HTA/AMNOG-Dokumentation für Apotheken-Reimbursement-Verhandlungen
Definition
AMNOG process (Arzneimittelmarktneuordnungsgesetz) now includes EU-level joint clinical assessments for oncology/ATMP (2025) and orphan drugs (2028). Pharmacy buyers must make purchasing decisions without knowing final reimbursement status. A 50-pharmacy chain stocking 5 new medicines/month × €50K avg. value = €250K/month in inventory at risk. If 1–2 products are rejected or heavily discounted due to HTA failure, pharmacy margin loss = 2–5% of sale value = €5,000–€12,500 per product. Annual impact: €60,000–€150,000 from suboptimal purchasing decisions.
Key Findings
- Financial Impact: €5,000–€12,500 per rejected/repriced pharmaceutical; annual: €60,000–€150,000 per 50-pharmacy chain
- Frequency: Per new product launch (5–12/month in large chains)
- Root Cause: No integrated AMNOG/HTA timeline visibility; manual status checking via BfArM website; procurement decisions made without regulatory-risk assessment.
Why This Matters
This pain point represents a significant opportunity for B2B solutions targeting Retail Pharmacies.
Affected Stakeholders
Pharmacy Buyer, Category Manager, Finance Manager, Supply Chain Lead
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.
Evidence Sources:
- [2] PPRI Pharma Brief: 'At the time of market launch, the pharmaceutical company has to submit a dossier to request a Health Technology Assessment (HTA). This is, in principle, mandatory for all reimbursable medicines'
- [4] Global Legal Insights: 'Upon launch, however, they are obliged to submit a dossier to the G-BA in order to establish the cost-effectiveness of the new pharmaceutical' and '3 months after the dossier has been submitted...the G-BA determines, within another three months'
Related Business Risks
Apothekenrabatt-Margin-Erosion durch Regeländerung
ePA-Dokumentationspflicht & Datenschutzverstöße durch manuelle Verarbeitung
Import-Arzneimittel: UK-Kennzeichnung & RPi-Compliance-Overhead
Lieferengpass-Meldepflicht & Lagerhaltung ohne Automatisierung
Fehlende Abrechnung von Zuschlägen bei Generika-Substitution
Abweichungen in der Berechnung der obligatorischen Apothekenrabatte
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