs at sharply reduced prices. When those drugs are dispensed to patients covered by state employee plans, the entities often bill at rates tied to list price or commercial benchmarks. The plan pays close to full price. The covered entity keeps the spread. The state employee health plan subsidizes the covered entity’s margin.

The question policymakers haven’t answered is what to do about it, because covered entities argue, often accurately, that they use those margins to cross-subsidize uncompensated care. The data doesn’t resolve that tension; it just makes the cost of ignoring a lot harder.

Show Me the Money. On Sunday, Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy (R-LA) sent a letter to Apexus, the Health Resources and Services Administration’s (HRSA) contractor running the 340B Prime Vendor Program, asking questions that go straight to the program’s operations: who gets paid, how, and with what guardrails.

The letter’s focus is incentive alignment and transparency. Cassidy asks Apexus to produce organizational charts, describe internal “firewalls,” and explain how data and decision-making are segregated from Vizient (Apexus’s parent). The document drills into conflicts-of-interest controls required under the Prime Vendor Agreement, including whether any 340B purchasing data is shared in ways that could advantage affiliated entities. It also requests information on administrative fees charged to covered entities, manufacturers, or distributors and asks for documentation on “share back” amounts moving through Vizient’s ownership structure.

This is oversight of a part of 340B that typically operates in the background: the entity that sits at the center of contracts, distribution solutions, and operational guidance. Cassidy’s framing is blunt: 340B has grown dramatically, and the public record on how core contractors profit, firewall data, and influence program behavior is thin. The letter itself won’t rewrite statute. But it does create some public accountability which has been missing.

Halfsies. On Tuesday,Axios reported that telehealth company eMed is partnering with CVS Caremark to offer employers a middle-ground option. Workers at participating employers can buy GLP-1s through eMed’s platform at what the company calls the most cost-effective prices currently available, outside of the employer’s main health plan. They get clinical support, side-effect management, weekly check-ins, and biannual blood testing. The employer doesn’t carry the full coverage cost. The employee gets access and wraparound services.

Axios notes the baseline constraint: fewer than 20% of employers covered GLP-1s for weight loss last year, citing the Kaiser Family Foundation (KFF), and some who tried it later backed away under cost pressure.

The policy-interesting question is the channel economics. GLP-1 volume is the kind of spend that shapes pharmacy benefit manager (PBM) leverage, rebate strategies, and formulary positioning. A carve-out approach pulls volume away from the traditional benefit, weakening the rebate-driven bargaining unit that PBMs use to negotiate. CVS Caremark’s involvement reads like a hedge: stay attached to the transaction even if the transaction migrates. If these “controlled leakage” models scale, the benefit channel doesn’t just manage GLP-1 costs, it slowly loses ownership of them.

Regret, I’ve had a Few.  On Tuesday, Senate HELP Committee Chair Bill Cassidy released a report laying out more than a dozen legislative and regulatory recommendations for modernizing the Food and Drug Administration. Nearly 20 pages. Bipartisan framing. Almost no chance of passing intact in this Congress.

The headline theme is predictability: reduce the “black box” feel of review, speed access, and tighten the signal to innovators about what evidence will meet the bar. The document explicitly describes inconsistent processes as a tax, especially on small and mid-sized companies that can’t afford regulatory ambiguity.

Substantively, the report pulls in several pharma-relevant levers; biosimilars and generics get a full section, including FDA’s October 2025 biosimilar guidance and the continuing debate over whether “interchangeability” should remain a separate designation.  

Politically, the package is less a near-term legislative vehicle than a menu for future attachments. Comprehensive FDA reform rarely moves as one bill; pieces get stapled onto user-fee reauthorizations or narrower must-pass items. The report’s real function is agenda-setting: it formalizes priorities, gives staff language to work with, and signals that FDA process, not just drug pricing, is back on the HELP Committee’s menu.

Good Cop, Bad Cop? PhRMA’s annual forum this week produced a split screen that tells you a lot about where the industry’s real anxieties are right now. CMS Administrator Mehmet Oz showed up warm, collegial, and open to closed-door meetings. FDA Commissioner Marty Makary showed up.

Makary got pressed on several fronts. His agency hasn’t reviewed Moderna’s new flu shot application, with his deputy Vinay Prasad apparently declining to engage with it. He defended narrower childhood vaccine schedules. And he reiterated his push to move drugs over-the-counter unless they’re unsafe or addictive, pointing specifically to nausea medications and vaginal estrogen as candidates currently in regulatory process.

The OTC push has real commercial stakes for manufacturers, not just ideological ones. When a drug goes OTC, the manufacturer loses the prescription channel, and with it, the ability to price to insurance, collect rebates, and maintain formulary positioning. Plus patients can lose insurance access and be forced to pay cash, which may be more than their current out of pocket. PhRMA filed formal comments opposing OTC transitions without manufacturer consultation.  

Oz, by contrast, is playing a longer game with pharma. He signals accessibility and partnership. Is it true? Maybe, but he is playing nice. Makary is signaling disruption in ways that heighten uncertainty. That’s not great for manufacturers or, quite frankly, patients.

If it Was Easy. Illinois advocates and AARP held a press conference this week urging passage of HB 1443 or SB 66, which would establish a Prescription Drug Affordability Board (PDAB) in the state. The pitch centers heavily on Colorado’s experience, specifically, the $32 million in savings the Colorado PDAB says they will generate by setting an upper payment limit for a single drug, Enbrel, based on the IRA’s Maximum Fair Price.

It’s worth pausing on what that evidence actually shows. Enbrel is a biologic facing heavy biosimilar competition, well past patent life, already losing market share on price. It tells you almost nothing about what a PDAB with broader authority would do to a novel therapy still in its commercial launch window, where pricing flexibility is what enables manufacturers to recoup the R&D investment and fund the next one.

Manufacturers facing price caps in commercial channels have options: they can restrict distribution, delay launch, or deprioritize markets where the return on investment doesn’t pencil out. That’s not a hypothetical, it’s what happens in countries with government price controls, and it’s why American patients currently get access to new drugs faster than patients in most of the countries whose pricing models MFN proposals want to import.

Federal Medicaid cuts under discussion in Congress are creating real urgency for states to find fiscal headroom on drug costs. That political pressure is real. But the Colorado PDAB’s potential $32 million on a single off-patent biologic is a thin foundation for extending price-setting authority into the commercial market of the country’s fifth-largest state.

Reimbursement Fundamentals: Call it what you’d like, it’s still a UPL

This week a paper I wrote with the Rare Access Action Project is out, and I want to walk you through it, because the issue it addresses is coming up a lot right now.

Truth — States are under real pressure to act on prescription drug costs. And as they look around for tools, Medicare’s Maximum Fair Price (MFP) keeps surfacing as an attractive model for prescription drug affordability boards (PDABs). It’s visible. It’s branded as “negotiation.” It has the political credibility of the Inflation Reduction Act behind it.  It makes sense that state legislators and their staffs are asking: why can’t we just do that here?

My paper argues that they can’t.

Medicare’s MFP is not a pricing benchmark you can lift and drop into a different system. It works because of where it sits. CMS negotiates as the single largest purchaser of prescription drugs in the country. Manufacturers aren’t just choosing whether to accept a lower price in one corner of the market. They’re deciding whether to participate in Medicare at all. If they don’t play ball, all their drugs lose Medicare coverage and they face severe financial penalties. That’s real leverage. States don’t have anything like it.

ERISA alone removes huge chunks of the commercial market from state authority. Even for fully insured plans, state reach is fragmented across payers, benefit designs, and employer arrangements. A manufacturer facing a state-imposed pricing limit doesn’t face the same binary choice they face at the federal level. They can decline and still sell to most of their patients in the state.

There’s also a more structural problem that doesn’t get enough attention. Medicare’s MFP operates as an acquisition price. It changes what pharmacies and wholesalers actually pay for the drug. That’s what CMS negotiates. PDABs, by contrast, can only set upper payment limits (UPLs), which cap what plans may reimburse. They cannot require manufacturers to sell at a given price to distributors. When a state sets an MFP-benchmarked UPL, the supply chain still has to acquire the drug at whatever price it’s selling for. If reimbursement doesn’t reliably cover acquisition costs and overhead, providers start making decisions about whether to stock, schedule, or offer certain therapies at all. Patients feel that as delays, referrals, and gaps in local access.

None of this means states are stuck. States can target patient out-of-pocket costs directly, using benefit design tools like cost-sharing caps and smoothing mechanisms that address affordability where people feel it, without imposing upstream price controls that create access risk downstream. They can push for PBM transparency and pass-through requirements that make sure negotiated savings flow to patients instead of sitting elsewhere in the system. For high-cost, low-volume therapies, risk pooling and reinsurance treat budget volatility as a financing problem rather than a reimbursement-cap problem. These approaches are genuinely different from what state PDABs have been pursuing, but they’re more likely to work without the access consequences that come with reimbursement ceilings that don’t match acquisition economics.

The thing I keep coming back to is this: MFP’s appeal to state policymakers is understandable precisely because it looks like something already proven. But it’s proven inside a closed federal system with national scope, statutory enforcement, and the ability to redesign coverage and payment rules around the negotiated price. Outside that system, it’s just a number. And in state markets, applying that number as a reimbursement ceiling produces the same problems any UPL produces: financial pressure moves downstream, providers absorb the gap or don’t, and patients end up in a system that’s managing affordability by shifting risk and friction onto them rather than resolving cost at the source.

That’s not a drug pricing solution. It’s a different kind of access problem.