EU HTA and Joint Clinical Assessment (JCA)

Superb ingredients

Strategy & Support

  • EU HTA readiness workshop
  • Competitive landscaping
  • EU HTA risk assessment
  • EU HTA market access strategy development and execution
  • EU HTA pricing strategy & launch price setting
  • JCA submission pathway mapping
  • PICO scoping, review, & feasibility assessment
  • Identification of data sources (SLR)
  • Key stakeholder advice: market access, clinical, statistical
  • Precedence analysis with data from proprietary MAIS database

A proven recipe

Evidence Generation

  • Full, robust & efficient (re-)analysis of clinical trial data
  • Real-world data incorporation (external/synthetic control arms, target trial emulation)
  • Direct & indirect treatment comparisons (NMA, MAIC, STC)
  • Clinical, HRU & quality-of-life outcome development
  • Patient-level identification & implementation of PICO

A master chef

Dossier Development

  • Aligned EU Market Access, pricing & dossier strategy
  • Data orchestration management for PICO iterations
  • Efficient, software-supported medical writing
  • Streamlined systems for insertion of figures, tables, listings

Joint Scientific Consultations (JSC)

Mastering EU HTA

JSC consultation

  • Strategic support and operational preparation of documents for the JSC

  • PICO simulation and strategic evaluation

  • Evaluation of the JSC report with regard to the European as well as to the national HTA strategy

  • Targeted support for the application of parallel scientific advice at the G-BA during the gap years