Newsletter · · Ashutosh Agarwal

Medicare's Part B International Price Test Shrinks to Four Companies - Drug Pricing & IRA Round 2: Weekly - Week of September 28 to October 5, 2026

Drug Pricing & IRA Round 2 for the week of September 28 to October 5, 2026. Podcast synthesis on CMS finalizing the GLOBE Part B international-pricing model and then exempting most of the industry, cutting projected savings from $11.9 billion to $400 million, plus Boehringer on slower launch ramps, the economists' case that most-favored-nation pricing shrinks Europe, 340B tightening, and GLP-1 patent and marketing shifts.

Drug Pricing & IRA Round 2: Weekly

Week of September 28 to October 5, 2026: Medicare's Part B International Price Test Shrinks to Four Companies

Last December, Medicare proposed a mandatory experiment that would tie what it pays for doctor-administered drugs to the prices other rich countries pay. Officials said it would save $11.9 billion.

This week CMS (the Centers for Medicare & Medicaid Services, which runs Medicare) published the final version. The savings estimate is now $400 million, a 97% cut. The reason is that nearly every big drugmaker has signed a pricing deal with the White House since then, and those companies are exempt.

"In the final rule... that leaves only about four manufacturers left who would be covered by GLOBE." Kathy Kelly, Pink Sheet senior writer, on Citeline Podcasts – Drug Fix (Oct 2)

That is the story of the week, and it says something bigger than the rule itself. The government's toughest pricing threats, GLOBE for Part B and the pending GUARD model for Part D, worked mainly as pressure to get companies to sign voluntary "most favored nation" (MFN) deals. They have now done that job. The rest of the week fills in the cost: an executive at a large private drugmaker described launching drugs that are "blocked until you negotiate," economists argued that MFN will make companies hold back European launches, and drugmakers kept pressing the 340B discount program.

TL;DR

  • CMS finalized GLOBE, its mandatory Part B international-pricing model, and then exempted most of the industry. Companies in the separate Medicaid MFN model (called GENEROUS) are excluded. So are orphan-only drugs, drugs with generic or biosimilar competition, and drugs that already have Medicare negotiated prices. Projected savings fell from $11.9B to $400M over seven years. Only about four manufacturers remain in scope; the transcript names Biogen, Takeda and Daiichi Sankyo. (Citeline – Drug Fix, trade journalists)
  • There is a catch in the timing. The exemption only applies in quarters when a company is in GENEROUS. That model ends in September 2030, but GLOBE runs to March 2032. Unless GENEROUS is extended, every MFN signer could fall under GLOBE for roughly 18 months. It works as a check on companies that might drop their deals after President Trump leaves office.
  • The Part D version (GUARD) is still pending. The Pink Sheet team expects it to wait until after the midterms, because CMS's own proposal admits it "will actually raise costs for beneficiaries."
  • A Boehringer Ingelheim executive (operator) put numbers on the squeeze. BI was "one of the 17 companies that were approached by the administration for that initial MFN deal" and is "the only company that's had three products negotiated" under the IRA. On launches: "the drug is blocked until you negotiate." That slows the early sales ramp that used to set peak sales. (Citeline – Strategic Intent)
  • The case that MFN shrinks Europe. On Vital Health Podcast, two health economists (commentators) said European prices for a 44-drug group went from 40–45% below US prices in 2005 to 65–75% below by 2020. Their point: under MFN, companies have a reason to skip low-price markets to protect the US, where "about 85% of all their profits come from."
  • 340B pushback keeps spreading. Eight manufacturers now require claims data from hospital- and clinic-owned pharmacies as a condition of 340B pricing. In Tennessee, the attorney general got one company to back down. (340Banter, compliance operators)
  • GLP-1s: patents and marketing. Viatris is challenging a Novo Nordisk semaglutide weight-loss patent that runs to October 2038 (On The Pen). STAT reports Novo is now openly calling its drugs "weight loss drugs" in ads ("Live Lighter," "Summer Glow Up") as insurance coverage stalls and sales shift to cash-pay (The Readout Loud).
  • IRA Round 2, the 2028 list and the EPIC Act: quiet, no updates. No podcast covered negotiation offers, the Part B drugs on the 2028 list, or the "pill penalty" fix. The 100% pharma tariff, which was due to start September 29, also got no substantive podcast coverage this week.

What's new

Ranked by how much it matters for a pharma long/short book.

1. GLOBE is final, and it was mainly a threat

Who's talking: Derek Ingerie, Kathy Kelly and Sue Sutter, editors and writers at Pink Sheet, on Citeline Podcasts – "Drug Fix: CMS Finalizes GLOBE Model And US FDA Adcomm, Personnel Changes" (Oct 2). They are specialist regulatory journalists, so they count as commentators, but they are the most careful readers of CMS rules on this beat.

What GLOBE is. It is a demonstration program that tests "international reference pricing for drugs covered by Medicare Part B. Those are the physician administered drugs." International reference pricing means setting what Medicare pays based on what other countries pay. And "GLOBE... is a mandatory model. It's not voluntary." Drugs qualify once they reach "spending levels of over a hundred million a year."

What the final rule exempts:

  • Companies in GENEROUS, the Medicaid MFN model that the White House deal signers joined. This is the big one.
  • Orphan-only drugs. This was added after the proposal "in an abundance of caution," because CMS accepted that the model could "disincentivize the development of orphans."
  • Drugs with generic or biosimilar competition.
  • Drugs with Medicare negotiated prices, meaning IRA drugs are not hit twice.

The result:

"The demonstration is expected to save $400 million over the seven years that it will be in operation. And that compares with projected savings of 11.9 billion, which CMS included in a proposed rule on GLOBE that was issued back in December."

The companies left in scope, per the rule as Kelly read it, "include Biogen and its... subsidiary, Takeda and Daiichi Sankyo." (The subsidiary's name is garbled in the transcript.) She added that "that could change if these companies also finalize agreements with the administration."

Why publish a rule that does so little? Kelly's reading:

"People sort of in the drug pricing world have understood that Globe and Guard were basically being used as leverage by the administration to bring manufacturers to the table and agree to these voluntary pricing deals... based on what the final rule said, that tactic seems to have worked. But still, it's unclear why the final rule was issued at all."

She offered three explanations. Drug pricing "is a politically popular issue with the midterms approaching." The rule could "be picked up by a future administration." And it "might deter manufacturers from abandoning the commitments they made to the Trump administration once President Trump leaves office."

The detail worth modeling. The GENEROUS exemption applies "only during a quarter in which a company participates in that model." GENEROUS currently ends in September 2030. GLOBE, if it runs its full course, ends in March 2032. So unless GENEROUS is extended, "there will be a period when... all of the generous participants could be subject to Globe." The exemption the big companies paid for has an end date, and it is earlier than the end date of the penalty.

A loophole flagged by Rachel Sachs, a well-known drug-pricing law professor, via Kelly: the exemption is based on "the manufacturer, not on the drug." So "manufacturers can choose to put certain drugs in the generous model that would not be included in... globe." Ingerie's response: "If you figure out a way to not have the most expensive drugs in the program, it kind of defeats the purpose."

On GUARD (the Part D version): "It's possible that the administration will, if it goes ahead with guard, will wait until after the elections because the proposed rule did acknowledge that... it'll save Medicare money, but it will actually raise costs for beneficiaries." Ingerie: "No one wants to hear that their premiums are going up."

Legal risk: the orphan exclusion and the GENEROUS carve-out weren't spelled out in the proposal, which could support an Administrative Procedure Act challenge. But "it's not clear how many individual companies would have standing to sue," and Kelly's bottom line is that "it seems unlikely this rule will advance."

Why it moves numbers: for the MFN signers ($PFE, $JNJ, $MRK, $BMY, $LLY, $AZN, $ABBV, $NVO and the rest), GLOBE now costs nothing in the near term, because their Part B biologics are protected by their GENEROUS participation. The risk has been pushed to 2030–2032 and depends on GENEROUS being renewed. That is a tail risk for long-dated DCF models, not a near-term number. The names still exposed, $BIIB, Takeda ($TAK) and Daiichi Sankyo, have a clear reason to sign a deal, and a signing would be the next headline.

2. Inside a 17-company MFN round: Boehringer's view

Who's talking: Brian Hilberdink of Boehringer Ingelheim on Citeline Podcasts – "Strategic Intent: Boehringer Ingelheim's Brian Hilberdink on Launching Into the GLP-1 Era" (Sept 28). Operator. He is a senior commercial executive at a large, privately held drugmaker, so he can speak more freely than a public-company executive.

He made three points that matter.

First, how far the MFN net was cast, and BI's IRA exposure:

"We're one of the, you know, 17 companies that were approached by the administration for that initial MFN deal. And that's just a function of our size and scale. At the same time too, we're the only company that's had three products negotiated through the IRA... CMS mechanism just because we do have products that disproportionately impact patients on Medicare or Part D."

(He didn't name them. BI's diabetes drug Jardiance, which it co-markets with $LLY, was in the first round of negotiations.) Being private doesn't help: "It's the same rules for us as it is for publicly traded companies."

Second, launches now ramp more slowly. This is the most useful line of the week for anyone modeling a new drug's sales curve:

"When we launched 10 years ago, it was kind of the default from plans was to cover the drug and then you negotiate. Now it tends to be the other way around. You know, the drug is blocked until you negotiate. So it used to be... that your first three quarters on market would dictate what your lifetime peak sales are going to be. And that ramp up might be a little bit slower now."

He drew a line between specialty launches, which "can be navigated differently," and "large scale primary care launches" such as BI's obesity candidate survodutide. He said those launches need direct-to-consumer advertising, which makes them "a much more big-ticket investment" and "an even bigger risk."

Third, a willingness to give up price for volume. "In many instances, you know, we'll trade out volume for value because it means we can treat more patients." He welcomed PBM transparency and said he is "a big fan of risk sharing agreements with different plans," meaning deals where the drugmaker refunds money if the drug underperforms.

Why it moves numbers: a slower launch ramp pushes revenue later and shrinks the present value of every new launch. That matters most for primary-care launches, which means obesity and cardiometabolic drugs. It is a model input, not just a story.

3. The economists' case: MFN means fewer launches in Europe

Who's talking: two health economists (hosts "Ben" and "Harry") on Vital Health Podcast – "VT Discusses MFN and Price Controls" (Oct 2). Commentators, policy researchers presenting their own data from a study they will present in Paris next month. They argue for markets, so read their numbers with that in mind.

The price gap is widening. For a group of 44 drugs, "in 2005, they were roughly, you know, 40, 45% lower than the U S price... going forward to 2020... we're seeing, you know, 65, 70, 75% drops in pricing relative to the U S."

How MFN changes the incentive. Today, selling cheaply in Europe is "classic price discrimination in segmented markets." It adds a little extra revenue on top of the US, "where about 85% of all their profits come from." MFN links the two markets, so that extra revenue "starts to vanish because now you put [at] threat all of the profits that you earn in the United States." The predicted response: companies "may just withhold introducing drugs into new markets because they cannot differentiate these prices."

The investment data they cite:

  • European late-stage venture funding fell to "3% of the total funding in late stage" by 2019. "There just was not a late stage market in Europe."
  • Europe's share of new biotech startups in their sample fell from "about 40%" in 2000 to "slightly less than... 20%, 19%" by 2020–21.
  • They date the sharpest drop to 2018, not COVID. They link it to US corporate cash returning home after the 2017 tax law, citing "close to a trillion dollars of treasury funds" (companies' cash, not government bonds) moving back to the US.
  • In France, government "clawbacks" (demands to repay revenue once a drug budget is exceeded) were "occurring 18 months after the revenues were booked," according to a French Senate report.

Why it moves numbers: this backs up last week's point about ex-US pricing. If MFN makes companies delay or skip European launches, ex-US revenue forecasts for new drugs are too high. And the "raise prices in Europe to offset the US" argument depends on Europe being willing to pay, which these economists doubt.

A biotech leader goes further. On Pharmaceutical Executive – "A Leadership Call to Action for Biotech" (Sept 30), the guest, a biotech executive and author identified in the transcript only as Jeremy (operator-side advocate), put it bluntly: "Most favoured nation. Catastrophic approach to innovation. [The IRA], really damaging." His proposal is for companies to pool part of their direct-to-consumer ad budgets into an industry campaign, because otherwise "politicians cannot [stop treating] the industry as a political pinata just to get votes for one or two cycles when our drug discovery lasts 10 years."

How much spending MFN actually covers. On Telltales – "Three Times GDP" (Sept 30), investor hosts (commentators) asked how much US drug spending the MFN deals cover. One answer: "The White House has said this 90% figure, which is not correct, but... it's a large amount." Another host's reminder: prescription drugs are only "12 or 13% of total healthcare spending."

4. 340B: drugmakers keep tightening

The 340B program requires drugmakers to sell at deep discounts to safety-net hospitals and clinics, which can then bill insurers the full price. Three podcasts this week showed the dispute moving into the details.

Claims-data requirements are spreading. On 340Banter Podcast – "Entity Owned Pharmacy Data Submission" (Oct 1), recorded at the RWC 340B grantee conference in Houston, FQHC compliance specialists (operators; FQHCs are federally funded community health centers) said:

"We're up to eight manufacturers now that are requiring covered entities to submit claims data for their entity-owned pharmacies in order to maintain access to 340B pricing for those drugs."

Claims must be submitted "within 45 days of the dispense." Many health centers don't use an outside administrator and are struggling to pull the data out of their software. Six other manufacturers run their policies on a second data platform, and none of those yet require data from clinic-owned pharmacies.

The pushback is happening state by state. In Tennessee, health centers went to the attorney general, who "pushed back and was able to get a change to the policy. And in fact, that manufacturer changed for several states and added exemptions."

The legal angle. On Our Curious Amalgam – "What's 340B? An Economist's View of the Recent Wave of 340B Litigation" (Oct 5), the ABA antitrust section's podcast, Archon Ruparel of Charles River Associates, a former FTC economist (expert insider, speaking for himself), went through the antitrust claims now being filed. Hospitals argue that drugmakers adopting similar contract-pharmacy and data restrictions amounts to collusion. His view as an economist is that similar behavior can be independent, because every manufacturer faces the same worry: "are these folks cheating? Are they claiming the 340B discount and then claiming rebates from us?" He also said that on some 340B sales manufacturers make "little to no profit."

He also explained why the program has grown so large:

  • Discounts can reach "one cent" per unit once Medicaid best-price rules and inflation penalties stack up.
  • Since 2010, covered entities can use "an unlimited number of contract pharmacies," which captures patients' "continual prescriptions, even if they're unrelated to the treatment they came in for."
  • Hospitals bunch just above the eligibility threshold: "very few hospitals that are just under the threshold... but a lot who are just above it."

The hospital side. On 340B Insight – "How 340B Hospitals Need To Be Thinking About New Specialty Drugs" (Sept 28), the podcast of the trade group 340B Health, Tina Doe of Yale New Haven Health (operator) said "more than 70% of the pipeline" is specialty drugs. Many of those are sold through limited distribution networks, which lets manufacturers control which pharmacies can dispense them. Her example: it took "two years of advocacy" for Yale's specialty pharmacy to get access to mavacamten, $BMY's heart drug Camzyos.

Why it moves numbers: each data requirement and limited-distribution decision cuts down on duplicate discounts and contract-pharmacy leakage. That is a slow improvement in gross-to-net (the gap between a drug's list price and what the company actually keeps) for branded makers. The risk is legal: antitrust claims and state laws that ban these restrictions. Tennessee shows the state route can work.

5. GLP-1s: patents, marketing and how the Medicare bridge works in practice

The patent fence around semaglutide. On On The Pen GLP-1 News – "They TRIPLED Wegovy Dose, Does it Beat Zepbound?" (Oct 1), host Dave Knapp (commentator) explained that Viatris, through Mylan, filed a "paragraph four" challenge in Delaware federal court. That is a generic maker's formal claim that a patent is invalid or not infringed. The target is US patent 12,551,536, "issued in February of this year and... scheduled to run until October of 2038," covering "the use of semaglutide for weight management." His point:

"These court fights that are happening today may determine whether generic competition starts in [the] 2030s or whether Novo patents can keep competitors out for a lot longer than that."

Also on that podcast: Novo agreed a deal "worth up to $2.6 billion" for a potential once-weekly GLP-1/GIP pill. At the EASD diabetes conference, $LLY presented indirect comparisons (not head-to-head trials) in which Zepbound 15mg produced "four and a half percentage points greater weight loss" than high-dose Wegovy 7.2mg. And the full phase 3 retatrutide paper showed 19%, 25.9% and 28.3% average weight loss at 4mg, 9mg and 12mg after 80 weeks. Knapp noted that the strong low dose raises the question of whether most patients would ever need the top dose. No ruling has been reported yet on Lilly's case to have retatrutide classed as a biologic.

On manufacturing cost, Knapp pointed out that the Wegovy pill "uses 10 times the amount of semaglutide per day" as the weekly shot. Lilly's orforglipron (Foundayo) is a small molecule, "easier to manufacture, easier potentially to scale up." That matters for margins as prices fall.

Novo's new pitch. On The Readout Loud – "415: Mistrust in science and a juicy gene-editing lawsuit" (Oct 1), STAT reporter Elaine Chen (journalist) said Novo once told her "they don't like people calling GLP-1s weight loss drugs." Now "Novo explicitly calls its GLP-1 drugs weight loss drugs in its ads," with slogans like "Live Lighter" and "Summer Glow Up":

"Because insurance coverage has stalled, they've increasingly turned to the direct-to-consumer channel... It ultimately seems like these drugs are headed towards the over-the-counter direction."

The tension: the argument that obesity is a disease is the argument that insurers should pay. Marketing the drugs as lifestyle products weakens it.

The Medicare bridge in practice. Two podcasts covered it:

  • The Dr. Francavilla Show – "Wegovy, Zepbound and Obesity Care for Older Adults With Dr. Melanie Jay" (Sept 28), with two obesity physicians (operators). Eligible Part D patients pay "like $50 a month," compared with "$500 or more per month" elsewhere, through "the end of 2027." The VA covers GLP-1s as first-line obesity treatment. TRICARE "doesn't yet."
  • The Plus SideZ – "GLP-1 Denied to Approved: Medicare Bridge Part 2" (Sept 30), with patients describing the process (consumer voices, not experts). You have to "be denied by your primary insurance" first, then get a separate prior authorization for the bridge. Past readings count: "if you ever had a BMI of 35 or higher, don't go with your current BMI." One patient said her application through LillyDirect came back in "72 hours." She also described hitting her annual out-of-pocket maximum "in the first two months of the year" from just two prescriptions, Wegovy and Eliquis, which "costs about four or $500." That is the $2,000 Part D cap redesign at work: it concentrates patient spending early in the year and moves the rest of the cost onto plans and manufacturers.

Why it moves numbers: Medicare volume for $LLY and $NVO is real but runs through paperwork. Commercial coverage is "stalled," so Novo is relying on cash-pay. Generic semaglutide timing is being fought patent by patent, and the outcome decides how long $NVO's US pricing lasts after the early 2030s.

6. Where the money hides in Part B drugs

Who's talking: Brian Cotter of BrightSpot Insights, a benefits data consultant (operator), on The Astonishing Healthcare Podcast – "AH118 - Chemo, Cars, & Where Health Plan Savings May be Hiding" (Oct 2).

His favorite example is the chemotherapy drug oxaliplatin. After going generic in 2012, its ASP (average sales price, the benchmark Medicare uses to pay for doctor-administered drugs) fell "from $2,053 for a dose of 200 milligrams to... Q1 2026... $9.40. That's a drop of over 99%." Yet one hospital's posted rate is now "$29,595." That is almost $30,000 for a dose Medicare reimburses at under $10.

He also found that 431 Part B drugs had ASP price drops between Q1 2025 and Q1 2026, and 348 between Q1 and Q3 2026. One employer now drives chemo patients to a center charging about 100% of Medicare instead of local providers charging "500% and above," saving "80% on all of the chemotherapy." His warning on biosimilars: "There's assumptions around biosimilar[s] always being lower cost... I've found cases that have gone the opposite direction."

Why it matters: generic and biosimilar price drops in Part B often don't reach commercial plans, because hospital markups absorb them. That limits how much biosimilar makers gain from site-of-care shifts and gives employers a reason to contract directly.

7. A former CMS chief on Part D at 20

Who's talking: Leslie Norwalk, former acting CMS administrator (insider), on 13th & Park – "Leslie Norwalk: Inside the Rooms Where America's Health Decisions Get Made" (Oct 1).

This is background rather than news, but useful. She said Part D "came in the first 10 years at about half the price of what they originally scored," against an actuarial estimate of "$535 billion." She also noted that one of the "very controversial things that recently changed" was the rule that Medicare could not interfere in negotiations between drug companies, PBMs and pharmacies. That ban was the "noninterference" clause, which the IRA ended. Her view on drug margins: "If you don't have margin, you don't have services," but "people get upset when the margins get to be well into double digits or more than that."

The debate

Is US drug-price pressure a bounded headwind that's already in the models, or a structural squeeze on US branded margins that will push R&D away from small molecules? This week gave the "manageable" side its best evidence in a while, and the "structural" side its best long-term argument.

"It's manageable. The threats were tools to get deals, and the deals are done."

  • GLOBE's savings fell 97%, from $11.9B to $400M. Drugs with Medicare negotiated prices, orphan-only drugs and anything facing generics are excluded, and so is every GENEROUS participant (Citeline – Drug Fix).
  • GUARD, the Part D version, raises costs for patients, so it is politically awkward and likely delayed until after the midterms.
  • The trade press itself thinks the final rule is unlikely "to advance."
  • A big-company executive who has been through MFN and three IRA negotiations talks about trading "volume for value" and risk-sharing, not about leaving the US market (Citeline – Strategic Intent).
  • In 340B, manufacturers are winning ground one restriction at a time (340Banter).

"It's structural. The deals are the squeeze, and they fix in place a weaker business model."

  • The exemption from GLOBE is conditional and temporary. If GENEROUS ends in 2030, MFN signers face GLOBE until 2032. The rule is a standing threat to keep companies in line after this administration.
  • Launches are "blocked until you negotiate," so the early ramp that used to set peak sales is slower. That compresses the value of every new drug, before any IRA negotiation even starts.
  • MFN links US and European prices. The economists' data suggest the likely result is fewer and later European launches, not higher European prices (Vital Health Podcast). An industry leader calls MFN "catastrophic" for innovation (Pharmaceutical Executive).
  • In the biggest growth category, insurers are stepping back and Novo is turning to cash-pay, consumer-style marketing (The Readout Loud). Volume is replacing price, not adding to it.

Net: for the large caps, the near-term regulatory risk fell this week. GLOBE no longer applies to them. The long-term risk moved into launch curves and ex-US forecasts, which are harder to see and slower to show up in reported numbers. Watch whether the last GLOBE holdouts ($BIIB, Takeda, Daiichi Sankyo) sign deals, and whether GUARD gets finalized or shelved.

Stocks in play

Biogen ($BIIB), Takeda ($TAK), Daiichi Sankyo (4568 JP)

  • Bear: They are among the roughly four manufacturers still covered by a mandatory Part B international-pricing model, per the Pink Sheet's reading of the final rule (Citeline – Drug Fix).
  • Bull: Total savings across the whole model are only $400M over seven years. A lawsuit is possible, and signing an MFN/GENEROUS deal would exempt them. The trade press thinks the rule is unlikely to advance.
  • Watch: An MFN deal announcement from any of the three, or a lawsuit.

Eli Lilly ($LLY)

  • Bull: An MFN signer, so GLOBE doesn't apply. The EASD indirect comparisons favored Zepbound over high-dose Wegovy and orforglipron over oral semaglutide, and orforglipron is a cheaper-to-make small molecule. Strong retatrutide phase 3 data across all three doses (On The Pen). LillyDirect is clearing Medicare bridge approvals quickly (The Plus SideZ).
  • Bear: Primary-care launches now ramp more slowly and need expensive consumer advertising (Citeline – Strategic Intent). Its Jardiance partner, Boehringer, has had three products through IRA negotiation.
  • Watch: The ruling on retatrutide's biologic status, which still hadn't been reported as of Oct 1.

Novo Nordisk ($NVO)

  • Bull: Exempt from GLOBE. A deal worth up to $2.6B for a once-weekly GLP-1/GIP pill. Wegovy's heart-protection data (about 20% lower cardiovascular risk in the SELECT trial) is still why older patients ask for it (Dr. Francavilla Show).
  • Bear: Insurance coverage has "stalled," and the move to cash-pay "weight loss" marketing weakens the case that insurers should cover the drugs (The Readout Loud). Viatris is challenging a semaglutide weight-loss patent that runs to 2038 (On The Pen).
  • Watch: The Delaware patent case, and Q3 commercial coverage trends.

Bristol Myers Squibb ($BMY)

  • Bull: Limited distribution of Camzyos gives it control over 340B dispensing. Yale needed two years of advocacy to get access (340B Insight). It is an MFN signer, so GLOBE doesn't apply.
  • Bear: Eliquis, a first-round IRA drug, still comes up in patient accounts as a monthly cost burden (The Plus SideZ). Restrictions on hospitals invite antitrust claims (Our Curious Amalgam).
  • Watch: Q3 Eliquis net price under the negotiated price.

Other large-cap pharma ($PFE, $JNJ, $MRK, $AZN, $ABBV)

  • Setup: No company-specific pricing news on the podcasts this week. As a group they benefit from the GLOBE exemption and the spread of 340B restrictions. Their longer-term exposure is the 2030–2032 GENEROUS/GLOBE gap and slower launch ramps.
  • Watch: Q3 earnings from mid-October, for any quantified MFN, GENEROUS or tariff impact.

Generics / biosimilars ($TEVA, $VTRS)

  • Bull: $VTRS is actively challenging Novo's newer semaglutide patents. That gives it a real, if distant, option on generic Wegovy (On The Pen). GLOBE excludes drugs with generic or biosimilar competition.
  • Bear: In Part B, hospital markups often absorb generic and biosimilar savings: oxaliplatin's ASP is $9.40, but one hospital charges $29,595. Biosimilars aren't always the cheaper option for plans (Astonishing Healthcare).
  • Watch: Whether the Delaware court rules on the '536 patent before 2027.

PBMs / managed care ($CVS, $CI, $UNH)

  • Bull: GUARD, which would raise Part D premiums, looks shelved until after the midterms (Citeline – Drug Fix). A big manufacturer says it would rather partner with PBMs than fight them (Citeline – Strategic Intent).
  • Bear: Employers are finding large savings by contracting directly and steering patients (Astonishing Healthcare). Vertically integrated pharmacy and administrator arrangements in 340B are now tying-claim targets (Our Curious Amalgam).
  • Watch: 2027 Part D bids and whether GUARD is revived after November.

Read-throughs

  • PBMs and managed care: For plans, GLOBE no longer matters and GUARD is on hold. The pressure is coming from employers doing their own data work: direct contracts, steering patients to cheaper sites, benchmarking to Medicare (Astonishing Healthcare). Manufacturers now describe PBMs as partners for risk-sharing, which suggests rebate negotiations are getting more complicated rather than less (Citeline – Strategic Intent).
  • Biosimilar and generic makers: The exclusion of drugs facing generics and biosimilars from GLOBE is a quiet win for the model of launching a lower-priced copy of a brand. The Viatris semaglutide case shows the generic GLP-1 opportunity will be fought one patent at a time, with some patents running to 2038 (On The Pen).
  • Small-molecule vs. biologic R&D mix: GLOBE excludes drugs with Medicare negotiated prices, so the IRA's timeline remains the main clock. The small-molecule cost advantage came up from an unexpected direction: the Wegovy pill needs about 10x the drug substance of the shot, while Lilly's small-molecule orforglipron is "easier to manufacture." Cheaper manufacturing partly makes up for the shorter IRA protection small molecules get (On The Pen).
  • Ex-US launch and pricing strategy: This was the strongest read-through of the week. Economists show the US–Europe price gap widened from 40–45% to 65–75% over 15 years and argue MFN gives companies a reason to withhold launches (Vital Health Podcast). Combined with last week's revenue-share clause on higher ex-US prices, our view is that forecasts for new European launches should be cut.
  • 340B-dependent providers: Eight manufacturers now require claims data, the antitrust theories against them face economic objections, and the main route to pushback is state attorneys general (340Banter, Our Curious Amalgam). Hospitals with large contract-pharmacy networks are losing 340B income gradually.

What changed vs. last week

  • New this week: GLOBE is final. Last week's focus was the tariff and voluntary MFN deals. This week the formal Part B international-pricing model arrived, with its scope mostly gone: $400M of savings instead of $11.9B, and about four companies covered.
  • The MFN picture expanded. Last week a mid-cap executive expected MFN to reach him. This week a big private company confirmed that 17 companies were approached in the first round.
  • The ex-US story got data. Last week brought the revenue-share clause and a host's doubts about whether Europe can pay. This week economists put numbers on the US–Europe price gap and the European funding decline.
  • Retatrutide: no ruling yet. Last week oral arguments were set for Sept 24. As of Oct 1, no decision had been reported.
  • 340B moved from courtrooms to compliance: eight manufacturers now require claims data, and the Tennessee AG won a change.
  • Tariff: the 100% rate was due on September 29, but no podcast this week covered whether it started or what guidance was issued. Treat last week's open questions as still open.
  • IRA Round 2 / 2028 list / EPIC Act: quiet, no updates.

Dates to watch: mid-October (Q3 earnings, with MFN, GENEROUS and tariff impacts); November 3 (midterms, after which GUARD may move); the retatrutide ruling; any MFN deal by Biogen, Takeda or Daiichi Sankyo; January 1, 2027 (Round 2 negotiated prices take effect); September 2030 (GENEROUS ends unless extended); March 2032 (GLOBE ends).