Closing the Gap Between Regulatory Approval and Public Pricing/Listing of Innovative BioPharmaceuticals
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Innovative medicines are increasingly coming to market with new modalities authorized under new trial designs and/or through accelerated marketing authorization pathways. In some instances, payers and HTA bodies are determining that the clinical data packages used to support regulatory approval as insufficient for pricing/reimbursement/formulary listing. In other instances, payers end up filling in data gaps with actual use and RWE after approval. The panel will explore avenues to minimize access delays due to varying evidence requirements. Panelists will discuss solutions, including convergence in evidence requirements between regulatory agencies, more targeted use of real-world evidence, better understanding of emerging and existing surrogate endpoints, effective input from the patient community and ways of fostering earlier dialogues with HTA bodies and payers.