Market access from Day 1: Navigating the new era of global pricing interdependence
As global pricing pressures accelerate and market access becomes increasingly complex, the importance of continued dialogue on how best to navigate these shifts has never been greater. In this Guest Column, experts from LCP Health Analytics outline the critical takeaways from their recent webinar, highlighting how global reforms are redefining launch and access strategies
A new era of global pricing disruption
The pharmaceutical industry is entering a period of unprecedented disruption. For decades, global pricing and market access evolved through slow, incremental regulatory shifts. Today, however, the rules are changing faster than manufacturers can comfortably react. This is driven largely by the US, but reinforced by parallel policy reforms across Europe, Canada, China and other major markets. These forces are not operating in isolation; they are unleashing knock-on effects, creating a level of interconnectedness the industry has never had to manage at this scale.
Against this backdrop, colleagues from LCP Health Analytics – Dr Jasim Uddin, Kevin Patterson, and Tim Moore – joined Jeff Henderson, former Head of Market Access at Ironwood Pharma and Vectiv Bio, for a webinar exploring how these global dynamics are transforming pricing strategy and evidence generation. Their combined backgrounds brought a unique 360‑degree perspective: Jasim’s expertise in global policy and value frameworks, Kevin’s insight into the structural logic behind pricing systems, Tim’s strategic and commercial focus, and Jeff’s deep experience navigating US and global access, contracting, and the evolving supply chain. Their discussions delivered a key message: the period ahead requires profoundly different thinking, where earlier planning involving all relevant stakeholders is key to ensuring optimal patient access to innovative new therapies.
Why this conversation matters now
The shift began with what many once viewed as theoretical: US alignment to international drug pricing. The theory shifted to practical reality with the recent emergence of Most-Favored-Nation (MFN) style approaches, which tie US payment benchmarks to Organisation for Economic Co-operation and Development (OECD) markets, pulling the US into the global pricing ecosystem in ways that will fundamentally influence launch sequencing, price corridor design, and cross‑market spillover effects. The panelists highlighted a key strategic consideration:
“US pricing can no longer be insulated by commercial dynamics alone and every decision in Europe, Canada, and even smaller reference markets carries potential downstream impact.”
At the same time, transparency pressures are intensifying. Net price disclosures, pharmaceutical benefit manager (PBM) transparency provisions, and stricter reporting requirements across value transfers are exposing previously opaque channels, from discounts and rebates to patient support structures. Jeff emphasized how the implications extend beyond payer negotiations to channel strategy, 340B mitigation, and even tariff‑related supply chain planning.
Globally, markets are responding in their own ways. The EU is progressing through Joint Clinical Assessment (JCA) implementation and pharma package reforms, reshaping evidence expectations, assessment timelines, exclusivity structures, and launch considerations – particularly for smaller biotechnology companies navigating resource‑intensive processes with overlapping regulatory and health technology assessment (HTA) demands. Meanwhile, countries like France and Germany are recalibrating pricing strategies in response to MFN effects, and Canada’s Patented Medicine Prices Review Board (PMPRB) is tightening list‑price discipline through more defined international reference thresholds.
The result is a global landscape where policy changes echo across borders, magnifying the consequences of every local decision.
What is driving the change?
Three themes dominated the panel’s reflections:
- The US is becoming a global price‑taker
MFN mechanisms, inflation reduction act (IRA) negotiation timelines, and expanding inflation rebates mean the US is increasingly basing its decisions on the actions of other developed countries rather than operating independently. This introduces entirely new constraints on global pricing freedom and incentivizes manufacturers to withdraw, delay, or reprioritize launches in certain European markets to protect US price positions.
- Evidence expectations are converging
If MFN and JCA push the US closer to HTA‑style value assessment, manufacturers must rethink evidence generation. The panel underscored how patient-reported outcomes (PROs), quality of life (QoL) measures, healthcare resource utilization (HCRU), and long‑term outcomes must be built into pivotal programs far earlier, often beginning in Phase 2, with market access playing a central role in study design. Many organizations still struggle to invest early, creating costly downstream gaps when payers later request evidence the clinical program was not built to generate.
- Global pricing interdependence is now unavoidable
External reference pricing, parallel trade, transparency registries, and updated price baskets mean visible list prices matter more than ever. Markets once treated as “lower priority” could now carry meaningful international reference pricing (IRP) risk, forcing companies to take a more deliberate, globally coordinated approach to price corridor planning and launch sequencing.
A more strategic future
Throughout the conversation, a common theme emerged: proactive strategies should take precedence over reactive ones. Our colleagues observed that numerous top companies now form global value committees early in the development process, design comprehensive risk matrices to connect list and net price risks, conduct launch simulations across various policy settings, and develop global value stories long before submitting to regulatory authorities. These organizations increasingly confront complex decisions regarding indication and launch order because clinical and reimbursement factors vary both within and across countries worldwide. The volume and sophistication of information needed for thorough early discussions is expanding rapidly.
Early value discussions are especially critical for biotechnology companies. With increasing evidence requirements, earlier involvement in market access considerations, complex global pricing constraints, and the necessity to demonstrate value across multiple HTA systems, early-stage organizations must not postpone access planning until Phase 3. This is particularly relevant as private equity and major pharmaceutical companies have begun to re-engage with biotechnology firms earlier in the clinical development process.
A new model for global market access
The market is undeniably moving toward more interconnected, more transparent, and more rigorously assessed pricing. As US, EU, and global policy reforms continue to collide and reinforce each other, the companies that will succeed are those that treat pricing and market access not as downstream operations, but as an early strategic discipline that shapes clinical development, investment decisions, and long‑term portfolio viability.
For LCP Health Analytics and its experts, one thing stands out above all:
“In a world where borders matter less and global policy forces matter more, market access must begin on Day 1 – with foresight, rigor, and coordination guiding every step.”
If you missed the webinar the first time, or would like to watch it again, view it on demand here: Beyond borders: The global policy forces transforming pharma pricing and market access
And if you want to interact with any of the panellists, their emails have been provided below:
Authors
Sreenidhi Venkatesh
Associate Consultant Market Access, LCP Health Analytics
Sreenidhi Venkatesh is an Associate Consultant in LCP's Health Analytics team. She has a strong foundation in data science and programming, specializing in the healthcare and life sciences sectors. She brings hands-on experience from projects focused on rare diseases across market access and evidence generation. With a keen interest in health equity, she is passionate about leveraging data-driven insights to support more inclusive and impactful healthcare solutions.
Jasim Uddin
Principal and Market Access Lead, LCP Health Analytics
As a seasoned market access consultant, with over 20 years of experience in the biopharmaceutical and allied industries, Jasim has significant experience in navigating client market access challenges. He has experience of working with products across a diverse range of therapy areas and a wide range of healthcare product types, including pharmaceuticals, medical devices, diagnostics, and digital prescription therapeutics. He has a specific interest in payer value communications, particularly how to optimally translate evidence into meaningful communications and tools that aim to facilitate optimal access. Prior to joining the LCP Health Analytics team, Jasim held senior leadership roles in other market access/HEOR consultancies, where he led multi-disciplinary teams across access, value communications, RWE, HEOR and digital solutions. In addition, he has a wealth of experience working in blue-chip pharmaceutical organizations (AstraZeneca and Novartis) across diverse roles spanning the entire product development life cycle. Jasim holds a BSc in Pharmacology with Toxicology from King’s College London and a PhD in Investigative Medicine from Imperial College London.
Kevin Patterson
Principal and US Access Solutions Lead, LCP Health Analytics
Kevin Patterson is one of the foremost authorities in the market access and pricing space. He has worked on pricing for more than 500 assets in the US and around the world. Originally a CPA, then hospital finance director, and CFO for CRM integrator and finally market access expert, Kevin brings a depth and breadth of business and healthcare experience to his practice. Kevin was one of the founding partners of Medical Marketing Economics, LLC (MME) where his practice focused on specialty assets. Today, he is the lead for US Access Solution at LCP Health Analytics. Kevin has deep expertise in oncology, gene therapy, rare and orphan disease diseases, and various other specialty areas. Kevin is a frequent advisor to the C-suite and Boards of Directors for Biopharma and the investor community. His passion for ensuring patients access to new therapies, improving care, and health equity guides his dedication to his clients.
Tim Moore
Principal and Global Business Development Lead, LCP Health Analytics
Tim Moore is a Principal and Business Development Lead for the LCP Health Analytics team. With more than 35 years of global experience, Tim has worked as both a C-level pharma operator, and a strategic consulting partner across large pharma and innovative biotech. As such, he can deeply appreciate and understand the realities and challenges biopharma companies face. Thus, Tim’s role during the webinar will be to moderate the discussion to create a dialogue from the pharma operator’s perspective.
Disclaimer
The opinions expressed in this feature are those of the authors and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.
Sponsorship for this Guest Column was provided by LCP Health Analytics.