Driving Smarter Market Access in a Complex Healthcare World
The Center of Excellence (COE) for Market Access, Pricing, and HEOR empowers clients with the intelligence, strategies, and solutions needed to succeed in rapidly evolving healthcare landscapes. Through thought leadership and global collaboration, we transform insights into action.
Our Mission
At the heart of our work is a simple mission: to drive exceptional market access outcomes. We do this by combining real stakeholder perspectives with practical solutions, giving our clients clarity and confidence as they navigate shifting healthcare systems worldwide.
Research Priorities 2025-2026
In the coming year, our work will concentrate on challenges that matter most to healthcare innovators and decision-makers. We are developing country-specific market access roadmaps, exploring new ways to demonstrate value for rare diseases, and assessing how policies like the Inflation Reduction Act will affect pricing and contracting. We are also working on sustainable access models, EU HTA implementation, and affordability solutions for high-cost therapies.
Explore our Thought Leadership
August 2025
The arrival of ultra-high-cost, potentially curative gene therapies for conditions like Sickle Cell Disease (SCD) presents a unique challenge for payers, especially state Medicaid programs. How can they expand access to these transformative treatments while protecting their budgets from financial risk?
The answer lies in the CMS Cell & Gene Therapy (CGT) Access Model. This new Medicaid demonstration program is a groundbreaking federal effort to coordinate outcomes-based payment (OBP) agreements across multiple states.
This report from the Clinigen market access team, offers a detailed overview of the model, starting with its pilot phase for SCD gene therapies Casgevy and Lyfgenia. We highlight the robust state participation (33 states plus DC and PR) , explore the implications for pharmaceutical manufacturers regarding market access and financial predictability, and discuss the model's potential for future expansion.
August 2025
In the rapidly evolving landscape of gene therapy, achieving market success is critical. Much has been explored regarding the First Mover Advantage (FMA) in the pharmaceutical industry, but its relevance to gene therapy has remained largely unexamined.
This preliminary research report from Clinigen Market Access offers a first look at this topic, exploring a fundamental question: Are gene therapy sales data consistent with a First Mover Advantage, as judged by higher sales, for the first product to market in a given indication?
Analyzing FDA-approved gene therapies across six indications where competitors have entered the market, we provide a data-driven, albeit preliminary, exploration. We compare earlier versus later market entrants and offer tentative conclusions on whether being first to market translates to greater commercial success in the gene therapy space.
September 2025
The global pharmaceutical balance of power is shifting. Once seen as the world’s generic manufacturer, China has rapidly evolved into a powerhouse of drug innovation - redefining how medicines are developed, priced, and accessed worldwide.
With Western companies facing over $140 billion in annual revenue losses from looming patent cliffs, Chinese biotechs are stepping in with next-generation therapies that challenge not only scientific conventions but the economic models underpinning global market access.
Clinigen’s white paper, The China Paradigm Shift, explores how this transformation - driven by accelerated regulatory pathways, evidence-generation speed, and aggressive pricing strategies - is disrupting traditional frameworks for health technology assessment (HTA), reimbursement, and global pricing coordination.
Drawing on exclusive data and expert analysis, this report offers critical insights for pharmaceutical and biotech leaders navigating the new era of “me-better” innovation at global scale - and strategies to build resilience in an increasingly China-influenced market.
September 2025
The traditional global launch model - led by the U.S., followed by major European markets and then the rest of the world - is being upended. In 2025, new pricing and reimbursement policies across key markets are forcing pharmaceutical companies to rethink how, where, and when they bring new therapies to patients.
From Canada’s revised Patented Medicine Prices Review Board (PMPRB) guidelines and the U.S. Most Favored Nation (MFN) pricing directive to the UK’s new Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG), the rules of launch sequencing are being rewritten. Each change introduces new risks for international reference pricing (IRP) and heightens the complexity of coordinating list prices, paybacks, and launch order across regions.
Clinigen’s white paper, Launch Sequencing and Prioritization in an Evolving Global Market, analyzes how these shifting frameworks are reshaping global pricing corridors and outlines actionable strategies to protect value while maintaining access.
Drawing on the latest policy developments, this report provides a roadmap for optimizing launch order, managing IRP spillover risk, and aligning pricing architecture across an increasingly fragmented regulatory landscape.
September 2025
Europe’s new Health Technology Assessment (HTA) framework is transforming how orphan drugs are evaluated, approved, and reimbursed. With the implementation of Joint Clinical Assessments (JCA) under the EU HTA Regulation, the evidence expectations for rare disease treatments are entering a new era of scrutiny and alignment.
From 2028, all orphan-designated medicinal products will fall under the JCA process - fundamentally changing how comparative evidence, endpoints, and patient relevance are assessed across the EU. While this shift promises greater consistency and transparency, it also introduces significant challenges for developers operating in data-limited rare disease settings.
Clinigen’s latest white paper, HTA and JCA Requirements for Rare Disease Products, explores how orphan drug developers can prepare for this regulatory evolution. Drawing on analysis of 17 recent EMA conditional approvals, it highlights where current evidence generation strategies fall short of JCA standards - and what sponsors can do now to close those gaps.
This report provides a practical framework for aligning clinical, regulatory, and market access strategies early in development, enabling innovators to navigate the new JCA landscape while continuing to deliver breakthrough therapies to rare disease patients across Europe.
October 2025
Generative Artificial Intelligence and foundation models are transforming Health Economics and Outcomes Research (HEOR) and market access by automating complex tasks including systematic literature reviews, health economic modeling, and real-world evidence generation.[1] The strategic implications differ significantly between HEOR and market access functions. Companies that integrate AI strategically across the product development timeline—from Phase II evidence planning through launch—can achieve earlier availability of economic insights, improved evidence quality, and more adaptive market access strategies.
December 2025
Health Economics and Outcomes Research (HEOR) has been an integral part of biopharma over the last few decades. However, since 2024 strong economic headwinds due to major policy developments (e.g. Inflation Reduction Act in US) and increasing global pricing pressures have led biopharma organisations to restructure.
Biopharma organisational leadership are asking their HEOR teams to become a key influencer of business decisions. While recent focus in literature and ISPOR has been on how HEOR teams need to evolve their ways of working, many practitioners are unsure as to what business-decisions they can impact.
This whitepaper examines what business decisions HEOR teams can influence or drive within biopharma, and across the lifecycle of a product. We conclude that HEOR has an instrumental role to play across different domains of business-decision-making, but this would require teams to upskill and evolve their ways of working.
Leadership team
Our team brings together expertise in market access, evidence generation, and pricing strategy.