G-BA on Dupixent in CSU: why added benefit was not proven
The G-BA found no proven added benefit for dupilumab in chronic spontaneous urticaria. The reason is an evidence gap against omalizumab, and remibrutinib faces the same comparator next.
What we do
We work across the full market access and evidence lifecycle - from early asset strategy to reimbursement and launch.
Global and regional market access strategy, pricing and launch sequencing, competitive landscape, payer research, and due diligence. Includes international reference pricing (IRP) simulation and optimised launch sequencing to protect price corridors across markets.
Systematic literature reviews and network meta-analyses, individual-patient-data and single-arm trial analysis, survival-curve extraction, cost-effectiveness and budget-impact models, and real-world evidence strategy. Built to withstand HTA scrutiny - including PICO alignment ahead of submission and EU JCA-ready data packages.
HTA landscape assessments, submission strategy and dossier development, payer engagement and advisory boards, reimbursement negotiation support. We work across the regulatory–HTA "double gate", so data generated for FDA or EMA also meets payer value requirements, including the EU Joint Clinical Assessment (JCA).
Global Value Dossiers, value proposition development, payer communication materials, and scientific publications strategy. Evidence packages that can be updated as new real-world data emerges, not static documents.
End-to-end project management, cross-functional workshop facilitation, and training. On time, on scope, on budget.
We build the AI workflows your access team will actually run (literature triage, evidence pipelines, dossier drafting, payer-decision simulation) and hand them over with the governance, validation, and training to use them safely. Outputs your committee will defend.
The new operating reality
HTA windows are tightening, the EU JCA is changing how submissions are planned and resourced, and lean teams are expected to produce evidence at enterprise scale. AI is now part of how that work gets done, not an optional extra.
Evidence windows are shrinking: an EU JCA scope reaches the developer only 60–100 days before the dossier is due. AI-accelerated modelling and automated evidence pipelines keep pace.
Senior teams, not large ones. Reusable value architectures and AI-augmented analysis let a lean group deliver what used to take a department.
One mis-coded comparator can sink a submission. We apply AI-enabled validation, version control and PICO alignment to every deliverable, so what you submit is what you meant.
Purpose-built platform
Cogience.Advise is our virtual advisory board: an async-first engagement platform that convenes 5–10 senior payers, HTA evaluators, KOLs, and patient advocates over two to three weeks. Built for indications where in-person advisory boards are impractical - orphan drugs, multi-market launches, time-pressured strategy work.
Insights
The G-BA found no proven added benefit for dupilumab in chronic spontaneous urticaria. The reason is an evidence gap against omalizumab, and remibrutinib faces the same comparator next.
The MHRA has accepted Ultragenyx's Sanfilippo type A gene therapy for review, with NICE aligning its HST evaluation. A single-arm evidence package and a $3.95 million US price make it a test case.
The Commission has published the joint clinical assessment report on camizestrant. We look at the SERENA-6 evidence behind it and what market access teams should plan for in national submissions.
NICE and NHS England are piloting a shorter first assessment for promising medicines, followed by managed access and a full evaluation. The evidence plan now matters before the first decision.
Germany has closed its first AMNOG assessment built on an EU joint clinical assessment report. Ojemda shows the JCA adds to national work rather than replacing it, and why single-arm and orphan programmes need to plan for PICO scoping now.
Interim results from Cogience.Predict: sealed, blind predictions of EU JCA PICO scope, presented at ISPOR Europe 2026.
A pre-registered test of AI title and abstract screening against Cochrane reviewers, presented at ISPOR Europe 2026.
"As a full-time consultant working with my Market Access team, Farzana impressed me with both her industry knowledge and technical pricing expertise."
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