Does this delay change how NHS decisions are made?

In short, no.

The decision to delay mergers appears to be driven largely by ongoing devolution discussions and wider local government reorganisation.

Many parts of England are currently reviewing how health, local government and other public services will work together in the future. Until there is greater clarity, creating new ICB structures risks introducing another layer of change to a system that is already adapting.

The strategic direction of travel remains largely unchanged.

Neighbourhood health, place-based care, integrated services and collaboration across larger geographies continue to sit at the heart of NHS planning.

And the challenges facing local healthcare systems remain:

• Financial pressure.
• Workforce shortages.
• Growing demand.
• Variation in care.
• The need to redesign pathways.

These are the issues influencing adoption decisions today, just as they influenced them before Integrated Care Systems existed.

Whether an organisation is called an ICB, a cluster, an alliance or something else in the future, decision-makers will still be asking similar questions:

Does this improve outcomes?

Does this fit within existing pathways?

Can we implement this with the workforce we have?

Does it support local priorities?

What the merger pause really means

Short-term uncertainty around structures may continue.

Leadership responsibilities may evolve.

Geographies may change.

Some systems may operate increasingly through informal collaboration before any formal merger occurs.

The result is that local engagement becomes more important, not less.

Healthcare adoption has always been more local than national.  National policy might shape the direction of travel, but local systems determine the pace.

This remains true regardless of how many ICBs ultimately exist.

Understanding local priorities, pathway challenges, implementation barriers and stakeholder relationships will continue to be critical long after the current merger discussions have been resolved.

A final thought

The story here is not really about mergers. It is about uncertainty.  And uncertainty is increasingly becoming a permanent feature of the NHS landscape.  The organisations most likely to succeed remain those focused on understanding local healthcare needs, building meaningful relationships and supporting implementation in the real world.

Because regardless of what NHS structures look like in 2028, adoption will still happen locally.

How resilient is your access and engagement strategy to NHS organisational change?

At NeoHealthHub, we help clients understand evolving NHS structures, map key stakeholders and develop practical strategies that support adoption at national, regional and local level.

From market access planning to implementation support, contact us to find out how we can we help organisations navigate complexity and deliver real-world results.

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Another NHS reform. Another operating model. Another ambition to move care closer to home, focus on prevention and reduce pressure on hospitals.

Recently, the Chair of NHS England called for an urgent redesign of urgent and emergency care, warning that the current model is not delivering what patients need. The argument itself is familiar. What is more interesting is what sits behind it: an acknowledgement that knowing what needs to change and making change happen are two very different things.

That lesson extends far beyond urgent and emergency care.

The gap between ambition and implementation

A year on from the NHS 10-Year Health Plan, the direction of travel is becoming clear. Prevention, neighbourhood health, integrated care, workforce transformation and digital enablement remain central priorities. Yet implementation remains uneven, with local systems progressing at very different speeds. National frameworks exist, but local readiness varies considerably.

For healthcare companies, this creates a challenge.

Many organisations continue to think about market access as a national exercise. Secure NICE approval, achieve a positive reimbursement outcome and uptake should follow.

The reality is more complex.

Even where national support exists, local funding arrangements, workforce capacity, service design and pathway requirements often determine whether innovation is adopted in practice. National approval may open the door, but local implementation determines whether anyone walks through it.

Why good ideas struggle to become routine care

The challenge facing the NHS is rarely a lack of good ideas.

Most healthcare leaders would agree on the importance of prevention. Few would argue against integrated care, earlier intervention or better management of long-term conditions.

The difficult part is translating these ambitions into everyday clinical practice.

Recent comments from NHS leadership on obesity illustrate this perfectly. The Chair of NHS England highlighted concerns about declining breastfeeding support, arguing that the health service is failing to promote an intervention that could significantly reduce obesity risk. The issue is not that the evidence is unavailable. The issue is turning evidence into consistent implementation across the system.

This pattern repeats itself throughout healthcare, the challenge applies to medicines, diagnostics, digital technologies and healthcare services.

Evidence exists. Guidance exists. Policy exists. Adoption varies.

The local NHS matters more than ever

One of the strongest signals emerging from the NHS 10-Year Health Plan is the increasing importance of neighbourhood and place-based healthcare. Care is gradually shifting away from traditional acute settings towards community-based models, multidisciplinary teams and local partnerships.

For life sciences companies, this changes the commercialisation challenge.

Understanding NICE remains important.

Understanding local systems is becoming essential.

Integrated Care Systems, Primary Care Networks, community providers, finance leads, pathway owners and voluntary sector organisations are playing an increasingly influential role in determining how innovation is adopted. A single national strategy is unlikely to be sufficient in a system where priorities, capabilities and readiness differ significantly between geographies.

The organisations seeing the greatest success are not necessarily those with the strongest national proposition. They are often the ones that understand local barriers, engage the right stakeholders and support implementation after launch.

Commercialisation is no longer just market access

Historically, many organisations viewed market access and commercialisation as separate activities.

Market access focused on reimbursement and approval.

Commercial teams focused on launch and uptake.

Those boundaries are becoming increasingly blurred.

Today’s NHS is looking for solutions that demonstrate clinical value, workforce impact, operational feasibility and financial sustainability simultaneously. Workforce pressures, pathway redesign, digital integration and health inequalities are all influencing decision-making. Products that can demonstrate how they fit into the realities of NHS delivery are more likely to gain traction than those relying on clinical data alone.

This is why commercialisation can no longer begin at launch.

It starts much earlier.

The decisions made during evidence generation, value proposition development, HTA planning and stakeholder engagement often determine how successfully a product is adopted years later.

Approval is only the beginning

The NHS does not have an innovation problem.

It has an implementation challenge.

Whether discussing urgent and emergency care, prevention, digital transformation or medicines adoption, the same question keeps emerging:

How do we move from knowing what should happen to making it happen?

For life sciences organisations, that means looking beyond approval and thinking more broadly about the path to adoption.

• How will local systems implement this?
• Who needs to be engaged?
• What barriers exist today?
• What does success look like in practice?

These are the questions that ultimately determine whether innovation reaches patients.

A final thought

The most successful healthcare innovations are rarely those with the strongest strategy alone.

They are the ones supported by a clear understanding of NHS reality, strong stakeholder engagement and practical implementation planning.

The NHS will continue to evolve. Structures will change. Priorities will shift. The challenge of turning good ideas into routine care will remain.

How prepared is your organisation for the journey from approval to adoption?

NeoHealthHub helps life sciences companies navigate NHS complexity through insight, strategy and implementation support across HTA, launch, adoption and lifecycle optimisation.

Get in touch to discuss how your organisation can accelerate adoption and maximise the value of innovation within the NHS.

The post The NHS Doesn’t Have an Innovation Problem It has an adoption challenge. appeared first on NeoHealthHub.

As highlighted in a recent issue of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)’s Value & Outcomes Spotlight, the introduction of Most Favored Nation (MFN) in the US has created one of the most significant changes to drug pricing and access policies. MFN moves the US toward international reference pricing (IRP), a mechanism long used in many other markets, including across Europe, thereby creating a convergence of pharmaceutical pricing systems that once operated in separate domains. In this article, we revisit this critical and evolving topic in HEOR and market access.

By linking US reimbursement to ex-US price benchmarks, MFN adds complexities for manufacturers, policymakers, and healthcare systems and raises questions about the impact on affordability, access, and innovation. It brings the US into the central issue surrounding IRP: the effect that pricing decisions in one country have on others through reference baskets (groups of socioeconomically comparable countries), benchmarking formulas, and pricing revision cycles.

For health economics and outcomes research (HEOR), evidence generation, and health technology assessment (HTA) leaders, the addition of the US to the IRP discussion means that evidence strategy must be able to support global value defensibility, launch sequencing, and uncertainty management across interconnected markets.

Key takeaways

Complex and colliding pricing and access policies

The data insights company GlobalData monitors more than 75 countries where IRP is used as a policy tool to inform or regulate medicine prices. The role IRP plays varies by market, creating a complex landscape for pricing negotiations and requiring regular adjustments and updates to IRP models. 

Key elements of IRP include:

• Basket size, or the number of reference countries included; 
• Referencing application — whether only at launch or updated periodically; 
• Benchmark methodology, such as average, median, or lowest price; 
• Adjustment factors, such as purchasing power parity, to account for differences in the general cost of living across countries and for exchange-rate considerations;
• Price level referenced (ex-manufacturer or wholesale price).

IRP policy change is common, and some countries in Europe have sought to shift away from it. One such example is Germany, which recently amended its Medical Research Act to introduce optional confidential discounted reimbursements so companies could keep their reimbursement price negotiations with statutory insurance funds private, and therefore not jeopardise their negotiations with other countries. 

Many questions about how MFN will be applied and its longer-term impact remain. What is known is that MFN, which President Trump issued as an Executive Order in May 2025, seeks to tie US drug prices to those in similarly developed countries.

In December 2025, Centers for Medicare & Medicaid Services (CMS) published the Global Benchmark for Efficient Drug Pricing (GLOBE) Model and the Guarding US Medicare Against Rising Drug Costs (GUARD) Model as mandatory IRP-style initiatives, using a 19-country reference basket for MFN benchmarking. 

Both GLOBE (Medicare Part B) and GUARD (Medicare Part D) include two IRP benchmarks: a default CMS-derived international benchmark that is based on international pricing data sources, and an optional manufacturer-submitted volume-weighted average net price benchmark.

The administration has also introduced a voluntary CMS model called GENEROUS (GENErating cost Reductions fOr US Medicaid), which adjusts Medicaid pricing based on manufacturer-reported average prices from 8 countries: the United Kingdom, France, Germany, Italy, Canada, Japan, Denmark, and Switzerland.

How GUARD and GLOBE will evolve remains uncertain, as both are proposed models covering 25% of their respective Medicare populations, equivalent to roughly 5% of the US population, given that Medicare covers approximately 20% of the population; however, the share may be larger in Medicare-concentrated therapeutic areas. The impact of GENEROUS, meanwhile, will depend on how many states and manufacturers choose to participate. Beyond Medicare and Medicaid, MFN’s implications across the US healthcare ecosystem remain uncertain. 

Implications for global drug pricing policy

The impact of reference pricing on launch sequencing and the pricing corridor is well understood in Europe. Typically, companies choose to delay or avoid launching a product in a country with a mandated low price to avoid a potential price decrease in countries that use reference pricing. Thus, lower-income countries in Europe face delays or even no access at all because pricing is anchored to countries that can afford to pay more for the product. 

With MFN, some manufacturers are now delaying European launches, opting not to launch, and even withdrawing existing products from markets for fear of price erosion in the US. Instead, manufacturers of some products — particularly more costly, innovative products — are opting to launch first in markets that offer incentives for innovation and pose a lower risk of IRP spillover than European markets, for example, Japan.

Implications for HEOR, evidence generation, and HTA strategy

These developments create new strategic implications for HEOR, evidence generation, and HTA teams. As MFN and IRP-style policies increase the consequences of price differences across markets, evidence becomes more than a requirement for local reimbursement; it becomes a foundation for global value defensibility. HEOR leaders will need to anticipate how payer and HTA critiques in one market may affect pricing expectations, launch sequencing, and value perception in others. Common evidence challenges include inappropriate comparators, non-representative populations, immature or non-clinically meaningful endpoints, limitations in indirect treatment comparisons or external controls, insufficiently reliable real-world data sources, and uncertainty over long-term outcomes.

In this environment, HEOR, evidence generation, and HTA leaders can play a more strategic role by taking four practical steps:

Conclusion

How MFN weighs on reference baskets, revision cycles, and pricing responses could result in significant disruption to affordability, access, and incentives for innovation. 

Much of MFN’s longer-term impact is difficult to predict. However, it will require manufacturers to think carefully about evidence, launch planning, and pricing. In a more globally interconnected pricing environment, it will increasingly be up to HEOR and HTA teams to find ways to address payer uncertainty, support value recognition, and prepare for more HTA-like scenarios in the US and other markets. Manufacturers that bring evidence generation closer to global pricing and access strategy will be better positioned to manage the risks ahead.

Note: Sources listed below

Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc. strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.

Sources

• Centers for Medicare & Medicaid Services. GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) model. Last modified 23 December 2025. Accessed 23 April 2026. https://www.cms.gov/priorities/innovation/innovation-models/generous  
• Centers for Medicare & Medicaid Services. GLOBE (Global Benchmark for Efficient Drug Pricing) model. Last modified 29 December 2025. Accessed 23 April 2026. https://www.cms.gov/priorities/innovation/innovation-models/globe 
• Centers for Medicare & Medicaid Services. GUARD (Guarding U.S. Medicare Against Rising Drug Costs) model. Last modified 29 December 2025. Accessed 23 April 2026. https://www.cms.gov/priorities/innovation/innovation-models/guard 
• Fick M, Satija B, Patton D. Drugmakers delay some European launches with a wary eye on Trump’s pricing policies. Reuters. Published 31 March 2026. Accessed 19 May 2026. https://money.usnews.com/investing/news/articles/2026-03-31/drugmakers-delay-some-european-launches-with-a-wary-eye-on-trumps-pricing-policies 
• Grueger J, Martin K, Sullivan SD. Referencing drug prices of other countries may not sustainably lower prices in the United States: Lessons from Europe. Value Health. 2025;28(9):1305-1308. doi: 10.1016/j.jval.2025.06.010.
• KFF. The facts about Medicare spending. Published 4 August 2026. Accessed 27 August 2026. https://www.kff.org/medicare/the-facts-about-medicare-spending/ 
• Kleja M. US cholesterol drug withdrawn in Denmark, MFN pricing policy blamed. Euractiv. Published 6 March 2026. Accessed 8 May 2026. https://www.euractiv.com/news/us-cholesterol-drug-withdrawn-in-denmark-mfn-pricing-policy-blamed/  
• Maini L, Pammolli F. Reference pricing as a deterrent to entry: Evidence from the European pharmaceutical market. Am Econ J Microecon. 2023;15(2):345-383. doi:10.1257/mic.20210053.
• Melck B. All change in Germany – confidential pricing in, IRP out. Pharmaceutical Technology. Published January 2025. Accessed 23 April 2026. https://www.pharmaceutical-technology.com/analyst-comment/all-change-germany-confidential-pricing-irp/ 
• Schott M, Brupbacher O, Batache D. Consultation opened on amendments to pharmaceutical pricing. Bär & Karrer Briefing. Published March 2026. Accessed 19 May 2026. https://www.baerkarrer.ch/userdata/20260318-ld-briefing-revision-kvv-klv.pdf 
• Sullivan SD, Grueger J, Martin K. International reference pricing comes to America: the MFN policies explained. Value Outcomes Spotlight. 2026;12(1). 
• Takamura K, Jinnai G, Niwa Y, Kondoh M. Overview of the Japanese rapid introduction premium as a drug pricing framework to enhance patient access to innovative drugs. Health Econ Rev. 2025;16:1. doi: 10.1186/s13561-025-00705-9.
• Watt A. International Reference Pricing (IRP) 2024: A year in review. Pharmaceutical Technology. Published 20 March 2025. Accessed 19 May 2026. https://www.pharmaceutical-technology.com/analyst-comment/international-reference-pricing-irp-2024/
• WhiteHouse.gov. The White House: Delivering Most Favored Nation Prescription Drug Pricing to American Patients [executive order]. Published 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/ 
• Wissinger E, Ringger D, Paardekooper C, Smith D, and de Alencar R. Most-favored nation policy and international reference pricing reshape global market access interdependencies. 2026. Value and Outcomes Spotlight. May/June. https://www.ispor.org/publications/journals/value-outcomes-spotlight/vos-archives/issue/view/drug-pricing-policies/when-worlds-converge–how-most-favored-nation-policy-and-international-reference-pricing-reshape-global-market-access-interdependencies  

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Innovation in the pharmaceutical industry continues to accelerate. In the coming years, the market is expected to see a steady flow of new therapies, including gene therapies, RNA-based treatments, cell therapies, and other specialized modalities.¹ These advances create new opportunities for patients, but they also increase the complexity of launch, pricing, and access planning.

At the same time, the commercialization environment is becoming more complex. Policy changes, funding pressures, and global competition are reshaping the conditions under which new therapies reach market.

In that context, the Most Favored Nation, or MFN, pricing framework is becoming an important consideration for pharmaceutical companies evaluating global launch strategy.

While much of the discussion around MFN has focused on policy design and near-term pricing risk, its broader significance may be strategic. MFN has the potential to influence where companies launch, how they sequence filings, and how they protect price integrity across interconnected markets.

Why MFN matters now

MFN links U.S. federal drug pricing to prices in other markets. As a result, pricing decisions that were once made largely market by market can have broader commercial implications. A lower price in one geography may affect pricing outcomes in another, particularly when reference pricing mechanisms are involved.

This shift does not affect every product or company in the same way. However, it does increase the need for coordinated planning across pricing, market access, regulatory, and commercial teams. For many organizations, launch sequencing is becoming a core element of global price architecture rather than a downstream market access decision.

Emerging impact on launch planning

One early signal of this shift is the apparent slowdown in new drug launches across Europe in the months following renewed U.S. attention to international reference pricing (IRP) and MFN-related policies. According to GlobalData, new drug launches in EU markets fell by approximately 35% in the 10 months after the May 2025 U.S. executive order, compared with the previous 10-month period.²  While launch patterns are influenced by a range of regulatory and commercial factors, the trend suggests that pricing considerations may be playing a more prominent role in geographic launch timing and sequencing.

There are several reasons why a company may delay or forgo filing in a given region, including development priorities, evidentiary requirements, resource constraints, and portfolio strategy. 

The implications may differ by company type. Large pharmaceutical manufacturers may be better positioned to manage pricing complexity across multiple assets and geographies. They often have broader infrastructure, more established European operations, and greater flexibility in how they manage portfolio risk.

For smaller biotech companies, the stakes may be higher. A single-asset company may have limited room to absorb pricing trade-offs across markets. In those situations, launch sequencing can become a strategic decision not only about market entry, but also about preserving future pricing flexibility.

Europe’s role in the access landscape

Europe remains a critical market for pharmaceutical manufacturers, both because of its scale and because of its influence on global reference pricing. At the same time, it remains a fragmented access environment.

A single EMA approval does not lead to a single access outcome. Instead, companies must navigate country-specific pricing, reimbursement, and health technology assessment (HTA) processes. Time from EMA authorization to patient access can vary significantly across member states.³  This complexity is further evolving with EU-level changes such as Joint Clinical Assessment, which may influence pricing and reimbursement dynamics across markets.

In an MFN environment, that variation becomes more strategically important. Delays in one market may carry consequences beyond that market, especially when pricing decisions influence future negotiations elsewhere.

The European Union pharmaceutical reform adds another layer of complexity. Proposed changes that tie portions of regulatory exclusivity to launch commitments across member states may encourage broader access, but they also create new trade-offs for manufacturers balancing access goals with pricing exposure.⁴  For companies planning global launches, Europe remains commercially important. In an MFN-sensitive environment, it is also becoming a more consequential determinant of launch timing, price signaling, and downstream access strategy.

Implications for access and competitiveness

The broader concern is not simply whether companies change launch order. It is whether changes in launch behavior could contribute to wider access gaps over time.

When companies delay filings in key reference markets, patient access may be delayed not only in those countries, but also in other markets that depend on them for pricing or regulatory benchmarks. This can create a longer and more fragmented path from approval to real-world availability.

At the same time, it is important to avoid overgeneralization. MFN exposure varies by therapy type, patient population, and reimbursement context. Rare disease and highly specialized assets may face different pressures than broader commercial products. Early access pathways, including named-patient and compassionate use programs, may also provide flexibility in some cases, although these options are not always used consistently.

Strategic considerations for pharma leaders

For pharmaceutical leaders, MFN reinforces the need to treat launch planning as a cross-functional pricing and access decision. Several priorities stand out:

These priorities also reflect common pitfalls organizations face when managing MFN and international reference pricing (IRP) exposure across markets.

Looking ahead

MFN is one part of a broader shift in global commercialization. It sits alongside manufacturing changes, tariff pressures, evolving policy frameworks, and increased international competition. Together, these trends are making launch strategy more interconnected and more complex.

Emerging policy proposals, including the pending GLOBE and GUARD models, could add further complexity to this evolving landscape. While these initiatives have not been finalized and their ultimate impact remains uncertain, they are increasingly influencing discussions around pharmaceutical pricing, investment commitments, and market access strategy. As companies navigate MFN-related considerations, they may need to account for a broader range of policy scenarios when making launch sequencing and pricing decisions. 

For pharmaceutical companies, the challenge is to balance three priorities: sustainable pricing, timely patient access, and continued incentives for innovation. In a more interconnected pricing environment, decisions made in one market may increasingly shape access outcomes in others. The companies best positioned to compete will align pricing, access, regulatory, and launch decisions earlier and with greater discipline across markets.

Disclaimer:
The information in this article is intended to inform readers about a topic related to Cencora’s capabilities and is not legal or purchasing advice. Cencora, Inc. encourages readers to review the cited references in this article and use their own knowledge and experience when making decisions.

Sources:

^1. Boston Consulting Group. New Drugs Modalities 2024. Accessed on June 29, 2026. https://www.bcg.com/publications/2024/new-drug-modalities-report 
^2. Reuters. Drugmakers delay some European launches with a wary eye on Trump’s pricing policies. Accessed on June 29, 2026. https://www.reuters.com/business/healthcare-pharmaceuticals/drugmakers-delay-some-european-launches-with-wary-eye-trumps-pricing-policies-2026-03-31/ 
^3. EFPIA. New data from EFPIA reveals multiple factors leading to unequal access to medicines for patients across Europe. Accessed on June 29, 2026. https://www.efpia.eu/news-events/the-efpia-view/efpia-news/new-data-from-efpia-reveals-multiple-factors-leading-to-unequal-access-to-medicines-for-patients-across-europe/ 
^4. European Commission. EU Pharmaceutical Reform: Incentives to steer innovation and achieve public health objectives. Accessed on June 29, 2026 64fdc425-c78d-4f08-aa34-4e6fd1f07bf4_en

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With the release of the first Joint Clinical Assessment (JCA) reports, a picture of the process and future implications is starting to emerge. Manufacturers are gaining insight into how the methods are being applied and the challenges these present. 

The next area of focus will be how the findings impact decisions at the country level and how they achieve the overarching goal of improving patient access across each European Union market. 

In an ISPOR panel discussion — Understanding the First JCAs: Practical Takeaways for Key Stakeholders – held on 23 June 2026, key stakeholders from industry, health technology assessment (HTA) authorities, patient advocacy groups, as well as a respected market access analyst came together to discuss the early reports and what the implications are for industry, innovation, and patient access.

Questions and concerns from early reports

As of mid-July 2026, the European Commission had published three JCA reports: one with critical findings relating to tovorafenib (Ojemda®) and two discontinuations. For industry stakeholders, the early reports pose questions about whether the framework has the necessary flexibility to adequately evaluate products for rare diseases where, in some cases, the gold standard of randomized controlled clinical trials (RCTs) is not feasible or ethical. 

During the panel discussion, James Ryan, Director, Global HTA Policy, HTA and Modelling Science at AstraZeneca, raised concerns about what would be feasible in evidence terms in the context of a rare disease and the real-world decision-making factors that surround it. However, Anja Schiel, PhD, Senior Advisor, Norwegian Medical Products Agency, disagreed, noting that the JCA assessors do consider indirect treatment comparisons and do not narrowly focus their reviews on randomized controlled clinical trials (RCTs). 

“When we do an HTA, we either assess the added benefit or we focus on cost-effectiveness, then we model and create scenarios, and we’re very open to all kinds of other constructs of evidence that will help us to understand the uncertainty around the methodology itself,” she said. However, she added that manufacturers need to ask how their single-arm trial can be designed to fit the real-world data, not the other way around. “Many HTAs are asking for real-world evidence. Make it convincing. Sometimes you have to generate your own. You can use different inclusion-exclusion criteria, you can look for a different population.”

The early reports also raise queries about patient input. Antonella Cardone, CEO of Cancer Patients Europe, a pan-European all-cancer patient association, noted that although patients and healthcare professionals were consulted per the JCA process and guidance, it is not clear how that feedback impacted the decisions in the report. 

“What is documented is that the patient asked for the quality-of-life assessment on the long-term safety, real-world comparators, discontinuation, and tapering, and equity of access,” she said. “But those criteria were considered non-accessible. So, what is the purpose of involving the experts if what they recommend cannot be taken into consideration?”

She added that there are several issues with regards to the meaningful involvement of experts in the process, including how experts are selected, whether a single individual or patient group is sufficient to represent an entire patient community, how their input influenced the definition of the PICOs (Population Intervention Comparator Outcome), the number of PICOs identified, and the final conclusions of the report. 

“We heard from the coordination group that they will be looking into ways to fix these problems and to be more transparent,” she said. 

Responding to the PICOs

In its own assessment of its evidence, Ipsen – the recipient of the first JCA report – flagged limitations inherent in their matching adjusted indirect comparison analysis, noting that they were attempting to answer the PICO. However, none of the company’s commentary on their own evidence was included in the report; only the assessor’s criticism.

As has been highlighted, there is a lack of evidence available on the very varied standards of care in the particular disease setting, pediatric low-grade glioma. While the JCA places the onus on manufacturers to expand their analysis, without the evidence required to conduct the analysis or to carry out a comparison arm, the credibility of the process is open to question, which then leaves those manufacturers at risk of criticism in the JCA report. 

Ryan noted that later JCAs that are based on large RCTs will have larger dossiers and will have much bigger JCA reports with far more available outcomes, including a lot of comparators and potentially many subpopulations. “When we get dossiers running to thousands of pages, we will get very large JCA reports and the question will be, how do people handle that and use it in a way that ultimately is focusing on the key bits that the decision maker needs to focus on?”

What’s next at the country level?

For the discontinuations and for any JCAs with negative findings, the question as to what happens to those products at the country level becomes pertinent. Do the products become blocked at a country level? If not, does that undermine the integrity of the JCA? And what are the implications for future JCAs and access to innovative products at a time when the European market is viewed negatively, especially in light of concerns over the impact of Most Favored Nation (MFN) policies and tariffs. 

Industry scrutiny will intensify as the JCA process progresses and as products from that process start to make their way into the country assessment and pricing process. “Countries are preparing and adapting their templates, but we don’t know how the JCA report is going to impact HTA decisions in the Member States,” said Cardone. 

While Schiel says HTA authorities have committed to reuse as much of the JCA as possible, it depends on the kind of assessment each member state wants to do and whether the report is relevant. “If the report contains nothing that is relevant for my decision-maker’s framework, then there’s little I can reuse.”
She added that many countries have different assessment criteria, including alternative pathways, simplified procedures and other approaches, and in very rare diseases the Norwegian Medical Products Agency does not do cost utility analysis at all and that decision-makers understand that they are often dealing with uncertainty. 

“Companies can submit something that’s not identical to the JCA, and they probably will because they will read the JCA and realize they haven’t addressed the relevant PICOs,” she said. “We are not actively going out reading JCAs and making HTA assessments because we rely on what is submitted to us.”

The JCA also has the potential to influence HTA markets outside of Europe, which will be looking at how they can bring something similar into their processes, panelists noted. 

“The limitations of taking a JCA report and applying it across healthcare and HTA systems that operate on different principles and standards of care may be open to question,” said Neil Grubert, independent pharmaceutical market access specialist.  “That being said, I’m sure there’s going to be enormous interest because it is new, it does represent a multi-country perspective, and it is in English. I know from panel discussions that NICE (UK’s National Institute for Health and Care Excellence) will be studying those first JCA reports with interest, but to what extent that influences their work remains to be seen.”

Impact of the JCA into the future

In 2028, orphan medicines will be subject to the mandatory JCA, which some observers have noted will raise further questions about the process and whether its methods support decision-making for medicines that may not fit traditional clinical evidence data models. 

“When the new HTA regulation came into place we hoped it would take some of the burden away from the HTA assessment in the countries and accelerate access to treatment. But will this happen? Nobody can tell,” Cardone said.

Ryan said it is his hope that the reports or the use of the regulatory dossier will provide some context at the local level, adding that if decision-makers depend solely on the JCA report, or more concerningly the summary report, it could pose a risk for how HTA decisions are reached across Europe. 

“The interesting thing to observe going forward will be what role the assessor and co-assessor play, and to what extent they may influence the output, even if that’s unintentional,” said Grubert, adding that he expects that over time there will be methodological convergence in the approach that different agencies bring to their work on the JCA as assessors and co-assessors. 

“I’m sure everyone is going to be studying not just this first one, but the others that follow and see what common features there are, and indeed what problems may arise that we need to address,” he added. “And that perhaps also speaks to the review process that is meant to start in a matter of months with a view to submitting a report in January 2028 to the Commission in terms of what adaptations may be required.

The overall goal of the European Commission and Member States is to promote broader availability, accessibility, and affordability of new medicines, and JCA plays a role in that objective. However, some of the core elements of the HTA lie beyond the scope of the JCA, Grubert noted, added to which there are geopolitical uncertainties impacting the launch of drugs in Europe. 

“The JCA is just one element in that broader picture, but if it goes to plan, it should lead to a convergence in terms of approaches to HTAs, which we hope will result in faster and more uniform access and reduction in the disparities in standard of care,” he said. 

Disclaimer:
The information in this article is intended to inform readers about a topic related to Cencora’s capabilities and is not legal or purchasing advice. Cencora, Inc. encourages readers to review the cited references in this article and use their own knowledge and experience when making decisions.

The post The JCA unleashed: Key takeaways and outlook from early reports appeared first on NeoHealthHub.

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). 

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.

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. 

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.

Disclaimer:
The information in this article is intended to inform readers about a topic related to Cencora’s capabilities and is not legal or purchasing advice. Cencora, Inc. encourages readers to review the cited references in this article and use their own knowledge and experience when making decisions.

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 

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What you’ll learn:

• Five key touchpoints where IRP can influence launch and lifecycle decisions.
• Six factors that drive differences in IRP rules across countries.
• Common risks that can contribute to downstream pricing pressure.
• Practical launch sequencing considerations to help manage global reference pricing dynamics.

IRP is not a single event. It is an ongoing launch and lifecycle consideration that can influence pricing and reimbursement outcomes across markets. Understanding these dynamics can support more informed pricing, launch, and market access strategies.

View the infographic to explore the pricing and reimbursement dynamics shaping global launch strategy. You can also download the whitepaper from our parent website.

The post IRP: The global impact of a single price decision appeared first on NeoHealthHub.

For pharmaceutical companies with a pipeline of new treatments, the transition away from NHS England will pose a unique challenge. With Integrated Care Boards (ICBs) now taking on this responsibility, there will be increased complexity and potentially variability in how new technologies will be adopted and embedded in local service pathways. For industry players, this means a heightened need for tailored strategies and a requirement to work closely with ICBs, ensuring timely and effective implementation of new therapies. Companies will need to adapt their approach, ensuring seamless collaboration and efficient market access.

Oncology services have been at the forefront of the shift from central to local commissioning. The absence of a central body responsible for coordinating the implementation of new treatments means that pharmaceutical companies will need to navigate a much broader network of NHS organisations. This could potentially lead to delays in patient access and make it more difficult to develop unified strategies to address product adoption challenges post-HTA approval. Companies will therefore be required to broaden their outreach, working with multiple organisations to ensure smoother transitions from approval to access.

At NeoHealthHub, we have always been a critical access lifeline to our clients. However, these recent announcements now mean that access, fused with up-to-date intelligence about what is happening within each locality, is now more important than ever. We are passionate about helping pharmaceutical, biotech and medical device companies navigate these complexities, providing tailored strategies from development to execution, ensuring the right patients receive the right therapies at the right time.

Contact us to learn how we can support you in adapting to the changing NHS landscape.

The post The Impact of NHS England’s Abolishment on Pharmaceutical Commercialisation in the UK appeared first on NeoHealthHub.

This report shares unique insights from critical decision makers within the NHS, giving a holistic view of the current state of evolution in the NHS, and an objective view of where to focus support, specifically covering:

• How NHS finances, service provision and structural changes are viewed.
• How manufacturers of pharmaceuticals or Medtech should adapt their value propositions to align with the challenges faced and maximise benefits to services and patients.
• How increased collaboration with industry and third-party partners would support local health systems.

The post Keeping up with the new NHS appeared first on NeoHealthHub.