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All resolutions by G-BA for HTA procedures of pharmaceuticals published in the first quarter of 2025:
Our highlights in a nutshell:
🏛️ 32 resolutions published by G-BA
🔝 Alectinib: Hint for major additional benefit for one subpopulation (highest category)
❌ Two assessments without dossier led to inclusion into existing reference price groups; one involved an orphan drug under the orphan privilege
⚠️ One assessment for antibiotic of last resort
🚫 Sotatercept: Orphan privilege waived by company for initial full assessment
🔁 Pembrolizumab: 35th assessment
🧬 Polihexanid: Assessment as known substance but under orphan status
The stats:
⭐ Major additional benefit: 1 (3%)
👍 Considerable additional benefit: 4 (13%)
👌 Minor additional benefit: 6 (19%)
🙆 Non quantifiable benefit: 5 (16%)
❌ No additional benefit proven: 15 (47%)
✅ Additional benefit considered proven: 1 (3%)
We are happy to share resolutions by Canada’s Drug Agency (CDA-AMC) from our partner MORSE Consulting Inc. as well:
Highlight:
⏳️ CDA-AMC issued a draft time-limited reimbursement (TLR) recommendation for Enhertu, the 2nd TLR ever issued after Epkinly. TLR recommendation is a new CDA-AMC review process whereby a temporary recommendation is issued based on a phase II clinical data assessment, and the final recommendation is contingent upon a future reassessment of additional evidence (i.e., phase III clinical data).
The stats:
✅ 14 Final Conditional Reimbursement
✔️ 6 Draft Conditional Reimbursement
⏳️ 1 Time-Limited Reimbursement
❌ 2 Do Not Reimburse
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