Accelerated processes are defined by Regulatory to grant authorization for therapies with high unmet medical needs often based on limited, or preliminary set of evidences. This high degree of uncertainty makes reimbursement decision a complex exercise and can lead to negative decisions:

• Delay of reimbursement, deferring access of innovative treatment to patients;
• Negative reimbursement while treatment may demonstrate its incremental benefits at a later stage, preventing patients’ access to innovative treatments;
• Positive reimbursement while treatment may