Benefit Assessment of Pharmaceuticals
A benefit assessment is mandatory for all new pharmaceuticals in Germany.
Ecker + Ecker is a service provider which covers all steps of a benefit assessment with in-house interdisciplinary experts. There are currently four teams with around 90 in-house specialists supporting clients in every aspect of this challenge.
Strategy
- Monitoring of current assessments
- GAP analysis and definition of a product specific dossier strategy
- Parallel consultation (EMA/ EUnetHTA)
- Lifecycle strategy (post launch evidence generation (PLEG), reassessment, etc.)
- Pre-launch pricing analysis
- Analysis of a potential reference price
Compiling the Dossier
- Preparing for counseling interview with G-BA
- Medical Writing of all modules (M1 to M5)
- Synopsis of guidelines to describe Standard of Care
- Synopsis of epidemiological data
- Modelling of prevalence
- Market research; research of treatment patterns
- Clinical trial research and assessment
- Check of dossiers compiled by others
- Documentation
- Clinical trial evaluation (SAS)
- Indirect comparisons and meta-analyses
Hearings
- Defining a strategy for hearings
- Compilation of written statements
- Simulation of oral hearing
Negotiation
- With GKV-Spitzenverband (German umbrella organisation of statutory health insurance funds)
- Arbitration
- Price modelling
- Direct contracts with individual statutory health insurances
- Communication strategy
- Evidence-based communication dossier for stakeholders
- Evaluation and controlling
Please contact
Dr. Thomas Ecker
Phone +49 (40) 41 33 081-10
