High impact
6
Medium impact
5
Low impact
1
| Impact | Market | Task | Description | Owner | Status |
|---|---|---|---|---|---|
High | 🇬🇧 UK | NICE HTA Submission | NICE OS extrapolation challenge likely — committee may request additional data cut. | Owen Briggs | Mitigating |
High | 🇮🇹 IT | AIFA Price Negotiation | AIFA Class C(nn) interim listing risk — could delay reimbursed access by up to 9 months. | Marco Bianchi | Open |
Medium | 🇫🇷 FR | HAS / Transparency Commission | Reference pricing exposure from German AMNOG outcome — CEPS may anchor below target. | Julien Moreau | Mitigating |
Medium | 🇩🇪 DE | Launch Stock Build (DE) | Single-source cold-chain partner — concentration risk for Q1 launch volume. | Lena Vogt | Mitigating |
Medium | 🇪🇸 ES | Iberian Distribution Setup | Autonomous community access fragmentation may slow national uptake post-launch. | Raúl Mendoza | Open |
Low | 🇩🇪 DE | HCP Campaign Activation | MLR approval cycle running tight — risk of delayed HCP campaign go-live. | Sofia Lang | Mitigating |
High | 🇩🇪 DE | EMA Filing & Approval | EMA Filing & Approval delayed by 1 month — cascade from EMA Filing & Approval | Anja Becker | Open |
High | 🇩🇪 DE | G-BA Early Benefit Assessment | G-BA Early Benefit Assessment delayed by 1 month — cascade from EMA Filing & Approval | Markus Hahn | Open |
High | 🇩🇪 DE | Launch Stock Build (DE) | Launch Stock Build (DE) delayed by 1 month — cascade from EMA Filing & Approval | Lena Vogt | Open |
Medium | 🇩🇪 DE | HCP Campaign Activation | HCP Campaign Activation delayed by 1 month — cascade from EMA Filing & Approval | Sofia Lang | Open |
High | 🇬🇧 UK | UK Launch Supply (depends on DE) | UK Launch Supply (depends on DE) delayed by 1 month — cascade from EMA Filing & Approval | James Patel | Open |
Medium | 🇩🇪 DE | Sales Force Training | Sales Force Training delayed by 1 month — cascade from EMA Filing & Approval | Karl Reiter | Open |