Market Access is the process that ensures patients can benefit from new medicines once they are proven to be well tolerated and effective. It brings together the evidence, policy and pricing strategies needed to secure payer approval and reimbursement. As part of Helios’ DECADE OF DIFFERENCE campaign, the Cogentia team highlight how strong Market Access foundations shape real outcomes for patients and healthcare systems.
It is not simply about reimbursement. Effective Market Access ensures that the value of innovation is recognised clinically, economically and socially so healthcare systems can adopt new therapies efficiently and equitably.
Across Europe, the European Federation of Pharmaceutical Industries and Associations Patients Waiting to Access Innovative Therapies Indicator shows that access timelines vary dramatically, from under 4 months in some countries to more than 3 to 4 years in others. The difference often comes down to preparation, particularly the quality of data, payer engagement and alignment with local evidence expectations.
Cogentia’s work in Market Access is rooted in that understanding. By aligning evidence and payer insight early, the team helps clients move from innovation to patient care and prepares for local negotiations with compelling value documents.
Commercial viability: sustaining innovation through value
Market Access also underpins commercial sustainability. It defines whether innovation can achieve a return on investment in a world where affordability and value are constantly reassessed.
As explored in Cogentia’s ‘By Any Genes Necessary’ white paper, demonstrating value is no longer only about efficacy. It relies on integrating payer expectations, health economic evidence and real-world relevance from the earliest stages of development.
In today’s environment, manufacturers face growing scrutiny of long-term value propositions. Cogentia helps clients respond with robust, data-driven Market Access strategies that support sustainable value in a changing global landscape.
Early development integration: access from the outset
Embedding Market Access thinking early is one of the most powerful shifts across the industry. Considering payer perspectives from Phase 1 helps shape evidence plans, trial design, comparators and pricing potential.
This reflects Cogentia’s ethos of integrating evidence with access from the beginning.
“The earlier you consider access, the smoother the pathway to patients,” says David Alderson, Director, Market Access.
Through Opportunity Assessment and other early-stage analyses, Cogentia helps clients understand what is required clinically, economically and operationally to succeed. This includes identifying scientific and regulatory risks alongside the commercial and reimbursement risks that can derail even the most promising asset.
Navigating complexity and demonstrating value
To secure access, innovation must demonstrate value that is both clinical and economical. Health Technology Assessment (HTA) bodies evaluate cost-effectiveness and real-world benefits, while payers consider budget impact, opportunity cost and comparative value. Each market applies its own criteria. The National Institute for Health and Care Excellence in England focuses on cost per quality-adjusted life-year, Germany’s Gemeinsamer Bundesausschuss assesses added benefit, and France’s Haute Autorité de Santé prioritises therapeutic value and price referencing.
The Market Access environment is increasingly dynamic. Global development programmes must adapt to diverse national HTA requirements and payer expectations. Across Europe, the introduction of the Joint Clinical Assessment (JCA) is reshaping how evidence is evaluated, creating a single European Union (EU)-level review of clinical data to reduce duplication and improve consistency between Member States. National authorities will still decide on pricing and reimbursement, but this harmonised review aims over time to shorten access timelines and enhance transparency for patients.
“Agility is essential,” notes Mark Orchard, Senior Consultant. “Understanding where policy is moving, aligning evidence and value strategy accordingly – is what keeps innovation on course.”
The Cogentia team are already helping clients prepare for the JCA by assessing implementation at the national level and shaping evidence packages that meet both EU and UK requirements, bridging regulatory, payer and policy needs across regions.
Product launch success: where access defines impact
Even the most effective therapy can falter if pricing, reimbursement and value communication are misaligned.
“As expectations evolve, it’s not just about building evidence, it’s about connecting that evidence to meaningful payer decisions,” adds Abbey Child, Head of Market Access. “Our role is to make sure the science, data and health economics tell one clear story about patient value.”
Common pitfalls include:
- Building payer evidence too late in development
- Failing to articulate value beyond clinical endpoints
- Underestimating local decision dynamics or budget constraints
Key success factors include:
- Early and continuous payer engagement
- Cross-functional collaboration between access, health economics and outcomes research (HEOR), and commercial teams
- Clear, data-driven communication of value and unmet need
Cogentia partners with clients across these stages, connecting evidence, payer insight and market understanding to position launches for long-term success.
Market Access is no longer a downstream function. It is a strategic discipline that shapes how science becomes care.
How Cogentia partners with medical affairs earlier in the journey
By involving Market Access thinking earlier, Cogentia helps medical affairs teams move from reacting to payer needs to confidently planning for them. Working alongside clinical and commercial colleagues, they build a joined-up view of the asset, clarify the value story and highlight where evidence or alignment is needed. The points below outline how they support teams in anticipating access challenges, strengthening stakeholder engagement and creating a clearer path from data to real-world impact.
- Create a unified access roadmap that brings medical affairs, HEOR and commercial teams together around a shared view of access goals, milestones and evidence needs from early development through launch
- Combine clinical insight with Market Access expertise to map and prioritise evidence gaps early, then design analyses and studies to plug those gaps and reduce the risk of late-stage surprises for payers
- Refine product positioning and target product profile, with payer expectations in mind, so the value story is clear, consistent and usable for both medical and commercial colleagues at every stage
- Strengthen internal stakeholder alignment by equipping global and affiliate medical teams with practical tools, narratives and training so they can communicate the asset’s value confidently and consistently
- Support focused external engagement in priority markets, helping teams understand local decision drivers and test value messages with payer and clinical stakeholders, so evidence and communication plans land effectively in each setting
Director, James Morris, gives final thoughts: “Securing Market Access requires effective collaborative working between multiple stakeholders, firstly to understand and characterise the value of innovative technologies, and then to communicate it clearly to decision makers.”
As part of the Helios Global Group, Cogentia continues to bring evidence and access together so innovators can deliver real-world patient impact faster.
About Cogentia
Cogentia is a leading Market Access and HEOR consultancy working across the full product lifecycle, from early development to HTA submissions and securing access. As part of the Helios Global Group, we support clients with the depth and breadth needed for today’s evidence and access challenges.
We work across cell and gene therapies, rare diseases and all major therapeutic areas, supporting pharmaceutical, device and diagnostic companies ranging from start-ups to global firms.
Our team brings experience from industry, consulting, public health and academia, allowing us to deliver integrated solutions that combine economic and access elements within a single project. Drawing on strong market insight, we support everything from opportunity assessments, access strategy and early economic modelling to payer engagement, value messaging, health economic modelling and HTA submissions. We also help clients refine target product profiles and evidence development plans, supported by our network of payers and key opinion leaders.
Our approach is collaborative, flexible and pragmatic. We work as a close partner, embedding ourselves in your team and focusing on the challenges that matter most to you.
James Morris
David Alderson
Abbey Child
Catherine Åkesson
