Historical and projected public spending on drugs for rare diseases in Canada between 2010 and 2025

Table 1 Assumptions for identifying pipeline DRDs and their first year of potential reimbursement

Current phase of development	Projected year of public reimbursement
In or completed pCPA negotiations	2021
HTA review complete	2022
FDA/EMA/HC approval, HTA review pending or in progress	2023
Completed phase 2 or 3 trial	2024
Active or recruiting phase 3 trial	2025

Assumptions are based on Lexchin et al. [29] and Government of Canada [28], plus assumptions based on professional experience
DRDs drugs for rare diseases, EMA European Medicines Agency, FDA US Food and Drug Administration, HC Health Canada, HTA health technology assessment, pCPA pan-Canadian Pharmaceutical Alliance

ISSN: 1750-1172