Early Benefit Assessment and AMNOG Price Negotiations
Early Benefit Assessment
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 80 in-house specialists supporting clients in every aspect of benefit assessment.
Strategy
- Monitoring of current assessments
- GAP analysis and definition of a product specific dossier strategy
- Early advice involving higher federal authorities (PEI, BfArM)
- Parallel consultation (EMA/ EUnetHTA)
- Lifecycle strategy (post launch evidence generation (PLEG), reassessment, etc.)
- Pre-launch pricing analysis
- Review of application for exemption
- Analysis of a potential reference price
Compiling the Benefit Dossier
- Preparing for counseling interview with G-BA
- Medical Writing of all modules (M1 to M5)
- Synopsis of evidence (guidelines, reviews, etc.)
- Synopsis of epidemiological data
- Modelling of prevalence
- Market research; research of treatment patterns
- Clinical trial research and assessment
- Check of dossiers compiled by others
- Data analyses and statistical analyses of clinical trials
- 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
AMNOG Price Negotiations
Based on the benefit assessment resolution of the Federal Joint Committee (G-BA), the negotiations of the reimbursement price with the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) will start promptly. Besides legal and formal criteria, in these negotiations, various factors will have an impact on the negotiation of the reimbursement price, not all of which are entirely within the control of the pharmaceutical entrepreneur and have to be taken into account for the entrepreneur's own negotiation strategy.
Ecker + Ecker provides strategic and operational support in the price negotiations and arbitration proceedings:
Price negotiation strategy
- Strategy development
- Stress testing of existing strategies
- Roadmap for the negotiation
Pricing analyses
- Market environment analyses
- Interactive tools for calculating the reimbursement amount
- (Pre-launch) Reimbursement price simulations
Operational support
- Continuous negotiation support
- Appendices I to III (European prices, expected annual volumes, comparable medicinal products)
- Simulation of price negotiation ("Mock-ups")
- Support of arbitration proceedings
Please contact
Dr. Danny Bot
Phone +49 (40) 41 33 081-22
Janine Leismann
Phone +49 (40) 41 33 081-26
Dr. Thomas Ecker
Phone +49 (40) 41 33 081-10