A new obesity drug launches Phase 3 the same day a hundred-percent pharma tariff switches on. Great timing. And both parties just found a villain in the middle: PBMs. It's GLP-1 Daily. Today, who ends up paying for the plumbing? First, Zealand and Roche, and what a real Phase 3 looks like. From Charlie King at Medical Update Online:
The Phase 3a program for petrelintide monotherapy, which is being conducted with Zealand Pharma’s partner Roche, consists of three trials: Zupreme-3, Zupreme-4, and Zupreme-5, evaluating the efficacy and safety of once-weekly petrelintide versus placebo in people with obesity or overweight without type 2 diabetes, people with obesity or overweight with type 2 diabetes, and people with obesity or overweight and established cardiovascular disease, respectively.
Zupreme-5 is the one I'm circling. Obesity plus established cardiovascular disease. That arm is what eventually decides whether a payer files petrelintide under heart drug or under lifestyle drug. And give Zealand and Roche their due here. Three double-blind, placebo-controlled trials, roughly seven thousand people, split by type 2 diabetes and heart disease. That's what a registrational program is supposed to look like. Still, 'clinically meaningful double-digit weight reduction' is just Zealand's CMO talking up Zealand's own earlier data. 'First-choice potential.' First choice for whom? If the patients on the thinnest coverage aren't enrolled in that cardiovascular arm, they won't show up in the coverage argument five years later either. I'd push back a little. Enrollment diversity matters, but what actually moves a formulary is the label claim, and you get that by powering the CVD trial right. Roche didn't sign on to build a niche product. From Molly Klote at Chemistry Today:
On 29 September 2026, the broader phase of the Section 232 pharmaceutical tariff regime takes effect. Imported patented medicines and covered ingredients become subject to a baseline 100 percent rate, except where a country-specific rate, an approved onshoring plan, a company agreement, an applicable exclusion or zero-rate provision, or another tariff heading applies
So as of today, September 29th, imported patented medicines and their covered ingredients hit a 100 percent baseline tariff. Now read the exceptions: approved onshoring plan, company agreement, country-specific rate. Who has the lawyers to negotiate a company agreement? The companies already selling the most GLP-1s. And the patient on thin coverage is the one who never gets a carve-out. Molly Klote, who used to run HHS's human research protections office, says in Chemistry Today the rates are the least interesting part. What matters is where in a chemical synthesis the substantial transformation happens, and what a company has to prove about every step before it. Which lands hard on anyone trying to launch a cheaper version. Mylan could win every patent fight and still owe on imported ingredients unless the transformation happens here. Here's what worries me more. Her argument is that the tariff, BIOSECURE, and FDA PreCheck each measure dependency differently, and none of them look below the API. So we could cut ribbons on shiny domestic plants that still run on the same upstream chemistry from the same places. And nobody's shown me a GLP-1 price that's moved because of this yet. Give it a quarter. From Dagens Diabetes:
This year’s European Association for the Study of Diabetes (EASD) 2026 Annual Meeting in Milan, Italy, (from September 28 to October 2) will feature new data on first-line treatment approaches for both type 1 diabetes (T1D) and type 2 diabetes (T2D), with a focus on recent trial results, diabetes complications, emerging technology, and obesity management.
Milan's on day two of EASD, running through Friday, and the incretin lineup reads like a pipeline roll call. Retatrutide, tirzepatide, orforglipron, survodutide, trevogrumab. Five names, and not one of them has a formulary tier yet. For me, the big one is the joint EASD-ADA consensus on type 2, presented and published the same day. The preview says first-line therapy may tilt toward GLP-1s or SGLT2 inhibitors, with metformin's role re-evaluated. Which lands right on every step-therapy form that opens with 'has the patient tried metformin?' Plans love quoting the ADA. Let's see if they still do when the ADA moves. And the cardiovascular and renal data coming out this week feed straight into the case for the roughly 700,000 seniors on Medicare's temporary access pathway. The evidence gets built in Milan while their clock's already running. Caveat: all of this is still billed as a preview until it's actually on the podium. KFF Health News, with Blake Farmer:
PBMs were conceived as a way to manage prescriptions and hold down costs. But these middlemen have become bipartisan punching bags, accused of sucking up profits at the expense of employers, governments, and patients. And while healthcare debates still divide Democrats and Republicans in Washington, D.C., taking on PBMs has become a unifying cause in an era of widespread frustration over rising healthcare costs.
Tennessee couple, married thirty-five years. She's a Republican, he's a Democrat, and the one thing they agree on? Per KFF Health News: 'We hate CVS.' And honestly, look at the org chart. Aetna, Caremark, and the biggest retail pharmacy chain in the country, all under one roof, four hundred billion in revenue last year. Tennessee wants to bar PBM owners from owning the stores. Which fixes getting steered to a CVS counter. Great. It doesn't touch the formulary, and it doesn't touch the patient with no diabetes code on her chart. Every state's already restricted PBMs, and I can't point to one Wegovy denial that got reversed because of it. So make it touch them. If lawmakers are finally reaching into the PBM layer, put the obesity-drug prior-auth criteria written before the phase three data existed in the bill. Otherwise this is a pharmacy-ownership fight with GLP-1 patients watching from the parking lot. Miranda McLaren, writing in Pharmaceutical Technology:
Notably, the company stated that over 80% of the prescriptions were for patients new to GLP-1 receptor agonists. This attests to the power of OSD pharmaceuticals. Not only do oral drugs address access barriers linked to needle aversion (an affliction that 20% to 30% of young adults are estimated to have)
Pharmaceutical Technology on scaling oral GLP-1s, and the number up top is Novo's own: three million U.S. semaglutide tablet scripts in just over five months, per the company's June announcement. Over eighty percent went to people who'd never been on a GLP-1. That's the part I'd actually believe, even discounting the source. Twenty to thirty percent of young adults are estimated to be needle-averse. A pill reaches people a pen was never going to. Reaches them how, though? A brand-new patient with no diabetes code on the chart is exactly who gets bounced at prior auth. Eighty percent new tells me demand. It doesn't tell me who paid. Fair. But this piece finally gives me something I've been wanting: the manufacturing ramp instead of the investor slide. Actual constraints on the table. Component shortages, anti-counterfeiting, low-volume runs at the CDMOs. And that matters for Mylan too. Clear every Novo patent you want, you still need a blister line and packaging supply that can scale. Stack that on the supply-chain piece we just hit. Legal wall, packaging wall, import-cost wall. Every one of those lands hardest on the patient with the thinnest plan. If you're finding GLP-1 Daily useful, subscribe or leave us a review wherever you're listening. Reviews help other people find the show, and we really appreciate it.
At EASD 2026 in Milan, running through October 2, watch for the final joint EASD/ADA type 2 diabetes consensus, set to be presented and published, plus incretin data on retatrutide, tirzepatide, orforglipron, and survodutide.
Links to every story are in the show notes, so dig into whatever caught your attention. That's GLP-1 Daily for today. This is a Lantern Podcast.