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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%)

All resolutions by Canada’s Drug Agency (CDA-AMC) from our partner MORSE Consulting Inc.:

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

 

We are happy to share resolutions by Danish Medicines Council (DMC) from our partner Zealth as well:

Highlights:

🏛️ 14 of 23 treatments were fully or partly recommended by the Danish Medicines Council.

💰️ Cost concerns led to several non-recommendations across multiple therapy areas.

🤝Nordic collaboration contributed to multiple HTA evaluations.

🧬 High-cost rare disease therapies were recommended under the severity principle.

The stats:

⭐ 1 Direct placement

✅ 11 Recommended

✔️ 2 Partly recommended

❌ 9 Not recommended

 

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