Strengthen dossier for agencies

Simulation Framework Screenshots

In order to base access, pricing and reimbursement decisions, regulators and payers are demanding that:

  • Clinical trials results be translated into real-world outcomes (“translation analysis”)
  • These real-world outcomes be compared against reference products (“comparative effectiveness analysis”)

The Effect Model is gradually gaining global recognition to perform these types of analyses, as evidenced by the EUnetHTA guideline published in 20131

Focus: predict a cardiovascular treatment’s public health impact 

In a previous collaboration, a large pharmaceutical company was asked by the French health regulator to estimate a cardiovascular treatment’s public health impact.

Using clinical trials results, cohort data and epidemiological studies, NOVADISCOVERY designed a virtual population representing the French patient population and determined, for each patient, the clinical event frequency without and with treatment (resp. Rc and Rt). The resulting Absolute Benefits and Number of Prevented Events were communicated to the agency to help them assess the treatment’s real-world impact.