Gene therapy (hematology)
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
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
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