From: Historical and projected public spending on drugs for rare diseases in Canada between 2010 and 2025
Assumption | Parameters |
---|---|
Only a subset of DRDs will be approved by the FDA or EMA after completing a phase 3 trial [35] | 66.3% of DRDs with a completed phase 3 trial are approved, 33.7% are not approved |
HC often delays/does not grant approval to DRDs that are approved by the FDA or EMA [11, 36] | HC approval rates were estimated as 16% after 1Â year, 30% after 2Â years, 40% after 3Â years, 50% after 4Â years, and 60% after 5Â years |
Some DRDs are not recommended for reimbursement despite HC approval [24] | 69.15% of DRDs would receive a positive HTA recommendation, 30.85% would receive a negative recommendation |
Canadian market penetration of reimbursed DRDs will increase over time [20] | DRDs capture 10% of the market in the first year of reimbursement, 12% in year 2, 15% in year 3, 20% in year 4, and 25% in year 5 |
Public and private payers pay for DRDs [assumption] | 60% of costs borne by public payers, 40% borne by private payers |
A half-cycle correction is applied during the launch year [assumption] | DRDs will capture 50% of their eligible market during the launch year |