The industry is upon an era of medicines with transformational patient benefits (including gene therapies, immuno-oncology, and CAR-T cell therapies) that will likely receive expedited marketing authorization through new regulatory approval pathways based on early promising clinical data.
Appropriate reimbursement of these potentially high-cost therapies based upon expedited data packages will be challenging for manufacturers and payer/HTA bodies to negotiate. Designing evidence generation strategies that can both support faster regulatory approval and can translate this into reimbursement success in a resource- and time-efficient manner will become a key challenge for companies trying to maximize commercial returns.
This webinar will discuss early scientific advice strategies to best-inform clinical evidence package designs and optimally navigate the evolving regulatory and multiple payer hurdles whilst balancing time and resource constraints.
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