How is it mid-November? I think of all of the things that need to get done by the end of the year and then try and pull out the productivity schemes (5 choices, pomodoro, eat the frog, etc.) I’ve learned over the years. The problem is that none of these create more time, just make better use of the same 24 hours. Onward!
I Wish I May, I Wish I Might. On Tuesday, the Center on Budget and Policy Priorities (CBPP) argued that expanding Health Savings Accounts (HSAs) won’t do much for Affordable Care Act (ACA) marketplace enrollees facing 2026 sticker shock. The group’s bottom line: HSAs skew benefits toward higher-income, healthier people and would not offset premium hikes if the enhanced premium tax credits lapse at year-end 2025.
Finalized 2026 rates point to unusually large increases on HealthCare.gov, and the ongoing shutdown drama has left subsidy extensions off any immediate deal, setting up significant net-premium jumps for millions. Without the enhanced credits, average payments for subsidized enrollees could more than double.
BUT THERE ARE NO EASY ANSWERS. The (long-term) answer is not premium tax credits or HSAs; the simple truth is we have an expensive system. That’s all of it – from hospitals, labs, doctors, drugs – all of it. We need to rebuild this sucker from the ground up, and that would take political will that just doesn’t exist. For now, keep an eye on whether Congress pairs any year-end budget maneuver with at least a temporary extension (seems unlikely); absent that, the market-level risk mix will get older and sicker as people go uninsured, pushing pressures into 2027 filings as well.
Budget Blues and Pharmacy Cues. On Thursday, KFF dropped its 25th annual 50-state Medicaid budget survey, and pharmacy shows up everywhere. States report FY 2025 actions and FY 2026 plans that lean on drug levers: tightening glucagon-like peptide-1 (GLP-1) criteria, expanding preferred drug list (PDL) management, and refining reimbursement mechanics (e.g., Colorado raised its Maximum Allowable Cost discount when Average Acquisition Cost or National Average Drug Acquisition Cost do not apply; Massachusetts is moving to tiered dispensing fees).
Several states are re-examining physician-administered drug reimbursement, with Delaware engaging a third party to identify efficiencies in FY 2026; others are tuning 340B. The issue brief quantifies the headwinds: state Medicaid spending growth of 12.2% in FY 2025, slowing but still high at a projected 8.5% in FY 2026 as enrollment levels off post-unwinding. For manufacturers: expect harder supplemental rebate negotiations, more state interest in outcomes-linked agreements (especially for cell and gene therapy), and closer scrutiny of claims. Bottom line: flat(-ish) enrollment does not equal a flat pharmacy trend – drug policy is the pressure valve that states are turning to next.
When Biosimilars Bring Receipts. On Tuesday, JAMA Network Open published a study using Medicare Part B Average Sales Price (ASP) data (Q1 2005–Q1 2025) to quantify how originator prices move after biosimilar entry across seven classes (bevacizumab, epoetin, filgrastim, infliximab, pegfilgrastim, rituximab, trastuzumab). The authors estimate originator ASP declines of ~7.4% at 1 year, ~31.7% at 3 years, and ~43.1% at 5 years after biosimilar launch. It shows that Medicare Part B is competitive – buy and bill does respond to market forces. The challenge is that we need to continue to support the biosimilar market because it can’t be just the existence of biosimilars that drives down reference product prices, but actual utilization.
Master Class on Drug Policy. On Tuesday, Brookings posted Marta Wosińska’s “Responses to Questions for the Record (QFRs)” from her Senate Special Committee on Aging appearance. It is dense (but great) reading for drug-policy watchers. The QFRs zero in on supply resilience for generics (especially in rural hospitals and clinics), incentives for active pharmaceutical ingredient manufacturing domestically, and strategies for making shortage mitigation more systematic (think transparency on quality metrics, targeted procurement reform, and contract terms that reward reliability).
Note the bipartisan appetite for tying purchaser behavior to quality and reliability signals. This isn’t the easiest bit of reading, but graduate school level education just waiting for your coffee and pastry on a lazy Sunday morning. Or is that just me?
Dementia Detectives. On Monday, JAMA Network Open published a randomized clinical trial testing a two-part, no-added-time approach to detecting Alzheimer’s disease and related dementias (ADRD) in primary care: the Quick Dementia Rating System (QDRS), a patient-reported tool, paired with a Passive Digital Marker (PDM) built from electronic health record data. The combined workflow increased new ADRD diagnoses versus usual care, with QDRS completion taking under three minutes and the PDM operating in the background.
The authors and the companion release emphasize scalability: both elements can be embedded in existing systems without extending clinician visits, which is critical as health systems confront growing diagnostic demand. For payers, earlier and more consistent identification can reshape risk adjustment, care planning, and prior authorization pathways for cognitive evaluations and new therapies. For primary care, the attraction is a zero-new-minutes workflow. Caveats remain, but how cool is this? We need to start talking more seriously about brain health and how to pull it into primary care without overtaxing the system, and this is one important step.
The Fundamentals – Food and Drug Administration (FDA) National Priority Review
I am fascinated by the FDA’s new Priority Review Voucher program. This initiative isn’t a tweak; it’s a commitment to a one- to two-month review cycle, effectively shaving crucial launch preparation time off the standard process. It’s a significant carrot, offered to sponsors whose drugs align with critical national objectives: unmet medical need, innovation, affordability, and domestic manufacturing.
The voucher program is like a high-speed sprint for the agency and manufacturers. Crucially, the voucher is a logistical tool, not a regulatory waiver. It is not supposed to lower the bar for evidence or dictate list price – its purpose is to pull forward the timeline for reviewer engagement and, ultimately, the final approval decision.
Looking at the initial slate of fifteen winners reveals that there is no pattern; the common thread is the absence of one. We see the groundbreaking potential of a gene therapy restoring hearing in otoferlin-related deafness, demonstrating visible functional gains. We see familiar drugs like teplizumab expanding its reach in Type 1 diabetes, and critical public health interventions like a new nicotine/vaping cessation drug. Alongside these are national security plays, such as on-shoring the domestic manufacturing of key generics like ketamine and Augmentin XR. The breadth of scope signals the FDA’s commitment to varied national interests.
But the accelerated FDA timeline creates a potential logistics crisis for manufacturers. Where companies once relied on months of behind-the-scene efforts during the FDA review period, they must now compress critical operational tasks.
A faster approval also means a launch team cannot afford to wait. The logistical dominoes must fall far sooner: manufacturing capacity must be locked down, distribution agreements finalized, data returns established and reimbursement tables loaded into claims processing systems. Failure in any of these areas risks turning the patient’s exciting day-one availability into a corporate and patient nightmare — a case study in day-one confusion, where early fills simply bounce.
This speed also creates an awkward disconnect with the payer environment. Pharmacy & Therapeutics (P&T) committees and Drug Utilization Review (DUR) boards, the gatekeepers of coverage on the payer side, typically meet on monthly or quarterly cycles. A one- to two-month FDA review can easily land between these critical meetings, leaving payers unable to finalize their policies.
The inherent tension is clear: expedited regulatory review versus standard commercial policy review. If payers react to the speed with skepticism, viewing the fast track as a compromise, they may delay coverage decisions. Without an equally expedited path from payers, new products inevitably enter distribution before policy is live. National Drug Codes (NDCs) flow into compendia and wholesaler files within days, and claims systems immediately recognize the drug. If coverage details like tiers, prior authorization requirements, step therapies, and coinsurance amounts are not set, early claims will either pay or deny under default rules.
Price dynamics sit uncomfortably in the background of this entire program. While the voucher does not set list price, affordability is named as a selection factor. This public mention creates a visible expectation that sponsors cannot ignore.
Sponsors must decide early whether to deploy bridge discounts to smooth patient access, or hold the list price steady and manage the net price through targeted contracting. The shorter runway leaves less time to convert initial interest into signed payer agreements. This compressed cycle can paradoxically keep net prices higher at the start, even if the list price remains stable, as the time to negotiate favorable contracts simply runs out.
The FDA has sped up the clock, but the rest of the ecosystem is struggling to keep pace. The coming months will reveal whether this speed creates genuine patient access, or a new form of commercial launch chaos.
