Different markets. Different evidence bars. Same standard of execution.

The access problem. Patient numbers are small, evidence bases are fragmented, and payer scrutiny is at its most intense exactly where the case is hardest to make. HTA bodies want comparator data that doesn't exist; trials are single-arm by necessity; and pricing has to clear a value bar set by mass-market oncology. With patient populations this small, even routine data — sites, diagnosis dates, demographic combinations — can re-identify individuals, so privacy and data-governance are first-order constraints, not paperwork.

How Cogience works here. Specialist HTA pathways (NICE HST, CADTH rare-disease review, HAS orphan pathway, G-BA AMNOG orphan provisions, PBAC LSDP, Japan Sakigake) baked into engagement design. Privacy-by-design across every workflow — minimum-necessary data, aggregation thresholds, k-anonymity checks on RWE, and GDPR-compliant handling of patient and caregiver contributions. Patient and caregiver input treated as a first-class workflow, not an add-on. Total-cost-of-care framing where drug cost is only part of the value story.

Representative engagement types. Pre-launch payer engagement (Cogience.Advise), early HTA simulation, JCA-ready evidence packages, IRP simulation for narrow markets, value-dossier development.

The access problem. The most competitive HTA landscape in healthcare: comparator chains that change before submission, indication-by-indication pricing erosion, and increasingly hostile cost-effectiveness thresholds.

How Cogience works here. PICO drift monitoring throughout development. Multi-indication pricing-corridor protection across markets. Real-world evidence strategy designed around HTA-acceptable comparator generation, not just publication.

Representative engagement types. Launch-sequencing strategy, IRP simulation, value-architecture for multi-indication assets, payer-engagement programmes.

The access problem. Premium pricing under structural pressure from biosimilar entry, mandatory rebate schemes, and value-based contracts that shift risk back to the manufacturer.

How Cogience works here. Lifecycle value defence — planned indication expansion, post-LoE strategy, payer-facing real-world evidence. Managed-entry and outcomes-based agreement design where the value story needs continuous proof.

Representative engagement types. Lifecycle pricing strategy, MEA / outcomes-based agreement design, post-launch evidence plans, payer-decision simulation for indication expansion.

The access problem. Reimbursement pathways diverge sharply from pharmaceuticals — DRG inclusion, procedural codes, hospital budgeting, and a HTA evidence bar that's tightening even where it used to be optional.

How Cogience works here. Device-specific economic modelling (DRG fit, procedure cost, downstream care impact). Coding and reimbursement-pathway strategy. Built on a decade of medical-device market access teaching at the University of Bern.

Representative engagement types. Reimbursement-pathway mapping, DRG-impact modelling, hospital-budget impact analysis, NICE Medtech / CDF / HCPCS strategy.

The access problem. Reimbursement frameworks are still being written. DiGA, NICE ESF, NICE EVA, CADTH digital review, FDA PCCP — the bar moves quarter by quarter, and there is no settled evidence playbook.

How Cogience works here. Pathway selection by market (DiGA fast-track vs national review vs hospital-only). Evidence design for software-as-medical-device where post-market real-world data is part of the regulatory story, not separate from it.

Representative engagement types. Pathway selection & evidence planning, DiGA fast-track strategy, NICE ESF / EVA submission support, post-market evidence design.