Access strategy for
a repriced world.

A major global oncology alliance was preparing to launch a novel ADC asset in platinum-resistant ovarian cancer requiring a companion diagnostic to identify eligible patients. Across 17 European and select international markets, CDx reimbursement pathways were fragmented, inconsistent, and in many cases untested for novel IHC-based diagnostics. Reliable funding could not be assumed to follow regulatory approval.

A structured three-phase engagement mapped CDx funding pathways and key stakeholders across all markets, segmented them by gap severity and mitigation feasibility, and produced a strategic playbook covering 7+ actionable options — from manufacturer funding models to policy shaping — each assessed by timing, effort, and risk. Validated throughout with in-country P&MA experts across EU4 and select global markets.

The alliance entered launch sequencing with a defensible, evidence-based playbook. CDx reimbursement gaps were identified and categorised before regulatory approval — enabling proactive rather than reactive management. The above-asset framework was designed for reuse across future pipeline assets.

A US-headquartered specialty biopharma was preparing simultaneous HTA submissions in three major EU markets for a novel oral treatment in a moderate-to-severe immunological condition — the first in its mechanism class to reach late-stage development. With NICE, G-BA, and HAS submissions running in parallel, the team needed rapid, independent advisory support to stress-test the HEOR framing and sharpen the payer narrative before dossiers were locked.

A focused two-week sprint reviewed the evidence package against current HTA methodology in each market, identified where the value story was vulnerable, and produced a concise HTA risk map with market-specific recommendations. The engagement led to a follow-on mandate: early access strategy for a late-stage pipeline asset, covering scenario modelling under EU HTA and IRP, launch sequencing across five EU markets, and a pricing corridor framework.

Dossiers submitted with strengthened HEOR rationale across all three markets, on schedule. The pricing corridor was established six months ahead of the first EU HTA assessment. The pipeline asset sequencing framework was adopted as the basis for the global launch plan.