Articol
EU JCA and US MFN collision: The next global pricing and market access risk frontier
How EU clinical assessments and US reference pricing policies could combine to reshape global pricing strategy and market access risk.
Two crucial market access and pricing policy areas, once regarded as largely separate strategic issues, are facing a collision that could pose significant barriers for companies and health technology assessment (HTA) negotiation processes.
When the European Union (EU) adopted the Joint Clinical Assessment (JCA) as the cornerstone of its Health Technology Assessment Regulation (HTAR),1 review of its implications largely sat with European market access, Health Economics and Outcomes Research (HEOR), and regulatory-adjacent teams. Meanwhile, separate teams reviewed US pricing policy, government affairs, and commercial leadership.
With the introduction of Most-Favored-Nation (MFN) policy in the United States (US),2 that separation is becoming increasingly difficult to sustain — and the risk this poses has potentially broad strategic implications. A strong JCA can significantly assist a company’s value story. However, an unfavorable, uncertain, or contested JCA could shape the clinical evidence narrative used in national pricing and reimbursement (P&R) negotiations across Europe. Those national outcomes may then influence European price corridors through international reference pricing (IRP).
When the European Union (EU) adopted the Joint Clinical Assessment (JCA) as the cornerstone of its Health Technology Assessment Regulation (HTAR),1 review of its implications largely sat with European market access, Health Economics and Outcomes Research (HEOR), and regulatory-adjacent teams. Meanwhile, separate teams reviewed US pricing policy, government affairs, and commercial leadership.
With the introduction of Most-Favored-Nation (MFN) policy in the United States (US),2 that separation is becoming increasingly difficult to sustain — and the risk this poses has potentially broad strategic implications. A strong JCA can significantly assist a company’s value story. However, an unfavorable, uncertain, or contested JCA could shape the clinical evidence narrative used in national pricing and reimbursement (P&R) negotiations across Europe. Those national outcomes may then influence European price corridors through international reference pricing (IRP).
This matters because US MFN-style policy mechanisms are increasingly looking to international prices as benchmarks for US drug pricing. The United States Department of Health and Human Services (HHS) has described MFN targets linked to prices in economically comparable countries, and the Centers for Medicare & Medicaid Services (CMS) has since advanced MFN-related models across Medicaid and proposed Medicare Part B and Part D mechanisms.4,5,6
This creates a new global Pricing & Market Access (P&MA) risk frontier that has far-reaching implications. If multiple European payers raise the specter of clinical uncertainty in their negotiations, others may follow suit. IRP can then amplify that pattern, reducing pricing potential, and US MFN-style mechanisms may be used as a benchmark against those unfavorable pricing outcomes.
While this complex new P&MA environment creates uncertainty for biopharma companies, these issues are not insurmountable with careful and early planning around potential price anchors, and a holistic approach to global pricing exposure.
JCA: Not a price decision, but a powerful evidence signal
JCA focuses on comparative clinical evidence, assessing the relative clinical effects of a medicine against relevant comparators. While it supports subsequent national HTA work, it does not determine reimbursement, does not set prices, and does not replace national appraisal or negotiation.
However, “not binding” should not be confused with “not influential.” A JCA report may become the common clinical evidence starting point for multiple national processes. If the report highlights uncertainty — around comparator relevance, immature survival data, indirect comparisons, subgroup robustness, endpoint validity, or generalizability to European clinical practice — those concerns may weigh on national negotiations.
While a challenging JCA does not automatically lead to poor access or a low price, it can change the burden of proof. It can make national payers more cautious, increase pressure for access restrictions, strengthen demands for rebates or managed entry agreements, and weaken the manufacturer’s ability to build the value narrative across countries.
This differs from national HTA negotiations, where a less favorable conclusion in one market could sometimes be balanced by a more favorable assessment elsewhere. Under the JCA framework, the clinical evidence layer becomes more coordinated, making it harder to compartmentalize evidence challenges market by market.
However, “not binding” should not be confused with “not influential.” A JCA report may become the common clinical evidence starting point for multiple national processes. If the report highlights uncertainty — around comparator relevance, immature survival data, indirect comparisons, subgroup robustness, endpoint validity, or generalizability to European clinical practice — those concerns may weigh on national negotiations.
While a challenging JCA does not automatically lead to poor access or a low price, it can change the burden of proof. It can make national payers more cautious, increase pressure for access restrictions, strengthen demands for rebates or managed entry agreements, and weaken the manufacturer’s ability to build the value narrative across countries.
This differs from national HTA negotiations, where a less favorable conclusion in one market could sometimes be balanced by a more favorable assessment elsewhere. Under the JCA framework, the clinical evidence layer becomes more coordinated, making it harder to compartmentalize evidence challenges market by market.
US MFN: International prices are becoming more relevant
At the same time, US pricing policy is moving toward greater use of international benchmarks. The May 2025 Executive Order on MFN pricing stated that Americans should have access to MFN prices for prescription drugs and biologics. This push comes amid findings that prices for the top 25 branded drugs rose an average of 81% after launch in the US market, but they decreased an average of 13% in 19 other high-income countries.7
HHS subsequently described expectations that manufacturers align US prices for certain brand products without generic or biosimilar competition with prices in economically comparable countries.3 The US government has reached voluntary MFN agreements with 17 of the largest pharmaceutical companies and other companies are preparing for an expansion of MFN,8 which would likely mean many more brand name drugs and biologics will be impacted.
Additionally, CMS has introduced the voluntary GENEROUS Medicaid model,4 which aims to align Medicaid net prices with prices paid in selected other countries. CMS has also released proposed mandatory MFN initiatives through its GLOBE5 and GUARD6 models for Medicare Part B and Part D, respectively, which would use international benchmarks to assess rebates when US prices exceed prices in comparable countries.
While legal, operational, political, and implementation questions may continue to evolve, the strategic direction is clear: European price outcomes may increasingly matter for US pricing exposure.
Compounding the challenge is the fact that many European markets are economically comparable, commercially significant, and embedded in IRP systems, despite differences in methods across countries.
HHS subsequently described expectations that manufacturers align US prices for certain brand products without generic or biosimilar competition with prices in economically comparable countries.3 The US government has reached voluntary MFN agreements with 17 of the largest pharmaceutical companies and other companies are preparing for an expansion of MFN,8 which would likely mean many more brand name drugs and biologics will be impacted.
Additionally, CMS has introduced the voluntary GENEROUS Medicaid model,4 which aims to align Medicaid net prices with prices paid in selected other countries. CMS has also released proposed mandatory MFN initiatives through its GLOBE5 and GUARD6 models for Medicare Part B and Part D, respectively, which would use international benchmarks to assess rebates when US prices exceed prices in comparable countries.
While legal, operational, political, and implementation questions may continue to evolve, the strategic direction is clear: European price outcomes may increasingly matter for US pricing exposure.
Compounding the challenge is the fact that many European markets are economically comparable, commercially significant, and embedded in IRP systems, despite differences in methods across countries.
Meeting the policy collision with smart planning
These strategic pricing risks pose challenges for biopharma companies. However, Europe remains an essential marketplace — clinically, commercially, and strategically — for launch success. The answer is not to avoid launching in Europe but to adopt stronger sequencing discipline, clearer evidence readiness, and better visibility into downstream pricing consequences. There are several key steps that biopharma leaders can take.
1. Conduct global price exposure planning
JCA preparation should not be done in isolation. Instead, companies should stress-test potential JCA outcomes against national P&R consequences, IRP connections, and US MFN scenarios.
2. Build a cross-functional pricing forum
Companies should bring together EU market access, global pricing, HEOR, US market access, policy, and priority local affiliates. Having this forum review evidence, risks, expected payer objections, launch sequence, pricing corridors, and contracting options before major market access decisions are locked can reduce the risk of costly global pricing exposure.
3. Stress-test the evidence narrative early
The most significant JCA risks often emerge before submission: comparator choice, endpoint maturity, trial generalizability to real-world patients, subgroup evidence, and indirect comparison credibility. These should be challenged during phase 2/3 planning, not after the JCA scope is finalized.
4. Map IRP transmission markets
Not all markets carry the same reference pricing risk. Companies should identify countries that are commercially important, frequently referenced, visible in official price sources, or likely to affect pricing across regions. This will result in a practical heat map of access opportunity vs. global price exposure.
5. Revisit launch sequencing
Launch sequencing should balance speed, patient access, evidence readiness, payer receptivity, price visibility, and reference pricing implications. The objective should be to ensure that early launches do not unintentionally set unfavorable global anchors, while seeking to limit the consequences of delayed access.
6. Prepare for multiple US MFN scenarios
US MFN policy remains dynamic. Companies should model several potential designs: Medicaid-only, Medicare Part B, Medicare Part D, gross vs. net benchmarks, different country baskets, lowest-price vs. average-price calculations, and treatment of confidential rebates. However, while implementation details may evolve, models already implemented by CMS show MFN thinking is no longer theoretical.
The strategic imperative: Integrate — do not retreat
The way JCA can impact MFN should not lead manufacturers to deprioritize Europe, which remains one of the most important regions for clinical adoption, scientific engagement, and global commercial strategy.
Instead, European launch planning now needs to be more globally integrated. Evidence planning, HTA readiness, national P&R preparation, launch sequencing, contracting, IRP management, and US policy monitoring can no longer be managed in isolation. They need to be connected earlier, governed more tightly, and evaluated through a global pricing lens.
Biopharma leaders should shift their thinking away from “How do we prepare for EU JCA?” or “How do we manage US MFN?” Instead, they should ask: “How do we manage the global pricing consequences of evidence and access decisions in a world where markets are increasingly linked?”
Companies that can answer this question will be better positioned to preserve patient access, sustain price integrity, retain crucial global clinical insights, and maintain strategic flexibility. Early and careful scenario planning will enable companies to be more resilient in a world where evidence narratives and price benchmarks collide.
Instead, European launch planning now needs to be more globally integrated. Evidence planning, HTA readiness, national P&R preparation, launch sequencing, contracting, IRP management, and US policy monitoring can no longer be managed in isolation. They need to be connected earlier, governed more tightly, and evaluated through a global pricing lens.
Biopharma leaders should shift their thinking away from “How do we prepare for EU JCA?” or “How do we manage US MFN?” Instead, they should ask: “How do we manage the global pricing consequences of evidence and access decisions in a world where markets are increasingly linked?”
Companies that can answer this question will be better positioned to preserve patient access, sustain price integrity, retain crucial global clinical insights, and maintain strategic flexibility. Early and careful scenario planning will enable companies to be more resilient in a world where evidence narratives and price benchmarks collide.
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Precizare:
Informațiile furnizate în acest articol nu constituie consultanță juridică. Cencora, Inc. încurajează insistent cititorii să revizuiască informațiile disponibile legate de subiectele discutate și să se bazeze pe propria experiență și expertiză în luarea deciziilor legate de acestea.
Sources:
1. Joint Clinical Assessments. European Commission. Accessed 30 June 2026. https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en
2. The White House: Delivering Most-Favored-Nation prescription drug pricing to American patients. WhiteHouse.gov. Posted 12 May 2025. Accessed 23 April 2026. https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/
3. US Department of Health and Human Services (HHS). HHS, CMS set Most-Favored-Nation pricing targets to end global freeloading on American patients. HHS.gov. Posted 20 May 2025. Accessed 30 June 2026. https://www.hhs.gov/press-room/cms-mfn-lower-us-drug-prices.html
4. Centers for Medicare & Medicaid Services. GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model. Page last modified: 23 December 2025. Accessed 30 June 2026. https://www.cms.gov/priorities/innovation/innovation-models/generous
5. Centers for Medicare & Medicaid Services. GLOBE (Global Benchmark for Efficient Drug Pricing) model. Page last modified: 29 December 2025. Accessed 23 April 2026. https://www.cms.gov/priorities/innovation/innovation-models/globe
6. Centers for Medicare & Medicaid Services. GUARD (Guarding U.S. Medicare Against Rising Drug Costs) model. Page last modified: 29 December 2025. Accessed 23 April 2026. https://www.cms.gov/priorities/innovation/innovation-models/guard
7. Phengsitthy N. US drug costs rise at home, fall abroad as Trump weighs action. Bloomberg Law. Published 28 May 2026. Accessed 30 June 2026. https://news.bloomberglaw.com/health-law-and-business/aarp-compares-us-drug-costs-as-trump-weighs-foreign-price-plans
8. Liu A. Touting $529B in savings over 10 years, White House looks to expand MFN deals with pharma. Fierce Pharma. Published 06 May 2026. Accessed 30 June 2026. https://www.fiercepharma.com/pharma/touting-529b-savings-over-10-years-white-house-looks-expand-mfn-deals-pharma
