OBJECTIVES: Canadian Agency for Drugs and Technologies in Health (CADTH) generally uses a willingness-to-pay threshold of $50,000 per Quality Adjusted Life Year (QALY). We reviewed non-oncology drug submissions made to CADTH, to understand the relationship between CADTH’s revised ICERs and unmet need, clinical benefit, price reductions and listing negotiation timelines.

METHODS: Reimbursement review reports of non-oncology submissions in 2021 and 2022 were obtained from the CADTH website to extract clinical and economic data. Time to engagement and negotiation duration were calculated using data obtained from the pan Canadian Pharmaceutical Alliance (pCPA).

RESULTS: Overall, 72 submissions were reviewed. Of the 60 positive reimbursement recommendations, the median CADTH revised base case ICER was more than twice that of the sponsor ($475,196/QALY vs $206,439/QALY). For rare diseases, the median CADTH revised ICER vs. sponsor base case was $907,578/QALY vs $358,763/QALY. For reviews with a clear clinical benefit (i.e., no mention of uncertainty in efficacy in clinical review report), the corresponding values were $423,392/QALY vs $134,117/QALY. A price reduction was recommended in 41/60 reviews. Of note, 71% (15/21) of positive recommendations for rare diseases had a price reduction target of ≥70% off the submitted price. In submissions with a clear clinical benefit, 59% (19/32) had a price reduction target of ≥70%, while 67% (12/18) addressing an unmet need according to the CADTH expert review committee had a price reduction target of ≥70%. Nearly 78% (47/60) of submissions completed pCPA negotiations; the median time to engagement was 3.8 months and the median time for negotiation was 3.9 months.

CONCLUSIONS: This analysis shows that CADTH revised ICERs were > 2x higher than sponsor reported ICERs, leading to significant price reduction recommendations even for reviews demonstrating a clear clinical benefit or addressing unmet need. ICER findings and their relationship to price reductions or other submission factors require further investigation.