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 40 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
Tel. +49 (40) 41 33 081-10
created by - sehstrand -