The non basket advantage: Poland’s launch sequencing position in a post MFN world

The proposed US Most Favoured Nation (MFN) pricing framework will require the Centers for Medicare & Medicaid Services (CMS) to set reimbursement for eligible medicines based on the price available in a group of comparable (reference basket) countries. Poland occupies an advantageous position among non‑MFN basket Central and Eastern European (CEE) countries for launching medicines potentially exposed to MFN pricing models.^1-6 This position reflects the interaction of four Polish market characteristics with three international policy developments: proposed US MFN price benchmarking (GLOBE/GUARD), the EU Pharma Package access conditionality, and EU‑wide compulsory licensing rules.^4-6,23-26

The MFN framework and its relevance for launch sequencing

On 23 December 2025, the U.S. CMS published proposed rules establishing two mandatory pricing frameworks for selected medicines – GLOBE (Medicare Part B) and GUARD (Medicare Part D) – implementing MFN pricing through international reference benchmarks.^4-7 Both models reference the same 19‑country basket (Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the United Kingdom).^5,6 Poland is not included.⁶

“Price” under GLOBE and GUARD refers to CMS‑constructed international benchmarks derived from list‑based public data (Method I) or voluntarily submitted basket‑country net prices (Method II).⁷ Two price benchmark mechanisms apply:

• Method I: CMS derives the lowest country‑level average price from publicly available data across basket countries, adjusted for purchasing‑power parity, without manufacturer input.⁷
• Method II: Manufacturers may voluntarily submit international net prices from basket countries, which CMS aggregates into a GDP‑PPP‑adjusted volume‑weighted benchmark.⁷

Where both are available, CMS applies the higher price benchmark.7 Under current proposals, prices from non‑basket countries are not directly incorporated into either mechanism.⁷

GLOBE is proposed to begin 1 October 2026 and GUARD 1 January 2027, subject to finalisation.^4-6 CMS projects USD 11.9bn (Part B) and USD 14.1bn (Part D) in net spending reductions over the respective model periods, indicating that MFN exposure for qualifying assets will be financially impactful.⁸

Regulatory status and boundary conditions

Currently, the MFN models remain at the proposal stage. Three considerations are relevant:

• Timing: CMS must finalise the policy approximately by August 2026 to meet Congressional Review Act requirements while retaining the proposed October 2026 GLOBE start.⁹
• Legal challenge: Industry stakeholders have indicated that litigation is likely following finalisation, drawing on arguments similar to those that led to the injunction of the 2020 MFN model.^9,10
• Manufacturer participation: Participation in the GENEROUS Medicaid model or direct bilateral MFN arrangements may modify or exempt manufacturers from GLOBE/GUARD rebate exposure.⁶ As of February 2026, 16 large manufacturers were reported to have entered such bilateral arrangements.^11,12

Recent bilateral agreements further illustrate that MFN exposure for manufacturers is not applied automatically. Under the December 2025 US–UK pharmaceutical pricing arrangement, the US committed that UK prices will not anchor Medicaid MFN benchmarks where the UK represents the lowest reference price, and that international benchmarking models would not be designed to uniquely disadvantage the UK.¹³ This confirms that MFN implementation is already being moderated through negotiated carve‑outs, reinforcing the relevance of launch sequencing under a risk‑adjusted MFN interpretation.¹³

Four reinforcing structural pillars

Within this evolving US policy landscape, manufacturers are placing higher scrutiny on list and net pricing differentials between the US and reference basket countries, including consideration of the likely impact on US pricing under MFN, and implications for the launch order sequence across reference basket countries. In this context, Poland occupies an advantageous position among non‑MFN basket CEE countries.

Pillar I: Non‑basket status with limited indirect IRP exposure

Poland’s absence from the MFN basket means that Polish prices do not directly enter Method I or Method II calculations.6 The Czech Republic is the only CEE country included in the basket.⁶

Some non‑basket markets indirectly influence basket prices through international reference pricing (IRP) linkages.¹⁴ Under current IRP rules as of 2026, Poland’s prices are referenced primarily within CEE and not by major Western European basket markets, resulting in limited indirect exposure.¹⁴

Pillar II: A favourable cost‑effectiveness threshold

The Agency for Health Technology Assessment and Tariff System (AOTMiT) applies an operative cost‑effectiveness threshold of PLN 244,821 per QALY (~EUR 58,000), confirmed in a November 2025 presidential communication.¹⁵ This represents a 12.5% increase from the November 2024 level of PLN 217,641.¹⁶

Although the explicit 3× GDP per capita formulation for the cost-effectiveness threshold was removed from statute in 2022, this concept persists as an administrative consideration.¹⁵ Poland’s GDP per capita (PPP) reached USD 45,113 in 2024 and is forecast to be USD 46,692 by the end‑2026, with OECD‑projected real growth of ~3.2–3.5% through 2026–2027.^17,18

Pillar III: Confidential discounting and MEAs

Poland’s reimbursement framework routinely incorporates confidential discounts and managed entry agreements (MEAs) negotiated by the Economic Commission.¹⁹ Under the current MFN models:

• Confidential Polish net prices do not appear in publicly available datasets used for Method I.⁷
• Poland’s non‑basket status means such prices are not submitted under Method II.⁷

This insulation holds provided that confidential Polish net prices remain non‑observable to basket markets and that Polish list prices are not actively referenced by MFN basket price‑setting countries through their own IRP frameworks.¹⁴

Pillar IV: Improving access timelines

Poland’s historical access‑timeline challenges have been partly addressed through successive reforms:

• A legally defined end‑to‑end timeline of up to 360 days for the reimbursement process, covering HTA assessment, price negotiations, and a final reimbursement decision by the Ministry of Health.^19,22
• A Medical Fund oncology pathway enabling accelerated review.²⁰
• The SZNUR amendment, signed into law on 25 August 2025, enabling rolling submissions and reducing procedural restarts.²¹

Evidence presented at the EPA Congress 2026 provides quantified confirmation of this acceleration. A poster presented at the conference, reports that the median time from application submission to reimbursement decision decreased from 568 days to 159 days over the past five years (or 191 days when accounting for procedural suspensions).²² Over the same period, the time from EMA Marketing Authorisation to reimbursement decision declined from 2,067 days to 668 days.²² These reductions are attributed to statutory process caps, procedural streamlining, and structured HTA and negotiation stages.²²

The 1 January 2026 reimbursement list in Poland, which added 24 new molecules, further indicates increased system throughput, consistent with data showing growth from fewer than 10 new reimbursed medical technologies annually in 2016–2018 to approximately 40 technologies per year by 2025, across oncology and non‑oncology indications.²⁵

Interaction with the EU Pharma Package

On 11 December 2025, EU institutions reached provisional agreement on the EU Pharma Package, retaining Article 56a access conditionality (i.e., regulatory data and market protection periods under EU pharmaceutical law).^23-25 Member States may request supply of authorised products, with loss of market protection as a potential sanction for non‑compliance. Application remains dependent on national transposition and enforcement practice.^24-26

For MFN‑exposed products, this framework increases the relative importance of launch sequencing choices, particularly between basket and non‑basket EU markets.

Risk‑adjusted comparison with Western European basket markets

Under MFN exposure, the relevant comparison shifts from absolute European revenue to the interaction between European net prices and U.S. rebate liability.^7,8 For certain high‑expenditure Part B or Part D medicines, this interaction can substantially affect overall value assessment.

A February 2026 survey of multinational market‑access leaders reports increasing use of flexible, situation‑specific launch sequencing, with non‑basket EU markets considered earlier than historically typical.¹¹ Within this group, Poland combines non‑basket status, a ~EUR 58,000/QALY cost-effectiveness threshold, widespread use of confidential pricing, improving access timelines, and EU membership.

Conclusion

For high‑expenditure specialty medicines potentially exposed to GLOBE or GUARD, Poland represents a structurally favourable non‑basket CEE EU market when assessed on a risk‑adjusted basis under current rules. This assessment is intended as a scenario‑planning input, conditional on MFN finalisation, exemption pathways, and confidential pricing execution. Within these parameters, Poland combines non‑basket insulation, a favourable cost‑effectiveness threshold, confidential pricing protected from IRP and U.S. benchmarking and demonstrably improving access timelines in a way not replicated by other EU markets.

Abbreviations

• AOTMiT – Agency for Health Technology Assessment and Tariff System
• CEE – Central and Eastern Europe
• CMS – Centers for Medicare & Medicaid Services
• EMA – European Medicines Agency
• EU – European Union
• GDP – Gross Domestic Product
• GENEROUS – Guiding and Evaluating National and Regional Opportunities in Medicaid
• GLOBE – Global Benchmark for Efficient Drug Pricing
• GUARD – Guaranteed Access to Lower‑Cost Drugs
• HTA – Health Technology Assessment
• IRP – International Reference Pricing
• MEA – Managed Entry Agreement
• MFN – Most‑Favoured‑Nation
• OECD – Organisation for Economic Co‑operation and Development
• PPP – Purchasing Power Parity
• QALY – Quality‑Adjusted Life Year
• SZNUR – Amendment to the Polish Reimbursement Act enabling procedural streamlining
• TLV – Tandvårds‑ och läkemedelsförmånsverket

Sources

1. PharmExec (2025). US pharma MFN and tariff dynamics: What EU and UK leaders need to know.
2. PharmPhorum (2025). The most‑favoured‑nation policy: outlook and implications.
3. US Chamber of Commerce (2026). Comments on proposed GLOBE and GUARD rules.
4. Federal Register (2025). Global Benchmark for Efficient Drug Pricing (GLOBE) Model.
5. Hogan Lovells (2025). CMS issues mandatory Medicare MFN models.
6. King & Spalding (2025). Overview of GENEROUS, GLOBE and GUARD.
7. FDA Law Blog (2026). MFN drug pricing update: Method I and Method II.
8. CMS (2025). Projected savings under GLOBE and GUARD models.
9. US Chamber of Commerce (2026). Congressional Review Act timing and MFN risk.
10. Federal Court Filings (2020–2021). MFN model injunction and rescission history.
11. CMS (2026). GENEROUS model participation and exemptions.
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13. Government of the United States & Government of the United Kingdom (2025). Arrangement on Pharmaceutical Pricing.
14. Kuriata E, Pelczarska A, Dzik M, Mucha K, Schneider P, Nemeth G (2025). External Reference Pricing (ERP) Availability vs. Reimbursement Timelines in Poland and Other European Countries: Analysis of EURIPID Database. ISPOR Europe poster
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16. AOTMiT (2024). Komunikat Prezesa AOTMiT – próg kosztu uzyskania.
17. Trading Economics (2026). Poland GDP per capita PPP forecast.
18. OECD (2025). OECD Economic Survey: Poland.
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20. Government of Poland (2026). Ustawa o Funduszu Medycznym (Medical Fund Act) and implementation of accelerated oncology access pathways.
21. Medexpress (2025). Prezydent podpisał nowelizację ustawy o refundacji (SZNUR).
22. Jachimowicz M, Pruszkowski C, Binkowski G (2026). Poland as an emerging strategic market for innovative pharmaceuticals. EPA Congress poster.
23. EMA (2025). Political agreement on new EU pharmaceutical legislation.
24. Crowell & Moring (2025). EU Pharma Package – Article 56a overview.
25. Arthur Cox (2026). EU Pharma Package adoption outlook.
26. Hannes Snellman (2026). EU Pharma Package implications for pharmaceutical companies.
27. TLV (2026). Delredovisning – Uppdrag att analysera hur det svenska prissättningssystemet påverkas av utvecklingen på den internationella läkemedelsmarknaden. Available from: https://www.tlv.se [Accessed April 2026]

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