Adapting market access strategies: Practical takeaways from ISPOR Europe

This year, ISPOR Europe was buzzing with conversations around four hot topics:

Joint Clinical Assessment (JCA): Success hinges on early, coordinated input. Without clear governance and country engagement, alignment risks stalling before it starts

Real-world data (RWD): RWD transportability has the potential to shift health technology assessment (HTA) from static snapshots to dynamic, cross-border learning, unlocking faster, smarter reappraisal across diverse health systems

Artificial intelligence (AI): From static models to intelligent networks, multi-agent AI enables parallel evidence generation and scenario testing, reducing uncertainty and accelerating HTA decision-making

Innovative pricing approaches: Value-based and performance-linked models promise flexibility, but fragmented regulations and inconsistent data systems across Europe create scalability challenges

So, what does all this mean for market access teams? In this post, we break down the key trends from ISPOR Europe and share practical steps you can take now to stay ahead of the curve.

Joint Clinical Assessments: Key lessons from early submissions

• Cross-country differences in standard of care and background therapy can lead to small, analytically valid but decision-irrelevant data
• Market access teams need to be involved in evidence generation planning and clinical trial design to ensure cohesion with JCA requirements
• Gathering patient insights on endpoint selection, in particular, quality of life measures, will be critical to success for orphan products
• Endpoint validation in orphan indications is a lengthy process so must be initiated early
• Defining population, intervention, comparator, outcomes (PICOs) for vaccines will bring additional challenges, discussed in our blog, available here

How can market access teams prepare?

1. Begin developing a Europe-wide evidence strategy at least 24 months before submission
2. Engage early with stakeholders, including in smaller markets, to align evidence strategies across countries

Making RWD travel: Unlocking value across borders

• Data transportability was a hot topic with positive case studies shared. However, uneven availability of data across countries remains a challenge
• In rarer indications, RWD may be the only opportunity to generate comparative effectiveness data, even if imperfect
• Lifecycle evaluation, supported by RWD, can help ease budget pressures by reassessing the value of technologies as the therapeutic landscape changes

How can market access teams prepare?

1. Embrace public-private partnerships to facilitate RWD generation
2. Register studies in ISPOR’s RWD registry to increase payer and regulator acceptability
3. Consider cross-market applicability when designing RWD generation plans

AI in HTA: From pilots to practice (with human in the loop)

• The National Institute for Health and Care Excellence (NICE) accepted the first submission using a hybrid human-AI SLR approachHowever, NICE did not endorse a particular platform for AI-assisted SLRs and emphasized the need for transparency and replicability as the main requirement when adopting AI
• Multi-agent systems are being used to overcome some of the challenges encountered by single-agent systems in early-stage economic models
• Hybrid approaches using multiple multi-agent systems have increased output quality, combining sequential, parallel processing and manager/worker systems

How can market access teams prepare?

• Engage early with HTA bodies on acceptability of methodology of AI-assisted evidence synthesis
• Combine automation with human strategic oversight and robust compliance guardrails
• Leverage AI-to-AI validation prior to human review

Innovative pricing models: Aligning evidence and expectations

• Main barrier to implementation remains misalignment between evidence generation and payer needs
• Practical considerations vary widely across Europe, contributing to uneven availability of medicines and creating challenges for smaller companies that lack resources to manage multiple schemes across jurisdictions
• High administration costs of cell and gene treatments for ultra-rare conditions proves a challenge for pricing sustainability, even under not-for-profit models

How can market access teams prepare?

1. Perform feasibility assessment of managing multiple different pricing models prior to implementation
2. Plan launch waves in alignment with pricing approaches
3. Establish clear governance and harmonised frameworks to support scalability

Conclusion

ISPOR Europe highlighted how rapidly the market access landscape is changing, driven by AI-powered evidence generation, compressed JCA timelines, and disruptive pricing strategies. To remain competitive, drug developers must adapt: investing in robust data infrastructure, embedding AI responsibly with strong governance, and engaging early with stakeholders to align evidence strategies across markets.

At Amiculum, we help market access teams to stay one step ahead and provide strategic advice to help you future-proof your evidence plans, navigate pricing challenges or integrate AI into workflows with robust safeguards.