With over 65 years combined experience, we have a long track record of delivering timely solutions for our clients.
Across the European Union, centrally authorised ATMPs demonstrate profound variability in availability. High-cost therapies have achieved widespread launch where systems are aligned. Others, despite an orphan designation and a clear unmet need, remain commercially absent.
Why?
Because European access depends on:
- National fiscal absorbability
- Managed entry agreement design
- Infrastructure readiness
- Certified centre capacity
- Cross-border treatment frameworks
- EU Joint Clinical Assessment timing
- Manufacturer launch prioritisation
Cost alone does not determine availability. Structure does.
One-off gene therapies combine substantial upfront cost with long-term therapeutic promise often supported by limited real-world durability data at launch.
To manage this uncertainty, healthcare systems have increasingly adopted innovative reimbursement mechanisms, including:
- Outcomes-based agreements
- Staged or annuity payments
- Managed entry schemes
- Conditional reimbursement frameworks
Such mechanisms are more widely implemented across European systems than in the United States, reflecting differences between single-payer and multi-payer structures and varying willingness-to-pay thresholds.
However, innovative payment models alone do not resolve access challenges.
Health systems differ in:
- Budget cycle flexibility
- Capacity to track long-term outcomes
- Tolerance for uncertainty
- Infrastructure for advanced therapy administration
Reimbursement mechanisms must therefore be engineered in alignment with system design — not merely replicated across markets.
Odelle models durability sensitivity, fiscal impact, and uptake trajectories to ensure that innovative reimbursement structures are credible, implementable, and sustainable.
Managing uncertainty is not simply a contractual exercise.
It is architectural.
Early Reimbursement Architecture
We engage before pivotal clinical strategy is fixed. We align:
- Comparator strategy
- Endpoint selection
- Health economic modelling
- Budget impact logic
- Launch sequencing
Ensuring that evidence is constructed to withstand both EU-level clinical assessment and national fiscal translation.
From 2025, newly authorised oncology medicines and ATMPs are subject to a mandatory Joint Clinical Assessment under EU Regulation 2021/2282.
This creates a shared European clinical evidence base, while economic decisions remain national.
We anticipate both levels simultaneously integrating evidence positioning with downstream reimbursement logic.
Pricing and reimbursement remain Member State competencies.
We model:
- Multi-year budget impact
- Uptake sensitivity
- Infrastructure feasibility
- Managed entry agreement scenarios
- Outcome-based payment structures
Our focus is not on theoretical cost-effectiveness. It is fiscal legibility.
Advanced therapies introduce constraints beyond conventional biologics:
- Manufacturing scale limitations
- Autologous product logistics
- Short shelf-life management
- Specialised certified centres
- Capacity bottlenecks
Availability is as much operational as economic.
We integrate infrastructure feasibility into reimbursement planning from the outset.
Regulatory approval reduces scientific risk. It does not eliminate access risk.
We provide structured reimbursement risk assessment to support:
- Financing rounds
- Equity narratives
- Partner negotiations
- EU expansion strategy
Odelle does not calculate cost-effectiveness at the end of development. We design reimbursement logic at the beginning. Ensuring that advanced therapies are not only authorised but adoptable.