Navigating the Need for Substantial Evidence Beyond Small, Initial Trial Populations or Limited Follow-Up Periods to Tackle Evidence Gaps & Maintaining Access to Patients

Time: 1:30 pm
day: Conference Day One


  • The single trial: absence of comparative data sets to understand the added benefit vs standard of care
  • Beyond market access: maintaining access to patients, re-evaluations and reward evidence
  • Providing real-world evidence that is generalizable to the Medicare beneficiary population that are the intended recipients of the intervention
  • Tackling material gaps in the evidence base relative to the reasonable and necessary standard as defined required for Medicare beneficiaries