Accelerating Global HEOR & RWE Function Buildout & Support
How we helped accelerate global HEOR & RWE output to achieve optimal
- Innovative gene therapy company obtained extraordinary clinical results, as such the pathway to launch of the product was accelerated.
- Accelerated HEOR and RWE output required to ensure product could successfully achieve reimbursement
- Company faced shifting market landscape and step-change in treatment with novel competition to its upcoming product launch
- Value demonstration required to ensure a viable price and market opportunity – “likely to be most expensive drug in the world”
- Data required to support market access was 2-3 years behind
- Supported the existing principal investigator to improve the relationship
- Prepared and guided the clinical site through FDA inspections
- Revised the protocol to reduce adverse events and improve patient safety
- Engaged additional clinical sites and investigators to diversify patient dosing
- Supported the value generation framework, focusing on creative ways to remediate gaps.
- Built out and operated the HEOR and RWE function, in partnership with sole functional lead.
- Created and operationalized an internal stakeholder management forum, which was required due to lack of understanding from internal team members.
- Leveraged key trusted vendors to help perform the detailed analysis and modeling
- Transitioned the strategy and supplemented internal hires to continue the rapid growth
- In partnership with functional lead, SSI enabled the client to catch up to market access evidence generation needs
- SSI supported the development of an international disease registry.
- Avoided expensive head-to-head comparison with standard of care yet sufficient product differentiation
- Developed staffing plans and assisted with onboarding.
- Defined requirements and geographical needs
- Resulted in favorable pricing in the marketplace – demonstrating cost-effectiveness and justifying pricing