Gene therapy (hematology)

The Challenge

The Challenge

Positive HTA assessment required for technology adoption and patient access Support requested for:

  • Adaptation of global material
    (e.g., health economic model) to conform with local requirements (Sweden, Norway, Finland, Denmark)
  • Consulting KOLs to reflect national perspective (e.g., clinical practice, patient population)
  • Compilation of HTA dossier for submission
  • Dialogue with HTA bodies during assessment process
The Solution

The Solution

Project led by Senior Manager with HTA experience from relevant countries.

  • Biopharma Excellence Project Leader (PL) with overall coordinating responsibility:
    • Main contact point for any questions
    • Responsible for timeline, budget and quality of deliverables
    • Strategic support
    • High level availability with fast response times
  • Part of customer market access team during HTA process
    • PL working close to customer during HTA process
    • Continuous dialogue and flexibility regarding strategy/process
The Outcome

The Outcome

Project successfully and timely completed due to long experience with HTA processes.

  • Wide experience from HTA processes in the Nordics
    • Good knowledge of HTA system and requirements
    • Informed best approach/strategy
  • Gap analysis ahead of submission;
    • Proactive collection of missing input
    • Complete and relevant dossier
    • Smooth and timely process
  • Post-assessment support at subsequent market access negotiations
    • Good knowledge of the therapeutic field and technology from preceding HTA work

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