Erhöhte Klinik- und Dokumentationskosten durch strengere HTA
Definition
GKV-FinStG enforces €3.7bn pharma cuts; stricter 2023-2024 G-BA assessments reduce 'added value' ratings, forcing price guardrails and higher compliance overhead.
Key Findings
- Financial Impact: €3.7bn industry-wide pharma cuts; €43M Phase I + €127M Phase III per drug (biopharma avg); €3M+ regulatory review fees
- Frequency: Per AMNOG dossier submission post-launch
- Root Cause: Manual preparation of complex HTA dossiers amid tightened criteria and EU joint assessments from 2025
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Biotechnology Research.
Affected Stakeholders
Regulatory Affairs Manager, HTA Specialist, R&D Director
Deep Analysis (Premium)
Financial Impact
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Current Workarounds
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Methodology & Sources
Data collected via OSINT from regulatory filings, industry audits, and verified case studies.
Related Business Risks
Strafen und Preisabschläge durch MFG-Nichteinhaltung
Marktrückzüge durch Preisdruck und Compliance-Barrieren
Kosten durch Datenqualitätsmängel in Experimenten
Kapazitätsverluste durch manuelle Datenprotokollierung
DSGVO-Risiken bei sensiblen Biotechnologie-Daten
Überwachungskosten für Fördermittelberichte
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