Latest developments & recent history

What has changed?

Updated 10 October 2026

Newest first. Scroll or swipe for older updates.

GLOBE litigation

PhRMA challenges the GLOBE final rule

PhRMA filed suit in federal court in Washington, DC, arguing that CMS exceeded its authority and asking the court to set aside GLOBE. The challenge is pending; no order pausing the model was identified in public sources checked on 10 October. CMS still lists a 1 January 2027 model start and 1 April performance start.

Medicare

GUARD final rule still under review

The Part D model’s final rule has been under OMB review since 15 June and had not been published by 3 October. CMS still describes GUARD as a proposal, so its proposed 1 January 2027 start is not yet confirmed.

GENEROUS · Reported update

All 50 states reported to have signed

Inside Health Policy reported that CMS said all 50 states had signed final participation agreements following the 30 September deadline. CMS’s public model page still carries the earlier application update. Signing does not establish that every product-level rebate arrangement is operational.

Tariff milestone

Pharmaceutical tariffs reached remaining manufacturers

The April proclamation now covers companies outside Annex III. Patented products face 100%, or 15% from the EU, Japan, Korea and Switzerland; an HHS MFN agreement plus an approved onshoring plan gives zero until January 2029. Commerce has zero-rated specified specialty products, such as orphan-only drugs, from qualifying jurisdictions.

Agreement disclosures

Pfizer and Lilly MFN agreement terms released

Redacted agreements published by Public Citizen reveal Lilly’s separate GLP-1 arrangements and Pfizer’s GENEROUS and overseas revenue-sharing terms. Important coverage and pricing details remain undisclosed, reinforcing the need to assess each agreement individually.

GENEROUS

40 states and Puerto Rico had signed

All 50 states, DC and Puerto Rico had applied; 40 states and Puerto Rico had signed participation agreements. CMS gave the remaining states until 30 September to sign. Signed participation does not confirm that every arrangement was operational.

Agreements

Announced MFN deals reached 26 manufacturers

Nine additional manufacturers joined the announced framework. Product coverage, implementation and duration still needed to be read against each company’s disclosed terms.

Tariff milestone

First pharmaceutical tariff phase began

The April proclamation set 31 July for the companies listed in Annex III and 29 September for others. Qualifying MFN and US investment agreements provide a route to zero tariff treatment; exposure depends on the company, product and origin.

GLP-1 access

Medicare GLP-1 Bridge began

The demonstration opened access to selected GLP-1 medicines for eligible Part D beneficiaries, with a $50 copay. It operates outside the normal Part D benefit and payment flow, separately from the proposed GUARD model.

Research context

HHS examined who funds drug innovation

An HHS analysis compared OECD countries’ shares of revenues from innovative medicines using 2020–2025 data. It adds context to the international burden-sharing debate behind MFN; it does not introduce a new pricing rule or demonstrate realised MFN savings.

June to October 2026. Each summary reflects the event or status check on its stated date.

Start here

Four MFN pathways. Different implications.

MFN connects US drug pricing to international prices. Who participates, which products are covered and how the benchmark is applied vary by pathway.

MedicaidLaunched

GENEROUS

Internationally informed supplemental rebates for participating manufacturers and state Medicaid programmes.

Participation
Voluntary
Reference basket
8 countries
Model period
2026–2030
Understand GENEROUS →
Medicare Part BFinal rule

GLOBE

An international benchmark within the Part B inflation-rebate framework for eligible drugs administered in clinical settings. PhRMA’s legal challenge is pending.

Participation
Mandatory, in randomly selected areas
Reference basket
19 countries
Model start
1 January 2027
First performance year from 1 April 2027
Understand GLOBE →
Medicare Part DProposed

GUARD

An international benchmark used to modify inflation rebates for eligible drugs covered under Medicare Part D.

Participation
Mandatory if implemented, in test regions
Reference basket
19 countries, proposed
Original proposed start
1 January 2027
Final rule pending
Understand GUARD →
Manufacturer commitmentsDeals announced

MFN agreements

Company-specific commitments covering Medicaid, selected direct-to-consumer offers and prospective pricing for new medicines.

Participation
Negotiated agreements
Manufacturers
26 announced
Duration & scope
Company-specific
Explore the deal framework →

Explore the detail

Compare MFN programmes, countries and dates.

Sources checked 10 Oct 2026

Compare two pathways

Choose any pair. Key differences stay visible on every screen.

AT A GLANCE

GLOBE

GUARD

Policy status

Final rule; PhRMA legal challenge pending. Published 2 October 2026; scheduled to take effect 30 November
Proposed; final rule under OMB review since 15 June 2026

Coverage

Selected Medicare Part B drugs; orphan-only, cell and gene therapy and plasma-derived products excluded
Eligible Medicare Part D drugs

Participation

Mandatory for manufacturers of selected drugs, for beneficiaries in randomly selected areas covering about 25% of Original Medicare Part B; CMS intends to waive GENEROUS participants
Proposed mandatory model in selected test regions

Mechanism

Alternative Part B inflation-rebate calculation
Modified Part D inflation-rebate calculation

Reference basket

19 countries, finalised as proposed
19 countries in the proposal

Pricing approach

Default and manufacturer-submitted benchmark approaches
Default and manufacturer-submitted benchmark approaches

Start / timing

Scheduled for 1 January 2027, with voluntary pricing data; first performance year from 1 April 2027
Original proposed start: 1 January 2027; final rule pending

Duration

Five performance years to March 2032; invoicing and reconciliation to March 2034
Five performance years; subsequent invoicing and reconciliation

Planning question

Track the legal challenge alongside product eligibility and any GENEROUS waiver.
Assess qualifying products and interaction with existing rebates.

Overview only. Product eligibility, benchmark calculations and exclusions require the relevant model documentation or disclosed agreement terms. Primary sources ↓

Which countries are referenced?

Explore the two baskets, then choose a country to see its economic context and illustrative Medicare price adjustment.

19GLOBE / GUARDMedicare basket
8GENEROUSAlso in the Medicare basket
11Additional marketsMedicare basket only
Explore the reference baskets
Interactive reference-country map. Select a highlighted country to open its profile.
Both basketsMedicare basket onlySelected

GLOBE / GUARD · 19 reference countries

Hover for a quick view; press Escape to dismiss it. Select a country on the map or use the dropdown for its full profile.

How to read the country data

Economic figures: World Bank, 2024 (July 2026 release). Adjusters: the final GLOBE rule’s illustrative Table 5, which divides US GDP per person by the country’s, with a minimum of 1.000. It is not an exchange rate.

Country inclusion differs by pathway. Basket membership does not mean every product or price is covered. View sources ↓

Compare all 19 country profiles
Reference-country economic figures. Sources: World Bank, 2024; adjusters from the final GLOBE rule, Table 5.
CountryGENEROUSReal GDP (PPP)GDP/person (PPP)% of USAdjuster
AustraliaOutside basket$1,961bn$72,10084%1.190
AustriaOutside basket$695bn$75,80088%1.161
BelgiumOutside basket$880bn$74,20086%1.167
CanadaIncluded$2,702bn$65,50076%1.328
CzechiaOutside basket$628bn$57,60067%1.498
DenmarkIncluded$484bn$80,90094%1.048
FranceIncluded$4,286bn$62,50073%1.372
GermanyIncluded$6,177bn$74,00086%1.167
IrelandOutside basket$760bn$140,800163%1.000*
IsraelOutside basket$573bn$57,30066%1.500
ItalyIncluded$3,672bn$62,30072%1.384
JapanIncluded$6,714bn$54,20063%1.648
NetherlandsOutside basket$1,533bn$85,20099%1.000*
NorwayOutside basket$589bn$105,700123%1.000*
South KoreaOutside basket$3,159bn$61,10071%1.406
SpainOutside basket$2,836bn$58,10067%1.480
SwedenOutside basket$753bn$71,20083%1.194
SwitzerlandIncluded$878bn$97,500113%1.000*
United KingdomIncluded$4,354bn$62,80073%1.383

All 19 countries are in the GLOBE/GUARD basket, final for GLOBE and proposed for GUARD. * The final rule’s table sets these adjusters at the 1.000 minimum. Adjusters are the final rule’s illustrative values, calculated from an earlier release of the same World Bank series, so they can differ slightly from a ratio of the GDP figures shown. The adjuster does not apply to every MFN pathway. CMS Table 5 ↗

Explore the MFN timeline

Follow GENEROUS, GLOBE and GUARD through reporting, performance and payment periods. Use the date control and filters to explore each model.

Open full window ↗

Confirmed dates are distinguished from proposed and illustrative milestones. GLOBE follows the final rule; GUARD remains proposed. Payment and reconciliation examples depend on reporting, receipt or agreement terms. Changing the selected date does not change a model’s policy status.

Key dates at a glance

A quick reference to announcements, participation deadlines and model start dates, with links to the sources.

Announcement

First manufacturer MFN agreement announced

Pfizer announcement begins the series of bilateral deals. Individual implementation dates vary.

Source ↗
Model launch

GENEROUS model launches

The model launches; participation and implementation arrangements follow their own milestones.

Source ↗
Announcement

Nine further deals bring the total to 26

The White House announces agreements with nine additional manufacturers.

Source ↗
Participation milestone

40 states and Puerto Rico signed

CMS reports applications from all 50 states, DC and Puerto Rico, with 40 states and Puerto Rico already signed. Operational arrangements still need to be checked.

Source ↗
CMS deadline

Remaining state participation agreements due

CMS gave the remaining states until this date to sign participation agreements. The subsequent participation report is listed below.

Source ↗
Final rule

GLOBE final rule released

CMS finalised the Part B model. The rule was published on 2 October and takes effect on 30 November 2026.

Source ↗
Reported participation

All 50 states reported to have signed

Inside Health Policy reports that CMS says all 50 states signed final participation agreements. Product-level implementation remains a separate step.

Source ↗
Legal challenge

PhRMA files GLOBE lawsuit

PhRMA asks the court to set aside the final rule. The filing itself does not change the scheduled model or performance dates.

Source ↗
Model start

GLOBE begins

The model opens with voluntary manufacturer submission of international net pricing data, ahead of the first performance year.

Source ↗
Original proposed start

GUARD performance period would begin

The final rule has been under OMB review since 15 June and had not been published by 3 October 2026. This original proposed date is not a confirmed launch.

Source ↗
Performance year

First GLOBE performance year begins

Five performance years run to 31 March 2032, with invoicing and reconciliation continuing to 31 March 2034.

Source ↗

Proposed dates are planning assumptions, not confirmation of implementation. Performance periods and later payment/reconciliation periods are different. Read the underlying sources ↓

The strategic implication

One pricing decision.
More than one market.

Compare separate pricing plans with an integrated global view. International list and net prices can affect US exposure through different pathways, depending on the product, agreement and policy status.

Previously

Pricing silos

Ex-US pricing

IRP networks ↔ country list prices

List pricesNet prices
Separate plans

US pricing

List price (WAC)
CommercialMedicareMedicaidDirect to consumer

Strategies ran in parallel but rarely integrated.

Drag the divider, click the diagram or choose a view above. With the divider focused, use the arrow keys; Home shows pricing silos and End shows integrated pricing.

The diagram is a simplified illustration: GLOBE is final and GUARD proposed; GENEROUS and manufacturer agreements can overlap. The orange agreement links show potential connections to commercial, Medicare, Medicaid and direct-to-consumer channels, subject to company-specific terms. Benchmark-linked prices and rebates do not automatically change the US list price (WAC).

Read the diagram in words

Previously, US pricing and international pricing were planned separately. The integrated view shows how international list and net prices can connect to US exposure through different policy pathways.

  • GLOBE and GUARD: international list and net prices from a 19-country basket, final for GLOBE and proposed for GUARD, feed the Medicare pathway.
  • GENEROUS: international net prices from an eight-country basket feed the Medicaid pathway.
  • Manufacturer agreements: international net-price commitments can affect commercial, Medicare, Medicaid and direct-to-consumer channels, depending on each agreement.

These pathways can overlap. The connections do not mean that every price or product is covered, or that the US list price (WAC) changes automatically.

Read “The End of Two Silos” →

Expert perspective

MFN policy and pricing analysis.

Selected reading from Symaptics. Articles reflect their publication date; use the status updates above for the current policy position.

The Art of the MFN Deal

The CEA’s savings analysis and the strategic choices behind voluntary manufacturer agreements.

The End of Two Silos

Why US and international pricing decisions need to be assessed together.

GENEROUS: Medicaid’s MFN test

An introduction to the model’s reference basket, net-price benchmark and supplemental rebates.

Redefining ex-US success

How launch sequencing and portfolio decisions can reshape the global value equation.

MFN and the shift of risk

What a US pricing policy could mean for access and investment decisions outside the US.

Introducing SyMAP 2.0

Connected pricing, MFN and revenue scenarios, with voluntary-agreement modelling.

Introducing SyMAP MFN

Bringing GENEROUS, GLOBE and GUARD into one portfolio modelling workflow.

All news & insights →

Put the policy into your portfolio

What could MFN mean
for your pricing strategy?

Use SyMAP MFN to compare policy scenarios, model rebate and revenue effects, and explore manufacturer agreement assumptions alongside global pricing decisions.

Updated GLOBE modelling: Assess rebate and revenue effects under the GLOBE final rule, then test how a hypothetical extension could change the outlook. Watch the GLOBE walkthrough →

01Compare CMS, voluntary and baseline paths

02Explore price and launch assumptions

03Connect policy exposure to revenue

Prefer an expert-led project? View projects →

A few useful distinctions

MFN, explained.

Clear answers to common policy and modelling questions.

What does most-favored-nation pricing mean?

MFN is an approach that links a US drug price or rebate calculation to prices in other countries. The term does not describe a single universal formula. Reference baskets, price measures and covered products depend on the pathway.

Are GLOBE and GUARD already in effect?

Not yet. GLOBE has a final rule, published on 2 October 2026 and scheduled to take effect on 30 November; the model is scheduled to begin on 1 January 2027 and its first performance year on 1 April 2027. PhRMA challenged the rule on 7 October. No order pausing the model was identified in public sources checked on 10 October. Follow the case. GUARD remains a proposal: its final rule was still under OMB review at the 10 October check. Distinguish both from GENEROUS and announced manufacturer agreements.

Are manufacturer agreements the same as GENEROUS?

No. Agreements can include wider commitments, while GENEROUS provides a Medicaid model. They can overlap: Merck discloses an MFN agreement and participation in GENEROUS. Model the interaction rather than simply adding two exposures.

Does every manufacturer agreement have the same duration?

No single duration should be assumed. Merck discloses a three-year agreement with exceptions for certain products. Use the relevant company disclosure and distinguish the agreement term from any continuing product obligations.

How does MFN relate to international reference pricing?

International reference pricing uses prices in other countries to inform domestic pricing decisions. MFN extends that connection to US pricing through different policy and agreement mechanisms. A change in one market can therefore matter to a wider pricing strategy.

Can these tools calculate my portfolio’s MFN liability?

These tools explain and compare pathways. A portfolio assessment needs product eligibility, pricing inputs, volumes, agreement terms and explicit policy assumptions. Explore modelling in SyMAP MFN.

Sources & policy context

Sources behind this update

Programme sources checked 10 October 2026

Recent developments link to their dated sources in the update archive above. Programme summaries distinguish agency proposals, announcements, legal challenges and company disclosures. The post-deadline GENEROUS participation count is attributed to Inside Health Policy; CMS’s public model page still shows the earlier application update. Historical analysis is linked separately above. About Symaptics and our pricing expertise.